DRF-6A/7B/8B/8PRO

Digital radiography and fluoroscopy system

Clinical Evaluation Report

Beijing Wandong Medical Technology Co.,Ltd.

©China Resources Medical copyright
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

VERSION HISTORY
VERSION EDITOR DATE REASON FOR
CHANGE
1.0 Yu Ran 2023.3.13 First edition
1.1 Yu Ran 2023.6.20 Files update
Any modifications of this Document due to changes to the product design will

be stated in the columns VERSION and REASON FOR CHANGE.

Editor:Yu Ran Date: 2023.6.20

Reviewer:Wang Xinwen Date: 2023.6.20

Approver:Fan Xiaomin Date: 2023.6.20

2 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

Contents
1. Administrative particulars .................................................................... 5
2. Summary ............................................................................................... 5
2.1 Scope of the clinical evaluation ............................................................... 5
2.2 Benefit/risk analysis for device ............................................................... 5
2.3 Summary for the acceptability under the state of the art in medical fields 7
3. Device description ................................................................................. 8
3.1 Configuration description ........................................................................ 8
3.2 Product Accessories .............................................................................. 10
3.3 Classification ........................................................................................ 10
3.4 Intended Use ......................................................................................... 11
3.5 Indications for Use ................................................................................ 11
3.6 Intended users ....................................................................................... 11
3.7 Intended Patient Population and Medical condition to be diagnosed ....... 12
3.8 Contra-indications................................................................................. 12
3.9 Working principles ................................................................................ 12
3.10 Medical supervision of patients .......................................................... 13
3.11 Basic technical parameters ................................................................. 13
3.12 Clinical performance and clinical safety ............................................. 15
3.12.1 Clinical performance endpoints ....................................................... 15
3.12.2 Clinical safety endpoints ................................................................. 15
3.13 Previous generations of the device and similar devices ....................... 15
3.14 Marketing history............................................................................... 16
4. Clinical Background, Current Knowledge, State of the Art ............... 16
4.1 Background .......................................................................................... 16
4.2 State of the art ...................................................................................... 17
4.2.1 Identification of medical field relevant medical conditions .............. 17
4.2.2 Common specifications, harmonised standards or other s olutions
applied ...................................................................................................... 21
4.3 Digital Radiography/Fluoroscopy(R/F) imaging technology and novelty 23
4.4 The alternative available options ........................................................... 25
4.5 Benchmark devices ............................................................................... 26
4.6 Literature search result (pertaining to the state of the art) ...................... 27
5. Device under evaluation ...................................................................... 31
5.1 Type of clinical evaluation .................................................................... 31
5.2 Demonstration of equivalence ............................................................... 32
5.3 Clinical data generated and held by the manufacturer ............................ 38
5.3.1 Pre-clinic testing ............................................................................. 38
5.3.2 PMS/PMCF data ............................................................................. 38
5.4 Clinical data from literature .................................................................. 39
5.4.1 Scientific literatures search ............................................................. 39
5.4.2 Output of the summary of the literatures searched ........................... 39

3 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

5.5 Summary and appraisal of clinical data ................................................. 42

5.5.1 Appraisal plan................................................................................. 42
5.5.2 Appraisal of the clinical data ........................................................... 43
5.6 Analysis of the clinical data .................................................................. 45
5.6.1 Requirement on safety (GSPR 1, 4, 5, 8) ......................................... 45
5.6.2 Requirement on acceptable benefit/risk profile (GSPR 1, 2, 8) ......... 46
5.6.3 Requirement on performance (GSPR 1, 6, 7) ................................... 47
5.6.4 Requirement on acceptability of undesirable side-effects (GSPR 8,
GSPR 1) .................................................................................................... 50
6. Conclusions ......................................................................................... 54
7. Date of the next clinical evaluation ..................................................... 55
8. Qualification of the responsible evaluator .......................................... 55
9. References ........................................................................................... 59
9.1 Documents generated of manufacturer ................................................... 59
9.2 Full text of scientific literature .............................................................. 59

4 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

1. Administrative particulars
 Medical device name and model:
DRF-6A/7B/8B/8PRO Digital radiography and fluoroscopy system
(Hereinafter referred to as: This system)
 Basic UDI-DI: 693896431300NC
 Risk Class: Medium
 EMDN-Code: Z110390
 Manufacturer(s) name and SRN: Beijing Wandong Medical Technology Co.,
Ltd. and CN-MF-000014174
 Authorized Representative name and SRN: Shanghai International Holding
Corp.GmbH(Europe) and DE-AR-000000001

2. Summary

2.1 Scope of the clinical evaluation

The Clinical Evaluation will be prepared in accordance with Annex XIV of
(EU) 2017/745, MEDDEV 2.7/1 Rev. 4, MEDDEV 2.12/2 Rev. 2, MDCG 2020-5,
MDCG 2020-6, MDCG 2020-13 and provides evidence that the clinical data
collected to date demonstrates this system meets the clinically relevant General
Safety and Performance Requirements of (EU) 2017/745, Annex I.
The data presented in this CER also demonstrates that this system is
substantially equivalent to in terms of clinical safety and performance to other
Mobile DR System and that the clinical benefits of this system outweigh any
potential risks. Before going public, the clinical evaluation will be based on
clinical literature evaluation route to assess the clinical safety and essential
performance.
The data provided in this CER also shows that the safety and effectiveness
of this system have been proved by the post marketing supervision and post
marketing clinical follow-up data collected so far.

2.2 Benefit/risk analysis for device

Benefits
DRF-6A/7B/8B/8PRO Digital radiography and fluoroscopy system is a
device intended to visualize anatomical structures by converting an X -ray pattern
into a visible image. The clinical benefit of the evaluated medical device results
from the performance and safety claims:
It can be used by medical institutions for
 gastrointestinal examinations, as well as

5 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

 medical X-ray examination and diagnosis of cranial, skeletal, thoracic,

lung, urogenital tract and other parts. And
 it may also be used in emergency applications, lymphography, endoscopy,
myelography, venography, arthrography and other parts radiography.
Combined with clinical practice, the benefits include: accurate diagnosis of
functional organic lesions; Wide observation range and reduced blind spots;
Gastrointestinal examination is less painful and suitable for disease screening;
High definition image quality, lower radiation dose, and wide range dynamic
observation.

Risks
A risk analysis according to ISO 14971 has been performed for the
DRF-6A/7B/8B/8PRO Digital radiography and fluoroscopy system .
The side effects of R/F system are generally observed in general and which
are described in the literature (see sections 4.2 regarding state of the art).Side
effects associated specifically is:
 电击伤害 Electric shock damage
 机械伤害 Mechanical damage
 生物学伤害 Biological damage
 声音伤害 Sound damage
 辐射伤害 Radiation damage
 热伤害 Thermal damage
 化学伤害 Chemical damage
 高压液体注射危险 High pressure liquid injection hazard
 生物相容危险 Biocompatible hazard
 可用性相关危险 Usability hazard
 功能安全危险 Functional Safety hazard
 电磁干扰 Electromagnetic interference
 污染 Pollution
Clinical hazards that have to be evaluated:
 辐射伤害 Radiation damage
 生物相容危险 Biocompatible hazard
 可用性相关危险 Usability hazard

Risk control measures were defined and implemented according to Risk

Management Files.
Implemented risk control measures are largely based on the compliance
with applicable harmonized standards. Additionally, the following technical
6 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

control and surveillance measures were implemented and successfully verified

for effectiveness:
• Validation
• Constructive actions
• Application of standards such as EN 60601-1
• System tests
Furthermore, hazards associated with use errors related to the device -user
interface were reduced to an acceptable risk level by:
• descriptions in the instructions for use
• user trainings
After implementation of these risk control measures the residual risk was
assessed again. Remaining individual risks and overall residual risks are
assessed in the Risk Management Files. Section 5.6.2 Risk/Benefit Assessment
provides an in-depth discussion of the risk/benefit profile.

2.3 Summary for the acceptability under the state of the art in medical

fields
Benefit and risk balance
Patient factors are important to consider in this balance of benefits and risks.
For example:
•Because younger patients are more sensitive to radiation, special care
should be taken in reducing radiation exposure to pediatric patients for all
types of X-ray imaging exams.
•Special care should also be taken in imaging pregnant patients due to
possible effects of radiation exposure to the developing fetus.
•The benefit of possible disease detection should be carefully balanced
against the risks of an imaging screening study on healthy, asymptomatic
patients.

Therefore, the risk management activities of the product are planned and the
risk management plan is formulated at the early stage of design and development
of the product. The risk management plan determines the risk acceptability
criteria for the product, and arranges the risk management activiti es for the
product design and development phase (including the pilot production phase)
and the review requirements for the methods for obtaining production and
post-production information. As the project progressed, the list of product safety
features was gradually completed, hazard judgment and initial Risk control
program analysis, prototype risk assessment (including risk control measures
record sheet and comprehensive residual risk analysis) and risk management
7 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

report, software risk management report, embedded software risk Management

Report. The risk management team formed by the company determines the
person in charge of risk management of the product to ensure the effective
implementation of all risk management activities of the product in accordance
with the risk management plan. The risk management review group conducts a
comprehensive analysis of all residual risks and considers the combined effect of
all residual risks. According to the risk management review group’s
communication with the clinician, we get the conclusion that the residual risks of
this system are acceptable.
In order to ensure that the products continuously meet the requirements of
clinical performance and safety performance, we have not only established a risk
management plan, but also collected product information during production and
after marketing..
During the production process, we conduct risk manage activities according
to the nonconforming product control procedure (WDCX8301), corrective action
control procedure (WDCX8505), preventive action control procedure
(WDCX8506), production and service control procedure (WDCX7501).
In the after-sales market, we conduct risk manage activities according to the
customer satisfaction survey procedure (WDCX8201), customer complaint
control procedure (WDCX8501), service and feedback control procedure
(WDCX7502) Adverse event monitoring and reevaluation control procedure
(WDCX8206) and post market surveillance control procedure (WDCX9008(CE)).
According to the analysis of the residual risk of this system, we conclude that the
residual risk of this system is acceptable and the profit is greater than the risk.

3. Device description

3.1 Configuration description

This system consists of high-voltage generator, X-ray tube assembly,
collimator, flat panel detector, diagnostic table, digital imaging system, display,
workstation and accessories.
The main components of this system and their models are listed in table 3-1
and the system structure chart is shown in figure 3-1.
Table 3-1 Main components
Name Digital radiography and fluoroscopy system
Model DRF-6A, DRF-7B, DRF-8B, DRF-8PRO
Name of
Beijing Wandong Medical Technology Co., Ltd.
manufacturer
Address of Building 3, No.9 Jiuxianqiaodong Road, Chaoyang District, Beijing
manufacturer 100015, P. R. China
Component Configuration Certifica
Model Manufacturer
name DRF DRF DRF DRF te
8 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

-8B -8P -6A -7B

RO
High-voltage GFS802-3 1 1 - 1 The Company -
generator GFS502-8 - - 1 - The Company -
Canon
Medical
Electron TUV:HD
diagnostic
E7254X - - 1 - Tubes & 6014536
X-ray tube
Devices Co., 00 0001
assembly
Ltd.
Canon
Electron TUV:HD
X-ray tube
E7869X 1 1 - 1 Tubes & 6014536
assembly
Devices Co., 00 0001
Ltd.
Collimator XS5-5 1 1 1 1 The Company -
WDF 4343RF - - 1 1 The Company -
Flat panel
WDF
detector 1 1 - - The Company -
4343RFX
TX-DSI4000
Digital - - 1 - The Company -
A
imaging
TX-DSI4000
system 1 1 - 1 The Company -
B
Monitor
display - 1 1 1 1 - -
(optional)
Monitor
- 1 1 1 1 - -
display
Workstation
- 1 1 1 1 - -
host
ZC90SY-2 - 1 - - The Company -
Diagnostic
ZC45SY-7 1 - - - The Company -
Table
ZC25SY-5 - - 1 1 The Company -
Steute
Tableside MKF 2
Schaltgeraete CA/1948
foot switch 1S/1S-MED 1 1 1 1
GP26 GmbH & 9/CSA
(optional)
Co.KG
CQC
HanYoung
Remote foot 2012010
HY-101 1 1 1 1 Elections
switch 3055243
Indonesia PT
34
Tableside
display
F325-XTPJ-11 1 1 1 1 The Company -
holder
(optional)
Shoulder rest - 2 2 2 2 The Company -

9 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

Control
Monitor display room

Remote
footswitch
Remote control
Workstation host
Mini console joystick

Com cable
High-voltage generator

HV& starting cable

Power Com cable
supply
cable

Diagnostic Flat panel X-ray tube

Collimator
table detector assembly

Tableside
footswitch Monitor display
(optional)
Tableside display Operating
holder (optional) room

Figure 3-1 the system structure chart

3.2 Product Accessories

Accessories of the product include remote footswitch, tableside footswitch
(optional), shoulder rest, tableside display holder.
This system is not expected to be used in combination with other devices.

3.3 Classification
According to the classification criteria in annex VIII of (EU) 2017 /745
Medical Device Regulation(MDR) standard, this system is Non -invasive device
and Active device intended for diagnosis and monitoring. This system should
conform to the rules for these kinds of devices.
For active device, 6.2 Rule 10 states that “Active devices intended to emit
ionizing radiation and intended for diagnostic or therapeutic radiology, including
interventional radiology devices and devices which control or monitor such
devices, or which directly influence their performance, are classified as class
IIb”. This system conforms to this rule, so it is Class IIb system.

10 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

3.4 Intended Use

This system has medical applications ranging from gastrointestinal
examinations to cranial, skeletal, thoracic and lung exposures as well as
examinations of the urogenital tract. The unit may also be used in emergency
applications, lymphography, endoscopy, myelography, venography, arthrography,
interventional radiology, digital angiography and digital subtraction angiography
(DSA).

3.5 Indications for Use

This system can be used by medical institutions for gastrointestinal
examinations, as well as medical X-ray examination and diagnosis of cranial,
skeletal, thoracic, lung, urogenital tract and other parts. This system may also be
used in emergency applications, lymphography, endoscopy, myelography,
venography, arthrography and other parts radiography. This system is not for
mammography and dental X-ray examination.
This system is applicable to patients with body weight less than 200kg.
The target user of this system is a medical institution. The operator should
have certain qualifications and comply with the relevant national regulations.
Before operating this system, the operator should also receive equipment
operation training.
This system can be reused. Please refer to the product manual for
requirements on product cleaning and disinfection.
This system is not intended to be used in combination with other devices.

3.6 Intended users

The intended user of this system is the medical institutions, and the operator
should have the following skills, knowledge and training:
1) Obtained the Medical Practicing Certificate, and the scope of practice is
medical imaging and radiotherapy or clinical specialty applicable to the
interventional therapy. It is better to have more than 3 years of e xperience in
interventional clinical diagnosis and treatment.
2) It has been systematically trained and passed the examination by the
intervention diagnosis and treatment training base recognized by the health
administrative department at or above the provincial level.
3) Professional nurses and other technical personnel shall be trained and
qualified in relevant professional systems of interventional diagnosis and
treatment.
4) Have the certificate of Radiation Safety and Protection Training.
5) After the operation training of the company's authorized professional and
technical personnel, and passed the examination.

11 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

3.7 Intended Patient Population and Medical condition to be diagnosed

The intended patient population of this system: patients with weight less
than 200kg.
This system is to provide digital X-ray fluoroscopy and radiography
images during diagnostic procedure.

3.8 Contra-indications
Contra-indications: not found yet.
Warning: Because medical X-ray diagnosis itself brings X-ray radiation
hazards, pregnant women or other patients who are not suitable for X-ray
radiation exposure should be prohibited or carefully used.

3.9 Working principles

This system consists of high frequency and high voltage generator, X -ray
tube assembly, collimator, flat panel detector, diagnostic t able, digital image
system, display, workstation and accessories. The high -frequency and
high-voltage generator supplies high voltage to both ends of the X -ray tube
filament and the metal target. A large number of electrons generated on the
cathode filament of the X-ray tube move at high speed in the vacuum tube,
hitting the metal target, thus generating X-ray. The X-ray emitted by the
high-frequency high-voltage generating device penetrates the parts with different
tissue densities such as human bones and muscles, and displays the images of
human tissues with different densities through the digital image receiver (flat
panel detector) for clinical diagnosis.
Working principle of X-ray tube assembly: X-ray tube assembly consists of
X-ray tube and X-ray tube housing, and the tube is installed in the tube housing.
X-ray tube is a kind of high vacuum device. The electrons generated by the
cathode are accelerated by the electric field and bombard the anode target to
produce X-ray.
Working principle of collimator: it controls the irradiation field of the
output ray of the X-ray tube, so as to minimize the projection range, avoid
unnecessary dose, absorb some scattered rays and improve the image definition
on the premise of meeting the requirements of X-ray imaging and diagnosis. It
also indicates the size of the irradiation field.
Working principle of flat panel detector: it converts X -ray directly into
digital image signals, and collects, processes, stores and displays digital signals
through the digital image system to obtain medical images that can be used for
examination and diagnosis.

12 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

Working principle of the diagnostic table: the table is used to install the flat
panel detector, X-ray tube assembly, collimator, and support the patient. It can
realize the rotation of the table, the longitudinal movement of the pulley and the
transverse movement of the table-top through the electrical control motor to
meet the needs of X-ray inspection. The diagnostic table contains a compressor
assembly, which is used to assist the gastrointestinal examination and compress
the abdomen during gastrointestinal radiography to display the gastrointestinal
mucosa.

3.10 Medical supervision of patients

When using this system, in order to ensure that the patient's current status is
known at any time, it is recommended that the user establish a set of monitoring
procedures to ensure the safety of the patient during the examination. Because
X-ray examination has certain radiation risks, in order to reduce unnecessary
radiation of operators, operators shall observe patients in the observation
window of the control room. It is recommended that users install voice
communication equipment, so that staff and patients can use voice equipment to
communicate at any time. When inspecting the following pati ents, the clinician
or nurse should supervise them in the operating room, and if necessary,
physiological monitoring should be carried out through devices that measure or
evaluate various physiological conditions:
 Patients most likely to have cardiac arrest;
 Patients with hearing or visual impairment cannot maintain effective
communication;
 Patients who have no rational or chaotic mentality or are extremely calm
cannot maintain reliable contact with them;
 Patients who cannot communicate with the operating room or operating
room personnel for other reasons;
 It is recommended that users establish medical supervision for patients
to ensure their safety.

3.11 Basic technical parameters

The imaging performance parameters of this system mainly include the
following:
Performance Parameters
It shall have the function of keeping the last frame of
Last frame hold
fluoroscopy
Automatic
There shall be automatic fluoroscopy function.
fluoroscopy
Nominal incident Nominal incident field size of detector in x and y
13 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

field size directions: 430mm × 430mm, the actual imaging size

should be greater than 95% of the nominal value.
DRF-6A/7B:
fluoroscopy spatial resolution：
in maximum field of view (430mm × 430mm) : Should
not be less than 1.4lp/mm；
High resolution mode (200mm×200mm): Should not be
less than 2.2lp/mm；
radiography spatial resolution:
in maximum field of view (430mm×430mm): Should not
be less than 3.7lp/mm
spatial resolution
DRF-8B,DRF-8PRO：
fluoroscopy spatial resolution:
Maximum field of view (430mm × 430mm，1364 × 1364
pixel matrix), should not be less than 1.8lp/mm;
High resolution mode (2046 × 2046 pixel matrix), which
should not be less than 2.5lp/mm;
Radiography spatial resolution:
in maximum field of view (430mm × 430mm) :
DRF-8B, DRF-8PRO: not less than 5.0lp/mm.
The ratio of the standard deviation R of the pixel gray
FPD image value at the specified sampling point of the X-ray image
uniformity V
to the mean value m of the pixel gray value at the
specified sampling point shall not be greater than 2.5%.
DRF-6A/7B:Continuous fluoroscopy:
At 430 × 430mm field of view, not less than 25 frames/s
under 1024 ×1024 pixel matrix;
At 430 × 430mm field of view, not less than 15 frames/s
under 1536 ×1536 pixel matrix;
Pulse fluoroscopy:
At 430 × 430mm field of view, not less than 25 frames/s
under 1024 ×1024 pixel matrix;
At 430 × 430mm field of view, not less than 15 fram es/s
Image acquisition under 1536 ×1536 pixel matrix;
rate Radiography:
At 430 × 430mm field of view, not less than 3 frames/s
under 3072 ×3072 pixel matrix;
Radiography grading: single frame, 1 frame/s, 2
frames/s, 4 frames/s, 7.5 frames/s, 15 frames/s.
DRF-8B/8PRO:
The maximum fluoroscopy image acquisition rate for
fluoroscopy should not be less than 30 frames/s.
Radiography grading: single frame, 1 frame/s, 2
frames/s, 4 frames/s, 7.5 frames/s, 15 frames/s.
X-ray fluoroscopy and X-ray radiography should not
Artifact
have artifacts that affect the diagnosis.

The characteristics shown above are main parameters image performance of

14 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

this system, which of other components of the system are described in “System
manual”.

3.12 Clinical performance and clinical safety

3.12.1 Clinical performance endpoints

A literature search about the state of the art of similar to this R/F product
was conducted to select the outcome parameters that have been established in
previous studies. The average level of clinical performance of these literatures
was calculated as the outcome index of the target device.
 Accuracy: ≥91.3%; Sensitivity: ≥85.6%; Specificity: ≥75.6%

3.12.2 Clinical safety endpoints

This system shall comply with applicable the latest version of safety
standards and special standards. The risk management is in accordance with the
requirements of ISO 14971, and the risk is acceptable.
By searching and analyzing the scientific literature of similar products
about clinical safety, the average level of clinical performance of these
literatures was calculated as the outcome index of the target device.
 Rate of adverse events:≤0.55%; rate of mild events: ≤0.55%; rate of
moderate events: ≤0%; rate of severe events: 0%

3.13 Previous generations of the device and similar devices

Previous generations of the device
The R&D and design of the DRF-6A/7B/8B/8PRO systems refers to and
follows the design ideas and empirical data of the DRF-3/4 (certificated by TÜV
SÜD, EC Certificate No.: G1 043895 0011 Rev.02) in terms of intended for use,
working principle, composition, and performance parameters.
Both of the devices utilize the same physic principle to obtain X-ray image
of patient. Both of these systems are X-ray system, uses the principle that the
X-ray emitted from the X-ray tube passes through different tissues and organs of
the patient's body with different attenuation of the X-ray, and transforms the
image formed by the X-ray passing through the patient and carrying enough
information onto the imaging medium into a visible gray image. The product is
usually used to lock the area of interest through dynamic image of fluoroscopy,
and then use large dose radiography to get a clear static image of the area.
Similar devices
Luminos dRF Max of Siemens AG/Siemens Healthcare GmbH has been
certificated by certificated by TÜV SÜD Product Service GmbH (Certification
Number: G10 091596 0052 Rev. 01).
Both of DRF-6A/7B/8B/8PRO and Luminos dRF Max utilize the same
15 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

physic principle to obtain X-ray image of patients. Both of these systems are
X-ray system, uses the principle that the X-ray emitted from the X-ray tube
passes through different tissues and organs of the patient's body with different
attenuation of the X-ray, and transforms the image formed by the X-ray passing
through the patient and carrying enough information onto the imaging medium
into a visible gray image.
For details, please refer to <js200.3.1Previous and similar generation of the
Product>.

3.14 Marketing history

In 2016, our company has started to develop Digital X-Ray Radiography /
Fluoroscopy system, and has successively launched DRF-3/DRF-4/DRF-5 series
products with dynamic flat-panel detector.
In 2021, DRF-6/DRF-7/DRF-8 series products were designed and developed
based on the previous generations of products. In particular, the previous
generation of DRF-3/4 of this system has obtained CE certification in 2019. And
the DRF-6/DRF-7 series products have also obtained NMPA certificate, and
DRF-8 series products are undergoing initial NMPA-marking.

4. Clinical Background, Current Knowledge, State of the Art

4.1 Background
The fluoroscopy and radiography X-ray device is an important part of the
diagnostic X-ray device. It is usually composed of X-ray generator, image
display system, and patient support device. It is used to assist the gastrointestinal
examination, and has both radiography and fluoroscopy functions. It is usually
used to lock the area of interest through dynamic image of fluoroscopy, and then
use large dose radiography to get a clear static image of the area. It is an X-ray
equipment that is used to assist gastrointestinal diagnosis and has the functions
of radiography, fluoroscopy function. It is widely used in the radiology
department of medical institutions.
Since 2011, flat-panel detector gastrointestinal machines have grown
rapidly. With the popularization of flat-panel detector technology and the decline
in price, especially the decline in the price of static flat-panel detector, the sales
of static flat-panel detector gastrointestinal machines have grown rapidly, and
there is a trend to gradually replace the traditional image intensifier. In terms of
dynamic flat panel detector, it is now mainly monopolized by several foreign
companies, but the research and development of domestic dynamic flat panel
detector is also progressing rapidly, and it is expected that the dynamic flat panel
detector will become a new sales trend. Therefore, in 2016, our company decided
16 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

to develop an economical dynamic flat panel detector to meet the needs of the
market and apply it to our dynamic flat panel detector gastrointestinal machine
products, so as to occupy a larger share of products in this fi eld as soon as
possible.

4.2 State of the art

4.2.1 Identification of medical field relevant medical conditions

X-ray
An X-ray is a common imaging test that’s been used for decades. It can help
your doctor view the inside of your body without having to make an i ncision.
This can help them diagnose, monitor, and treat many medical conditions.
Different types of X-rays are used for different purposes. For example, your
doctor may order a mammogram to examine your breasts. Or they may order an
X-ray with a barium enema to get a closer look at your gastrointestinal tract.
X-rays were found emanating from Crookes tubes, experimental discharge tubes
invented around 1875, by scientists investigating the cathode rays, that is
energetic electron beams, that were first created in the tubes.
The earliest known experimenter with X-rays was actuary William Morgan.
In 1785 he presented a paper to the Royal Society of London describing the
effects of passing electrical currents through a partially evacuated glass tube, the
first X-ray tube. This work was further extended by Humphry Davy and his
assistant Michael Faraday.
In 1876, Eugen Goldstein proved that they came from the cathode, and named
them cathode rays.

Figure 4-1 A simplified diagram of a water-cooled X-ray tube

German physicist Wilhelm Röntgen is usually credited as the discoverer of
X-rays in 1895, because he was the first to systematically study them, though he
is not the first to have observed their effects. He is also the one who gave them
the name "X-rays" (signifying an unknown quantity though many others referred
to these as "Röntgen rays" (and the associated X-ray radiograms as,
"Röntgenograms") for several decades after their discovery and even to this day
17 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

in some languages, including Röntgen's native German.Röntgen referred to the

radiation as "X", to indicate that it was an unknown type of radiation.
Early in 1896, just a few weeks after Röntgen published his first X -ray
photograph, Pulyui published high-quality X-ray images in journals in Paris and
London.
Advances in radiology
The first use of X-rays under clinical conditions was by John Hall -Edwards
in Birmingham, England on 11 January 1896, when he radiographed a needle
stuck in the hand of an associate. On 14 February 1896 Hall -Edwards was also
the first to use X-rays in a surgical operation. In early 1896, several weeks after
Röntgen's discovery, Ivan RomanovichTarkhanov irradiated frogs and insects
with X-rays, concluding that the rays "not only photograph, but also affect the
living function”.
The first medical X-ray made in the United States was obtained using a
discharge tube of Pulyui's design. In January 1896, on reading of Röntgen's
discovery, Frank Austin of Dartmouth College tested all of the discharge tubes in
the physics laboratory and found that only the Pulyui tube produced X-rays. This
was a result of Pulyui's inclusion of an oblique "target" of mica, used for holding
samples of fluorescent material, within the tube. On 3 February 1896 Gilman
Frost, professor of medicine at the college, and his brother Edwin Frost,
professor of physics, exposed the wrist of Eddie McCarthy, whom Gilman had
treated some weeks earlier for a fracture, to the X -rays and collected the
resulting image of the broken bone on gelatin photographic plates obtained from
Howard Langill, a local photographer also interested in Röntgen's work.
Hazards discovered
With the widespread experimentation with x‑rays after their discovery in
1895 by scientists, physicians, and inventors came many stories of burns, hair
loss, and worse in technical journals of the time. In February 1896, Professor
John Daniel and Dr. William Lofland Dudley of Vanderbilt University reported
hair loss after Dr. Dudley was X-rayed.In August 1896 Dr. HD. Hawks, a
graduate of Columbia College, suffered severe hand and chest burns from an
x-ray demonstration. It was reported in Electrical Review and led to many other
reports of problems associated with x-rays being sent in to the publication.
Other effects were sometimes blamed for the damage including ultravio let
rays and (according to Tesla) ozone. Many physicians claimed there were no
effects from x-ray exposure at all. On 3 August 1905 at San Francisco, California,
Elizabeth Fleischman, American woman X-ray pioneer, died from complications
as a result of her work with X-rays.
Development within 20th century and beyond
In 1904, John Ambrose Fleming invented the thermionic diode, the first

18 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

kind of vacuum tube. This used a hot cathode that caused an electric current to
flow in a vacuum. This idea was quickly applied to X-ray tubes, and hence
heated-cathode X-ray tubes, called "Coolidge tubes", completely replaced the
troublesome cold cathode tubes by about 1920.
In about 1906, the physicist Charles Barkla discovered that X -rays could be
scattered by gases, and that each element had a characteristic X-ray spectrum. He
won the 1917 Nobel Prize in Physics for this discovery.
In 1912, Max von Laue, Paul Knipping, and Walter Friedrich first observed
the diffraction of X-rays by crystals. This discovery, along with the early work
of Paul Peter Ewald, William Henry Bragg, and William Lawrence Bragg, gave
birth to the field of X-ray crystallography.
The Coolidge X-ray tube was invented during the following year by
William D. Coolidge. It made possible the continuous emissi ons of X-rays.
X-ray tubes similar to this are still in use in 2012.
The X-ray microscope was developed during the 1950s.

(A patient being examined with a thoracic fluoroscope in 1940, which displayed continuous moving
images. This image was used to argue that radiation exposure during the X -ray procedure would be
negligible)
Figure 4-2
An X-ray laser device was proposed as part of the Reagan Administration's
Strategic Defense Initiative in the 1980s.
Phase-contrast X-ray imaging refers to a variety of techniques that use
phase information of a coherent x-ray beam to image soft tissues. It has become
an important method for visualizing cellular and histological structures in a wide
range of biological and medical studies.These methods provide higher contra st
compared to normal absorption-contrast x-ray imaging, making it possible to see
smaller details.
Current state of the X-ray image
With the development of the relevant technology and medical needs,
Medical x-rays are also used in other types of examinations and procedures,
including CT scans and fluoroscopy.Different imaging procedures expose
patients to different amounts of radiation. Conventional and dental x -ray
procedures and mammography use relatively low amounts of radiation. CT scans
19 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

and fluoroscopic procedures involve multiple exposures and/or a longer

exposure to radiation resulting in higher doses. As with any medical test, the
information gained from an x-ray procedure should outweigh the risk from
radiation. Medical imaging is a very powerful and valuable technique that can
provide important and lifesaving information.
Dental X-Rays
Dental x-rays let your dentist see the condition of your teeth from the crown
to the roots. They also show the bones of the jaw and the overall condition of the
bones of your face.
Mammography
A mammogram is an x-ray picture of breast tissue intended to detect breast
cancer. There are two kinds of mammograms, screening and diagnostic.
Screening mammograms are used to check healthy women with no signs of
disease. Screening mammograms use very small doses of x-ray radiation.
Diagnostic mammograms are used when there are some symptoms of breast
cancer. Diagnostic mammograms require views from more angles. As a result,
more x-rays are needed and patients receive more radiation.
CT Scans
Computed tomography scans (also known as CT scans, CAT scans or
computed axial tomography scans) are advanced x-ray procedures that create
cross-sectional views and three dimensional images of a patient's internal organs.
When a person has a CT scan, many x-rays of their body or body part are taken
at nearly the same time.
CT scans are useful because they help doctors diagnose problems by creating
very clear images of internal organs. The detailed images help identify problems
inside the body, such as tumors or damage to organs. CT scans can also help
doctors prepare for surgery by providing a map of the inside of the patient that
surgeons can follow when operating.
When a person has a CT scan, they are being exposed to more radiation than
when they have a conventional x-ray. The radiation exposure of a CT scan can be
up to several hundred times that of a conventional x -ray. Like any medical test,
the beneficial information gained from a CT scan should outweigh the risk of
radiation exposure from the test performed. Medical imaging is a very powerful
and valuable technique that can provide important and lifesaving information.

20 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

Figure 4-3 Drawing of CT fan beam (left) and patient in a CT imaging system
Fluoroscopy
Fluoroscopy is like a real-time x-ray movie. It can show the movement of a
body part (like the heart) or the path that a medical instrument or dye (contrast
agent) takes as it travels through the body.
Unlike conventional x-rays, fluoroscopy uses an x-ray beam that is passed
continuously through the body. The image is transmitted to a monitor so that
doctors can see the body part and its motion in real-time. A medical instrument
or dye is then added to show the function of the body part. The total exposure to
x-rays depends on the length of time of the fluoroscopy procedure.
Fluoroscopy is used in many types of examinations and procedures,
including:
• Viewing movement of materials through the stomach and intestines.
• Directing the placement of a catheter during heart surgery.
•Visualizing blood flow to organs.
•Helping doctors properly set broken bones.

4.2.2 Common specifications, harmonised standards or other solutions

applied

1 IEC 60601-1:2005+AMD1:2012+AMD2:2020/
EN 60601-1:2006+A1:2013+A12:2014+AC:2014+A2:2021
Medical electrical equipment -- Part 1: General requirements for basic safety
and essential performance
医用电气设备-第一部分：安全通用要求
2 IEC 60601-1-2:2014+AMD1:2020 /
EN 60601-1-2:2015+A1:2021
Medical electrical equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic disturbances -
Requirements and tests
医用电气设备-第 1-2 部分：基本安全和基本性能的通用要求-并列标准：电
磁干扰-要求和测试

21 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

3 IEC 60601-1-3: 2008 +AMD1:2013 +AMD2:2021/

EN 60601-1-3: 2008 +A1:2013 +A2:2021
Medical electrical equipment - Part 1-3: General requirements for basic safety
and essential performance - Collateral standard: Radiation protection in
diagnosis X-ray equipment
医用电气设备-第 1-3 部分：基本安全和基本性能的通用要求-并列标准：诊
断Ｘ射线设备辐射防护通用要求
4 IEC 60601-1-6:2010+ AMD1:2013+AMD2:2020 /
EN 60601-1-6:2010+A2:2021
Medical electrical equipment - Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability 医用电气设备-第 1-6
部分：基本安全和基本性能的通用要求 -并列标准：可用性
5 IEC 60601-2-28:2017 /
EN IEC 60601-2-28:2019
Medical electrical equipment -- Part 2-28: Particular requirements for the basic
safety and essential performance of X-ray tube assemblies for medical
diagnosis
医用电气设备 第 2-28 部分:医疗诊断用 X 射线管组件的基本安全和基本性
能专用要求
6 IEC 60601-2-54:2009+A1:2015+A2:2018 /
EN 60601-2-54:2009+A1:2015+A2:2019
Medical electrical equipment -- Part 2-54: Particular requirements for the basic
safety and essential performance of X-ray equipment for radiography and
radioscopy 医用电气设备- 第 2-54 部分：X 射线摄影和透视设备的基本安全
和基本性能专用要求
7 EN ISO 14971:2019+A11: 2021
Medical devices - Application of risk management to medical devices 医疗器械
-风险管理对医疗器械的应用
8 ISO/TR 24971:2020
Medical devices — Guidance on the application of ISO 14971
9 IEC 62366-1:2015+ AMD1:2020 /
EN 62366-1:2015+AC:2015+A1:2020
Medical devices - Application of usability engineering to medical devices 医疗
器械-可用性工程对医疗器械的应用
10 EN ISO 15223-1:2021
Medical devices – Symbols to be used with medical device labels, labeling and
information to be supplied – Part 1: General requirement 医疗器械-用于医疗
器械标签、标记和提供信息的符号 - 第 1 部分：通用要求
11 EN ISO 20417:2021
Medical devices-Information to be supplied by the manufacturer
12 EN ISO 10993-1: 2020
Biological evaluation of medical devices - Part 1: Evaluation and testing within
a risk management process 医疗器械生物学评价- 第 1 部分：风险管理过程
中的评价与试验
13 IEC 62304: 2006 + AMD1: 2015 /
EN 62304:2006+AC:2008+A1:2015
Medical device software – Software life cycle processes
医疗器械软件- 软件生命周期
22 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

14 ISO 780: 2015

Packaging – Pictorial marking for handling of goods 包装-货物搬运的图形标
志
15 IEC TR 60788:2004
Medical electrical equipment - Glossary of defined terms
医疗电气设备.定义的术语汇编
16 IEC TR 60878: 2022
Graphical symbols for electrical equipment in medical practice 医用电气设备
用的图形符号
17 IEC 62563-1:2009+AMD1:2016+AMD2:2021 /
EN 62563-1:2010+A1:2016+ A2:2021
Medical electrical equipment – Medical image display systems – Part 1:
Evaluation methods
医用电气设备医用影像显示系统第 1 部分：评价方法
18 EN ISO 13485:2016+A11:2021
Medical devices -- Quality management systems -- Requirements for regulatory
purposes 医疗器械 -质量管理体系 -用于法规的要求
19 (EU) 2017/745 Medical Device Regulation(MDR)
20 MEDDEV 2.7/1 rev. 4 Clinical evaluations: A guide for manufacturers and
notified bodies
21 MEDDEV 2.12/2 rev2 Post market clinical follow-up studies
22 MDCG 2020-5 Guidance on clinical evaluation – Equivalence
23 MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
24 MDCG 2020-13 Clinical evaluation assessment report
25 Directive 2013/59/EURATOM

4.3 Digital Radiography/Fluoroscopy(R/F) imaging technology and novelty

Gastrointestinal X-ray imaging device was born in 1989 and transformed
from DSA technology. It is an imaging device used by the radiology department
of hospitals to perform gastrointestinal fluoroscop y. Its main uses include:
gastrointestinal radiography, esophagography, gastrointestinal examination,
chest photography, skull and whole body skeleton photography, and some non
vascular interventional radiation therapy applications. Gastrointestinal
radiography, as one of the imaging examination items, in combination with
gastrointestinal endoscopy technology, can conduct a general survey and
diagnosis of most digestive tract diseases, and has the advantages of low
technical difficulty, high inspection efficiency, less pain for the subject, and low
cost.
Early analog gastrointestinal X-ray imaging device used scintillator screens
to form analog images that were observed by doctors' naked eyes and could not
undergo any digital processing. Later, the gastrointestinal X-ray imaging device
used an image intensifier and a digital CCD to collect and store spot images,
which were adjusted, typeset, and labeled before being printed out. After
entering the 21st century, flat panel detectors are gradually replacing ima ge
23 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

intensifiers as the mainstream imaging system for digital gastrointestinal X -ray

imaging device. Compared with analog gastrointestinal X -ray imaging device,
digital gastrointestinal X-ray imaging devices have the characteristics of simple
operation, wide application range, high host power, high inverter frequency, and
clear images. During the entire examination, patient information can be digitally
stored, replayed, and imaged, greatly improving the detection rate of lesions and
the accuracy of diagnosis.
The DRF device with a dynamic flat panel is the representative of the latest
technology in the field of general radiography, and is a multi -functional DR with
a higher configuration. It can easily achieve multiple functions such as digital
radiography(conventional, special angle photography, and long bone splicing),
digital fluoroscopy, digital angiography, digital gastrointestinal, and
high-definition spot radiography, and enables digital fluoroscopy to achieve
ultra-large dimensions and image effects comparable to flat panel radiography.
Although CT, endoscopic ultrasound, interventional radiology, and other
devices can provide a lot of diagnostic information from different aspects.
However, gastrointestinal diseases are complex, and different symptoms h ave
their own unique examination methods. Human organs are divided into solid
organs (such as the liver, spleen, kidney, and pancreas) and hollow organs (such
as the gastrointestinal tract). Imaging methods such as CT, B-ultrasound, and
magnetic resonance imaging have a good detection rate for solid organ lesions,
but most of them are difficult to use for the examination of hollow organs . As the
most common examination method for gastrointestinal diseases, digital
gastrointestinal machines have their irreplaceable clinical significance. The
clinical advantages and technical novelty of gastrointestinal machines are mainly
reflected in:
 With ordinary fluoroscopy and DR spot function, and can dynamically
and multi-directionally observe organ lesions, making the image clearer;
 The application of various special examinations: gastrointestinal tract
imaging (such as gastrointestinal barium meal), urogenital tract imaging
(such as retrograde nephroureterography), gynecological imaging (such
as hysterosalpingography), as well as arthrography, myelography,
cholangiography, and so on. During real-time monitoring, image
acquisition is performed at any time, capturing key images, and
continuous image acquisition and playback of the entire process is
possible.
 Partial angiography and interventional therapy function: It can reduce
the overlapping images in some conventional angiography, thereby
improving image quality and reducing the rate of misdiagnosis and
missed diagnosis.

24 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

In addition, the digital gastrointestinal machine also has the following

technical advantages:
 Better image quality. Digital image acquisition: All images collected are
more clear after digital processing, enabling doctors to observe subtle
lesions under various conditions, thereby improving diagnostic accuracy.
 Timely dynamic image acquisition. The digital gastrointestinal machine
can adjust the imaging speed according to the different examination sites,
and can dynamically observe whether the physiological movements of
the organs have changed.
 The fluoroscopy dose was significantly reduced. Significantly reduce the
adverse effects of radiation on patients and staff.
 Image storage and processing functions. The hard disk can store image
data of patients, thereby avoiding information loss.
This product has established mature control standards, including IEC
60601-2-54 and so on. Based on electrical safety testing, electromagnetic
compatibility testing, performance testing, and the above study of the product's
clinical background, current knowledge and scientific background, as well as the
following clinical documentation assessment, fully demonstrates that DRF
system uses principles to achieve its intended use. Therefore, it is not innovative
medical devices.

4.4 The alternative available options

X-ray, CT, and magnetic resonance imaging are several commonly used
methods for medical imaging examination in clinical practice. Their imaging
principles are different, their inspection methods also have their own strengths,
and their emphasis on detecting diseases is also different. X-ray examination can
be the first choice for disease screening, and has good diagnostic value in
diseases such as gastrointestinal tract, bone, chest, opaque foreign bodies,
cardiopulmonary organic diseases, digestive system, and other dis eases; CT
examination is significantly superior to X-ray film in displaying cross-sectional
areas, especially for tissue imaging with high density, and has higher accuracy in
measuring the distance between bone structures. CT examination can also clearly
display the direction of blood vessels and vascular lesions, and the sensitivity of
tumor detection is higher than that of ordinary X-ray examination. However, the
clarity and resolution of CT imaging of soft tissue are not high enough.
Compared with X-ray and CT examinations, MRI has no X-ray radiation
and less damage to the human body. MRI is mainly used to detect soft tissue
diseases, with high sensitivity to vascular, neurological, and other related
diseases. However, the imaging accuracy of MRI for some bone tissues is not as
good as that of CT products.
25 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

Ultrasound is also an examination that does not involve radiation damage. It

can provide a good display of various parenchymal organs and lesions
throughout the body, and the ultrasound image is closer t o the true anatomical
structure. Ultrasound has a gray scale cross-sectional image that can accurately
locate the lesion based on the display structure and characteristics of the image.
However, the limitation of ultrasound is that the gas in the lung and
gastrointestinal tract may produce a total reflection of the incident light
generated by ultrasound, seriously affecting the effectiveness of the examination.
In addition, if the patient is too fat, due to the inability of ultrasound to penetrate
the fat in the patient's body, the image clarity is poor. Generally speaking,
ultrasound examination is very effective for some large or cystic objects, but the
organ structure and lesions shown in ultrasound image are not as clear as CT and
MRI images.
According to different situations (patient's body, disease, economy, etc.),
consider taking X-ray, CT, ultrasound, or magnetic resonance imaging. Generally,
it is best to have an X-ray examination or ultrasound first to see if there are any
abnormalities. If no obvious abnormalities are found or abnormalities are not
clear, further examination such CT and MRI examination can be considered.
Although X-ray defines detail differently than other imaging modalities, on
occasion alternative tests can be performed. Among ot hers, these include CT
scan, MRI, and ultrasound. The advantages and disadvantages of these devices
are summarized in the table below:
Table 4-1
actor X-ray CT MRI Ultrasound
3-7 5-10
Duration 2-3 min 30-45 min
minutes minutes
Cost Cheap Cheaper Expensive Cheap
Dimensions 2 3 3 2
Poor Poor Excellent
Soft tissue Poor detail
detail detail detail
Excellent Excellent
Bone Poor detail Poor detail
detail detail
Radiation 0.15mSv 10mSv None None
4.5 Benchmark devices
Benchmark devices give a representative view of device performance and
safety. This product is designed by investigating and referring to the technical
characteristics and parameters of similar products in the market , and the
following equipment was listed as the benchmark devices.
Table 4-2
NO. Device Manufacture
1 Juno DRF PHILIPS

26 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

2 Sonalvision Safire 2 SHIMADZU

3 Zexira FD TOSHIBA
4 (Baccara) Platinum DMS Apelem
5 Connexity GE
The performance of the benchmark devices is weighted according to the
literature on the device described above, and the results are detailed in 3.12.1.
The safety of the benchmark devices is in accordance with the harmonised
standards.

4.6 Literature search result (pertaining to the state of the art)

The literature search strategy applied for retrieval of clinical data inc ludes:
1. Objectives: To identify relevant and specified clinical outcome
parameters for the intended clinical benefits, based on the published clinical data
pertaining to the similar device(s) or the alternative available options.
2. Scientific literatures search protocol
See Annex 2 <Literature Search Protocol> for literature search strategies.
3. Clinical data appraisal (pertaining to the state of the art)
For these 10 literatures searched, we give a summary of the contents and
information in the following Table 4-3.

27 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

Table 4-3 Summary of the selection literatures (SOTA)

No. First Author, Study Number Remark
Results Conclusion
Year Type of lesions
Accuracy: N/A Literature about
In a population where most tuberculosis was
Sensitivity: the clinical
Gamuchirai Prospectiv smear-positive, LUNIT-reported
1. n=2190 87.7% performance with
Tavaziva, 2022 e Study radiographic abnormalities were associated
Specificity: Chest X-ray (CXR)
with culture-confirmed disease.
64.3%
GPs should consider lung cancer in patients Literature about
with persistent symptoms even when CXR is the clinical
Retrospecti Accuracy: N/A negative. Despite longer duration to performance with
Stephen H ve Sensitivity: diagnosis for those with false-negative Chest X-ray (CXR)
2. n=2129
Bradley, 2021 Observatio 82.3% CXRs, there was no evidence of an adverse
nal Study Specificity: N/A impact on stage at diagnosis or survival;
however, this comparison is likely to be
affected by confounding variables.
Literature about
Accuracy: N/A Our study demonstrated a pronounced
the clinical
Sensitivity: increase in likelihood ratio for infection
O Kenechi Retrospecti performance with
3. n=397 87.5% when both native fluid and lavage samples
Nwawka, 2021 ve Review fluoroscopically
Specificity: from image‐guided joint aspiration are in
guided joint
99.4% concordance.
aspiration
Accuracy: 90.8% Our proposed computer-aided system is Literature about
Retrospecti the clinical
4. Yilin Xie, 2020 n=909 Sensitivity: superior to current systems that can be used
ve Review performance with
87.4% to assist radiologists in diagnoses and public whole chest X-rays
28 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

No. First Author, Study Number Remark

Results Conclusion
Year Type of lesions
Specificity: health providers in screening for
94.3% tuberculosis in areas where tuberculosis is
endemic.
PS placement using PF and DPMPs to assist Literature about
Accuracy: 97.4% and confrm PS placement lowers radiation the clinical
Rex A W Retrospecti performance with
5. n=576 Sensitivity: N/A exposure to the patient and surgical team
Marco, 2020 ve Review pulsed fuoroscopy
Specificity: N/A without compromising accuracy compared to (PF)
O-arm and fuoroscopy with Sis.
Fluoroscopy is accurate in measuring Literature about
Accuracy: 73% the clinical
James D Wylie, Retrospecti correction in PAO. However, surgeons
6. n=133 Sensitivity: N/A performance with
2019 ve Review should take care not to undercorrect the
Specificity: N/A fluoroscopy
posterior wall.
Accuracy: 76% Literature about
Individualized LAO is a quick and highly the clinical
Fabien Squara, Prospectiv Sensitivity:
7. n=50 reliable patienttailored fluoroscopy performance with
2018 eStudy 91.4%
projection for RV lead positioning. fluoroscopy
Specificity:40%
Accuracy: In addition, the segmentation results using Literature about
Ivan the clinical
Retrospecti 95.68% the intraclass variance thresholding method
8. Cruz-Aceves, n=50 performance with
ve Review Sensitivity: N/A provided a segmentation accuracy of 0.9568
2018 X-ray angiograms
Specificity: N/A with the test set of coronary angiograms.
Number of Literature about
Caroline Cohort No adverse event linked to DVB was the clinical safety
9. n=51 adverse events: 0
Diffre， 2020 Study notified. with fluoroscopic
(0%) guidance
29 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

No. First Author, Study Number Remark

Results Conclusion
Year Type of lesions
Mild: 0 (0%)
Moderate: 0 (0%)
Severe: 0 (0%)
Number of Literature about
adverse events: 6 the clinical safety
Only six complications were encountered, with fluoroscopic
Keith Bush， Prospectiv (0.57%)
10. n=1047 all spontaneously self-resolving without
2020 e Study Mild: 6 (0.57%)
intervention and considered minor (grade 1).
Moderate: 0 (0%)
Severe: 0 (0%)

30 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

5. Device under evaluation

5.1 Type of clinical evaluation

Relevant clinical data to prove that this system achieves its intended
performance during normal conditions of use, for the indications as described in
this clinical evaluation report, results from:
1) literature search
The use and application of the evaluated medical device in the scope of the
intended use is described in section 3.4. The literature search in PubMed,
ClinicalTrials.gov and Cochrane Library to identify the safety and performance
of the evaluated medical devices is deemed to be sufficient. The literature review
and the corresponding results are documented in section 5.4.1.
The search is carried out regularly and new results are included. Depending
on the findings and other relevant new information, a summarizing assessment of
new data is carried out at least once a year in the context of the CER .

2) PMS activities

Internal PMS/PMCF data

We have conducted the post-marketing clinical follow-up according to
<After-sales service and feedback control procedure> (WDCX7502), <Customer
satisfaction survey control procedure> (WDCX8201), <Customer complaint
handling procedure> (WDCX8501), <Adverse Event Monitoring and
Reevaluation Control Procedure> (WDCX8206), <Vigilance system control
procedure> (WDCX9007), <Post-marketing Surveillance control procedure>
(WDCX9008(CE)) to collect the adverse events, recalls and the customers ’
compliant, which serves as the inputs of design changes to improve clinical
performance and safety.
PMCF is a continuous process that updates the clinical evaluation. When
conducting PMCF, we have established <Clinical evaluation procedure>
(WDCX7303) to collect and evaluate clinical data from the use on humans of a
device which has been placed on the market or put into service within its
intended purpose as referred to in the relevant conformity assessment procedure,
confirming the safety and performance throughout the expected lifetime of the
device, of ensuring the continued acceptability of identified risks and of
detecting emerging risks on the basis of factual evidence.
In section 5.3.2, the internal clinical experience data including the internal
PMS/PMCF data are summarized and evaluated.
PMS data from safety databases
Retrospectively, the data of clinical experiences are analyzed and evaluated.

31 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

All results are documented in section 5.6.4 of this CER. The following databases
were searched with focus on medical device alerts, recommendations and recalls
related to the evaluated devices:
 PMS data from adverse events dataset
a) From the Adverse Events published by the FDA, the FDA Applicant and
User Institution Device Usage Database (MAUDE):
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAU
DE/Search.cfm
b) From adverse events published by the European Union, European Databank
on Medical Devices (EUDAMED):
http://ec.europa.eu/consumers/sectors/medical-devices/mar
ket-surveillance-vigilance/eudamed/

 PMS data from corrective action dataset related to clinical risk

a) From the medical device recalls issued by the FDA, website:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/
res.cfm
b) From the field corrective actions issued by the Bundesinstitut für
Arzneimittel und Medizinprodukte (BfArM), website:
https://www.bfarm.de/SiteGlobals/Forms/Suche/EN/Expert
ensuche_Formular.html?nn=708434&cl2Categories_Forma
t=kundeninfo
c) From the post-market surveillance issued by the Netherlands Inspectie
Gezondheidszorg en Jeugd (IGJ), website:
https://www.igj.nl/
5.2 Demonstration of equivalence
This system is equivalent with Luminos dRF Max of Siemens AG/Siemens
Healthcare GmbH(certificated by TÜV SÜD Product Service GmbH
(Certification Number: G10 091596 0052 Rev. 01).
Both of the devices utilize the same physic principle to obtain X-ray image
of patient. Both of these systems are digital Radiography/Fluoroscopy system.
The imaging principle is to use the principle that the X -ray emitted from the
X-ray tube has different attenuation to the X-ray when it passes through different
tissues and organs of the patient's body. The image formed by the X -ray passing
through the patient and carrying sufficient information is projected onto the
imaging medium, and is converted into a universal X-ray equipment with visible
plane gray scale images. The equivalence analysis was conducted by comparing
the technical characteristics, biological characteristics and clinical
32 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

characteristics of the two systems.

Table 5-1 Equivalence table for the comparison of this system and Luminos dRF
1.Technical Luminos dRF Max (marketed DRF-6A/7B/8B/8PRO (under Identified
characteristics device) clinical evaluation) differences or
conclusion
that are no
differences in
characteristic
Device is of 1.1 design information 1.1 design information Same
similar design Luminos dRF Max is a device DRF-6A/7B/8B/8PRO is a device
intended to visualize anatomical intended to visualize anatomical
structures by converting an X-ray structures by converting an X-ray
pattern into a visible image. The pattern into a visible image. This
system uses the principle that the system uses the principle that the
X-ray emitted from the X-ray tube X-ray emitted from the X-ray tube
passes through different tissues and passes through different tissues and
organs of the patient's body with organs of the patient's body with
different attenuation of the X-ray, different attenuation of the X-ray,
and transforms the image formed by and transforms the image formed by
the X-ray passing through the patient the X-ray passing through the patient
and carrying enough information and carrying enough information
onto the imaging medium into a onto the imaging medium into a
visible gray image. visible gray image.

Used under 1.2 Conditions of use 1.2 Conditions of use Similar.

similar a) Environment temperature: This system is intended to be used in No
conditions of +15℃～+30℃ the radiology room of a medical differences in
use b) Relative humidity: 20％～75％ institution. characteristic.
c) Atmosphere pressure range: The product can be used normally in
700hPa～1,060hPa the following environment
conditions:
a) Environment temperature:
+15℃～+35℃
b) Relative humidity: 30％～75％
c) Atmosphere pressure range:
700hPa～1,060hPa
The product should not be exposed to
direct sunlight, dust, corrosive gas,
flammable gas, oil mist, steam, water
dripping and vibration, and should
avoid salty environment.
The product is a permanently
installed equipment.
Similar 1.3-1 Electrical power supply 1.3-1 Electrical power supply Similar
specifications Power supply voltage: 3-phase 400V, Power supply voltage: 3-phase 380V,
and properties 50 or 60Hz 50Hz, the voltage fluctuation should
including Power consumption: standby: ≤ be within ±10%(342V-418V)
physiochemical 0.7kVA, Power capacity:
properties such DRF-6A:80kVA(momentary),8kVA(C
During fluoroscopy: ≤ 2.5kVA,
as intensity of ontinuous)
energy, tensile Exposure: ≤ 110kVA
DRF-7B/DRF-8B/8PRO:150kVA(mo
strength,
viscosity, mentary),8kVA(Continuous)
surface 1.3-2 product components 1.3-2 product components Similar
characteristics, Luminos dRF Max is mainly DRF-6A/7B/8B/8PRO is mainly
composed of High voltage generator, composed of High frequency and
33 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

wavelength X-ray tube assembly, Collimator, flat high voltage generator, X-ray tube
and software panel detector, Image processing assembly, Collimator, Flat panel
algorithms system, Auxiliary equipment: vertical detector, Digital imaging system,
chest frame, X-ray tube assembly Auxiliary equipment: patient support
suspension device, patient support device(diagnostic table), console,
device, console, options and options and accessories
accessories
1.3-3 Output Nominal electric power: 1.3-3 Output Nominal electric power: Similar
80kW 80kW or 50kW
1.3-4 Tube voltage range 1.3-4 Tube voltage range Same
40～150 40～150
1.3-5 Tube current range of Similar
1.3-5 Tube current range of radiography:
radiography: 1～1000mA GFS802-3: 10～1000mA
GFS502-8: 10～630mA
1.3-6 Pulse fluoroscopy range: 0.2～ 1.3-6 Pulse fluoroscopy range: 5～40 Similar
23mA mA
1.3-7 Loading time: 0.001～5s 1.3-7 Loading time: 0.001~10s Similar
1.3-8 Current time product: 0.5 ～ 1.3-8 Current time product: 0.1 ～ Similar
800mAs 1000mAs
Uses similar 1.4 Site Planning 1.4 Site Planning Same
deployment Typical installation sites for X-ray Typical installation sites for X-ray
methods where system is lead shielding room and system is lead shielding room and
relevant operating room in radiation operating room in radiation
department of medical unit. The lead department of medical unit. The lead
shielding room is mainly equipped shielding room is mainly equipped
with high-frequency high-voltage with high-frequency high-voltage
generator and patient support generator and patient support
devices, where patients can undergo devices, where patients can undergo
X-ray exposure. The operation room X-ray exposure. The operation room
is mainly equipped with console, is mainly equipped with console,
image display, host, etc. The image display, host, etc. The
operation room is used by the operation room is used by the
operator to control the equipment in operator to control the equipment in
the shielding room and other the shielding room and other
necessary equipment through the necessary equipment through the
console, and perform image console, and perform image
acquisition operations and acquisition operations and
diagnostics. diagnostics.
Has similar 1.5 principles of operation 1.5 principles of operation Same
principles of The patient to be examined lies on The patient to be examined lies on
operation and the diagnostic table (patient support the diagnostic table (patient support
device). After adjusting the position device). After adjusting the position
of the diagnostic table according to of the diagnostic table according to
the position to be examined, the the position to be examined, the
operator sends an exposure enable operator sends an exposure enable
command to the device through the command to the device through the
console. The high-frequency console. The high-frequency
high-voltage generaor outputs DC high-voltage generaor outputs DC
high voltage to the X-ray tube high voltage to the X-ray tube
assembly, and the electrons emitted assembly, and the electrons emitted
by the filament of the X-ray tube by the filament of the X-ray tube
assembly are accelerated by DC high assembly are accelerated by DC high
voltage and hit the anode target voltage and hit the anode target
surface, thereby generating X-ray. A surface, thereby generating X-ray. A
34 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

collimator installed in the output collimator installed in the output

window of the X-ray tube assembly window of the X-ray tube assembly
controls the radiation field of the controls the radiation field of the
X-ray, so as to minimize the radiation X-ray, so as to minimize the radiation
range, avoid unnecessary doses, and range, avoid unnecessary doses, and
absorb some scattered rays to absorb some scattered rays to
improve image clarity on the premise improve image clarity on the premise
of satisfying X-ray imaging and of satisfying X-ray imaging and
diagnosis. The flat panel detector diagnosis. The flat panel detector
converts the received X-ray into a converts the received X-ray into a
digital image signal. And the imaging digital image signal. And the imaging
acquisition system performs digital acquisition system performs digital
signal acquisition, processing, signal acquisition, processing,
storage, and display to obtain storage, and display to obtain
medical images that can be used for medical images that can be used for
examination and diagnosis. examination and diagnosis.
Critical 1.6-1 Last frame hold 1.6-1 Last frame hold Same
performance 1.6-2 Automatic fluoroscopy 1.6-2 Automatic fluoroscopy Same
requirements 1.6-3 Nominal incident field size Same
Nominal incident field size of
1.6-3 Nominal incident field size detector in x and y directions:
420mm(H)×426mm(V) 430mm × 430mm, the actual imaging
size should be greater than 95% of
the nominal value.
1.6-4 spatial resolution 1.6-4 spatial resolution Similar
radiography spatial resolution: DRF-6A/7B:
3.4lp/mm radiography spatial resolution:
in maximum field of view
(430mm×430mm): not be less than
3.7lp/mm
DRF-8B,DRF-8PRO：
Radiography spatial resolution:
in maximum field of view (430mm ×
430mm) :
DRF-8B, DRF-8PRO: not less than
5.0lp/mm.
1.6-5 Image uniformity 1.6-5Image uniformity Similar
No more than 2.2% No more than 2.5%
1.6-6 Maximum frame rate 1.6-6Maximum frame rate Similar
0.5 to 8 images/second in 1440² DRF-6A/7B:
matrix Maximum frame rate(acquisition): 25
Digital pulsed fluoroscopy: frames/s
3 p/s, 7.5 p/s, 10 p/s, 15 p/s in DRF-8B/8PRO:
1024²/12-bit matrix.; Maximum frame rate(acquisition):
30 p/s in 512²/12-bit matrix 30 frames/s.
1.6-7Artifact Similar
1.6-7Artifact X-ray fluoroscopy and X-ray
Actual measurement radiography should not have artifacts
that affect the diagnosis.
Scientific justification why there would be no clinically significant difference in the safety and Clinically
clinical performance of the device, OR a description of the impact on safety and or clinical significant
performance difference
Yes/No☒
1.2 The conditions of use between Luminos dRF Max and DRF-6A/7B/8B/8PRO are very similar,
so there is no differences in characteristic. In addition, the relevant tests and studies are
carried out under the conditions of use.
35 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

1.3-1 The power supply voltage of DRF-6A/7B/8B/8PRO can be applied to target sales markets such
as China, EU, North America, etc. And the power supply capacity is consistent with the
hardware power requirements.
So there is no clinically significant difference in the safety and clinical performance of the
device.
1.3-2/3/5/6/7/8 The component composition, tube current range, loading time, and related parameters are
different, but do not constitute any safety and effectiveness issue, as indicated in performance
data < Electrical Safety Test Report> provided.
1.6-4/5/6/7 The same exposure protocol is used to test the imaging performance of the declared product
and the comparative product. The comparison results show that the declared product is equal
to or better than the comparative product. Refter to <System performance test report> for
details.
2. Biological Luminos dRF Max (marketed DRF-6A/7B/8B/8PRO (under Identified
characteristics device) clinical evaluation) differences or
conclusion
that are no
differences in
characteristic
Uses the same 2.1-1Surface of Component cover 2.1-1Surface of Component cover Same
materials or Material: carbon fiber Material: carbon fiber
substances in Intact Skin-contacting Intact Skin-contacting
contact with 2.1-2 Surface of Button 2.1-2 Surface of Button Same
the same Material: ABS plastic Material: ABS plastic
human tissues Intact Skin-contacting Intact Skin-contacting
or body fluids 2.1-3 Table-top of the patient support 2.1-3 Table-top of the patient support Same
device(diagnostic table) device(diagnostic table)
Material: wood pulp+TiO2 Material: wood pulp+TiO2
Intact Skin-contacting Intact Skin-contacting
2.1-4 Surface of Compressor 2.1-4 Surface of Compressor Same
Material: polycarbonate; Material: polycarbonate;
Intact Skin-contacting Intact Skin-contacting
2.1-5 Shoulder rest 2.1-5 Shoulder rest Same
Material: Polyurethane sponge, Material: Polyurethane sponge,
Polyvinyl chloride Polyvinyl chloride
Intact Skin-contacting Intact Skin-contacting
Similar kind 2.2-1 Categorization by nature of 2.2-1 Categorization by nature of Same
and duration of contact type contact type
contact with •surface-contacting devices •surface-contacting devices
the same 2.2-2 Categorization by duration of 2.2-2 Categorization by duration of Same
human tissues contact contact
or body fluids Short-term Contact (A): Device Short-term Contact (A): Device
which contact duration is within 24 which contact duration is within 24
hours when it is used once or many hours when it is used once or many
times times
Similar release N/A N/A N/A
characteristics
of substances
including
degradation
products and
leachables
Scientific justification why there would be no clinically significant difference in the safety and Clinically
clinical performance of the device, OR a description of the impact on safety and or clinical significant
performance difference
Yes/No☒
N/A -
36 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

3. Clinical Luminos dRF Max (marketed DRF-6A/7B/8B/8PRO (under Identified

characteristics device) clinical evaluation) differences or
conclusion
that are no
differences in
characteristic
Same clinical 3.1-1 Clinical condition 3.1-1 Clinical condition Same
condition or Imaging Diagnosis Imaging Diagnosis
purpose, 3.1-2 Intend purpose 3.1-2 Intend purpose Same
including Clinical X-ray Diagnosis Clinical X-ray Diagnosis
similar severity
and stage of
disease
Same site in 3.2 Application site in the body 3.2 Application site in the body Same
the body The system has medical applications The system has medical applications
ranging from gastrointestinal ranging from gastrointestinal
examinations to cranial, skeletal, examinations to cranial, skeletal,
thoracic and lung exposures as well thoracic and lung exposures as well
as examinations of the urogenital as examinations of the urogenital
tract. The unit may also be used in tract. The unit may also be used in
emergency applications, emergency applications,
lymphography, endoscopy, lymphography, endoscopy,
myelography, venography, myelography, venography,
arthrography, interventional arthrography, interventional
radiology, digital angiography and radiology, digital angiography and
digital subtraction angiography digital subtraction angiography
(DSA). (DSA).
Similar 3.3 Suitable the population 3.3 Suitable the population Similar
population, suitable for all patients except suitable for all patients except
including as contraindications contraindications and patients
regards age, weighing over 200 kg
anatomy and
physiology
Same kind of 3.4 Kind of user 3.4 Kind of user Same
user radiologists and radiology radiologists and radiology
technologists technologists
Similar 3.5-1 accuracy 3.5-1 accuracy Same
relevant Up to 91.6 % Up to 91.6 %
critical 3.5-2 sensitivity 3.5-2 sensitivity Same
performance in Up to 85.7% Up to 85.7%
view of the 3.5-3 specificity 3.5-3 specificity Same
expected Up to 71.1% Up to 71.1%
clinical effect
for a specific
intended
purpose
Scientific justification why there would be no clinically significant difference in the safety and Clinically
clinical performance of the device, OR a description of the impact on safety and or clinical significant
performance difference
Yes/No☒
3.2 DRF-6A/7B/8B/8PRO do not include interventional radiology, digital angiography and digital
subtraction angiography (DSA) function. And the applicable parts and function of the
equivalent device can cover the declared produ ct.
3.3 DRF-6A/7B/8B/8PRO is suitable for patients who weigh less than 200kg . And the applicable
patient population of the equivalent device can cover the declared product .
Summary: DRF-6A/7B/8B/8PRO has the same intended use, biological characteristics and similar technological

37 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

characteristics than the predicate device Luminos dRF Max, so that the subject device does not raise new
questions of safety or effectiveness and is substantially equivalent (SE) to the predicate device.

5.3 Clinical data generated and held by the manufacturer

5.3.1 Pre-clinic testing

According the GENERAL SAFETY AND PERFORMANCE
REQUIREMENTS of Annex I, MDR (EU) 745/2017, relevant tests had been
implemented and completed with the applicable standards. Test reports were
listed in the following table.
Table 5-2 Tests reports of applicable standards
Report No. Report name
DRF-6A:CN22GRHM 001 IEC/EN 60601-1 Test Report
DRF-6A/7B/8B/8PRO:
CN22CK73 001
DRF-6A:CN22JNU8 001 IEC/EN 60601-1-2 Test Report
DRF-7B:CN22BDYW 001
DRF-8B:CN22OSRA 001
DRF-8Pro:CN22KZ8M
001
DRF-6A:CN22GRHM 001 IEC/EN 60601-1-3 Test Report
DRF-6A/7B/8B/8PRO:
CN22CK73 001
DRF-6A:CN22GRHM 001 IEC/EN 60601-2-54 Test Report
DRF-6A/7B/8B/8PRO:
CN22CK73 001
js01112.10 IEC/EN 62304 Test Report
js01112.4 IEC/EN 62366-1:2015 Test Report
js01112.4.1 IEC/EN 60601-1-6 Test Report
js200.17.2 Clinical Evaluation Report
js0137.01 Risk Management Report
js0137.02 Software Risk Management Report
js200.8.1 Biocompatibility Report
js200.9.3 Transport Evaluation
js200.17.3 System performance test report

5.3.2 PMS/PMCF data

DRF-6A/7B have obtained the NMPA registration certificate in
January/February, 2022. And the product has been running stably without
38 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

adverse events after being launched in China. The DRF-6A/7B/8B/8PRO system

is undergoing initial CE-marking, and the relevant plans or report are as follows:
 PMS Plan: please refer to js200.18.1 <Post Market Clinical Surveillance
Plan>.
 PMCF Plan: please refer to js200.18.2<Post Market Clinical Follow-up
Plan>.
 PSUR: DRF-6A/7B/8B/8PRO system is not CE-marked, so there is no
incident report, or complaints regarding performance and safety sent to
manufacturer.

5.4 Clinical data from literature

5.4.1 Scientific literatures search

The literature search strategy applied for retrieval of clinical data includes:
1. Objectives
To collect, appraise and analyse clinical data pertaining to
Radiography/Fluoroscopy X-ray imaging device, which is not generated and held
by the manufacturer and to evaluate whether there is sufficient clinical eviden ce
to confirm compliance with relevant general safety and performance
requirements when using DRF-6A/7B/8B/8PRO system according to instruction
for use.
2. Scientific literatures search protocol
See Annex 1 <Literature Search Protocol> for literature search strategies.
3. Scientific literatures search report
See Annex 2 <Literature Search Report> for literature search process and
results.

5.4.2 Output of the summary of the literatures searched

For these 7 literatures searched, we give a summary of the contents an d
information in the following Table 5-3.

39 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

Table 5-3 Summary of the selection literatures

No. First Author, Number of Remark

Study Type Results Conclusion
Year lesions
Accuracy: N/A Decreased relative function and increased extents of Clinical
Sensitivity: cortical defects on DMSA scan may be associated with performance
Il Ki Hong, Comparativ
1. n=31 41.7% the presence of VUR. These findings may assist
2018 e Study
Specificity: pediatricians to decide whether febrile UTI children
91.1% need to undergo VCUG.
Barium proctography was more sensitive than MRI for Clinical
detecting pelvic floor descent and intra rectal performance
Deepa Accuracy: N/A
Prospective intussusception. Although patients perceived better
2. Rebecca n=8 Sensitivity: 50%
Study rectal emptying with barium proctography, the overall
Korula, 2021 Specificity: 93%
patient experience was better for dynamic MRI
proctography.
Accuracy: 100% Clinical
Ultrasonic measurement of the tibiofibular distance
Sensitivity: performance
Yueh Chen, Prospective under forceful knee flexion is clinically valuable for
3. n=20 100%
2021 Study diagnosing PTFJ instability with functional
Specificity:
significance
100%
Accuracy: 100% Clinical
Tiina Prospective Sensitivity: The clinical swallowing evaluation is a relevant performance
4. Ihalainen, Cohort n=37 100% adjunct in the management of these patients and can
2018 Study Specificity: improve the detection of penetration and aspiration.
100%

40 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

No. First Author, Number of Remark

Study Type Results Conclusion
Year lesions
Accuracy: 100% DTI parameters obtained within two weeks of stroke Clinical
Sensitivity: onset may help classify those with dysphagia, predict performance
Youngkook Prospective
5. n=69 100% recovery and help plain therapeutic strategies to
Kim, 2022 Study
Specificity: maintain the adaptive role of the white matter tract,
100% which is crucial in swallowing recovery.
Te barium X-ray study of the digestive tract, Clinical
Accuracy: 100%
performed before and afer different treatment performance
Diego Sensitivity:
Comparativ approaches, demonstrates that the surgical treatment
6. Palladino, n=8 100%
e Study has to be considered as the treatment of choice of
2015 Specificity:
achalasia, reserving endoscopic treatment to patients
100%
with high operative risk and refusing surgery.
Number of Clinical safety
adverse events:
0 (0%)
Prospective All 14 cases were reduced successfully, with no
7. I Shavit, 2019 n=14 Mild: 0 (0%)
Study procedure complications.
Moderate: 0
(0%)
Severe: 0 (0%)

41 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

5.5 Summary and appraisal of clinical data

5.5.1 Appraisal plan

 Once the clinical data is about the clinical trials of this kind of medical
device, the assessment of methodological quality shall be reasonable, and for
each data set shall be from the scientific database or the third party
testing/research institute.
 The relevant clinical data set shall have relevance to the device and to the
different aspects of its intended purpose. See the following table 5-3 below.
 The contribution of each data set shall be weighted to the overall clinical
evaluation, see the following table 5-4 below.
 Level of Evidence:
Level 1 data means references that are mostly classified 1 (D1, A1, P1, R1)
and not classified 3 in any category.
Level 2 data means references that are mostly classified 2 (D2, A2, P2, R2)
and have a maximum of one topic classified 3 if another topic is classified 1.
Level 3 data means references that are classified 3 (D3, A3, P3, R3) at least
twice or three times if the classification in another heading is 1.
Level 4 data means references that are only classified 3.
Level 1 > Level 2 > Level 3 > Level 4

Table 5-4 relevance requirements criteria used for the data appraisal
Suitability Description Grading System
Criteria
Appropriate Were the data generated from the D1 Actual device
device device in question? D2 Equivalent device
D3 Other device
Appropriate Was the device used for the same A1 Same use
device intended use (e.g., methods of A2 Minor deviation
Application deployment, application, etc.)? A3 Major deviation
Appropriate Where the data generated from a P1 Applicable
patient patient group that is P2 Limited
group representative of the intended P3 Different population
treatment population e.g., age,
sex, etc.) and clinical condition
(i.e., disease, including state and
severity) ?
Acceptable Do the reports or collations of R1 High quality
report/data data contain sufficient R2 Minor deficiencies

42 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

Collation information to be able to R3 Insufficient

undertake a rational and objective information
assessment?

Table 5-5 contribution requirements criteria used for the data appraisal
Data Description Grade Grading
Contribution System
Criteria
Data source type Was the design of the study T1 Yes
appropriate? T2 No
Outcome measures Do the outcome measures reported O1 Yes
reflect the intended performance of O2 No
the device?
Follow up Is the duration of follow-up long F1 Yes
enough to assess whetherduration of F2 No
treatment effects and identify
complications?
Statistical Have the data been provided and is S1 Yes
significance it appropriate? S2 No
Clinical Was the magnitude of the treatment C1 Yes
significance effect observed clinically C2 No
significant?

5.5.2 Appraisal of the clinical data

Based on the criteria defined in 5.5.1, the appraisal of the clinical data as
following is shown in the following table.
Table 5-6 appraisal of the relevant data
Type/No. Methodological Relevance Contribution Level of Remark
quality/ Evidence
scientific effect
Data held by the manufacturer
Pre-clinical Tested in the The actual Safety and N/A Selected as the
Testing qualified labs device performance, clinical data
reports under including the
(section testing EMC
5.3.1)
Data from literature
Gamuchirai Meet the D3, A1, P1, T1, O1, F1, S1, Level 2 Selected as the
Tavaziva, statistics R1 C1 SOTA data
2022 requirements
Stephen H Meet the D3, A1, P1, T1, O1, F1, S1, Level 2 Selected as the
43 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

Bradley, statistics R1 C1 SOTA data

2021 requirements
O Kenechi Meet the D3, A1, P1, T1, O1, F1, S1, Level 2 Selected as the
Nwawka, statistics R1 C1 SOTA data
2021 requirements
Meet the D3, A1, P1, T1, O1, F1, S1, Level 2 Selected as the
Yilin Xie,
statistics R1 C1 SOTA data
2020
requirements
Meet the D3, A1, P1, T1, O1, F1, S1, Level 2 Selected as the
Rex A W
statistics R1 C1 SOTA data
Marco, 2020
requirements
Meet the D3, A1, P1, T1, O1, F1, S1, Level 2 Selected as the
James D
statistics R1 C1 SOTA data
Wylie, 2019
requirements
Meet the D3, A1, P1, T1, O1, F1, S1, Level 2 Selected as the
Fabien
statistics R1 C1 SOTA data
Squara, 2018
requirements
Ivan Meet the D3, A1, P1, T1, O1, F1, S1, Level 2 Selected as the
Cruz-Aceves, statistics R1 C1 SOTA data
2018 requirements
Meet the D3, A1, P1, T1, O1, F1, S1, Level 2 Selected as the
Caroline
statistics R1 C1 SOTA data
Diffre， 2020
requirements
Meet the D3, A1, P1, T1, O1, F1, S1, Level 2 Selected as the
Keith Bush，
statistics R1 C1 SOTA data
2020 requirements
Meet the D2, A1, P1, T1, O1, F1, S1, Level 1 Selected as the
Il Ki Hong,
statistics R1 C1 clinical
2018
requirements performance data
Deepa Meet the D2, A1, P1, T1, O1, F1, S1, Level 1 Selected as the
Rebecca statistics R1 C1 clinical
Korula, 2021 requirements performance data
Meet the D2, A1, P1, T1, O1, F1, S1, Level 1 Selected as the
Yueh Chen,
statistics R1 C1 clinical
2021
requirements performance data
Tiina Meet the D2, A1, P1, T1, O1, F1, S1, Level 1 Selected as the
Ihalainen, statistics R1 C1 clinical
2018 requirements performance data
Meet the D2, A1, P1, T1, O1, F1, S1, Level 1 Selected as the
Youngkook
statistics R1 C1 clinical
Kim, 2022
requirements performance data
Diego Meet the D2, A1, P1, T1, O1, F1, S1, Level 1 Selected as the
Palladino, statistics R1 C1 clinical
2015 requirements performance data
Meet the D2, A1, P1, T1, O1, F1, S1, Level 1 Selected as the
I Shavit,
statistics R1 C1 clinical safety
2019
requirements data

44 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

5.6 Analysis of the clinical data

5.6.1 Requirement on safety (GSPR 1, 4, 5, 8)

1) Clinical safety
According to the outcome indicators and the adverse events number of these
literatures (section 5.4.2), the weighted averages were calculated:
Rate of adverse events: 0%
Rate of Mild events: 0%
Rate of Moderate events: 0%
Rate of Severe events: 0%
In summary, it has reached the target requirements in section 3.12.2,
proving that the substantially equivalent (SE) device can meet the expected
clinical safety requirements.
2) Pre-clinical safety study
The information materials supplied by the manufacturer including label,
instruction for use and other available promotional materials are consistent with
the relevant clinical data and all hazards, information on risk mitigation and
other relevant information have been identified appropriately. For details, please
refer to risk management documents.
The list of applicable standards and test reports:
Table 5-7 applicable standards and test reports

No. Standards Report No.

1 IEC 60601-1:2005+AMD1:2012+AMD2:2020/ DRF-6A:CN2
EN 60601-1:2006+A1:2013+A12:2014+AC:2014+A2:2021 2GRHM 001
Medical electrical equipment -- Part 1: General requirements for DRF-6A/7B/8
basic safety and essential performance B/8PRO:
医用电气设备-第一部分：安全通用要求 CN22CK73
001
2 IEC 60601-1-2:2014+AMD1:2020 / DRF-6A:CN2
EN 60601-1-2:2015+A1:2021 2JNU8 001
Medical electrical equipment - Part 1-2: General requirements DRF-7B:CN2
for basic safety and essential performance - Collateral standard: 2BDYW 001
Electromagnetic disturbances - Requirements and tests DRF-8B:CN2
医用电气设备-第 1-2 部分：基本安全和基本性能的通用要求- 2OSRA 001
并列标准：电磁干扰 -要求和测试 DRF-8Pro:CN
22KZ8M 001
3 IEC 60601-1-3: 2008 +AMD1:2013 +AMD2:2021/ DRF-6A:CN2
EN 60601-1-3: 2008 +A1:2013 +A2:2021 2GRHM 001
Medical electrical equipment - Part 1-3: General requirements DRF-6A/7B/8
for basic safety and essential performance - Collateral standard: B/8PRO:
Radiation protection in diagnosis X-ray equipment CN22CK73
医用电气设备-第 1-3 部分：基本安全和基本性能的通用要求- 001
并列标准：诊断Ｘ射线设备辐射防护通用要求
45 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

4 IEC 60601-1-6:2010+ AMD1:2013+AMD2:2020 / js01112.4.1

EN 60601-1-6:2010+A2:2021
Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral standard:
Usability 医用电气设备-第 1-6 部分：基本安全和基本性能的
通用要求-并列标准：可用性
5 IEC 60601-2-28:2017 /
EN IEC 60601-2-28:2019
Medical electrical equipment -- Part 2-28: Particular
requirements for the basic safety and essential performance of
X-ray tube assemblies for medical diagnosis
医用电气设备 第 2-28 部分:医疗诊断用 X 射线管组件的基本
安全和基本性能专用要求
6 IEC 60601-2-54:2009+A1:2015+A2:2018 / DRF-6A:CN2
EN 60601-2-54:2009+A1:2015+A2:2019 2GRHM 001
Medical electrical equipment -- Part 2-54: Particular DRF-6A/7B/8
requirements for the basic safety and essential performance of B/8PRO:
X-ray equipment for radiography and radioscopy 医用电气设备- CN22CK73
第 2-54 部分：X 射线摄影和透视设备的基本安全和基本性能 001
专用要求
7 EN ISO 14971:2019+A11: 2021 Risk
Medical devices - Application of risk management to medical Management
devices 医疗器械-风险管理对医疗器械的应用 files
8 ISO/TR 24971:2020
Medical devices — Guidance on the application of ISO 14971
9 IEC 62366-1:2015+ AMD1:2020 / js01112.4
EN 62366-1:2015+AC:2015+A1:2020
Medical devices - Application of usability engineering to
medical devices 医疗器械-可用性工程对医疗器械的应用
10 EN ISO 15223-1:2021 js200.4.1Ratin
Medical devices – Symbols to be used with medical device g Label and
labels, labeling and information to be supplied – Part 1: General Markings
requirement 医疗器械-用于医疗器械标签、标记和提供信息的
符号- 第 1 部分：通用要求
11 EN ISO 20417:2021
Medical devices-Information to be supplied by the manufacturer
12 EN ISO 10993-1: 2020 js200.8.1
Biological evaluation of medical devices - Part 1: Evaluation and Biocompatibil
testing within a risk management process 医疗器械生物学评价- ity Report
第 1 部分：风险管理过程中的评价与试验
13 IEC 62304: 2006 + AMD1: 2015 / js01112.10
EN 62304:2006+AC:2008+A1:2015
Medical device software – Software life cycle processes
医疗器械软件- 软件生命周期

5.6.2 Requirement on acceptable benefit/risk profile (GSPR 1, 2, 8)

The benefits and residual risks of the DRF-6A/7B/8B/8PRO systems have
46 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

been discussed in detail in the previous chapters and are summariz ed in the
following table:
Table 5-8 Benefit
Benefits Reference for
benefit
noninvasively and painlessly help to diagnosis Section 2.2
disease and monitor therapy;
support medical and surgical treatment planning; Section 2.2
guide medical personnel as they insert catheters, Section 2.2
stents, or other devices inside the body, treat tumors,
or remove blood clots or other blockages.

Table 5-9 Risk

Residual Risks Reference for residual risks
Biological hazards H-03, FE2, FE4 in the Risk
Management Files
Noise hazards: acoustic noise H-04, FE2 in the Risk
Management Files
Electromagnetic interference H-E1, FE9, FE10 FE35 in
the Risk Management Files

According to IEC 60601-1and EN ISO 14971, all individual risks and the
total risks have been assessed as acceptable after the implementation of
respective risk control measures, and the intended use of the device has been
described correctly in instruction for use. In risk management documents and
instruction for use, the correct information to reduce the risk of use error and
information on residual risks are contained. For details, please refer to
instructions for use and risk management documents.
DRF-6A/7B systems have been marketed in China, and no reported recalls,
and/or adverse events during this time (please refer to section 5.3.2), a safe
application of the evaluated medical devices can be assumed.
Based on the findings from literature, clinical data as well as risk analysis it
can be inferred that the probability of a patient experiencing a substa ntial benefit
when using the DRF-6A/7B/8B/8PRO Systems outweighs the probability of
suffering harm due to a residual risk of the device significantly.

5.6.3 Requirement on performance (GSPR 1, 6, 7)

1) Clinical performance:
According to the outcome indicators and the overall lesions number of these
literatures (section 5.4.2), the weighted averages were calculated:
47 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

Accuracy: 100%
Sensitivity: 87.2%
Specificity: 98.1%
In summary, it has reached the target requirements in section 3.12.1,
proving that the substantially equivalent (SE) device can meet the expected
clinical performance requirements.

2) Product non-clinical performance:

Diagnostic table
1 1
Table rotation angle  ，（0 1）
ZC25SY-5: （903）  ， （253）
1
;
0～ 0～ 0
ZC45SY-7:

° ° °
ZC90SY-2: ～ ～

Moving range of table-top ZC25SY-5: not less than 220mm

ZC45SY-7: 250 ± 20mm
ZC90SY-2: 340 ± 20mm
Moving range of imaging device ZC25SY-5: not less than 1200mm
ZC45SY-7: 1450 ± 20mm
ZC90SY-2: 1700 ± 20mm
Tube tilt angle range - 50 °~50 °
Equivalent filtration of table-top no more than 1.2mmAl@100kV
Compressor pressure ZC25SY-5: 70N-100N
ZC45SY-7/ZC90SY-2: 70N-200N

Imaging performance
It shall have the function of keeping the last frame of
Last frame hold
fluoroscopy
Automatic fluoroscopy There shall be automatic fluoroscopy function.
Nominal incident field size of detector in x and y directions:
Nominal incident field
430mm × 430mm, the actual imaging size should be greater than
size
95% of the nominal value.
DRF-6A/7B:
fluoroscopy spatial resolution：
in maximum field of view (430mm × 430mm) : Should not be
less than 1.4lp/mm；
spatial resolution High resolution mode (200mm×200mm): Should not be less
than 2.2lp/mm；
radiography spatial resolution:
in maximum field of view (430mm×430mm): Should not be less
than 3.7lp/mm

48 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

DRF-8B,DRF-8PRO：
fluoroscopy spatial resolution:
Maximum field of view (430mm × 430mm，1364 × 1364 pixel
matrix), should not be less than 1.8lp/mm;
High resolution mode (2046 × 2046 pixel matrix), which should
not be less than 2.5lp/mm;
Radiography spatial resolution:
in maximum field of view (430mm × 430mm) :
DRF-8B, DRF-8PRO: not less than 5.0lp/mm.
The ratio of the standard deviation R of the pixel gray value at
the specified sampling point of the X -ray image to the mean
FPD image uniformity Vm
value of the pixel gray value at the specified sampling
point shall not be greater than 2.5%.
Maximum image DRF-6A/7B: 25 frames/s
acquisition rate DRF-8B/8PRO: 30 frames/s
X-ray fluoroscopy and X-ray radiography should not have
Artifact
artifacts that affect the diagnosis.

Site Requirement
Control room 1.8m×4.9m×3.2m
Operating room 3.85m×4.9m×3.2m

Power Supply
Voltage three phases 380V ， the voltage
fluctuation should be within ±10%
Frequency 50Hz
Power capacity DRF-6A:
80kVA(momentary),8kVA(Continuous)
DRF-7B/DRF-8B/8PRO:
150kVA(momentary),8kVA(Continuous)

For the parameters listed in the table, they are the basic p arameters for the
this devices, meanwhile, they are the basic parameters for the images. Some of
the parameters listed in the table above are the requirements from NMPA; the
relevant tests had been completed in the third lab. What’s more, the relevant
performances from the applicable IEC 60601-1, IEC60601-1-2, IEC60601-1-3,
IEC60601-2-28 and IEC 60601-2-54 had been tested in the third part lab also,
the performances are qualified. Because these parameters are the basic
performance to be as a R/F device, there are almost no special clinical literatures
to evaluate them, with the rational description and the compared with the

49 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

essential performances met the GSPR of MDR. DRF-6A/7B/8B/8PRO Systems

are designed based on mature technology and its performance is stable.

5.6.4 Requirement on acceptability of undesirable side-effects (GSPR 8,

GSPR 1)
1) Safety data from clinical use

The side effects on patients in DRF-6A/7B/8B/8PRO Systems examination

mainly reflect X-ray radiation. As a fluoroscopy X-ray machine, this system is
an X-ray device suitable for long-term fluoroscopy operations. During normal
use, the patient's skin dose can be high enough to cause a risk of deterministic
effects. When patients are exposed to excessive radiation, radiation damage can
occur, such as dermatitis, cataracts, hematopoietic system damage, skin cancer,
chronic radiation sickness, and so on. Therefore, all unnecessary X-ray exposure
should be avoided and the necessary exposure maintained at a reasonably
achievable minimum level. Pay attention to controlling the skin dose during
normal use, and ensure that the dose equivalent received by individuals should
not exceed the specified standards.
During X-ray irradiation, the radiation of the X-ray is directional and
controllable, which can basically ensure that only the inspected part will have
radiation, and the radiation dose is also relatively small. With the progress of
equipment technology, the radiation dose has been greatly reduced compared to
the past.
Generally speaking, the human body receives approximately 0.02
millisieverts of radiation per X-ray spot. In China's relevant regulations, the
maximum acceptable annual radiation dose for the human body is only 50
millisieverts, which poses less harm to human health. X-rays are a
"double-edged sword", but the overall benefits outweigh the disadvantages. Long
term clinical experience has proved that the amount of radiation received by
patients during routine medical X-ray examination is very small, and generally
will not cause direct injury to patients with appropriate protective measures and
professional operation.

2) PMS data from adverse events dataset

① Analysis method
Statistical and retrospective analysis of Luminos dRF Max adverse events
from the above websites was conducted to analyze the types, causes and numbers
of adverse events.
② Data analysis
a) From March 1, 2018 to March 1, 2023, MAUDE retrieved a total of 8
50 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

complaints and adverse events concerning Siemens Luminos dRF Max, all of
which were device malfunctions. The specific description and classification of
adverse events are shown in Annex 6. The classification statistics of different
causes are shown in Table 4.2.1.
Table 4.2.1 Classification of adverse event causes

No. Classification of adverse event causes Number

1 Detachment of device or device component 4

2 Unintended movement 1

3 Unintended collision 2

4 Use of device problem ( product-unrelated ) 1

There were no serious adverse events resulting in death. After analyzing the
causes of these events one by one, among the complaints and adverse events, the
detachment of device or device component accounted for the highest proportion
of 50%, which was mainly caused by the separation of foot support. The second
is unintended collision accounted for 25%, due to the incorrect setting of room
configuration parameters; unintended movement and use of device problem were
1 case each, accounting for about 13%.
b) Through a study of the European Databank on Medical Devices -
EUDAMED, we found that the data obtained from vigilance pro cedures and
clinical investigation data are stored in this database, but are not publicly
available. Therefore, the literature study of the EU is not comprehensive and
authentic.

3) PMS data from corrective action dataset related to clinical risk

① Analysis method
Statistical and retrospective analysis of Siemens Luminos dRF Max recall
events from the websites was conducted to analyze the types, causes and
numbers of adverse events.
② Data Analysis and Evaluation
a) Through the above website, we can view a total of 5 recall events of
Siemens Luminos dRF Max (510(k) No.: K173639) issued by the FDA. No
adverse events have occurred in these events. After discovering that there may be
safety risks, report to active recall. Please refer to Table 4.2.3 for classification
information and analysis results.

51 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

Table 4.2.3 Analysis results of FDA's active recalls about Luminos dRF Max
Active recalls
Description Number /%
type

Unintended Any event that may result in a collision is classified as

2/40
collision such.

Software Any event that may affect the diagnosis due to a

2/40
problem software issue is classified as this category

Detachment of Any recall that may result in the detachment of device

1/20
device or device component
Total 5/100

b) Through the above website, we can view a total of 5 field corrective

actions of Siemens Luminos dRF Max issued by the BfArM. No adverse events
have occurred in these events. After discovering that there may be safety risks,
report to active recall. Please refer to Table 4.2.4 for classification information
and analysis results.

Table 4.2.4 Analysis results of BfArM's field corrective actions about Luminos

dRF Max
Field corrective
Description Number /%
actions type
Unintended Any event that may result in a collision is classified as
1/20
collision such.

Software Any event that may affect the diagnosis due to a

3/60
problem software issue is classified as this category

Recall events not classified into the above two

Other 1/20
categories

Total 5/100
c) Through the above website, we can view a total of 3 recalls of Siemens
Luminos dRF Max issued by the Netherlands Inspectie Gezondheidszorg en
Jeugd (IGJ). No adverse events have occurred in these events. After discovering
that there may be safety risks, report to active recall. Please refer to Table 4.2.5
for classification information and analysis results.

Table 4.2.5 Analysis results of IGJ's recalls about Luminos dRF Max
52 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

Active recalls
Description Number /%
type

Unintended Any event that may result in a collision is classified as

2/67
collision such.

Detachment of Any recall that may result in the detachment of device

1/33
device or device component
Total 3/100

4) Conclusion of the safety claim

 adverse event data collection

A total of 8 complaints and adverse events related to equivalent products
were found in the MAUDE database of the United States. A statistical analysis of
these events revealed that the detachment of device or device component
accounted for 50%, followed by unintended collision at 25%, and unintended
movement and product-unrelated adverse events at 13%. The specific statistical
results are shown in Figure 4.2.1.

Figure 4.2.1 Complaints and Adverse Events Type Statistics

 Corrective actions data collection related to clinical risks

53 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

According to the official data released by FDA, there are 5 recalls of

Luminos dRF Max related to clinical risks, including 2 for unintended collision,
2 for software problem, 1 for detachment of device.
According to the official data released by BfArM, there are 5 recalls of
Luminos dRF Max related to clinical risks, including 3 for software problem, 1
for unintended collision and 1 for other type of recall.
According to the official data released by IGJ, there are 3 recalls of
Luminos dRF Max related to clinical risks, including 2 for unintended collision
and 1 for detachment of device.

6. Conclusions
DRF-6A/7B/8B/8PRO Systems has been designed and manufactured under
a quality management system developed in accordance with EN ISO 13485. Risk
management activities for this systems have been carried out in accordance with
EN ISO 14971, taking account of the content deviations to ensure compliance
with all applicable GSPR. This system has conducted a thorough assessment of
all risks related to DRF-6A/7B/8B/8PRO systems. These risks were valuated
individually and collectively as part of the overall device design. Results of this
risk evaluation demonstrate that this system dose not compromise the clinical
condition or safety of patients or the safety and health of users. Furthermore, no
new clinical risks what has been presented in this clinical evaluation report are
anticipated with this system. Therefore, the clinical benefits of this system are
expected to outweigh the potential risks related to the device.
Therefore, based on the safety and performance data of this system and
substantially equivalent devices presented in this clinical evaluation report,
when used in accordance with the IFU, this system is expected to meet its
intended use. The results of this clinical evaluation, as well as the non-clinical
safety and performance testing and risk evaluation demonstrate that this system
meets the clinically relevant GSPR in that.
The following clinically relevant parameters defined in the section 3.12
have been demonstrated:
Clinical Performance endpoints:
 Diagnosis for better treatment decision (performance)
 Usability
 Accuracy: 100%; Sensitivity: 87.2%; Specificity: 98.1%
Clinical Safety endpoints:
 Electrical safety
 Biocompatibility
 Rate of adverse events: 0%; rate of mild events: 0%; rate of moderate

54 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

events: 0%; rate of severe events: 0%.

This system is compliance to GSPR, which appears in:

 The benefit/risk profile according to current knowledge/ the state of the
art in the medical field concerned and according to available medical
alternatives is acceptable.
 The information materials supplied by the manufacture are adequate and
the intended purpose and risk reduction measures are adequate.
 The instructions for use for the intended users and usability aspects are
suitable.
 The clinical data and information materials supplied by the manufacturer
are consistence with the risk management documentation for the device
under evaluation. They are consistence with the current knowledge/ the
state of the art.

7. Date of the next clinical evaluation

The date of the next clinical evaluation is suggested December, 202 4

8. Qualification of the responsible evaluator

SN Name Techni Job Educa Profe Assign Work Unit
cal Title tion ssion ment of
Title Backg Respon
round sibility
1 PengJ Senior Directo Bache Medi Clinica Director of Radiology
ianpin Profess r of the lor cine l Dept. of Chinese PLA 371
g ional Radiolo degree Apprai Central Hospital; Chief
( 彭 建 Title gy sal and physician of 154 Central
平) Depart Evaluat Hospital;
ment, ion Working on the medical
Chief imaging for about 40
Physici years, PengJianping has
an rich experience in clinical
practice and imaging
reading. He, as a presider,
always organizes teamfor
imaging reading and
implements the
comprehensive provisions
for imaging reading of
regular X-ray, CT, MRI.
55 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

He also reviews and signs

the significant diagnosis
report, participants in
clinical consultation and
diagnosis/therapy of
intractable case, as well as
examines the
radioactivediagnosis and
therapy, projection quality
study, introduces advanced
medical technology
inside/outside the hospital
and develops scientific
research. Besides, he takes
charge in teaching task,
and engages in training
task for person in further
study and practice.
2 TuShi
Mediu Doctor- Bache Medi Clinica uzhou Medical College
qi m-grad in-char lor cine l Sichuan Provincial People
(涂诗 e ge Degre Apprai ' s Hospital Sichuan
琦) profess e sal and Ho’sOrthopedic Hospital
ional Evaluat She engages in medical
Title ion imaging for 10 years and
has rich experience in
clinical practice and
imaging reading. She
always participates in team
reading and especially has
rich clinical experience in
the imaging of DR, CT and
MRI. Besides, she always
takes part in clinical
consultation and
diagnosis/therapy of
intractable case, examines
radioactive
diagnosis/therapy and
conducts technical
communication and study
56 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

with peers.
3 Wang Engine Product Gradu Mech Product He is the product manager
Xinwe er manage ate anical technol for digital radiography and
n (王 r degree and ogy fluoroscop system and has
新文) Electr and use been engaged in the
onic system research and
Engin development for nearly 20
eerin years, having rich
g experience in R&D,
system testing and clinical
application of digital
radiography and
fluoroscop system. He has
led the system
performance test and
clinical evaluation of
several the products.
4 Yu Mediu Electric Maste Biom Product After graduating with a
Ran m-grad al r edical technol master's degree in July
( 于 e enginee degree Engin ogy 2013, She joined Wandong
苒) profess r eerin and and was responsible for
ional g use, the electrical research and
Title Regulat development of
ory angiography system and
require mammography X-ray
ments system. And she is also
responsible for collection
national and international
regulatory regularly, the
NMPA, EU and FDA
registration of the
products.

57 / 59
 js200.17.2DRF-6A/7B/8B/8PRO Clinical Evaluation Report

9. References

9.1 Documents generated of manufacturer

[1] System Manual, version: V1.0
[2] Image software Manual, version: V1.0
[3] Risk Management Documentations
[4] Rating Label and Markings, version: 1.0
[5] WDCX7302 Risk management program
[6] WDCX8301 the nonconforming product control procedure
[7] WDCX8505 Corrective action control procedure
[8] WDCX8506 preventive action control procedure
[9] WDCX7501 production and service control procedure

9.2 Full text of scientific literature

59 / 59