July 30, 2021

Zhuhai Linte Medical Instrument Co., Ltd.

℅ Kevin Wang
Consultant
Chonconn Medical Device Consulting Co., Ltd.
Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District,
Shenzhen, Guangdong 518067
China

Re: K210274
Trade/Device Name: Fingertip Pulse Oximeter, Model LT-F20 and LT-F21
Regulation Number: 21 CFR 870.2700
Regulation Name: Oximeter
Regulatory Class: Class II
Product Code: DQA
Dated: June 29, 2021
Received: July 2, 2021

Dear Kevin Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal

U.S. Food & Drug Administration

10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 .04 .2 7
Silver Spring, MD 20993
www.fda.gov
K210274 - Kevin Wang Page 2

statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturin g practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation -emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,
Todd D. Courtney -S
Todd Courtney
Assistant Director
DHT1C: Division of ENT, Sleep Disordered
Breathing, Respiratory and
Anesthesia Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 Al Response to Deficiency K210274-SO01

DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (ifknown)

K210274
Device Name
Fingertip Pulse Oximeter , model: LT-F20 and LT-F21

Indications for Use (Describe)

The Fingertip Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of
arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical
institution and home environments.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D) E Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (6120) Page 1 of 1 PSC Publishing Servies (301) 443-6740 EF

Section 2 IFU Statement 2 2

 K210274 Page 1 of 5

510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2021/07/25

1. Submission sponsor
Name: Zhuhai Linte Medical Instrument Co., Ltd.
Address: 4th Floor, Building 1, No.66, Yongda Road, Hongqi Town, Jinwan District, Zhuhai, Guangdong
519090 P.R. China
Contact person: Kezheng Ma
Title: Management Representative
E-mail: [email protected]
Tel: +86 135 30230360

2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R.
China 518067
Contact person: Kevin Wang
E-mail: [email protected]
Tel: +86-755 33941160

3. Subject Device Information

Trade/Device Name Fingertip Pulse Oximeter
Model LT-F20 and LT-F21
Common Name Fingertip Pulse Oximeter
Regulatory Class Class II
Classification 21CFR 870.2700 / Oximeter / DQA
Submission type Traditional 510(K)

4. Predicate Device
Manufacturer: Shenzhen Aeon Technology Co., Ltd.
Device name: Pulse Oximeter
510(K) Number: K190869

5. Device Description
The Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation
of arterial hemoglobin (SpO2) and pulse rate (PR).
The Fingertip Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor
contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red
light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a
 K210274 Page 2 of 5

constant amount of light over time. The photodetector in finger sensor collects and converts the light into
electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and
absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The
ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This
measurement is referred to as SpO2. The Pulse Oximeter is powered by 2 AAA alkaline batteries.
The device mainly composed of PCB board, On/Off button, mode button, OLED or LED screen, battery
compartment, and plastic shell.
The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-
supporting or life-sustaining.

6. Intended use & Indication for use

The Fingertip Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in
adult patients in clinical institution and home environments.

7. Comparison to the Predicate Device

Features Subject Device Predicate Device K190869 Compariso
Fingertip Pulse Oximeter AEON Pulse Oximeter n
Applicant Zhuhai Linte Medical Shenzhen Aeon Technology /
Instrument Co., Ltd. Co., Ltd.
Classification 21CRF 870.2700 21CRF 870.2700 Same
Regulation
Classification and Class II, DQA Class II, DQA Same
Code
Common name Fingertip Pulse Oximeter Fingertip Pulse Oximeter Same
Intended use The Fingertip Pulse Oximeter The Pulse Oximeter is a non- Same
is a non-invasive device invasive device intended for
intended for spot checking of spot checking of functional
functional oxygen saturation of oxygen saturation of arterial
arterial hemoglobin (SpO2) hemoglobin (SpO2) and pulse
and pulse rate (PR). This rate (PR). This portable device
portable device is indicated for is indicated for use in adult
use in adult patients in clinical patients in clinical institution
institution and home and home environments.
environments.
Patient populations Adults Adults Same
Principle The device displays numerical The device displays numerical Same
values for functional oxygen values for functional oxygen
saturation of arterial saturation of arterial
hemoglobin (SpO2) and pulse hemoglobin (SpO2) and pulse
 K210274 Page 3 of 5

Features Subject Device Predicate Device K190869 Compariso

Fingertip Pulse Oximeter AEON Pulse Oximeter n
rate by measuring the rate by measuring the
absorption of red and infrared absorption of red and infrared
(IR) light passing through (IR) light passing through
perfused tissue. Changes in the perfused tissue. Changes in
absorption caused by the the absorption caused by the
pulsation of blood in the pulsation of blood in the
vascular bed are used to vascular bed are used to
determine oxygen saturation determine oxygen saturation
and pulse rate. and pulse rate.
Light Emitting Red: 660 nm Red: 660 nm Same
Infrared: 905 nm Infrared: 905nm
Power source 2 AAA alkaline batteries 2 AAA alkaline batteries Same
Display data SpO2%, PR SpO2%, PR Same
SpO2 Measuring 35%-100% 35%-100% Same
Range
SpO2 Resolution 1% 1% Same
SpO2 Accuracy 70% ~ 100%, Arms ± 3%. 70 ~ 100%, ±3%. Same

<70%, unspecified. <70%, unspecified;

PR Range 30 bmp – 250 bmp 30 bmp – 250 bmp Same
PR Resolution 1 bpm 1 bpm Same
PR Accuracy ±1% or ±3bpm, whichever is ±2 Different (1)
greater
Sterile No No Same
Application site Finger Finger Same
Electrical Safety Complied with IEC 60601-1 Complied with IEC 60601-1 Same
EMC Complied with IEC 60601-1-2 Complied with IEC 60601-1-2 Same
Performance Complied with ISO 80601-2- Complied with ISO 80601-2- Same
61 61
Cytotoxicity Complied with ISO 10993-5 Complied with ISO 10993-5 Same
Biocompatibility

Skin Irritation Complied with ISO 10993-10 Complied with ISO 10993-10 Same
Sensitization Complied with ISO 10993-10 Complied with ISO 10993-10 Same

Justifications for differences between proposed device and the predicate device are shown as below:
Different (1): The accuracy of PR is different. The PR measurement has been verified according to
declared range and accuracy. Thus, this difference does not raise different questions of safety and
effectiveness.
 K210274 Page 4 of 5

8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing
The biocompatibility evaluation for the Fingertip Pulse Oximeter was conducted in accordance with the
FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO
10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process". The battery of testing included the following tests:
⚫ Cytotoxicity
⚫ Sensitization
⚫ Irritation
The subject devices are considered surface contacting for a duration of not exceed 24 hours.

Non-clinical data
The Fingertip Pulse Oximeter has been tested according to the following standards:
⚫ IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment-
Part 1: General requirements for basic safety and essential performance
⚫ IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic
safety and essential performance- Collateral standard: Electromagnetic compatibility-
Requirements and tests
⚫ IEC 60601-1-11: 2015, Medical electrical equipment- Part 1-11: General requirements for basic
safety and essential performance- Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment.
⚫ ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for
Basic Safety and Essential Performance of Pulse Oximeter Equipment.
⚫ FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical
Devices.
⚫ FDA Guidance for Pulse Oximeters - Premarket Notification Submissions [510(k)s]
The test was selected to show substantial equivalence between the subject device and the predicate.

Clinical data
Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were
conducted per following standards:
⚫ ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for
Basic Safety and Essential Performance of Pulse Oximeter Equipment.
⚫ Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and
Drug Administration Staff
Clinical testing has been performed under an approved protocol with subject informed consent. Clinical
 K210274 Page 5 of 5

hypoxia test results were obtained in human adult volunteers to validate the accuracy of Pulse Oximeter
versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device
accuracy claims for the specified saturation range.

9. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject
device is substantially equivalent to the predicate device.