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.

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 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 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, OLED or LED 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.

AI/ML Overview

Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and the study proving the device meets them:

The document is a 510(k) Premarket Notification for a Fingertip Pulse Oximeter (Model LT-F20 and LT-F21). It seeks to demonstrate substantial equivalence to a legally marketed predicate device. The core of the performance data revolves around meeting established standards for pulse oximeters.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the ISO 80601-2-61:2017 standard for pulse oximeter equipment, which the subject device claims compliance with. The reported performance is directly stated.

Parameter	Acceptance Criteria (from ISO 80601-2-61)	Reported Device Performance
SpO2 Accuracy	70% ~ 100%, Arms ± 3%. <70%, unspecified.	70% ~ 100%, Arms ± 3%. <70%, unspecified.
SpO2 Measuring Range	35%-100%	35%-100%
SpO2 Resolution	1%	1%
PR Range	30 bpm – 250 bpm	30 bpm – 250 bpm
PR Resolution	1 bpm	1 bpm
PR Accuracy	Varies (Predicate: ±2 bpm)	±1% or ±3bpm, whichever is greater

Note on PR Accuracy: The document explicitly highlights a difference in PR accuracy between the subject and predicate devices. While the predicate states "±2", the subject device states "±1% or ±3bpm, whichever is greater." The manufacturer justifies this difference by stating, "The PR measurement has been verified according to declared range and accuracy. Thus, this difference does not raise different questions of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document states that "Clinical hypoxia test results were obtained in human adult volunteers." However, it does not specify the exact number of subjects or the sample size used for the clinical test set.
Data Provenance: The data is described as collected from "human adult volunteers." The document doesn't explicitly state the country of origin, but given the manufacturer's location (Zhuhai Linte Medical Instrument Co., Ltd. in China), it's highly probable the study was conducted there. The clinical study is described as having been performed under an "approved protocol with subject informed consent," implying a prospective data collection.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. It mentions "co-oximetry," which is an objective measurement, not expert consensus.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The primary ground truth for oxygen saturation (SpO2) is stated as "arterial oxygen saturation (SaO2) as determined by co-oximetry," which is an objective, quantitative measurement technique and does not typically require human adjudication in the same way as, for example, image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document describes the validation of a medical device (pulse oximeter) against physiological measurements and established standards, not a comparative effectiveness study involving human readers and AI assistance for interpretation. Therefore, there is no discussion of MRMC studies or effect sizes of human reader improvement with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, implicitly. The core of the product is an automated measurement device. The clinical study evaluated the device's accuracy (its "algorithm" or measurement capability) in determining SpO2 and PR against a "human reference standard" (arterial co-oximetry). The device itself functions without human interpretation of its raw sensor data to produce the SpO2 and PR readings.

7. The Type of Ground Truth Used

The ground truth for SpO2 accuracy was "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is an objective, gold-standard laboratory measurement for hemoglobin derivatives.

8. The Sample Size for the Training Set

This document describes a premarket notification for a hardware device (pulse oximeter) with embedded software/firmware for calculating SpO2 and PR. While such devices have internal algorithms, the document does not discuss a "training set" in the context of machine learning/AI models that might have distinct training and test phases. The performance validation is described as a clinical study evaluating the device's output against a reference standard. If an internal algorithm was developed using a dataset, that information is not provided here.

9. How the Ground Truth for the Training Set was Established

As no specific "training set" for an AI/ML model is mentioned, there is no information on how its ground truth was established. The clinical study described is for performance validation, not algorithm training.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

{1}------------------------------------------------

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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K210274

Device Name

Fingertip Pulse Oximeter, model: LT-F20 and LT-F21

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

_ 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 PRAStaff@fda.hhs.gov

"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 Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

{3}------------------------------------------------

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: mark.ma(@)lintemed.com

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: kevin(@chonconn.com

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)

3. Subject Device Information

4. Predicate Device

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

ട്. 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

{4}------------------------------------------------

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 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, OLED or LED 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 lifesupporting or life-sustaining.

6. Intended use & Indication for use

	7. Comparison to the Predicate Device
Features	Subject Device	Predicate Device K190869AEON Pulse Oximeter	Comparison
	Fingertip Pulse Oximeter		n
Applicant	Zhuhai Linte MedicalInstrument Co., Ltd.	Shenzhen Aeon TechnologyCo., Ltd.	/
ClassificationRegulation	21CRF 870.2700	21CRF 870.2700	Same
Classification andCode	Class II, DQA	Class II, DQA	Same
Common name	Fingertip Pulse Oximeter	Fingertip Pulse Oximeter	Same
Intended use	The Fingertip Pulse Oximeteris a non-invasive deviceintended for spot checking offunctional oxygen saturation ofarterial hemoglobin (SpO2)and pulse rate (PR). Thisportable device is indicated foruse in adult patients in clinicalinstitution and homeenvironments.	The Pulse Oximeter is a non-invasive device intended forspot checking of functionaloxygen saturation of arterialhemoglobin (SpO2) and pulserate (PR). This portable deviceis indicated for use in adultpatients in clinical institutionand home environments.	Same
Patient populations	Adults	Adults	Same
Principle	The device displays numericalvalues for functional oxygensaturation of arterialhemoglobin (SpO2) and pulse	The device displays numericalvalues for functional oxygensaturation of arterialhemoglobin (SpO2) and pulse	Same
Features	Subject DeviceFingertip Pulse Oximeter	Predicate Device K190869AEON Pulse Oximeter	Comparison
	rate by measuring theabsorption of red and infrared(IR) light passing throughperfused tissue. Changes in theabsorption caused by thepulsation of blood in thevascular bed are used todetermine oxygen saturationand pulse rate.	rate by measuring theabsorption of red and infrared(IR) light passing throughperfused tissue. Changes in theabsorption caused by thepulsation of blood in thevascular bed are used todetermine oxygen saturationand pulse rate.
Light Emitting	Red: 660 nmInfrared: 905 nm	Red: 660 nmInfrared: 905nm	Same
Power source	2 AAA alkaline batteries	2 AAA alkaline batteries	Same
Display data	SpO2%, PR	SpO2%, PR	Same
SpO2 MeasuringRange	35%-100%	35%-100%	Same
SpO2 Resolution	1%	1%	Same
SpO2 Accuracy	70% ~ 100%, Arms ± 3%.<70%, unspecified.	70~ 100%, ±3%.<70%, unspecified;	Same
PR Range	30 bmp – 250 bmp	30 bmp – 250 bmp	Same
PR Resolution	1 bpm	1 bpm	Same
PR Accuracy	±1% or ±3bpm, whichever isgreater	± 2	Different (1)
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 80601-2-61	Complied with ISO 80601-2-61	Same
Biocompatibility	Cytotoxicity	Complied with ISO 10993-5	Same
	Skin Irritation	Complied with ISO 10993-10	Same
	Sensitization	Complied with ISO 10993-10	Same

7 Comparison to the Predicate Device

{5}------------------------------------------------

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.

{6}------------------------------------------------

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

{7}------------------------------------------------

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.

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).