This Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check of SpO2, PR of adult or pediatric patients (weight >=40kg) in home. This device is not intended for continuous monitoring. It is intended to be used by both lay person or healthcare professional in the home environment.

Device Description

The Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The 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 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&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

The provided FDA 510(k) summary for the Pulse Oximeter (Model: PO101, PO102, PO103) includes information about acceptance criteria and a study to demonstrate performance.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Metric	Acceptance Criteria (Stated)	Reported Device Performance
SpO2 Accuracy (70%-100%)	ARMS ±3%	ARMS ±3%
SpO2 Accuracy (<70%)	Unspecified	Unspecified
SpO2 Resolution	1%	1%
PR Range	30 bpm – 250 bpm	30 bpm – 250 bpm
PR Resolution	1 bpm	1 bpm
PR Accuracy	±2bpm or ±2% (select larger)	±2bpm or ±2% (select larger)

Notes on the table:

The document explicitly states the "SpO2 Accuracy" and "PR Accuracy" directly as acceptance criteria within the comparison table between the subject and predicate devices.
The "Reported Device Performance" for these parameters is shown to match the acceptance criteria, indicating the device meets them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated in the provided document. The document mentions "human adult volunteers" for the clinical hypoxia test.
Data Provenance: Not explicitly stated in the provided document. The manufacturer and correspondent are based in China, but the location of the clinical study is not specified. The study was prospective in nature as it involved deliberately inducing hypoxia in human volunteers.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable in this context. The "ground truth" for oxygen saturation (SpO2) in pulse oximetry studies is typically established by arterial blood gas analysis (co-oximetry), not by expert consensus. The document states: "Clinical 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."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret medical images or data and their interpretations need to be reconciled to establish a consensus ground truth. In pulse oximetry, the gold standard (co-oximetry) is an objective measurement, not subject to interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers are assisted by AI. The Pulse Oximeter is a standalone medical device that provides readings of SpO2 and PR, not an AI-assisted diagnostic tool for human interpretation.

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

Yes, a standalone performance study was done. The entire clinical study for the Pulse Oximeter is inherently a standalone performance evaluation, as the device itself is measuring SpO2 and PR, and its readings are compared against the gold standard (co-oximetry) without human interpretation in the loop impacting the device's measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used was arterial oxygen saturation (SaO2) as determined by co-oximetry. This is considered the gold standard for measuring oxygen saturation directly from arterial blood.

8. The sample size for the training set

Not applicable. This device is a traditional medical device, not an AI/machine learning model that requires a "training set" in the computational sense. Its performance is based on its physical and optical design, algorithms for signal processing, and calibration during manufacturing.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of this traditional medical device.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

February 25, 2022

Shenzhen Mericonn Technology 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: K212300

Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: February 25, 2022 Received: February 23, 2022

Dear Kevin Wang:

We have reviewed vour 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

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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 and Part 809); 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-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 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K212300

Device Name

Pulse Oximeter (Model: PO101, PO102, PO103)

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)

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5 510(k) Summary

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2022/2/7

1. Submission sponsor

Name: Shenzhen Mericonn Technology Co., Ltd. Address: Room 20203, Building 6, Donglongxing Kejiyuan, Huaning Road, Xinshishequ, Dalang Street, Longhua district, Shenzhen City, Guangdong, 518109 P.R. China Contact person: Jiang Chuanyuan Title: General manager E-mail: info@digitalems.net Tel: 0086 13928416535

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

Trade/Device Name	Pulse Oximeter
Model	PO101, PO102, PO103
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 Creative Industry Co., Ltd. Device name: Pulse Oximeter, AP-10 510(K) Number: K201468

ട്. Device Description

The Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The 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

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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 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&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

This Pulse Oximeter is intended for measuring and recording the functional oxygen saturation (SpO2) and pulse rate (PR).

It is intended for spot check of SpO2, PR of adult or pediatric patients (weight >=40kg) in hospitals, clinics, or home. This device is not intended for continuous monitoring. It is intended to be used by both lay person or healthcare professional in the home environment.

Features	Subject Device	Predicate Device	Comparison
	Pulse Oximeter,PO101/PO102/PO103	K201468Pulse Oximeter, AP-10
Applicant	Shenzhen MericonnTechnology Co., Ltd.	Shenzhen CreativeIndustry Co., Ltd.	/
ClassificationRegulation	21CRF 870.2700	21CRF 870.2700	Same
Classificationand Code	Class II, DQA	Class II, DQA	Same
Commonname	Pulse Oximeter	Pulse Oximeter	Same
Intended use	This Pulse Oximeter isintended formeasuring andrecording thefunctional oxygensaturation (SpO2) andpulse rate (PR).It is intended for spotcheck of SpO2, PR ofadult or pediatric	This Pulse Oximeter isintended for measuringand recording thefunctional oxygensaturation (SpO2) andpulse rate (PR). It isintended for spot checkand continuous recordingof SpO2, PR of adult orpediatric patients in	The subject devicesdo not supportcontinuous recordingcompared with thepredicate, but the restis the same. Thedifference does notraise any safety andeffectivenessquestions.
Features	Subject Device	Predicate DeviceK201468	Comparison
	Pulse Oximeter,PO101/PO102/PO103patients in hospitals,clinics, or home. Thisdevice is not intendedfor continuousmonitoring. It isintended to be used byboth lay person orhealthcareprofessional in thehome environment.	Pulse Oximeter, AP-10hospitals, clinics, orhome.This device is notintended for continuousmonitoring.
Patientpopulations	adult or pediatric	adult or pediatric	Same
Type ofSpO2 Sensor	Transmittance OpticalSensor	Transmittance OpticalSensor	Same
ApplicationSite	Finger	Finger	Same
LightEmitting	Red: 660 nmInfrared: 905nm	Red: 660 nmInfrared: 905nm	Same
MeasuringMode	Spot-check	Spot-check andContinuous recording	Different
SpO2MeasuringRange	35%-100%	0%-100%	Different
SpO2Resolution	1%	1%	Same
SpO2Accuracy	70~100%,ARMS±3%.<70%, unspecified.	70~100%, ±3%.<70%, unspecified;	Same
PR Range	30 bmp – 250 bmp	30 bmp – 250 bmp	Same
PRResolution	1 bpm	1 bpm	Same
PR Accuracy	±2bpm or±2% selectlarger	±2bpm or ±2%(whichever is greater)	Same
Power source	2 AAA alkalinebatteries	Rechargeable Lithium-Ion Polymer Battery(3.7V,500mAh)	Different
Data update	/	USB, Bluetooth	Different
Features	Subject Device	Predicate Device	Comparison
	Pulse Oximeter,PO101/PO102/PO103	K201468Pulse Oximeter, AP-10
Type ofProtection	Internal Powered	Internal Powered	Same

7. Comparison to the Predicate Device

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In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness.

8. Performance Data

The following performance data were provided in support of the substantial equivalence determination. Software

Software verification and validation were provided in compliance with FDA Guidance for the Content of the Premarket Submission for Software Contained in Medical Devices. These verifications and validations demonstrate that the subject device work functionally and the software for the device is considered as a "moderate" level of concern, as defined by the FDA guidance.

Biocompatibility testing

The biocompatibility evaluation for the 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 biocompatibility 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 Pulse Oximeter has been tested according to the following standards:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 . (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
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 Edition 2.0 2015-01Medical 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 .

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Basic Safety and Essential Performance of Pulse Oximeter Equipment.

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 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).