This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.

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 Fingertip Pulse Oximeter is powered by 2 AAA batteries. The device mainly composed of PCB board, one key, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check Fingertip Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Fingertip Pulse Oximeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (as per ISO 80601-2-61:2017)	Reported Device Performance (Subject Device)
SpO2 Accuracy (70-100%)	≤ 3.5% Arms (Root Mean Square) for SpO2 values between 70-100%	The document states "70~100%, ±2%." This likely refers to the error tolerance claimed by the manufacturer which is tighter than the ISO standard. The clinical study section 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. Clinical test results support device accuracy claims for the specified saturation range." implying that the device met acceptable accuracy within the specified range.
SpO2 Accuracy (<70%)	Unspecified (as per the standard)	Unspecified
Pulse Rate Accuracy	±3 bpm (The predicate has ±1bpm but the subject device states ±3bpm)	±3bpm (As per the subject device specifications)
Pulse Rate Range	25 bpm – 250 bpm (subject device)	25 bpm – 250 bpm

2. Sample Size for Test Set and Data Provenance

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."

Sample Size for Test Set: The exact number of human adult volunteers is not specified in the provided text.
Data Provenance: The study involved human adult volunteers, suggesting a prospective study. The country of origin is not explicitly mentioned.

3. Number of Experts and Qualifications for Ground Truth

The document mentions "co-oximetry" as the method for determining arterial oxygen saturation (SaO2) which is the ground truth. This is an objective measurement from a laboratory instrument.
No information is provided about the number of experts or their qualifications as establishing ground truth was done through a laboratory instrument (co-oximetry), not subjective expert assessment.

4. Adjudication Method for the Test Set

Since ground truth was established through objective co-oximetry measurements, an adjudication method like 2+1 or 3+1 by human experts is not applicable and therefore not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This device is a standalone measurement device (Fingertip Pulse Oximeter) and does not involve human readers interpreting output with or without AI assistance. The performance evaluation focuses on the device's accuracy against a gold standard (co-oximetry) in measuring SpO2 and pulse rate.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone performance study was done. The entire clinical study described is focused on the device's inherent accuracy in measuring SpO2 and pulse rate without human intervention beyond application of the device and co-oximetry measurement.

7. Type of Ground Truth Used

The ground truth used was outcomes data (specifically, arterial oxygen saturation (SaO2) as determined by co-oximetry). Co-oximetry is considered a highly accurate and objective method for measuring arterial oxygen saturation.

8. Sample Size for the Training Set

Not applicable / Not explicitly mentioned. The provided document describes a premarket notification (510(k)) for a medical device that measures physiological parameters. It does not indicate the use of machine learning or AI models that would typically require a training set. The device appears to operate based on established physiological principles and signal processing algorithms, not a deep learning model.

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

Not applicable. As mentioned above, there is no indication of a training set for machine learning in this context.

Summary

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December 30, 2022

Shenzhen Witleaf Medical Electronics 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: K213430

Trade/Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 18, 2022 Received: November 18, 2022

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

James J. Lee -S

James J. Lee, Ph.D. 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213430

Device Name Fingertip Pulse Oximeter

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

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2021/11/17

1. Submission sponsor

Name: Shenzhen Witleaf Medical Electronics Co., Ltd. Address: 13/F-B2, Block 1, Senyang Science Park, No.7 Road, West District of High-Tech Park, Guangming, Shenzhen City, Guangdong, 518109 P.R. China Contact person: Wu Tao Title: Management Representative E-mail: wutao@szwitleaf.com Tel: +86-755 21384132

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	Fingertip Pulse Oximeter
Model	WIT-S200, WIT-S400
Common Name	Fingertip Pulse Oximeter
Regulatory Class	Class II
Classification	21CFR 870.2700 / Oximeter / DQA
Submission type	Traditional 510(K)

3 Subiect Device Information

4. Predicate Device

Manufacturer: Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd Device name: Pulse Oximeter, A2, A3, A4, A5 510(K) Number: K203854

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

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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 Fingertip Pulse Oximeter is powered by 2 AAA batteries. The device mainly composed of PCB board, one key, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check Fingertip Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

6. Intended use & Indication for use

Features	Subject Device	Predicate Device K203854	Comparison
	Fingertip Pulse OximeterWIT-S200, WIT-S400	Pulse Oximeter, Model: A2, A3, A4, A5
Applicant	Shenzhen Witleaf MedicalElectronics Co., Ltd.	Shenzhen Hexin ZONDANMedical Equipment Co., Ltd.	/
ClassificationRegulation	21CRF 870.2700	21CRF 870.2700	Same
Classificationand Code	Class II, DQA	Class II, DQA	Same
Prescription orOTC	Prescription	Prescription	Same
Intended use	This Fingertip Pulse Oximeteris non-invasive deviceintended for spot-checking offunctional oxygen saturation ofarterial hemoglobin (SpO2)and pulse rate (PR). It isindicated for adult patients inhome and hospitalenvironment. The device is not	The Pulse Oximeter is intendedfor measuring the functionaloxygensaturation and pulse rate (PR)through apatient's finger. It is applicable forspot-checking SpO2 and pulserate (PR) of adult and pediatricpatients in homes and clinics.	Same
Indication foruse	intended for continuousmonitoring, use during motionor use with low perfusion.	The Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen	Same
Features	Subject Device	Predicate Device K203854	Comparison
	Fingertip Pulse OximeterWIT-S200, WIT-S400	Pulse Oximeter, Model: A2, A3, A4, A5saturation of arterial hemoglobin(SpO2) and pulse rate (PR). Theportable fingertip device isindicated for adult and pediatricpatients in home and hospitalenvironment(including clinicaluse in internist/surgery,anesthesia, intensive care, etc.)
Designprinciple	A mathematical formula is established making use of Lambert BeerLaw according to Spectrum Absorption Characteristics of Reductivehemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and near-infrared zones. Operationprinciple of the instrument: Photoelectric OxyhemoglobinInspection Technology is adopted in accordance with CapacityPulse Scanning and Recording Technology, so that two beams ofdifferent wavelength of lights can be focused onto a human nail tipthrough a clamping finger-type sensor. A measured signal obtainedby a photosensitive element, will be shown on the Oximeter'sdisplay through process in electronic circuits and microprocessor.		Same
Environmentofuse	Home and Hospital	Home and Hospital	Same
Patientpopulations	adult	adult or pediatric	different
Motioncondition	Not applicable	Not applicable	Same
Perfusioncondition	Not applicable for lowperfusion	Not applicable for low perfusion	Same
Type of SpO2Sensor	Transmittance Optical Sensor	Transmittance Optical Sensor	Same
ApplicationSite	Fingertip	Fingertip	Same
Light Emitting	Red: 660 nmInfrared: 905nm	Red: 660 nmInfrared: 905nm	Same
SpO2MeasuringRange	0%-100%	0%-100%	Same
SpO2	1%	1%	Same
Features	Subject Device	Predicate Device K203854	Comparison
	Fingertip Pulse OximeterWIT-S200, WIT-S400	Pulse Oximeter, Model: A2, A3,A4, A5
Resolution
SpO2	70~100%, ±2%.	70~100%, ±2%.	Same
Accuracy	<70%, unspecified.	<70%, unspecified.
PR Range	25 bmp – 250 bmp	30 bmp – 240 bmp	different
PR Accuracy	±3bpm	±1bpm
PR Resolution	1 bpm	1 bpm	Same
Power source	2*AAA 1.5V alkalinebattery	2*AAA 1.5V alkalinebattery	Same
Type ofProtection	Internal Powered	Internal Powered	Same
Degree ofProtection –sensor	Type BF – applied part	Type BF – applied part	Same
Contactingmaterial	ABS for enclosure, silicone forclip	ABS for enclosure, silicone forclip	Same
Contact type	Skin surface-contacting	Skin surface-contacting	Same
Patient ContactMaterials	Complies with ISO10993-1	Complies with ISO10993-1	Same
Operating	Temperature: :10°C~~40°CRelative Humidity :30%~~75%Atmospheric pressure:700hPa~1060hPa	Temperature: 5°C ~ 40°CHumidity: 30% ~ 80% (non-condensing)Atmospheric pressure: 70kPa ~106kPa	different
Storage	Temperature :-40°C~+60°CRelative humidity :5%~~95%Atmospheric pressure:500hPa~~1060hPa	Temperature: -20°C ~ +55°CHumidity:10% ~ 93% (non-condensing)Atmospheric pressure:70kPa ~ 106kPa	different

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.

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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 .

Non-clinical data

The 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 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 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).