The pulse oximeter (YK-81C ) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult and pediatric in clinic environment. This medical device can be reused. Not for continuously monitoring,

Device Description

The proposed device, fingertip pulse oximeter, YK-81C, can display SpO2%, pulse rate value, and vertical bar graph pulse amplitude;

The pulse oximeter, YK-81C, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring.

The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically a Fingertip Pulse Oximeter (Model YK-81C). While it describes the device, its intended use, and a clinical study for SpO2 accuracy, it does not present a formal table of "acceptance criteria" for the device's performance in the typical sense of a pre-defined set of metrics that must be met. Instead, it describes compliance with recognized standards and presents the results of a specific performance test.

Here's an attempt to extract and synthesize the information based on your request, with an understanding that the document isn't structured around explicit "acceptance criteria" in a table format but rather demonstrates compliance and performance results.

I. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with the relevant ISO standard for pulse oximeters regarding SpO2 accuracy.

Metric (Implicit Acceptance Criteria)	Reported Device Performance (YK-81C)
SpO2 Accuracy (Arms) for 70-100% SaO2	2.53%
(Implicit acceptance criteria based on ISO 80601-2-61:2011 Appendix EE.2)	(This value indicates the accuracy of the device based on the study)
SpO2 Measurement Range	0-100%
SpO2 Accuracy (stated specification)	70%~100%, ±3%
SpO2 Resolution	±1%
PR Measurement Range	30-254 bpm
PR Accuracy	±2 bpm
PR Resolution	±1 bpm
Electrical Safety	Complies with IEC 60601-1
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2
Biocompatibility	Complies with ISO 10993-1
Labeling	Conforms to FDA Regulatory Requirements

Note on Acceptance Criteria: The document does not explicitly state an "acceptance criteria" value for the SpO2 accuracy (Arms) that the device must be less than or equal to. However, the study was performed according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 "Procedure for invasive laboratory testing on healthy volunteers." This standard outlines the methodology for evaluating pulse oximeter accuracy, and the resulting Arms value is used to demonstrate performance. Typically, a lower Arms value indicates better accuracy, and regulatory bodies often have an expectation around this value based on the standard. For many pulse oximeters, an Arms value of 3.0% or less in the 70-100% range is often considered acceptable for regulatory clearance. The reported 2.53% falls within typical acceptable ranges.

II. Study Details

Sample Size used for the Test Set and Data Provenance:
- Sample Size: 12 healthy adult volunteer subjects.
- Data Provenance: The study was conducted in a laboratory setting (likely in China, given the manufacturer's location, though not explicitly stated for the study site). It was a prospective study involving induced hypoxia.
Number of Experts used to establish the Ground Truth for the Test Set and the Qualifications of those Experts:
- The document does not specify the number of experts used to establish ground truth or their qualifications.
- The ground truth was established by arterial blood CO-Oximetry, a laboratory analytical method, not by human expert assessment.
Adjudication Method for the Test Set:
- Not applicable / None directly stated. The ground truth (SaO2) was determined by an objective lab measurement (CO-Oximetry) of arterial blood samples, not by expert consensus or adjudication. The device's SpO2 readings were compared to these objective measurements.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was NOT done. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. For a pulse oximeter, the primary evaluation is device accuracy against a physiological reference.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The clinical trial evaluated the device's SpO2 accuracy performance by comparing its readings directly to arterial blood CO-Oximetry. While a human applies the device, the performance metric (Arms) is a direct measure of the device's algorithmic output against the physiological reference.
The Type of Ground Truth Used:
- Outcomes Data / Physiological Standard (Arterial Blood CO-Oximetry): The ground truth for SpO2 accuracy was established by analyzing arterial blood samples using a reference CO-Oximeter, which provides functional SaO2. This is considered the gold standard for SpO2 accuracy assessment in pulse oximetry.
The Sample Size for the Training Set:
- Not applicable / Not stated in the context of this document. This document describes a 510(k) submission for a finished medical device. The clinical study described is a validation study (test set) for the device's accuracy, not a study for training an AI model. Pulse oximeters typically rely on well-established physiological principles and calibrations, not 'training data' in the machine learning sense, although their internal algorithms are developed and refined using extensive data. The document focuses on proving the device's performance against a standard after its design and internal algorithms are finalized.
How the Ground Truth for the Training Set was Established:
- Not applicable. As mentioned in point 7, there's no "training set" described in the context of this 510(k) document. The device's internal algorithms would have been developed and calibrated by the manufacturer, likely using proprietary methods and data, but this information is not part of the regulatory submission's clinical performance evaluation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 8, 2017

Xuzhou Yongkang Electronic Science Technology Co., Ltd % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd. Li Yuan Town, Tongzhou District, Beijing, 101121 CHINA

Re: K161938

Trade/Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 26, 2017 Received: March 30, 2017

Dear Ray 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. 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.

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Page 2 - Ray Wang

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation 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)

K161938

Device Name Fingertip Pulse Oximeter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K161938

1. Date of Preparation
  03/27/2017
Sponsor 2.

Xuzhou Yongkang Electronic Science Technology Co., Ltd

4F Building C8, 40 Jingshan Road, Econonic and Technolgical Development Zone, Xuzhou, Jiangsu, China Establishment Registration Number: Not yet registered or the Number Contact Person: YanLi Li Position: General Manager Tel: 86-516- 87892766-631 Fax:86- 516-87892766 -606 Email: lyl@yonker.cn

Submission Correspondent 3.
Mr. Ray Wang

Beijing Believe Technology Service Co., Ltd.

5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China Tel: +86-21-50313932 Fax: +86-21-68093116 Email: ray.wang@believe-med.com

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4. Identification of Proposed Device

Trade Name: Fingertip Pulse Oximeter Common Name: Pulse Oximeter Model(s): YK-81C

Regulatory Information: Classification Name: Oximeter Classification: II; Product Code: DQA; Regulation Number: 21 CFR 870.2700; Review Panel: Anesthesiology;

Intended Use Statement:

The pulse oximeter, YK-81C, is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.

Device Description 5.
The proposed device, fingertip pulse oximeter, YK-81C, can display SpO2%, pulse rate value, and vertical bar graph pulse amplitude;

The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.

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6. Identification of Predicate Device

Predicate 1# 510(k) Number: K142687 Product Name: Pulse Oximeter Manufacturer: Shanghai Berry Electronic Tech Co., Ltd.

Predicate 2# 510(k) Number: K093757 Product Name: MD300C1 Fingertip pulse oximeter Manufacturer: Beijing Choice Electronic Technology Co., Ltd

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2012, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance.

IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

ISO 80601-2-61:2011, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.

ISO 10993-10: 2010. Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

IEC 60601-1-8:2012 Medical electrical equipment General requirements for safety - for collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

Performance Test: SpO2 and PR accuracy/SpO2 and PR accuracy under low perfusion/SpO2 and PR accuracy test after cleaning and low-level disinfection (500 times)

Performance Test: Vertical Pulse Amplitude feature.

Performance Test: Finger Off and Low Battery indicator.

8. Clinical Test Conclusion

The clinical trial was performed according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers.

The purpose of the clinical trial was to evaluate the SpO2 accuracy performance of the YK-80C

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Fingertip Pulse Oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry.

After Institutional Review Board (IRB) approval, 12 healthy adult volunteer subjects (ages 21-28yr, 46-74kg, 156-176cm, with light to dark pigmentation) were included in the study conducted Nov. 27-29, 2015 to evaluate the SpO2 accuracy performance of proposed devices.

Each system was evaluated during steady state/non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison.

The SpO2 accuracy performance results showed the fingertip pulse oximeter to have an Arms of 2.53 (YK-81C) during steady state conditions over the range of 70-100%.

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ITEM	Proposed DeviceFingertip Pulse Oximeter(YK-81C)	Predicate DevicePulse Oximeter (BM1000A &BM2000A)	Predicate Device MD300C1Fingertip pulse oximeter
Product Code	DQA	DQA	DQA
Regulation No.	21 CFR 870.2700	21 CFR 870.2700	21 CFR 870.2700
Class	2	2	2
Indications ForUse	The pulse oximeter (YK-81C) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.	The pulse oximeter (BM1000A & BM2000A) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.	MD300C1 Finger pulse oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/ surgery, anesthesia, intensive care and etc). Not for continuously monitoring.
Application Site	Fingertip	Fingertip	Fingertip
	ITEM	Proposed Device	Predicate Device	Predicate Device
		Fingertip Pulse Oximeter(YK-81C)	Pulse Oximeter (BM1000A &BM2000A)	MD300C1 Fingertip pulseoximeter
	Measurementwavelength	Red: 660nmInfrared: 940nm	Red: 660nmInfrared: 940nm	Red: 660nmInfrared: 940nm
	LED RadiantPower	21.8 mW/cm²	N/A	21.8 mW/cm²
	SpO2 IndicationWaveform	Yes	Yes	Yes
	SpO2measurementrange	0-100%	0-100%	0-100%
	SpO2accuracy	70%~100%, ±3%	70%-100% ±3%; Undefined for<70%	70%~99%, ±3%
	SpO2resolution	±1%	±1%	1%
	PR measurementrange	30-254 bpm	25-250 bpm	30~235bpm
	PR accuracy	±2 bpm	±2 bpm	±2 bpm or ±2%
	PR resolution	±1 bpm	±1 bpm	1bpm
	Vertivcal bar graphpulse amplitude	The Pulse bar graph displayscorresponding with thepatient's pulse beat. The heightof the bar graph shows thepatient's pulse strength asdefined as below0-15 level 9 block display inhorizontal display mode (oneblock = 3/5 level)15 block display in verticaldisplay mode (one block = 1level)	N/A	The Pulse bar graphdisplays correspondingwith the patient's pulsebeat. The height of the bargraph shows the patient'spulse strength.
	Data update time	<10s	<15s	<15s
Technical Characteristics	Device Form	Finger clip Pulse Oximeterwith built-in sensor	Handheld Pulse Oximeter withseparate sensor	Finger clip Pulse Oximeterwith built-in sensor
	Sensor type	Clip type	BM1000A: wrap typeBM2000A: Fingertip type	Clip type
Display Information	SpO2 measurement dataPR measurement dataBattery and finger off indicatorSpO2/PR alarm setting	SpO2 measurement dataPR measurement dataBattery and finger off indicatorSpO2/PR alarm setting(BM1000A only)	SpO2 measurement dataPR measurement dataBattery and finger offindicatorSpO2/PR alarm setting

9. Substantially Equivalent (SE) Comparison

Table 1 General Comparison

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Table 2 Performance Comparison

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Table 3 Testing Comparison

ITEM	Proposed DeviceFingertip Pulse Oximeter(YK-81C)	Predicate DevicePulse Oximeter (BM1000A& BM2000A)	Predicate Device MD300C1Fingertip pulse oximeter
Power Supplier	2 A AA alkaline batteries	BM1000A: 2AA BatteriesBM2000A: Li ion battery	2 A AA alkaline batteries
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1	Comply with IEC 60601-1
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
Biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1	Comply with ISO 10993-1
Label andLabeling	Conforms to FDA RegulatoryRequirements	Conforms to FDA RegulatoryRequirements	Conforms to FDA RegulatoryRequirements
Level of Concernof the Software	Moderate	Moderate	Moderate

The indications for use of the proposed device is identical to K142687, but varies slightly compared to K093757,However, they have same intended population, same usage environments, same intended use (spot checking and not for continuously monitoring), the only difference is the narrative style. These differences do not affect the safety and effectiveness of the device when used as labeled.

10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.

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).