The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.

Device Description

The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what's available for this pulse oximeter:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (from Predicate Device/Standards)	Reported Device Performance (from Subject Device)
SpO2 Range	0% ~ 100%	0% ~ 100%
SpO2 Resolution	1%	1%
SpO2 Accuracy	70% ~ 100%: ±2%	70% ~ 100%: ±2%
	0% ~ 69%: unspecified	0% ~ 69%: unspecified
Pulse Rate Range	25 bpm ~ 250 bpm	25 bpm ~ 250 bpm
Pulse Rate Accuracy	±2 bpm	±2 bpm
Pulse Rate Resolution	1 bpm	1 bpm
Biocompatibility	ISO 10993-1, ISO 10993-5, ISO 10993-10 compliant	Compliant (Cytotoxicity, Skin Sensitization, Skin Irritation passed)
Electrical Safety	IEC 60601-1 compliant	Compliant
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 compliant	Compliant
General Performance	ISO 80601-2-61 compliant	Compliant

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

The document explicitly mentions a "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment."

However, the specific sample size for this clinical test set is not provided in the given text.

The data provenance (country of origin, retrospective/prospective) is not explicitly stated beyond stating it was "clinical testing... in human subjects."

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

This information is not provided in the document. For pulse oximetry, the "ground truth" (reference SpO2) is typically established by arterial blood gas analysis performed by trained medical personnel, but the specifics of who performed it or how many were involved in establishing the ground truth are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted or reported. This type of study is more relevant for diagnostic imaging interpretation where human readers are involved. For a pulse oximeter, the primary performance evaluation is a direct comparison to a reference standard (arterial blood gas) rather than comparing human interpretation with and without AI assistance.

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

Yes, a standalone performance evaluation was done. The entire premise of a pulse oximeter's performance testing (as described by ISO 80601-2-61) is to assess the device's accuracy in measuring SpO2 and pulse rate independently. The "clinical testing... in human subjects" is a standalone performance evaluation against a reference standard.

7. The Type of Ground Truth Used

The ground truth used for the clinical testing of SpO2 accuracy is arterial blood gas analysis (ABG). This is inferred from the reference to "evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61," as this standard mandates ABG as the reference method for determining true arterial oxygen saturation for pulse oximeter accuracy studies.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. Pulse oximeters are based on established biophysical principles (spectrophotometry) and do not typically use AI/machine learning models that require a "training set" in the conventional sense for their core SpO2 and pulse rate algorithms. The device's internal algorithms are based on physics and calibrated using empirical data, but this is distinct from "training data" for a machine learning model.

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

This information is not applicable as outlined in point 8.

Summary

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December 7, 2020

Shenzhen AOJ Medical Technology Co., Ltd. Wendy Lin Marketing Manager 601, 6th floor, B2 Building, An'le Industrial Park #172 Hangcheng Avenue Shenzhen, Guangdong 518126 China

Re: K202173

Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 2, 2020 Received: November 9, 2020

Dear Wendy Lin:

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.

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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 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

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Indications for Use

510(k) Number (if known) K202173

Device Name

Pulse Oximeter, models AOJ-70A, AOJ-70B, AOJ-70C, AOJ-70D and AOJ-70E

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

Prepared in accordance with the requirements of 21 CFR Part 807.92

K202173

1. Submitter: Shenzhen AOJ Medical Technology Co., Ltd. 601, 6th floor, B2 Building, An'le Industrial Park, #172 Hangcheng Avenue, Hangcheng Street, Bao'an, Shenzhen, 518126 P.R. China Tel.: +86 13631601525 Contact Person: Wendy Lin Prepare date: 2020-07-25 2. Device name Device Name: Pulse Oximeter and classification Models: AOJ-70A, AOJ-70B, AOJ-70C, AOJ-70D and AOJ-70E Classification Name: 21 CFR 870.2700 Oximeter Product code: DQA Regulatory Class: Class II New Application. No prior submission associated with the current 3. Reason for Submission submission. 4. Predicate Shenzhen Yimi Life-Technology Co.,Ltd., YM101 Pulse Oximeter / K191430 Device(s) The oximeter consists of probe, electronic circuits, and display and plastic 5. Device Description enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. 6. Indications for The pulse oximeter is a reusable device and intended for spot-checking of Use oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.

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7. Predicate Device Comparison

Please refer to following table to find differences between the subject device and predicate device.

ITEM	Predicate DeviceYM series Pulse OximeterK191430	Proposed DeviceAOJ-70A, AOJ-70B,AOJ-70C, AOJ-70D andAOJ-70E	ComparisonResult
Manufacture	Shenzhen YimiLife Technology Co., Ltd.	Shenzhen AOJ MedicalTechnology Co., Ltd.	---
Indications forUse	The pulse oximeter isintended for measureoxygen saturation and pulserate of adult patients inhealthcare environments.And it is not intended to beused under motion or lowperfusion scenarios.	The pulse oximeter isintended for measure oxygensaturation and pulse rate ofadult patients in healthcareenvironments.And it is not intended to beused under motion or lowperfusion scenarios.	Same
Operational Specifications
Intended patientpopulation	Adult	Adult	Same
Intendedapplication site	Finger	Finger	Same
use under motionand low perfusionconditions	No	No	Same
MeasurementPrinciples	2-wavelength RelativeOptical Absorption	2-wavelength RelativeOptical Absorption	Same
Signal DetectionMethod	Photodetector	Photodetector	Same
SpO2 Range	0~100%	0~100%	Same
SpO2 Resolution	1%	1%	Same
SpO2 Accuracy	70~100%: ±2%0% to 69%: unspecified	70~100%: ±2%0% to 69%: unspecified	Same
Pulse RateRange	25 bpm ~ 250 bpm	25 bpm ~ 250 bpm	Same
Pulse RateAccuracy	±2 bpm	±2 bpm	Same
PulseRate Resolution	1 bpm	1 bpm	Same
Shipped Sterile	No	No	Same
Power supplier	2*1.5V AAA alkaline battery	2*1.5V AAA alkaline battery	Same
Storage andTransportEnvironment	Temperature: -20°Cto 60°CAtmospheric Pressure: 50kPa to 107.4 kPaRelative Humidity:10%-95% (nocondensation)	Temperature: -20°Cto 60°CAtmospheric Pressure: 50kPa to 107.4 kPaRelative Humidity: 10%-95%(no condensation)	Same
OperatingEnvironment	Temperature: 15°Cto 40°CAtmospheric Pressure: 70 kPa to 106 kPaRelative Humidity:15%-95% (nocondensation)	Temperature: 15°Cto 40°CAtmospheric Pressure: 70 kPa to 106 kPaRelative Humidity: 15%-95%(no condensation)
Compliance Standards
Bio-compatibility	ISO 10993-1ISO 109903-5ISO 10993-10	ISO 10993-1ISO 109903-5ISO 10993-10	Same
Electrical Safety	IEC 60601-1IEC 60601-1-11	IEC 60601-1IEC 60601-1-11
EMC	IEC 60601-1-2	IEC 60601-1-2
Performance	ISO 80601-2-61	ISO 80601-2-61
Physical Specifications
Dimension(WidthHeightDepth)	57mm×30mm×30 mm	63mm×36mm×34mm	Different

Table 1 Comparison between the predicate YM101 and the subject device

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As seen in the comparison tables, the subject and predicate devices have same design principle, design features and performance specifications. The different physical size between the subject and predicate devices will not raise different questions of safety or effectiveness.

8. Performance Testing

Performance data includes "Non-Clinical Data", brief description of which are shown as below.

Non-Clinical Testing:

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

Biocompatibility testing

The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the testing included the following tests, results of which demonstrate the biocompatibility of the subject device:

Cytotoxicity
Skin Sensitization
Skin Irritation

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2007 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.

Bench Testing

Bench testing was conducted and the results show that the subject device complies with the ISO 80601-2-61: 2011 Medical electrical equipment — Part 2-61: Particular requirements for

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basic safety and essential performance of Pulse Oximeter Equipment standard. And Pulse Rate Accuracy meets the requirements defined in ISO 80601-2-61, Clause 201.12.1.104.

Software Verification and Validation Testing

Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software in Medical Devices for software with a moderate level of concern.

Cleaning Validation

Cleaning and disinfection validation testing was conducted in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17,2015. Moreover, the performance of the subject device shows no degradation after repeated cleaning and disinfection as suggested in the manual.

Clinical data:

Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

9. Conclusion

Verification and validation testing was conducted on the subject device Pulse Oximeter and all testing passed pre-specified criteria. The subject device and the predicate device have the same intended use and the differences in technological features do not raise different questions of safety and effectiveness. This premarket notification submission demonstrates that the 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).