The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults in professional healthcare facility or home conditions when physician follow-up and operated by a physician. 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 for the Pulse Oximeter, models SO611, SO711, SO811, and SO911:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by Standard ISO 80601-2-61:2017)	Reported Device Performance (K212665)
SpO2 Accuracy: 70-100%: ±2%	70-100%: ±2%
SpO2 Range: 0%-100%, effective measurement range 70%-100%	0%-100%, effective measurement range 70%-100%
SpO2 Resolution: 1%	1%
Pulse Rate Range: 25 bpm ~ 250 bpm (Predicate device's criteria, subject device is within a comparable range)	30 bpm ~ 250 bpm
Pulse Rate Accuracy: ±3 bpm (Meets requirements defined in ISO 80601-2-61, Clause 201.12.1.104)	±3 bpm
Pulse Rate Resolution: 1 bpm	1 bpm
Biocompatibility: Complies with ISO 10993-1 (Cytotoxicity, Skin Sensitization, Skin Irritation)	Passed (Cytotoxicity, Skin Sensitization, Skin Irritation)
Electrical Safety: Complies with IEC 60601-1:2005/A1:2012, IEC 60601-1-11:2015	Complies with IEC 60601-1:2005/A1:2012, IEC 60601-1-11:2015
EMC: Complies with IEC 60601-1-2:2014	Complies with IEC 60601-1-2:2014
Software Verification & Validation: Complies with FDA Guidance for "moderate level of concern" software	Provided and passed
Cleaning Validation: No degradation after repeated cleaning/disinfection as per FDA guidance	No degradation observed

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

Sample Size (Clinical Test Set): 13 healthy volunteers.
Data Provenance: The document does not explicitly state the country of origin but implies a clinical study conducted by the manufacturer or a contracted clinical research organization. The study included "3 light skin subjects and 3 dark skin subjects" suggesting an attempt at diversity but does not specify nationality. The study is prospective as it's a clinical trial designed to evaluate the device's accuracy.

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

The document does not mention the use of experts to establish ground truth for the clinical test set. Instead, it refers to a clinical study conducted "per Annex EE Guideline for evaluating and documenting SpO₂ACCURACY in human subjects of ISO 80601-2-61:2011". This typically implies comparison against a co-oximeter or another highly accurate, reference method for blood oxygen saturation measurement directly from blood samples as the ground truth.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth for SpO2 accuracy is typically established by high-precision medical reference devices (e.g., co-oximeters) which do not involve expert adjudication in the same way as imaging studies.

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

No MRMC comparative effectiveness study was mentioned. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. For a pulse oximeter, the performance is typically assessed by objective accuracy measurements against a reference standard.

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

Yes, the performance testing described is for the device in a standalone capacity. The clinical testing evaluates the device's ability to accurately measure SpO2 and pulse rate on its own, without human intervention affecting the measurement output. The device itself is "intended for spot-checking oxygen saturation and pulse rate" and is operated by a physician, but the performance validation is of the device's direct measurement capabilities.

7. Type of Ground Truth Used

The ground truth used for SpO2 accuracy in the clinical study is established "per Annex EE Guideline for evaluating and documenting SpO₂ACCURACY in human subjects of ISO 80601-2-61:2011". This standard typically refers to fractional oxygen saturation measured directly from arterial blood samples using a co-oximeter as the reference standard. The document implies a direct comparison of the device's readings against this gold standard.

8. Sample Size for the Training Set

The document does not provide information on a training set sample size. For traditional medical devices like pulse oximeters, particularly those not heavily relying on complex machine learning algorithms for core functionality, dedicated "training sets" are often not explicitly defined in the same way as for AI/ML devices. The device's calibration and algorithm development might be based on extensive in-house data and engineering, but not typically disclosed as a distinct "training set" in regulatory submissions for these types of devices.

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

Not applicable, as a distinct training set and its ground truth establishment are not described in the document for this device.

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.

June 22, 2022

Huizhou Xiaoou Technology Co., Ltd. Xia Wang General Manager 3rd Floor, No.113 (Building D), Xikeng Industrial Zone Zhongkai High-tech Zone Huizhou, Guangdong 516000 China

Re: K212665

Trade/Device Name: Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number-SO711), Pulse Oximeter (SO811), Pulse Oximeter (SO911) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: May 15, 2022 Received: May 23, 2022

Dear Xia 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.

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

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 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 medical devices and radiation-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

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

Indications for Use

510(k) Number (if known) K212665

Device Name

Pulse Oximeter, Models SO611, SO711, SO811 and SO911

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)

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."

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

510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter:Contact Person:	Huizhou Xiaoou Technology Co., Ltd.3rd Floor, No.113(Building D), Xikeng Industrial Zone, Zhongkai High-tech Zone,Huizhou, Guangdong, Shenzhen, 516000, P.R. ChinaTEL: +86 752-3302188Xia Wang
Prepare date:	2022-04-30
2. Device name andclassification	Device Name: Pulse OximeterModels: SO611, SO711, SO811 and SO911Classification Name: 21 CFR 870.2700 OximeterProduct code: DQARegulatory Class: Class IIClass III Summary and Certification: Not applicableIVD Classification: Not applicable
3. Reason forSubmission	New Application. No prior submission associated with the current submission.
4. PredicateDevice(s)	Shenzhen Yimi Life Technology Co., Ltd., YM101/YM201/YM301 Pulse Oximeter /K191430. No recall or medical device report have been happened to the predicatedevice.
5. Device Description	The oximeter consists of probe, electronic circuits, and display and plasticenclosures. And one side of probe is designed to locate light emitting diodes and alight detector (called a photo-detector). Red and Infrared lights are shone throughthe tissues from one side of the probe to the other. Then parts of the light emittedabsorbed by blood and tissues. The light absorbed by the blood varies with theoxygen saturation of haemoglobin. After that, the photo-detector detects the lightvolume 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 theuser 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 Use	All the four models included in this submission, which share the sameappearance&size, intended use, performance and similar operation. Thedifferences between all the models is the sound beep and displayed font colors.Sound beep is available for SO811 only, not available for other devices. Regardingthe displayed font colors, SO611 and SO711 can show fonts in blue or yellowrespectively without multiple colors, while SO811 and SO911 can show the fonts ingreen/yellow/blue three colors. And the sound beep difference is realized byremoving the component buzzer, and the font color difference is realized by minordifferentiate the software. Therefore, it can be concluded that all the models sharethe similar hardware and software in this submission.The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rateand the device is a reusable device and intended to be used with the finger ofadults in professional healthcare facility or home conditions when physicianfollow-up and operated by a physician. And it is not intended to be used undermotion or low perfusion scenarios.

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

7. Predicate Device Comparison

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

ITEM	Predicate DeviceYM 101/YM201/YM301 PulseOximeterK191430	Proposed DevicePulse Oximeter SO611/SO711/SO811/SO911	ComparisonResult
Manufacture	Shenzhen Yimi Life TechnologyCo., Ltd.	Huizhou Xiaoou Technology Co.,Ltd.	---
Indications for Use	The pulse oximeter is a reusabledevice and intended forspot-checking of oxygensaturation and pulse rate for usewith the finger of adult patientsin healthcare environments. Andit is not intended to be usedunder motion or low perfusionscenarios.	The Pulse Oximeter is intended forspot-checking oxygen saturationand pulse rate, and the device is areusable device and intended to beused with the finger of adults inprofessional healthcare facility orhome conditions when physicianfollow-up and operated by aphysician. And it is not intended tobe used under motion or lowperfusion scenarios.	Different
Intended patientpopulation	Adult	Adult
Contraindications	Not intended to be used undermotion or low perfusionscenarios.	Not intended to be used undermotion or low perfusion scenarios.	Same
Operational Specifications
Intendedapplication site	Finger	Finger	Same
MeasurementPrinciples	2-wavelength RelativeOptical Absorption	2-wavelength RelativeOptical Absorption	Same
Signal DetectionMethod	Photodetector	Photodetector	Same
Display content	SpO2%, PR, battery indicator,Pulse ratebar graph, pulse waveform	SpO2%, PR, battery indicator, Pulseratebar graph, pulse waveform	Same
SpO₂ Range	0%~100%, of which effectivemeasurement range is70%~100%	0%~100%, of which effectivemeasurement range is 70%~100%	Same
SpO2 Accuracy	70~100%: ±2%0% to 69%: unspecified	70% ~100%:±2%;0% to 69%: unspecified
SpO2 Resolution	1%	1%	Same
Pulse Rate Range	25 bpm ~ 250 bpm	30 bpm ~ 250 bpm	Different
Pulse RateAccuracy	±2 bpm	±3 bpm
PulseRate Resolution	1 bpm	1 bpm	Same
Data Memory	Not available	Not available	Same
Shipped Sterile	No	No	Same
Power suppler	2*1.5V AAA alkaline battery	2*1.5V AAA alkaline battery	Same
Safety classification	Class IIa, Internally powered,Type BF applied part, IP22	Class IIa, Internally powered, Type BF applied part, IP22	Same
Storage andTransportEnvironment	Temperature: -20°C to 60°CAtmospheric Pressure: 50 kPa toI07.4 kPaRelative Humidity: 10%-95% (nocondensation)	Temperature: -10°Cto 40°CAtmospheric Pressure: 50 kPa to106 kPaRelative Humidity: <95% (nocondensation)	Different
OperatingEnvironment	Temperature: 15°Cto 40°CAtmospheric Pressure: 70 kPa to106 kPaRelative Humidity: 15%-95% (nocondensation)	Temperature: 5°Cto 40°CAtmospheric Pressure: 86kPa to106 kPaRelative Humidity: 15%-80% (nocondensation)
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

Table 1 Comparison between the predicate and the subject devices

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

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

8. Performance Testing

Performance data includes "Non-Clinical Data" and "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/ A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and 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 for safety and the IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and

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

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: 2017 Medical electrical equipment — Part 2-61: Particular requirements for 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 Contained 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 SpO₂ACCURACY 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. There are 13 healthy volunteers aged between 18 - 50 years old were selected in this study, of which includes 8 females and 5 males, 3 light skin subjects and 3 dark skin subjects. The demographic statistical indicators of the subjects is show in the table below. And no adverse effects and complications happened during the clinical study.

	N	Average mean, Sd	Minimal	Maximum
Age (year)	13	30.15±11.25	18	50
Height (cm)	13	166±9.61	150	180
Weight (kg)	13	63.04±12.39	47	89

The arm, hand or finger moves may affect the accuracy of SpO2 measurement, while the gender, age and finger size have no effect to the accuracy of SpO2 measurement, as the skin pigmentation, in this study, the statistical shows no effect to the safe and effective performance of the oximeter.

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 difference 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).