The Pulse Oximeter is a non-invasive device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot- check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.

Device Description

The Pulse Oximeter is a lightweight, portable health finger ring oximeter for home or healthcare facilities. SpO2 measurement technology is based on the developed photoelectron method and circuit design, and Shenzhen Viatom Technology Co., Ltd. developed calculation software. The SpO2 sensor receives the optical signal from the red light and infrared light through the finger into the oximeter. Two emitting tubes (red light diodes and infrared diodes) are located on the inner right side of the sensor, and they can emit red light and infrared. The receiving end is located on the inner left side of the sensor, and it can receive the red light and infrared through the finger. The MCU receives the pulse signal, gets the frequency signal by counting, processes its digital signal, and finally gets the measured SpO2 value. The PR is calculated on average by the above peak intervals of the PR waveform.

AI/ML Overview

The provided text is a 510(k) summary for a Pulse Oximeter (Models PO2, PO2A, PO2B) and does not contain information about an AI/ML-driven device. Therefore, it is not possible to describe acceptance criteria or a study related to an AI/ML device based on this document.

The document primarily focuses on demonstrating the substantial equivalence of the subject pulse oximeter to a predicate pulse oximeter (K191088 Checkme O2 Pulse Oximeter) by meeting established performance standards for pulse oximeters, such as ISO 80601-2-61.

Here's an analysis based on the information available in the document, demonstrating why it doesn't fit the AI/ML framework you've described:

General Device Performance (Pulse Oximeter):

A table of acceptance criteria and the reported device performance:
The document does not present a formal "acceptance criteria table" in the context of an AI/ML model. Instead, it provides a comparison table of the subject device's specifications and performance metrics against a predicate device.

Characteristic	Acceptance Criteria (Implicit from Predicate & Standards)	Reported Device Performance (Subject Device)
SpO2 Accuracy (70-100%)	±2%	1.77% ARMS
Pulse Rate Accuracy	±2bpm or ±2% (whichever is greater)	±2bpm or ±2% (whichever is greater)
SpO2 Measurement Accuracy (ARMS)	≤ 2% (from ISO 80601-2-61)	1.77%
Work Mode	Spot-check and continuous data collection (not continuous monitoring)	Spot-check and continuous data collection (not continuous monitoring)
Intended Application Site	Finger	Finger

Sample sized used for the test set and the data provenance:
- Test Set Description: The "clinical validation testing of the SpO2 performance" was conducted on "healthy adult volunteers."
- Sample Size: The exact number of healthy adult volunteers is not specified in the document.
- Data Provenance: The document states "Measured values are from a controlled lab study in healthy volunteers." It does not specify the country of origin. The study appears to be prospective, as it involved actively testing subjects with the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable to this device. For a pulse oximeter, "ground truth" for SpO2 and pulse rate is established using a co-oximeter and ECG (or similar reference standard) on induced hypoxia studies, as per ISO 80601-2-61. There are no "experts" in the AI/ML sense establishing ground truth labels for images or other complex data. The "ground truth" clinical values are collected by qualified personnel trained in conducting such studies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies and establish a consensus ground truth. For a pulse oximeter, the reference measurements from the co-oximeter are the ground truth, and human adjudication is not part of the process.
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:
This question is not applicable. The device is not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This question is not applicable in the context of an AI/ML algorithm. The performance of the pulse oximeter itself (which contains an algorithm to calculate SpO2 and PR from optical signals) was evaluated in a standalone manner against reference standards in the clinical study. The device's performance is inherently "standalone" in its measurement function, as it provides direct numerical outputs.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For SpO2 accuracy, the ground truth was arterial oxygen saturation measured by a co-oximeter (from blood samples) during induced hypoxia, as per ISO 80601-2-61. For pulse rate, the ground truth would typically be derived from an electrocardiogram (ECG) monitor. This is a physiological reference standard, not expert consensus or pathology.
The sample size for the training set:
This question is not applicable. The document describes a traditional medical device (pulse oximeter) that uses a pre-defined algorithm based on physical principles (absorption of red and infrared light). It does not mention any "training set" for an AI/ML model. The "algorithm" for SpO2 calculation is based on principles of spectroscopy and physiological models, not machine learning from a dataset in the way a deep learning model would be trained.
How the ground truth for the training set was established:
This question is not applicable for the same reasons as #8. There is no training set for an AI/ML model described.

In summary, the provided document details the regulatory clearance for a traditional medical device (pulse oximeter) based on established performance standards, and therefore, the questions tailored for AI/ML device evaluations are generally not relevant.

Summary

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February 28, 2025

Shenzhen Viatom Technology Co., Ltd. % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249

Re: K242876

Trade/Device Name: Pulse Oximeter ( PO2, PO2A, PO2B) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: February 3, 2025 Received: February 3, 2025

Dear Charles Mack:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep 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) K242876

Device Name 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)

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510(k) SUMMARY K242876

Preparation Date:	February 27, 2025
Manufacturer's Name and Address:	Shenzhen Viatom Technology Co., Ltd.501, Building B, Ganghongji High-TechIntelligent Industrial Park, No.1008Songbai Road, Xili Street, NanshanDistrict, Shenzhen Guangdong, China518055Tel:+86-755-86638929
Corresponding Official:	Charles Mack
Telephone Number:	931-625-4938
Email Address:	charliemack@irc-us.com
Trade Name:	Pulse OximeterModel: PO2, PO2A, PO2B
Common Name(s):	Oximeter
Regulation Name(s):	Oximeter
Regulation Number(s):	21CFR870.2700
Primary Product Code:	DQA
Device Class:	Class II
Predicate Device:	K191088
Device Name:	Checkme O2 Pulse Oximeter
Common Name(s):	Oximeter
Regulation Name(s):	Oximeter
Regulation Number(s):	21CFR870.2700
Primary Product Code:	DQA
Device Class:	Class II

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Device Description:

Principles of Operation:

The pulse oxygen saturation, the percentage of HbO2 in the total Hb in the blood, namely the so-called O2 concentration in the blood, is an important bio-parameter for respiration. The intergradations of oxygen molecules in the blood and hemoglobin in erythrocytes are reversible. Hemoglobins integrated with oxygen are called HbO2, and those released O2 are called HbR. Oxyhemoqlobin and deoxyhemoglobin (HHb) absorb red Marqinally and infraredly at a specific wavelength. Thus the Marginal of the two wavelengths emitted from the SpQ2 sensor is absorbed when it passes through the finger, and approximate pulse oxygen saturation is calculated by measuring the absorption of the Marginal.

Indications for Use

The Pulse Oximeter is a non-invasive device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.

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Characteristics	Subject Device	Predicate Device	Remark fordesign changes
Device Name	Pulse Oximeter	Checkme O2 Pulse Oximeter	-
Model	PO2, PO2A, PO2B	Oxiband	-
Manufacturer	Shenzhen Viatom Technology Co., Ltd.	Shenzhen Viatom Technology Co.,Ltd.	-
510(K)Number	Pending	K191088	-
CFR	21 CFR 870.2700	21 CFR 870.2700	Same
Product code	DQA	DQA	Same
Classification	2	2	Same
ClassificationName(s)	Oximeter	Oximeter	Same
Indication for Use	The Pulse Oximeter is a non- invasivedevice indicated for use in measuring,displaying, storing, and transmittingfunctional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate foradult patients. It is intended for spot-check and/or continuous data collection,and not for continuous monitoring. It canbe used in sleep labs, long-term care,hospital and home use.	The Oxiband Pulse Oximeter is a wristpulse oximeter indicated for use inmeasuring, displaying, storing, andtransmitting functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate for adultpatients. It is intended for spot-checkand/or continuous data collection, andnot continuous monitoring. It can beused in sleep labs, long-term care,hospital and home use.	Same
Work mode	Spot-check and continuous datacollection of oxygen saturation of arterialhemoglobin(SpO2) andPulse Rate. The device is not used forcontinuous monitoring.	Spot-check and continuous dataCollection of oxygen saturation ofarterial hemoglobin(SpO2) and PulseRate. The device is not used forcontinuous monitoring.	Same
Rx or OTC	Rx	Rx	Same
Patient type	Adults	Adults	Same
Intendedapplication site	Finger	Finger	Same
Design Principle	The device displays numerical valuesfor functional oxygen saturation ofarterial hemoglobin (SpO2) and pulserate by measuring the absorption of redand infrared (IR) light passing throughperfused tissue. Changes in theabsorption caused by the pulsation ofblood in the vascular bed are used todetermine oxygen saturation andpulse rate.	The device displays numerical valuesfor functional oxygen saturation ofarterial hemoglobin (SpO2) and pulserate by measuring the absorption ofred and infrared (IR) light passingthrough perfused tissue. Changes inthe absorption caused by the pulsationof blood in the vascular bed are usedto determine oxygen saturation andpulse rate.	Same
LEDwavelength	Red=660 nmInfrared=940 nm	Red=660 nmInfrared=940 nm	Same
Sensor type	Integrated SpO2 sensor	External detachable SpO2 sensor	Similarrefer to Note 1
Characteristics	Subject Device	Predicate Device	Remark fordesign changes
SpO2display range	0%-100%	0%-100%	Same
SpO2 accuracy	70-100%:±2%0-69% not defined	70-100%:±2%0-69% not defined	Same
SpO2measurementaccuracy	70%-100%: 1.77%90%-100%: 1.00%80%-90%: 1.70%70%-80%: 2.22%*Measured values are from a controlledlab study in healthy volunteers.	70%-100%: 1.866%70%-80%: unknown80%-90%: unknown90%-100%: unknown	Similar
SpO2resolution	1%	1%	Same
Pulse ratemeasurementrange	30 bpm~250 bpm	30 bpm~250 bpm	Same
Pulse rateaccuracy	±2bpm or ±2% (whichever is greater)	±2bpm or ±2% (whichever is greater)	Same
Pulse rateresolution	±2bpm or ±2% (whichever is greater)	±2bpm or ±2% (whichever is greater)	Same
Type, Degree ofprotection againstelectric shock	Internal electric power supply; Type BFapplied parts.	Internal electric power supply;Type BF applied parts.	Same
Power supply	Lithium rechargeable battery	Lithium rechargeable battery	Same
Display screen	OLED	OLED	Same
Wireless	Bluetooth	Bluetooth	Same
Storage data	Yes	Yes	Same
Physical dimension(mm)	38mm (L)×29mm (W)×18mm (H)	44mm (L) × 25mm (W) × 15mm(H)	Similarrefer to Note 2
Contacting duration	Less than 24h	Less than 24h	Same
Contacting Material	Fingertip pad: Silica GelEnclosure: PC	Fingertip pad: Silica GelEnclosure: PC	Same
Contacting type	Skin surface- contacting	Skin surface- contacting	Same
Software Level ofconcern	Moderate	Moderate	Same
OperatingTemperature	5~40 °C	5~40 °C	Same
Storage/ Transporttemperature	-25~70°C	-25~70°C	Same
Relative humidity	10%~95%	10%~95%	Same
Atmosphericpressure	70KPa~106KPa	70KPa~106KPa	Same
Performance andClinical Study	Comply with ISO 80601-2-61.	Comply with ISO 80601-2-61.	Same
Electrical Safety	Comply with IEC 60601-1 and IEC60601-1-11.	Comply with IEC 60601-1and IEC 60601-1-11.	Same
ElectromagneticCompatibility	Comply with IEC 60601-1-2.	Comply with IEC 60601-1-2.	Same
Biocompatibility ofpatient contactparts	Comply with ISO 10993-1, ISO10993-5, ISO 10993-10 and ISO10993-23	Comply with ISO10993-1, ISO 10993-5 and ISO 10993-10.	Same

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Note 1:

The subject device is the design changes version of the predicate device we cleared in K191088. The main change is that the subject device uses the integrated SpO2 sensor, unlike the predicate, which uses external detachable SpO2 sensors with external cable. Both sensors have the same ring type on the finger, and there are no changes in electrooptical components (LED), emission power, finger-pad size, etc. The subject device conforms to the same performance standards requirements of IEC 60601-1. IEC 60601-1-11. and ISO 80601-2-61 as a predicate. Thus, this difference does not raise new questions of safety and effectiveness.

Note 2:

Although the subject device's size is shorter, narrower, and higher than the predicate device's, it still conforms to the same performance requirement. Thus, this difference does not raise new questions of safety and effectiveness.

Test Summary:

To establish substantial equivalence to the identified predicate devices, we performed the test below on the subject devices: Pulse Oximeters, Models PO2, PO2A, and PO2B. The testing results proved that the devices comply with the requirements of applicable standards and are substantially equivalent to the predicate devices.

Non-Clinical Study:

Safety and EMC

To verify the basic safety and essential performance of the PO2 Pulse Oximeter. PO2. PO2A, PO2B, we performed the tests noted below:

IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 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

Performance Data:

ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

FDA Guidance of Non-Invasive Pulse Oximeter issued on Mar. 4, 2013

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Biocompatibility

The subject device is classified as a surface device that contacts the skin for prolonged use due to the potential for cumulative use. Testing was conducted per the ISO standards below:

Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation (ISO 10993-23)

Software Verification and Validation

Software verification and validation were provided in compliance with FDA Guidance "The Content of the Premarket Submission for Software Contained in Medical Devices." The verifications and validations demonstrate that the subject device works functionally.

Clinical

Clinical performance was conducted per ISO 80601-2-61. The clinical validation testing of the SpO2 performance under no motion on healthy adult volunteers was 70% to 100%. The ARMS for SpO2 under no motion was 1.77%, which meets the accuracy requirement of less than or equal to 2% under no motion condition. The result met the criteria specified in ISO 80601-2-61. In addition, no adverse effects or complications happened during the clinical study.

Conclusion:

Per the Federal Food, Druq, and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, the subject device is as safe and effective as and substantially equivalent to the predicate devices described herein.

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).