Pulse Oximeter ( PO2, PO2A, PO2B)

K242876 · Shenzhen Viatom Technology Co., Ltd. · DQA · Feb 28, 2025 · Cardiovascular

Device Facts

• Record ID: K242876
• Device Name: Pulse Oximeter ( PO2, PO2A, PO2B)
• Applicant: Shenzhen Viatom Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 28, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

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 Story

Finger-ring pulse oximeter; measures SpO2 and pulse rate via photo-plethysmography. Emits red (660 nm) and infrared (940 nm) light through finger; sensor detects transmitted light; MCU processes signals to calculate SpO2 and pulse rate. Used in hospitals, sleep labs, long-term care, or home; operated by patients or healthcare providers. Data stored and transmitted via Bluetooth. Provides numerical values for clinical assessment of oxygenation; aids in monitoring respiratory status. Benefits include non-invasive, portable, continuous data collection capability.

Clinical Evidence

Clinical validation conducted per ISO 80601-2-61 on healthy adult volunteers under no-motion conditions. Primary endpoint: SpO2 accuracy (ARMS). Results: ARMS of 1.77% for the 70%-100% SpO2 range, meeting the requirement of ≤2%. No adverse effects reported.

Technological Characteristics

Finger-ring form factor; PC enclosure with silica gel fingertip pad. Sensing: Red (660 nm) and IR (940 nm) LEDs. Power: Lithium rechargeable battery. Connectivity: Bluetooth. Software: Moderate level of concern. Standards: ISO 80601-2-61, IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 10993-5/10/23.

Indications for Use

Indicated for adult patients requiring measurement, display, storage, and transmission of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate. Intended for spot-check or continuous data collection; not for continuous monitoring. Use in sleep labs, long-term care, hospitals, or home settings.

Regulatory Classification

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.

Predicate Devices

• Checkme O2 Pulse Oximeter (K191088)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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.<br>501, Building B, Ganghongji High-Tech<br>Intelligent Industrial Park, No.1008<br>Songbai Road, Xili Street, Nanshan<br>District, Shenzhen Guangdong, China<br>518055<br>Tel:[phone] |
| Corresponding Official: | Charles Mack |
| Telephone Number: | 931-625-4938 |
| Email Address: | [e-mail] |
| Trade Name: | Pulse Oximeter<br>Model: 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:

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.

#### 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 for<br>design changes |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Device Name | Pulse Oximeter | Checkme O2 Pulse Oximeter | - |
| Model | PO2, PO2A, PO2B | Oxiband | - |
| Manufacturer | Shenzhen Viatom Technology Co., Ltd. | Shenzhen Viatom Technology Co.,<br>Ltd. | - |
| 510(K)<br>Number | Pending | K191088 | - |
| CFR | 21 CFR 870.2700 | 21 CFR 870.2700 | Same |
| Product code | DQA | DQA | Same |
| Classification | 2 | 2 | Same |
| Classification<br>Name(s) | Oximeter | Oximeter | Same |
| Indication for Use | The Pulse Oximeter is a non- invasive<br>device indicated for use in measuring,<br>displaying, storing, and transmitting<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate for<br>adult patients. It is intended for spot-<br>check and/or continuous data collection,<br>and not for continuous monitoring. It can<br>be used in sleep labs, long-term care,<br>hospital and home use. | The Oxiband Pulse Oximeter is a wrist<br>pulse oximeter indicated for use in<br>measuring, displaying, storing, and<br>transmitting functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and pulse rate for adult<br>patients. It is intended for spot-check<br>and/or continuous data collection, and<br>not continuous monitoring. It can be<br>used in sleep labs, long-term care,<br>hospital and home use. | Same |
| Work mode | Spot-check and continuous data<br>collection of oxygen saturation of arterial<br>hemoglobin(SpO2) and<br>Pulse Rate. The device is not used for<br>continuous monitoring. | Spot-check and continuous data<br>Collection of oxygen saturation of<br>arterial hemoglobin(SpO2) and Pulse<br>Rate. The device is not used for<br>continuous monitoring. | Same |
| Rx or OTC | Rx | Rx | Same |
| Patient type | Adults | Adults | Same |
| Intended<br>application site | Finger | Finger | Same |
| Design Principle | The device displays numerical values<br>for functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse<br>rate by measuring the absorption of red<br>and infrared (IR) light passing through<br>perfused tissue. Changes in the<br>absorption caused by the pulsation of<br>blood in the vascular bed are used to<br>determine oxygen saturation and<br>pulse rate. | The device displays numerical values<br>for functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse<br>rate by measuring the absorption of<br>red and infrared (IR) light passing<br>through perfused tissue. Changes in<br>the absorption caused by the pulsation<br>of blood in the vascular bed are used<br>to determine oxygen saturation and<br>pulse rate. | Same |
| LED<br>wavelength | Red=660 nm<br>Infrared=940 nm | Red=660 nm<br>Infrared=940 nm | Same |
| Sensor type | Integrated SpO2 sensor | External detachable SpO2 sensor | Similar<br>refer to Note 1 |
| Characteristics | Subject Device | Predicate Device | Remark for<br>design changes |
| SpO2<br>display range | 0%-100% | 0%-100% | Same |
| SpO2 accuracy | 70-100%:±2%<br>0-69% not defined | 70-100%:±2%<br>0-69% not defined | Same |
| SpO2<br>measurement<br>accuracy | 70%-100%: 1.77%<br>90%-100%: 1.00%<br>80%-90%: 1.70%<br>70%-80%: 2.22%<br>*Measured values are from a controlled<br>lab study in healthy volunteers. | 70%-100%: 1.866%<br>70%-80%: unknown<br>80%-90%: unknown<br>90%-100%: unknown | Similar |
| SpO2<br>resolution | 1% | 1% | Same |
| Pulse rate<br>measurement<br>range | 30 bpm~250 bpm | 30 bpm~250 bpm | Same |
| Pulse rate<br>accuracy | ±2bpm or ±2% (whichever is greater) | ±2bpm or ±2% (whichever is greater) | Same |
| Pulse rate<br>resolution | ±2bpm or ±2% (whichever is greater) | ±2bpm or ±2% (whichever is greater) | Same |
| Type, Degree of<br>protection against<br>electric shock | Internal electric power supply; Type BF<br>applied parts. | Internal electric power supply;<br>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<br>(mm) | 38mm (L)×29mm (W)×18mm (H) | 44mm (L) × 25mm (W) × 15mm<br>(H) | Similar<br>refer to Note 2 |
| Contacting duration | Less than 24h | Less than 24h | Same |
| Contacting Material | Fingertip pad: Silica Gel<br>Enclosure: PC | Fingertip pad: Silica Gel<br>Enclosure: PC | Same |
| Contacting type | Skin surface- contacting | Skin surface- contacting | Same |
| Software Level of<br>concern | Moderate | Moderate | Same |
| Operating<br>Temperature | 5~40 °C | 5~40 °C | Same |
| Storage/ Transport<br>temperature | -25~70°C | -25~70°C | Same |
| Relative humidity | 10%~95% | 10%~95% | Same |
| Atmospheric<br>pressure | 70KPa~106KPa | 70KPa~106KPa | Same |
| Performance and<br>Clinical Study | Comply with ISO 80601-2-61. | Comply with ISO 80601-2-61. | Same |
| Electrical Safety | Comply with IEC 60601-1 and IEC<br>60601-1-11. | Comply with IEC 60601-1<br>and IEC 60601-1-11. | Same |
| Electromagnetic<br>Compatibility | Comply with IEC 60601-1-2. | Comply with IEC 60601-1-2. | Same |
| Biocompatibility of<br>patient contact<br>parts | Comply with ISO 10993-1, ISO<br>10993-5, ISO 10993-10 and ISO<br>10993-23 | Comply with ISO<br>10993-1, ISO 10993-<br>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.