Oxyfit Pulse Oximeter

K203812 · Shenzhen Viatom Technology Co., Ltd. · DQA · Nov 8, 2022 · Cardiovascular

Device Facts

• Record ID: K203812
• Device Name: Oxyfit Pulse Oximeter
• Applicant: Shenzhen Viatom Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The Pulse Oximeter is a non-invasive device intended for spot checking and/or continuous data collection of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in home environments and clinical institutions except acute clinical environment.

Device Story

Portable pulse oximeter; measures SpO2 and pulse rate via red (660 nm) and infrared (940 nm) light absorption through perfused finger tissue; utilizes MCU and measurement circuits to process optical signals; powered by internal lithium rechargeable battery; intended for adult patients in home or clinical settings (excluding acute care); operated by patient or clinician; data transmitted via Bluetooth; output displayed numerically; assists clinicians in monitoring oxygenation status; benefits patients through non-invasive, continuous or spot-check monitoring.

Clinical Evidence

Controlled desaturation study conducted on 12 healthy adult subjects (light-to-dark-skinned) under induced hypoxia. Subject device SpO2 accuracy compared to CO-oximeter (control). Results: Arms of 1.57% for 70-100% SpO2 range, meeting ISO 80601-2-61 requirements (≤2%). No adverse effects reported.

Technological Characteristics

Materials: PC (enclosure), Silicone (finger sleeve). Sensing: Red (660 nm) and IR (940 nm) LEDs. Power: Internal lithium rechargeable battery. Connectivity: Bluetooth. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61, ISO 10993-1/5/10. Software: Moderate level of concern.

Indications for Use

Indicated for adult patients for non-invasive spot checking and/or continuous monitoring of functional oxygen saturation (SpO2) and pulse rate (PR) in home and clinical settings, excluding acute clinical environments.

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

• Pulse Oximeter A310B (K200414)

Reference Devices

• Checkme Pro Health Monitor (K150869)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

November 8, 2022

Shenzhen Viatom Technology Co., Ltd. Weifeng Tao Regulatory Manager 4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road Block 67, Xin'an Street, Baoan District, 5 Shenzhen, Guangdong 518101 China

Re: K203812

Trade/Device Name: Oxyfit Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: November 7, 2022 Received: November 7, 2022

Dear Weifeng Tao:

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.

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

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

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# James J. Lee -S

James J. Lee, Ph.D. 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) K203812

Device Name Pulse Oximeter

Indications for Use (Describe)

The Pulse Oximeter is a non-invasive device intended for spot checking and/or continuous data collection of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in home environments and clinical institutions except acute clinical environment.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">×</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|---------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span>□</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

#### 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 K203812

This summary of 510(k) information is submitted as required by requirements of SMDA and21 CFR §807.92.

#### 1. Submission sponsor

| Submission Date | Dec.18.2020 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name | Shenzhen Viatom Technology Co., Ltd. |
| Address | 4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road, Block 67, Xin'an Street, Baoan District, Shenzhen, 518101, Guangdong, China |
| Contact person | Zhou Saixin |
| Title | General Manager |
| E-mail | [e-mail] |
| Tel | [phone] |

#### 2. Submission correspondent

| Name | Shenzhen Viatom Technology Co., Ltd. |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Address | 4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road, Block 67, Xin'an Street, Baoan District, Shenzhen, 518101, Guangdong, China |
| Contact person | Mr.Weifeng Tao |
| E-mail | [e-mail] |

#### 3. Subject Device Information

| Trade/Device Name | Oxyfit Pulse Oximeter |
|-------------------|-----------------------------|
| Model | PO6,PO6A |
| Common name | Pulse Oximeter |
| Regulatory Class | Class II |
| Classification | 21CFR 870.2700/Oximeter/DQA |
| Submission type | Traditional 510(K) |

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

#### 4. Predicate Device Information 4.1Primary Predicate Device

510(k) Number: K200414 Trade/ Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Manufacturer: Shenzhen Aeon Technology Co., Ltd.

#### 4.2Reference Predicate Device

510(k) Number: K150869 Trade/ Device Name: Checkme Pro Health Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: II Product Code: MWI Manufacturer: Shenzhen Viatom Technology Co., Ltd.

### 5. Device Descriptions

The Pulse Oximeter is a non-invasive device intended for spot checking and/or continuous data collection of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in home environments and clinical institutions except acute clinical environment.

The Pulse Oximeter has two models.Model PO6 and Model PO6A are almost the same (include principle, structure, material, production process, performance) except appearance, details see below:

| Model | Appearance color |
|-------|------------------|
| PO6 | Blue |
| PO6A | Gray |

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

The device consists of main unit, SpO2 sensor and charging cable. The main unitis mainly composed of MCU, power management circuit,SpO2 measurement circuit,display control circuit, etc.

The device is powered by internal battery. The device is not for life supporting or life-sustaining, not for implant. The device or sensor is not sterile, the sensor does not needsterilization, and the sensor is reusable but does not need re-sterilization since it is notsterile. The device is for prescription. The device does not contain drug or biological products.

#### 6. Intended Use/ Indications for Use

The Pulse Oximeter is a non-invasive device intended for spot checking and/or continuous data collection of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in home environments and clinical institutions except acute clinical environment.

| Character<br>istics | Subject Device | Primary Predicate<br>Device | Reference Predicate<br>Device | Remark |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Name of<br>the device | Oxyfit Pulse<br>Oximeter<br>PO6,PO6A | Pulse Oximeter<br>A310B | Checkme Pro Health<br>Monitor | --- |
| Manufactu<br>rer | Shenzhen Viatom<br>Technology Co.,<br>Ltd | Shenzhen Aeon<br>Technology Co.,<br>Ltd. | Shenzhen Viatom<br>Technology Co.,<br>Ltd | --- |
| 510(K)<br>Number | N/A | K200414 | K150869 | --- |
| Product<br>code | 21 CFR 870.2700,<br>DQA | 21 CFR 870.2700,<br>DQA | 21 CFR 870.2300,<br>MWI<br>Secondary product<br>codes: 21 CFR<br>870.2700, DQA<br>21 CFR 870.2340, DPS<br>21 CFR 880.2910, FLL<br>21 CFR 870.2300, DRT | Substantial<br>equivalent |
| Classificat<br>ion | II | II | II | Substantial<br>equivalent |
| Indication<br>for Use | The Pulse Oximeter<br>is a non-invasive<br>device intended for<br>spot checking<br>and/or continuous<br>data collection of<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2)<br>and pulse rate (PR).<br>This portable device<br>is indicated for use<br>in adult patients in<br>home environments<br>and clinical<br>institutions except<br>acute clinical<br>environment. | The Pulse Oximeter<br>is a non-invasive<br>device intended for<br>spot checking of<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2)<br>and pulse rate (PR).<br>This portable device<br>is indicated for use in<br>adult patients in<br>clinical institution<br>and home<br>environments. | The Checkme Pro<br>Health Monitor is<br>intended to be used<br>for measuring,<br>displaying, reviewing<br>and storing of ECG<br>(adults only), oxygen<br>saturation and pulse<br>rate (adults only for<br>continuous data<br>collection and<br>recording, adults and<br>pediatrics for spot-<br>checking) and<br>temperature in the<br>home or in healthcare<br>facilities. This device<br>is not intended to<br>substitute for a<br>hospital diagnostic<br>ECG device and not<br>to be used on patients<br>with implanted<br>cardiac devices, such<br>as pacemakers and/or<br>implanted cardio-<br>defibrillators (ICDs). | Different<br>1) |
| Rx or<br>OTC | Rx | Rx | Rx | Substantial<br>equivalent |
| Patient<br>type | Adults | Adults | Adult and pediatric | Different 2) |
| Intended<br>applicatio<br>n site | Finger | Finger | Finger | Substantial<br>equivalent |
| Principle | The device displays<br>numerical values<br>for functional<br>oxygen<br>saturation of arterial<br>hemoglobin (SpO2)<br>and pulse rate by<br>measuring the<br>absorption of red<br>and infrared (IR)<br>light passing | The device displays<br>numerical values for<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2)<br>and pulse rate by<br>measuring the<br>absorption of red<br>and infrared (IR)<br>light passing<br>through perfused | The device displays<br>numerical values for<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2)<br>and pulse rate by<br>measuring the<br>absorption of red<br>and infrared (IR) light<br>passing<br>through perfused | Substantial<br>equivalent |
| | | | | |
| | through perfused<br>tissue. Changes<br>in the absorption<br>caused by the<br>pulsation of blood<br>in the vascular<br>bed are used to<br>determine oxygen<br>saturation and pulse<br>rate. | tissue. Changes<br>in the absorption<br>caused by the<br>pulsation of blood in<br>the vascular<br>bed are used to<br>determine oxygen<br>saturation and pulse<br>rate. | tissue. Changes<br>in the absorption<br>caused by the<br>pulsation of blood in<br>the vascular<br>bed are used to<br>determine oxygen<br>saturation and pulse<br>rate. | |
| LED<br>wavelength | Red=660 nm;<br>Infrared=940 nm; | Red=660 nm;<br>Infrared=905 nm; | Red=660 nm;<br>Infrared=940 nm; | Different 3 |
| SpO2<br>display<br>range | 0%-100% | 0%-100% | 0%-100% | Substantial<br>equivalent |
| SpO2<br>measurem<br>ent<br>accuracy | 70%-100%: ±2%<br>(Arms:1.57)<br>70%-80%: ±3%<br>80%-90%: ±2%<br>90%-100%: ±2%<br>0%-69%: not defined | 70-100%, ±3%;<br>0-69%, unspecified; | 70%-100%: ±2%<br>(Arms:1.88)<br>70%-80%: ±3%<br>80%-90%: ±2%<br>90%-100%: ±2%<br>0%-69%: not<br>defined | Substantial<br>equivalent |
| SpO2<br>resolution | 1% | 1% | 1% | Substantial<br>equivalent |
| Pulse rate<br>measurem<br>ent range | 30 bpm~250 bpm | 30 bpm~250 bpm | 30 bpm~250 bpm | Substantial<br>equivalent |
| Pulse rate<br>accuracy | ±2bpm or ±2%<br>(whichever is greater) | ±2bpm | ±2bpm or ±2%<br>(whichever is greater) | Substantial<br>equivalent |
| Pulse rate<br>resolution | 1bpm | ±2bpm | 1bpm | Substantial<br>equivalent |
| Power<br>supply | Lithium<br>rechargeable<br>battery | 2 AAA<br>alkaline<br>batteries | Lithium<br>rechargeable<br>battery | Different 4 |
| Wireless | Bluetooth | Bluetooth | Bluetooth | Substantial<br>equivalent |
| Contacting<br>duration | Prolonged (24h to 30<br>day) | Less than 24h | Less than 24h | Substantial<br>equivalent |
| Contacting<br>type | Skin surface-<br>contacting | Skin surface-contacting | Skin surface-contacting | Substantial<br>equivalent |
| Biocompati<br>bility of<br>patient<br>contact<br>parts | Comply with ISO<br>10993-1 | Comply with ISO<br>10993-1 | Comply with ISO<br>10993-1 | Substantial<br>equivalent |
| Standard | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>ISO 80601-2-61<br>ISO 10993-5<br>ISO 10993-10 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>ISO 80601-2-61<br>ISO 10993-5<br>ISO 10993-10 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>ISO 80601-2-61<br>ISO 10993-5<br>ISO 10993-10 | Substantial<br>equivalent |

#### 7. Substantial equivalence Comparisons to the 510(k) Cleared Devices(Predicate Devices)

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

{7}------------------------------------------------

{8}------------------------------------------------

Shenzhen Viatom Technology Co., Ltd. Product: Pulse Oximeter

VOL 008: 001 510(k) Summary Version: A/1

{9}------------------------------------------------

#### Justification of difference:

Different 1):

Compared with Primary Predicate Device:

The subject device is used for spot-check and/or continuous data collection whereas the primary predicate device is used in adults for spot-checking.

The difference is the function "and/or continuous data collection".But the reference predicate device is also used in adults for spot-check and continuous data collection. And the subject device is based on the reference predicate device. So the difference does not affect the safety and effectiveness of the subject device.And the subject device together meets the requirements of the IEC 60601-1,IEC 60601-1-11,ISO 80601-2-61 and IEC 60601-1-2.

Compared with Reference Predicate Device:

The subject device is used for spot-check and/or continuous data collection in adults, whereas the reference predicate device is used in adults only for continuous data collection and recording, as well as adults and pediatrics for spot-checking.The subject device is based on the reference predicate device, So they are substantially equivalent, just different expression.

Both the subject device and the reference predicate device have similar function including measuring, displaying, storing and transmitting of pulse oxygen saturation(SpO2) and Pulse Rate.The reference predicate device is a Cardiac Monitor and has more function (such as ECG and Temperature).The function of the subject device is obviously within the range of the Reference Predicate Device. So the differences will not raise new questions of safety and effectiveness. The subject devices passed the test of bench test and ISO 80601-2-61.

Different 2):

Compared with Primary Predicate Device:

Both the subject device and the primary predicate device are same.

Compared with Reference Predicate Device:

The subject device is used for adult patients whereas the reference predicate device is used in a wider range of patient types like adults and pediatric patients. The Patient type of the subject device is obviously within the range of the Reference Predicate Device.The differences does not affect the safety and effectiveness of the subject device.

{10}------------------------------------------------

#### Different 3):

Compared with Primary Predicate Device:

Infrared LED Wavelength of the subject device is 940nm, and primary predicate's wavelength is 905nm. These two wavelengths are both adopted widely in measurement of SpO2. What's more, the reference predicate's wavelength is 940nm. And the subject device together meets the requirements of the IEC 60601-1, IEC 60601-1-11, ISO 80601-2-61 and IEC 60601-1-2.The differences does not affect the safety and effectiveness of the subject device.

Compared with Reference Predicate Device:

Both the subject device and the reference predicate device are same.

Different 4):

Compared with Primary Predicate Device:

The power supply of the subject device is Lithium rechargeable battery, and the power supply of the primary predicate device is 2 AAA alkaline batteries. And the subject device together meets the requirements of the IEC 60601-1.IEC 60601-1-11,ISO 80601-2-61 and IEC 60601-1-2.What's more,the power supply of the reference predicate device is Lithium rechargeable battery.So the differences does not affect the safety and effectiveness of the subject device.

Compared with Reference Predicate Device:

Both the subject device and the reference predicate device are same.

{11}------------------------------------------------

#### 8. Brief discussions of the non-clinical tests

The subject device conforms to the following guidances and standards:

- IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for ● Basic Safety and essential performance
- IEC 60601-1-2: 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: Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
- IEC 60601-1-11: 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
- I SO 10993-1 Fourth edition 2009-10-15 Biological evaluation of nedical devices - Part 1: Evaluation and testing within a risk nanagement process [Including: Technical Corrigendum 1 (2010)]
- I SO 10993-5 Third edition 2009-06-01 Biological evaluation of nedical devices - Part 5: Tests for in vitro cytotoxicity
- I SO 10993-10 Third Edition 2010-08-01 Biological evaluation of nedical devices -Part 10: Tests for irritation and skin sensitization
- I SO 14971 Risk Minagement
- 47 CFR FCC PART 15. Subpart C Unintentional Radiators/ Mscellaneous ● Wrel ess Commit at i ons Ser vi ce
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- FDA Guidance for Pulse Oximeters - Premarket Notification Submissions [510(k)s]
- FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It is concluded that the subject Pulse Oximeter device is in compliance with the requirements of the aforementioned tests.

{12}------------------------------------------------

#### 9. Brief discussions of clinical tests

The pulse oximeter(PO6、PO6A) was subjected to clinical testing. The functional oxygen saturation (SpO2) measurement has been validated in accordance with ISO 80601-2-61.

Clinical testing (controlled desaturation study) was conducted, during induced hypoxia studies ona total of 12 healthy adult ( healthy, non-smoking, light-to-dark-skinned ) in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the subject device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter (control device). The accuracy of the subject device is in comparison with the control device over the SpO2 range of 70~100%.

The SpO2 accuracy results include:

• 1.57% which meets the accuracy requirement of less than or equal to 2% under no motion condition. The accuracy specification is reported as accuracy root mean square (Arms).

The result met the criteria specified in the ISO 80601-2-61; In addition, there were no reported adverse effects during these investigations.

#### 10. Brief discussions of Biocompatibility tests

The patient-contacting components and materials are listed together with the corresponding test items in the following table. The contact duration is limited to be within 24 hours to 30 days, and the type of contact belongs to surface medical device-intact skin with prolonged duration

| Patient-contacting<br>Components | Contact Materials | Leverage<br>biocompatibility<br>test items |
|----------------------------------|-------------------|----------------------------------------------------|
| Enclosure | PC | Cytotoxicity |
| Finger sleeve | Silicone | Skin Sensitization<br>Test<br>Skin Irritation Test |

The PC, Silicone of the test article is identical to the medical device in its final finished form in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).

Based on International Standard ISO 10993 and FDA Biological evaluation guidance,the material are tested for vitro cytotoxicity, irritation and Skin Sensitization.

{13}------------------------------------------------

The biocompatibility test results demonstrated that there's no cytotoxic potential, no evidence of significant irritation nor evidence of sensitization. Thus, the device meets the requirement of Biocompatibility.

#### 11. Brief discussions of Bluetooth tests

The device Bluetooth will be enabled automatically after it's turned on.

To establish a Bluetooth connection:

- Keep the device Bluetooth enabled.
- Make sure the phone Bluetooth is enabled.

And the testing included the Wireless Coexistence tests via Bluetooth, results of which demonstrate the Bluetooth performance of the subject device.

#### 12. Software information

The software level of concern for the subject device is MODERATE. According to FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff", the software validation documentation summarizes the required information for a MODERATE Level of Concern device. And a testing included the Cybersecurity tests, results of which demonstrate the Cybersecurity of the subject device.

## 13. Other information (such as required by FDA guidance):

No other information.

#### 14. Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Shenzhen Viatom Technology Co., Ltd. concludes that the subject device has the same intended use as the predicate device, and the technological differences do not raise different questions of safety and effectiveness.