Vitals360 Multi-Vitals Mobile Monitor

K210086 · Vocare, Inc. · MWI · May 20, 2021 · Cardiovascular

Device Facts

• Record ID: K210086
• Device Name: Vitals360 Multi-Vitals Mobile Monitor
• Applicant: Vocare, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: May 20, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age. This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently. This VITALS360® device is intended for use in a clinical or home environment. This VITALS360® device is a reusable device following thorough cleaning between uses.

Device Story

Vitals360® is a multi-parameter mobile monitor for spot-checking physiological data. Inputs include photoelectric signals for SpO2/PR, oscillometric pressure for NIBP, infrared radiation for forehead temperature, and single-lead ECG via two embedded metal electrodes. Device stores and displays measurements on a 3.66-inch screen; intended for use by trained adults in clinical or home environments. Data facilitates patient health tracking; device is reusable after cleaning. No alarms are present; battery status is indicated via icon. Device operates on battery or AC power.

Clinical Evidence

Clinical studies conducted per ISO 80601-2-61 (SpO2), ISO 81060-2 (NIBP), and ISO 80601-2-56 (TEMP) standards. Testing verified accuracy of physiological measurements within specified ranges. Results support device performance claims.

Technological Characteristics

Class II device; 145x80x25mm; 0.25kg. Materials: surface-contacting (ISO 10993-1 compliant). Sensing: photoelectric (SpO2), oscillometric (NIBP), infrared (TEMP), metal electrodes (ECG). Power: 3.7V rechargeable lithium battery or AC (100-240V). Connectivity: smartphone-integrated. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, ISO 80601-2-61, ISO 80601-2-30, ISO 80601-2-56, IEC 62133.

Indications for Use

Indicated for adults ≥18 years for measuring/monitoring NIBP, SpO2, pulse rate, forehead temperature, ECG, weight, and height. Intended for use by trained adults proficient in smartphone use in clinical or home settings.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• All-in-One Health Monitor, PC-303 (K170047)
• Infrared Thermometer, RN-50A, RN-50B (K200578)

Submission Summary (Full Text)

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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 20, 2021

VoCare, Inc. Deon Vigilance Chief Medical Officer 4950 Turkev Foot Road Zionsville, Indiana 46077

Re: K210086

Trade/Device Name: Vitals360® Multi-Vitals Mobile Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA, DSH, DXN, FLL Dated: April 19, 2021 Received: April 19, 2021

Dear Deon Vigilance:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular 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) K210086

Device Name

Vitals360® Multi-Vitals Mobile Monitor

### Indications for Use (Describe)

Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age.

This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.

This VITALS360® device is intended for use in a clinical or home environment.

This VITALS360® device is a reusable device following thorough cleaning between uses.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY - K210086

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

#### I. SUBMITTER

Contact Person: Steve Peabody VoCare, Inc. 4950 Turkey Foot Road Zionsville, IN 46077 USA Tel: [phone] Fax: N/A Submission Contact: Deon Vigilance Date Prepared: April 15, 2021

#### II. DEVICE

| Name of Device: | Vitals360® Multi-Vitals Mobile Monitor – Model: VC-001 |
|------------------------------|-----------------------------------------------------------------------------|
| Classification Name: | Monitor, Physiological, Patient (Without Arrhythmia Detection On<br>Alarms) |
| Regulation: | 21 CFR §870.2300 |
| Regulatory Class: | Class II |
| Product Classification Code: | MWI, DQA, DSH, DXN, and FLL |

#### PREDICATE DEVICE III.

| Primary Predicate Manufacturer: | Shenzhen Creative Industry Co., Ltd. |
|---------------------------------|--------------------------------------|
| Primary Predicate Trade Name: | All-in-One Health Monitor, PC-303 |
| Primary Predicate 510(k): | K170047 |

| Secondary Predicate Manufacturer: | Ningbo Ranor Medical Science & Technology Co., Ltd. |
|-----------------------------------|-----------------------------------------------------|
| Secondary Predicate Trade Name: | Infrared Thermometer, RN-50A, RN-50B |
| Secondary Predicate 510(k): | K200578 |

No reference devices were used in this submission.

#### DEVICE DESCRIPTION IV.

The Vitals360® is a device designed for spot-checking measuring of the patient's physiological parameters. It

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can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology. Additionally, it can record single lead ECG signal.

The Vitals360® capabilities include storing, displaying measuring data.

#### INTENDED USE & INDICATION FOR USE V.

Vitals360® device is intended to be used for measuring, displaying and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 vears of age.

This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.

This VITALS360® device is intended for use in a clinical or home environment.

This VITALS360® device is a reusable device following thorough cleaning between uses.

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### COMPARISON TO THE PREDICATE DEVICE VI.

| Features | Subject Device - Vitals360 | Primary Predicate Device - PC-<br>303 (K170047) | Secondary Predicate Device -<br>Infrared Thermometer RN-<br>50A, RN-50B (K200578) | Justification for Differences |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | VoCare Inc. | Shenzhen Creative Industry<br>Co., Ltd. | Ningbo Ranor Medical Science<br>& Technology Co., Ltd. | N/A |
| Classification<br>Regulation | 21 CRF 870.2300 | 21 CRF 870.2300 | 21 CFR 880.2910 | The secondary predicate is<br>limited to the regulation for<br>clinical thermometers. |
| Classification<br>and Code | Class II, MWI, DQA, DSH,<br>DXN, and FLL | Class II, MWI, DQA, DXN,<br>FLL, NBW, DSH | Class II, FLL | The subject device does not<br>include a glucometer function,<br>and therefore the NBW code is<br>not applicable to the subject<br>device. The secondary predicate<br>is limited to the clinical<br>thermometer product code. |
| Common name | Patient Monitor | Patient Monitor | Thermometer, electronic, clinical | The secondary predicate is<br>limited to the clinical<br>thermometer function. |
| Intended use | Vitals360® device is intended to<br>be used for measuring,<br>displaying, reviewing and storing<br>of non-invasive blood pressure<br>(NIBP), non-invasive monitoring<br>of functional oxygen saturation<br>of arterial hemoglobin (SpO2),<br>pulse rate (PR), forehead<br>temperature (TEMP), ECG,<br>weight and height in adults no<br>less than 18 years of age.<br>This VITALS360® device is<br>intended for use by trained adults<br>only who can use smartphones | The All-in-One Health<br>Monitor, PC- 303 is a device<br>designed for spot- checking<br>measuring of the patient's<br>physiological parameters, such<br>as Non-Invasive Blood<br>Pressure (NIBP), Oxygen<br>saturation (SpO2), Pulse Rate<br>(PR) and Body Temperature<br>(TEMP);<br>Additionally, the device is<br>available to communicate with<br>the compatible Blood Glucose<br>Monitoring System and ECG | The Infrared thermometer is a<br>non-contact infrared<br>thermometer intended for the<br>intermittent measurement of<br>human body temperature<br>from forehead for people of<br>all ages. The device is<br>reusable for home use and<br>clinical use. | The subject device is limited<br>to patients 18 years of age<br>and older and does not<br>include indications for<br>glucose measurement. These<br>omissions do not introduce<br>any additional risks, and<br>otherwise the indications are<br>equivalent to the primary<br>predicate. The secondary<br>predicate is limited to body<br>temperature measurement and<br>also applies to a wider patient<br>range. |
| | | | | |
| | proficiently.<br>This VITALS360® device is<br>intended for use in a clinical or<br>home environment.<br>This VITALS360® device is<br>a reusable device following<br>thorough cleaning between<br>uses. | monitor to make the<br>measurement.<br>This device is applicable for<br>Adult and Pediatric (age≥3<br>years old) use in clinical<br>institutions and has no<br>conditions or factors of<br>contraindication. | | |
| Physical<br>dimension(mm)<br>/weight(kg) | 145(L) × 80(W) × 25(H) / 0.25kg | 165(L) × 96(W) × 68(H) / 0.44kg | N/A | The subject device is smaller than<br>the primary predicate which does<br>not create any negative issues<br>regarding portability or usability<br>of the device, and the smaller<br>size of the clinical thermometer<br>is due to its limited functionality. |
| Display | 3.66 inch | 4.3 inch | LCD Display | The display size of the subject<br>device and the predicate are<br>equivalent, and no readability<br>issues were identified during<br>usability testing. The LCD<br>display for the clinical<br>thermometer is appropriate only<br>for the display of a single<br>temperature. |
| Type, Degree of<br>protection<br>against electric<br>shock | Class II with internal electric<br>power supply.<br>SpO2/NIBP/TEMP: Type BF<br>applied part. | Class II with internal electric<br>power supply.<br>SpO2/NIBP/TEMP: Type BF<br>applied part. | Class II with internal electric<br>power supply.<br>TEMP: Type BF applied part. | The subject device and the<br>primary predicate are identical.<br>The applicable applied part of the<br>subject device is also equivalent<br>to the clinical thermometer. |
| Power supply | Battery or AC | Battery or AC | Battery | The subject device and the<br>primary predicate are identical.<br>The lack of AC charging for the<br>clinical thermometer is<br>appropriate for the lower power<br>requirements. |
| Power<br>requirement | (100-240) VAC, 50/60Hz, 0.5A,<br>Rechargeable lithium battery,<br>3.7VDC | (100-240) VAC, 50/60Hz,<br>15VA,<br>Rechargeable lithium battery,<br>3.7VDC | AAA*3, DC 3V | The subject device and the<br>primary predicate are equivalent.<br>The lack of AC charging for the<br>clinical thermometer is<br>appropriate for the lower power<br>requirements. |
| Alarm | No alarm | No alarm | Low Battery Indication | The subject device and primary<br>predicate do not include alarms<br>for low battery indication,<br>because the display is able to<br>show a battery icon that indicates<br>the remaining battery % and the<br>device will not take<br>measurements if the battery level<br>is too low. |
| Features | Subject Device - Vitals360 | Primary Predicate Device -<br>PC-303 (K170047) | Secondary Predicate Device -<br>Infrared Thermometer RN-<br>50A, RN-50B (K200578) | Justification for Differences |
| SpO2 / Pulse Rate | | | | |
| Patient | 18 years and older | Adult, pediatric | Adult, pediatric | The subject device is limited to<br>patients 18 years of age and<br>older, while both predicates are<br>indicated for adult and pediatric<br>patients. This omission does not<br>introduce any additional risks. |
| SpO2<br>measure<br>ment<br>accuracy | Displayed range: 70%~100%<br>±2% (during 90~100%),<br>±4% (during 70~89%) | Displayed range: 70%~100%<br>±3% (during 70%-100%)<br>Undefined (during 0-70%) | N/A | Subject device and primary<br>predicate are equivalent, and<br>secondary predicate does not<br>include SpO2 feature. |
| Pulse rate<br>measurement<br>range | 30 to 150 bpm | 30 bpm-240 bpm | N/A | Subject device and primary<br>predicate are equivalent, and<br>secondary predicate does not<br>include SpO2 feature. |
| Pulse rate<br>accuracy | ±2bpm or ±2%, whichever is<br>greater | ±2bpm or ±2% (whichever is<br>greater) | N/A | Subject device and primary<br>predicate are identical, and |

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| | | | | secondary predicate does not<br>include SpO2 feature. |
|-------|----------|----------|-----|---------------------------------------------------------------------------------------------------------------------|
| Alarm | No alarm | No alarm | N/A | Subject device and primary<br>predicate are identical, and<br>secondary predicate does not<br>include SpO2 feature. |

| Features | Subject Device - Vitals360 | Primary Predicate Device - PC-303 (K170047) | Secondary Predicate Device -<br>Infrared Thermometer RN-50A, RN-50B (K200578) | Justification for Differences |
|----------------------------------------|----------------------------|---------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NIBP | | | | |
| Method | Oscillometric method | Oscillometric method | N/A | Subject device and primary predicate are identical, and secondary predicate does not include NIBP feature. |
| Patient type | 18 years and older | Adult and Pediatric patients | N/A | The subject device is limited to patients 18 years of age and older and does not include indications for glucose measurement. These omissions do not introduce any additional risks, and otherwise the indications are equivalent to the primary predicate. The secondary predicate does not include NIBP feature. |
| Unit of measure | mmHg & kPa | mmHg & kPa | N/A | Subject device and primary predicate are identical, and secondary predicate does not include NIBP feature. |
| Pressure measurement range - Systolic | 60 mmHg ~230mmHg | 60 mmHg - 255mmHg | N/A | Subject device and primary predicate are equivalent, and secondary predicate does not include NIBP feature. |
| Pressure measurement range - Diastolic | 40 mmHg ~130mmHg | 30 mmHg - 195mmHg | N/A | Subject device and primary predicate are equivalent, and secondary predicate does not |

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| | | | | include NIBP feature. |
|-------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BP accuracy | Mean deviation values: ±5 mmHg.<br>Standard deviation <= 8 mmHg. | Mean deviation values: ±5 mmHg.<br>Standard deviation <= 8 mmHg. | N/A | Subject device and primary predicate are identical, and secondary predicate does not include NIBP feature. |
| Cuff pressure range | 0 to 300mmHg | 0 to 300mmHg | N/A | Subject device and primary predicate are identical, and secondary predicate does not include NIBP feature. |
| Over pressure protector | Cuff pressure exceeds<br>300mmHg at any time. | Cuff pressure exceeds 300mmHg (Adult and pediatric mode) at any time. | N/A | Subject device is limited to subjects 18 years an older, while the primary predicate is indicated for adult and pediatric patients. The secondary predicate does not include NIBP feature. |
| Alarm | No alarm | No alarm | N/A | Subject device and primary predicate are identical, and secondary predicate does not include NIBP feature |

| Features | Subject Device - Vitals360 | Primary Predicate Device -<br>PC-303 (K170047) | Secondary Predicate Device -<br>Infrared Thermometer RN-<br>50A, RN-50B (K200578) | Justification for Differences |
|-----------------------------------------|----------------------------|------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TEMP | | | | |
| Fundamental<br>scientific<br>technology | Infrared technology | Infrared technology | Infrared technology | All three devices are identical with regard to technology. |
| Patient type | 18 years and older | Adult, Pediatric | Adult, Pediatric | The subject device is limited to patients 18 years of age and older, while both predicates are indicated for adult and pediatric patients. This omission does not |

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| | | | | introduce any additional risks. |
|----------------------------------------|--------------------------------|--------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Unit of measure | °C or °F | °C or °F | °C or °F | All three devices are identical<br>with regard to unit of measure. |
| Measurement<br>site | Forehead | Ear | Forehead | The secondary predicate was<br>selected, because the primary<br>predicate uses a different<br>measurement site. The secondary<br>predicate and the subject device<br>are identical with regard to<br>measurement site. |
| Temperature<br>measurement<br>range | 34.0°C ~43.0°C(93.2°F~109.4°F) | 32.0°C to 43.0°C (90°F to<br>109.4°F) | 32.0°C ~42.9°C<br>(89.6°F~109.2°F) | The temperature ranges of all<br>three devices are slightly<br>different, but they are equivalent<br>and meet the requirements of the<br>applicable standards for clinical<br>thermometers. |
| Temperature<br>measurement<br>accuracy | ±0.3°C (±0.5°F) | ±0.2°C (36.0°C to 39.0°C),<br>±0.3°C other range | ±0.2°C (36.0°C to 39.0°C)<br>±0.3°C other range | The temperature accuracy of the<br>subject device is equivalent to<br>both predicates, and all three<br>devices meet the requirements of<br>the clinical thermometer<br>standards. |

| Features | Subject Device - Vitals360 | Primary Predicate Device -<br>PC-303 (K170047) | Secondary Predicate Device -<br>Infrared Thermometer RN-<br>50A, RN-50B (K200578) | Justification for Differences |
|-------------------------------------|-----------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ECG | | | | |
| Patient type | 18 years and older | Adult, pediatric patients | N/A | The subject device is limited to<br>patients 18 years of age and<br>older, while both predicates are<br>indicated for adult and pediatric<br>patients. This omission does not<br>introduce any additional risks. |
| Number of<br>electrodes<br>employed | 2 embedded metal electrodes | 3 embedded metal electrodes or<br>using 3 adhesive ECG<br>electrodes by | N/A | Subject device and primary<br>predicate are equivalent, and<br>secondary predicate does not |

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| | | connection to the lead wire | | include ECG feature. |
|--------------------------------------|---------------------------------------|---------------------------------------|-----|---------------------------------------------------------------------------------------------------------------------|
| Heart rate<br>measuring<br>range | 30bpm-240bpm | 30bpm-240bpm | N/A | Subject device and primary<br>predicate are identical, and<br>secondary predicate does not<br>include ECG feature. |
| Resolution | 1bpm | 1bpm | N/A | Subject device and primary<br>predicate are identical, and<br>secondary predicate does not<br>include ECG feature. |
| Heart rate<br>measuring<br>precision | ±2bpm or ±2%, whichever is<br>greater | ±2bpm or ±2%, whichever is<br>greater | N/A | Subject device and primary<br>predicate are identical, and<br>secondary predicate does not<br>include ECG feature. |
| Sweep speed | 25mm/s, 50mm/s | 20mm/s±10% | N/A | Subject device and primary<br>predicate are equivalent, and<br>secondary predicate does not<br>include ECG feature. |
| Signal<br>bandwidth | 0.67Hz-40Hz | 0.5Hz-40Hz | N/A | Subject device and primary<br>predicate are equivalent, and<br>secondary predicate does not<br>include ECG feature. |
| Internal noise<br>level | ≤50uV p-v | ≤30uVp-p | N/A | Subject device and primary<br>predicate are equivalent, and<br>secondary predicate does not<br>include ECG feature. |

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#### VII. PERFORMANCE DATA

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

# Biocompatibility testing

The biocompatibility evaluation for VC-001 was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:

- Cytotoxicity
- Sensitization
- . Irritation

The subject devices are considered surface contacting for a duration of not exceed 24 hours.

# Non-clinical data

The Pulse Oximeter has been tested according to the following standards:

- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- IEC 60601-1-11: 2015 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.
- IEC 60601-2-47: 2012 Medical Electrical Equipment Part 2-61: Particular Requirements for Basic . Safety and Essential Performance of ambulatory electrocardiographic systems.
- ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- . ISO 80601-2-30: 2018 Medical Electrical Equipment - Part 2-30: Particular Requirements for Basic Safety and Essential Performance of automated non-invasive sphygmomanometers.
- ISO 80601-2-56: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of clinical thermometers for body temperature measurement.
- . IEC 62133: 2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications

The test was selected to show substantial equivalence between the subject device and the predicate.

# Clinical data

Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:

- . ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.

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- . Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff
- . ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
- . ISO 80601-2-56: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of clinical thermometers for body temperature measurement.

Clinical testing has been performed under an approved protocol with subject informed consent. Clinical test results support device accuracy claims for the specified measurement range.

#### VIII. CONCLUSION

Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate devices.