Fever Scout

K181013 · VivaLNK, Inc. · FLL · Aug 21, 2018 · General Hospital

Device Facts

• Record ID: K181013
• Device Name: Fever Scout
• Applicant: VivaLNK, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Aug 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use and a non-invasive and single patient use in the hospital. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

Device Story

Fever Scout VV-200 is a wearable, non-invasive, reusable electronic thermometer for continuous axillary temperature monitoring. Device consists of a patch, smartphone app (iOS/Android), and a charging system with BLE relay. Thermistor-based sensor measures temperature every 15 seconds; data transmitted via Bluetooth Low Energy (BLE) to a paired smartphone. App displays temperature, trends, and alerts. Used in home or hospital settings; intended for non-urgent monitoring. In hospital, device is designated for single-patient use to mitigate cross-contamination risks. Healthcare providers or patients view data on the app to track temperature trends, supporting clinical decision-making for fever management.

Clinical Evidence

Bench testing only. Device performance verified against ASTM E1112 standards. Biocompatibility testing conducted per ISO 10993-1, ISO 10993-5, and ISO 10993-10. Electrical safety and electromagnetic compatibility confirmed per IEC 60601-1.

Technological Characteristics

Thermistor-based temperature sensing. Wireless connectivity via 2.4GHz Bluetooth Low Energy (BLE). Powered by 3.0V DC rechargeable lithium battery. Form factor: wearable patch. Operating range: 10-40°C, 15-85% humidity. Measurement range: 35-42°C. Accuracy: ±0.1°C (37-39°C), ±0.2°C (35-37°C and 39-42°C). Standards: ASTM E1112, IEC 60601-1, ISO 10993 series.

Indications for Use

Indicated for non-urgent ambulatory continuous axillary body temperature monitoring in patients aged 29 days and older, for home use or single-patient use in hospital settings.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

• Fever Scout Continuous Monitoring thermometer (K162137)
• Cloud Smart Thermometer (K160306)

Submission Summary (Full Text)

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### August 21, 2018

VivaLnk Inc. Christine Kuo Director, Regulatory Affairs and Ouality Assurance 4655 Old Ironsides Drive. Suite 390 Santa Clara, California 95054

### Re: K181013

Trade/Device Name: Fever Scout™ Continuous Monitoring Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 29, 2018 Received: July 3. 2018

### Dear Christine Kuo:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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### Page 2 - Christine Kuo

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Hea

Enclosure

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# Indications for Use

510(k) Number (if known) K181013

Device Name

Fever ScoutTM Continuous Monitoring thermometer

#### Indications for Use (Describe)

The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use and a non-invasive and single patient use in the hospital. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

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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# K181013

# 510(k) Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the Fever Scout™ Continuous Monitoring thermometer.

| Type of Submission: | Traditional 510(k) for expanded indications of K162137 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | VivaLNK Inc.<br>51 East Campbell Avenue Suite #160<br>Campbell, CA 95008 USA<br>Phone: [phone] |
| Contact Person: | Christine Kuo |
| Date Prepared: | July13, 2018 |
| Device Identification: | |
| Trade Name: | Fever Scout ^TM Continuous Monitoring thermometer |
| Device Common Name: | Armpit thermometer |
| Classification: | 21 CFR Sec. 880.2910, Clinical electronic thermometer |
| Product Code: | FLL |
| Classification Panel: | General Hospital |
| Class: | II |
| Device Description: | The VivaLnk Fever Scout VV-200 is an ambulatory continuous body temperature monitor designed for armpit location, and uses Bluetooth Low Energy (BLE) for wireless communication with the Smartphone app for temperature display, trending and alert. |
| | The product is composed of |
| | <ul><li>The Fever Scout VV-200 patch</li><li>The Smartphone app (supporting Apple iOS and Android devices)</li><li>AAA charging system with BLE relay function</li><li>Eight disposable adhesives</li></ul> |
| Indications for Use: | The wireless Fever Scout ^TM Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use and a non-invasive and single patient use in the hospital. This product |

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is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

| Reason for Submission: | Expanded Indications for Use of the predicate |
|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicates: | Fever Scout Continuous Monitoring thermometer (K162137) |
| Trade Name:<br>Device Common Name:<br>Classification:<br>Product Code:<br>Classification Panel:<br>Class: | Fever Scout Continuous Monitoring thermometer<br>Armpit thermometer<br>21 CFR Sec. 880.2910, Clinical electronic thermometer<br>FLL<br>General Hospital<br>II |
| Summary of Substantial<br>Equivalence: | Fever Scout is substantially equivalent to the primary predicate<br>(K162137) and is the identical product as the predicates with the<br>expanded indications adding and a non-invasive and single patient<br>use in the hospital. |

The expanded indications is comparable to the secondary predicate (K160306) used for household and medical institutions.

## Device Substantial Equivalent Comparison

| | Technology Characteristics | | | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Proposed Device<br>(K181013) | Primary<br>Predicate<br>(K162137) | Secondary<br>Predicate<br>(K160306) | Comparison |
| Product code | FLL | FLL | FLL | Identical |
| Regulation # | 21 CFR 880.2910 | 21 CFR<br>880.2910 | 21 CFR<br>880.2910 | Identical |
| Regulation<br>description | Clinical electronic<br>thermometer | Clinical<br>electronic<br>thermometer | Clinical<br>electronic<br>thermometer | Identical |
| Device class | II | II | II | Identical |
| Indications for use | The wireless Fever<br>Scout Continuous<br>Monitoring<br>thermometer is a<br>non-invasive and<br>re-usable electronic<br>device for home<br>use. This product is<br>intended for non-<br>urgent ambulatory<br>continuous armpit | The wireless<br>Fever Scout<br>Continuous<br>Monitoring<br>thermometer is<br>a non-invasive<br>and re-usable<br>electronic<br>device for home<br>use and a non-<br>invasive and | The Cloud<br>Smart<br>Thermometer is<br>a battery-<br>operated<br>electronic<br>device with<br>intended use of<br>measuring and<br>monitoring<br>human axillary | Home use is<br>identical to primary<br>predicate and<br>comparable to<br>secondary predicate<br>(household use).<br><br>Hospital use:<br>comparable to<br>secondary predicate<br>(used for) |
| | body temperature<br>monitoring from<br>ages 29 days and<br>older. | single patient<br>use in the<br>hospital. This<br>product is<br>intended for<br>non-urgent | temperature<br>continuously via<br>wireless signal<br>transmission of<br>the measuring<br>result. | institutions) |
| | | ambulatory<br>continuous<br>armpit body<br>temperature<br>monitoring<br>from ages 29<br>days and older. | Meanwhile, the<br>device is<br>reusable and is<br>intended for<br>axillary<br>temperature<br>monitoring for<br>persons over<br>two years old,<br>and it is used for<br>household and<br>medical | |
| | | | institutions | |
| Display Use<br>Specification | Apple device and<br>Android device<br>display | Apple device<br>and Android<br>device display | iOS or Android<br>device display | Identical |
| Working Voltage | 3.0 V DC | 3.0 V DC | 3V DC | Identical |
| Battery | MS Lithium<br>Rechargeable<br>Battery 3.0V | MS Lithium<br>Rechargeable<br>Battery 3.0V | MAXELL<br>CR2025 Button<br>battery (3.0 V,<br>170mAh) | Comparable |
| Reuse | Re-usable for home<br>use and single<br>patient use in the<br>hospital | Re-usable for<br>home use | Reusable for<br>household and<br>medical<br>institutions | Comparable to<br>primary/secondary<br>predicates for home<br>use;<br>comparable to<br>secondary predicate<br>for<br>hospitable/medical<br>institution use |
| Measurement<br>Range | 35 ~ 42°C | 35 ~ 42°C | 25 ~ 45°C | Comparable |
| Accuracy | ±0.1°C<br>From 37 ~ 39°C,<br>±0.2°C<br>from 35 ~ 37°C and<br>39 ~ 42°C | ±0.1°C<br>From 37 ~<br>39°C, ±0.2°C<br>from 35 ~ 37°C<br>and 39 ~ 42°C | ±0.1ºC (at 36.0<br>to 40.0°C)<br>±0.2ºC at other<br>temperature<br>range | Comparable |
| Signal Transmission | Wireless 2.4G<br>Bluetooth BLE | Wireless 2.4G<br>Bluetooth BLE | Wireless 2.4 G<br>Bluetooth 4.0 | Comparable |
| Receiver | Wireless 2.4G<br>Bluetooth<br>BLE enabled<br>smart devices | Wireless 2.4G<br>Bluetooth<br>BLE enabled<br>smart devices | iOS7.0 or above<br>smartphone or<br>tablet; | Comparable |
| | | | Android 4.3 or | |
| | Apple devices:<br>iPhone 5S+ or later,<br>and iOS 8.0 or<br>later, and Android<br>device: 4.3 or later. | Apple devices:<br>iPhone 5S+ or<br>later, and iOS<br>8.0 or later, and<br>Android device:<br>4.3 or later. | above<br>smartphone,<br>tablet or<br>television | |
| Valid Transmission | Up to 40 meters<br>(with relay) | Up to 40 meters<br>(with relay) | Up to 15 meters<br>(under barrier-<br>free<br>environment) | Comparable |
| Operating<br>Condition | 10~40°C<br>15-85% humidity | 10~40°C<br>15-85%<br>humidity | 0~40°C<br>15-85% (non-<br>condensing) | Comparable |
| Anatomical<br>Application | Axillary (armpit)<br>temperature<br>measuring and<br>monitoring | Axillary<br>(armpit)<br>temperature<br>measuring and<br>monitoring | Axillary<br>(armpit)<br>temperature<br>measuring and<br>monitoring | Identical |
| Temperature<br>Measurement<br>Interval | Continuous<br>transmitter<br>measures body<br>temperature every<br>15 seconds | Continuous<br>transmitter<br>measures body<br>temperature<br>every 15<br>seconds | Every 4 seconds | Comparable |
| Performance Data: Safety and Performance | | | | |
| Performance | Proposed Device<br>(K181013) | Primary<br>Predicate<br>(K162137) | Secondary<br>Predicate<br>(K160306) | Comparison |
| Biocompatibility | Conformed to ISO<br>10993-1, ISO<br>10993-5, and ISO<br>10993-10 | Conformed to<br>ISO 10993-1,<br>ISO 10993-5,<br>and ISO 10993-<br>10 | Conformed to<br>ISO 10993-1. ISO<br>10993-5 and ISO<br>10993-10 | Identical |
| Electrical Safety | Conformed to IEC<br>60601-1 | Conformed to<br>IEC 60601-1 | Complied with<br>IEC 60601-1 | Identical |
| Electromagnetic<br>Compatibility | Conformed to IEC<br>60601-1 | Conformed to<br>IEC 60601-1 | Complied with<br>IEC 60601-1 | Identical |
| Performance | Conformed to<br>ASTM E1112 | Conformed to<br>ASTM E1112 | Complied with<br>ASTM E 1112 | Identical |

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## Technological Characteristics:

The Fever Scout product is technologically substantially equivalent to the primary predicate device (K162137) and is the identical product as the primary predicates with the expanded indications adding "and a non-invasive and single patient use in the hospital".

The expanded indications for hospital use is comparable to the secondary predicate (K160306) used for household and medical institutions.

## Performance Data (Safety and Performance):

The primary mode of action for measuring temperature is by thermistor.

The performance and safety compliance testes of the Fever Scout product with the expanded indications is substantially equivalent to the primary predicate device (K162137) and is the identical product as the primary predicates with the expanded indications adding "and a noninvasive and single patient use in the hospital.

The expanded indications for hospital use is comparable to the secondary predicate (K160306) used for household and medical institution.

## Safety Measure for Single Patient Use in the Hospital

VivaLNK would establish procedure to segregate the device shipping to the hospital with a box label "stating "Single Patient Use in the hospital". The risks associated with single patient use in the hospital are summarized in Fever Scout Risk Management Report which identifies and mitigates the hazard of cross contamination between the patient use in the hospital.

VivaLNK will control the products shipping to the hospital with a box label stating "Single Patient Use in the Hospital" and the precautions in the Instructions for Use (IFU) stating "The device is for single patient use in the hospital.

### Conclusion:

VivaLNK concludes that the device with the expanded indications by adding "and a noninvasive and single patient use in the hospital" is substantially equivalent to the currently legally marketed primary predicate device (K162137) and secondary predicate device (K160306).