Fever Scout™ Continuous Monitoring thermometer

K162137 · VivaLNK, Inc. · FLL · Jan 19, 2017 · General Hospital

Device Facts

• Record ID: K162137
• Device Name: Fever Scout™ Continuous Monitoring thermometer
• Applicant: VivaLNK, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Jan 19, 2017
• 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. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

Device Story

Fever Scout is a wearable, reusable electronic patch for continuous armpit temperature monitoring; intended for home use. Device consists of a flexible patch with a temperature sensor, control module, BLE communication module, and rechargeable lithium battery; includes a charging system with BLE relay function to extend range. Patch adheres to skin; transmits temperature data via BLE to a smartphone app. App provides GUI for temperature display, trending, and user-defined alerts. Healthcare providers or caregivers use the app to monitor patient temperature trends; facilitates non-urgent clinical decision-making regarding fever management. Benefits include continuous, non-invasive monitoring without manual spot-checks.

Clinical Evidence

Bench testing only. Performance demonstrated via product verification, software verification, usability validation, biocompatibility (ISO 10993-1), mechanical hazards, EMC (IEC 60601-1-2), and electrical safety (IEC 60601-1, IEC 60601-1-11). Accuracy verified against ASTM E1112-2000 (Reapproved 2011).

Technological Characteristics

Flexible PCB patch; temperature sensor; BLE communication; 3.0V DC rechargeable lithium battery. Standards: ASTM E1112, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62304, ISO 10993-1. Connectivity: BLE to smartphone app. Type B applied part.

Indications for Use

Indicated for non-urgent ambulatory continuous armpit body temperature monitoring in patients aged 29 days and older.

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

• TempTraq Model TT-100 (K143267)

Reference Devices

• iThermonitor WT-701 (K132761)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 19, 2017

Vivalnk Inc. Christine Kuo Director, RA/QA 4655 Old Ironsides Dr. #390 Santa Clara, California 95054

Re: K162137

Trade/Device Name: Fever Scout™ Continuous Monitoring thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 20, 2016 Received: December 23, 2016

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 may, 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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 Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K162137

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. This product is intended for non-urgent ambulatory continuous armpir body temperature monitioring 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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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# Section 5 – 510(k) Summary

# K162137

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.

| Type of Submission: | Traditional 510(k); this is the first submission for this device |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | VivaLnk Inc.<br>4655 Old Ironsides Dr. #390<br>Santa Clara, CA 95054 USA<br>Phone: [phone] |
| Contact Person: | Christine Kuo |
| Date Prepared: | January 19, 2017 |
| Device Identification: | |
| Trade Name: | Fever Scout™ 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 |
| Indications for Use: | The wireless Fever Scout™ Continuous Monitoring thermometer<br>is a non-invasive and re-usable electronic device for home use.<br>This product is intended for non-urgent ambulatory continuous<br>armpit body temperature monitoring from ages 29 days and older. |
| Device Description: | Fever Scout Continuous Monitoring thermometer is an ambulatory<br>continuous body temperature monitor designed for armpit location,<br>and uses Bluetooth Low Energy (BLE) for wireless<br>communication with the Smartphone app for temperature display,<br>trending and alert. |
| | This product is composed of <ul><li>The Fever Scout VV-200 patch</li><li>The Smartphone app (supporting iOS)</li><li>AAA charging system with BLE relay function</li></ul> |

- . Eight adhesives

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| | The patch hardware primarily includes the following function<br>modules: 1) temperature sensor, 2) control module, 3) Bluetooth<br>Low Energy (BLE) communication module and 4) battery. All are<br>integrated onto a flexible electronic printed circuit board. A MS<br>Lithium rechargeable battery is attached to the board to supply<br>3.0V DC internal power. |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The app includes 1) User account, profile and alert temperature<br>setup and 2) GUI for temperature display, trending and alerts. |
| | The charging system provides a cordless charging method to the<br>patch, a storage to the replaceable double-sided adhesives, as well<br>as an alternative BLE communication channel from the patch to<br>the charger and then to the iPhone, in order to extend<br>communication range. |
| | This product contains Type B applied part (per IEC 60601-1:<br>2012). All components, the patch, charger and adhesives are all<br>user accessible parts. However, the user is only expected to change<br>the charger AAA batteries, but not to open or modify any other<br>parts of the product. |
| Predicates: | TempTraq Model TT-100 by Blue Spark Technologies (K143267) |
| Trade Name: | TempTraq Model TT-100 |
| Device Common Name: | Armpit thermometer |
| Classification: | 21 CFR Sec. 880.2910, Clinical electronic thermometer |
| Product Code: | FLL |
| Classification Panel: | General Hospital |
| Class: | II |

#### Summary of Substantial Equivalence:

Fever Scout Continuous Monitoring thermometer is substantially equivalent to the predicate, TempTraq TT-100.

### Device Comparison

| Characteristics | Proposed<br>Device<br>Fever Scout | Primary<br>Predicate<br>TempTraq<br>TT-100 | Reference<br>Predicate<br>iThermonitor<br>WT-701 | Comparison | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k) Number | NA | K143267 | K132761 | NA | |
| Product Code | FLL | | | Identical | |
| Regulation # | 21CFR880.2910 | | | | Identical |
| Class | Clinical electronic thermometers | | | | Identical |
| Indications for Use | The wireless<br>Fever Scout<br>Continuous<br>Monitoring<br>thermometer<br>is a non-<br>invasive and<br>re-usable<br>electronic<br>device for<br>home use.<br>This product<br>is intended for<br>non-urgent<br>ambulatory<br>continuous<br>armpit body<br>temperature<br>monitoring<br>from ages 29<br>days and<br>older. | The Wireless<br>thermometer,<br>model TT-100,<br>is<br>a battery-<br>operated<br>electronic<br>device<br>with intended<br>use<br>of measuring<br>human body<br>temperature<br>precisely. This<br>device is single<br>use<br>and intended<br>for armpit<br>temperature<br>measurement for<br>persons of all<br>age. | The Wireless<br>Thermometer<br>is a battery<br>operated<br>electronic<br>device with<br>intended use<br>of measuring<br>human armpit<br>temperature<br>continuously<br>via wireless<br>signal<br>transmission<br>of the<br>measuring<br>results. This<br>system is<br>reusable and<br>intended for<br>armpit<br>monitoring for<br>persons over<br>two years old. | Equivalent.<br><br>All three devices<br>are for human<br>armpit<br>temperature<br>measurements.<br>Difference are<br>demonstrated to<br>not raise<br>questions of<br>safety and<br>effectiveness per<br>requirements set<br>forth in the<br>standards listed<br>in Section 5-<br>510(k)<br>Summary | |
| Display Use Specification | iOS device<br>display | iOS and<br>Android device<br>display | iOS device<br>display | Equivalent<br><br>iOS is what all<br>three devices<br>support. Not<br>supporting<br>Android will not<br>impact safety or<br>efficacy<br>concerns, but<br>limit market<br>share (number<br>of users who can<br>use this device). | |
| Working Voltage | 3.0 V DC | | | Identical | |
| Battery | MS Lithium<br>Rechargeable<br>Battery 3.0V | Two (2)<br>Blue<br>Spark 1.5 V<br>batteries<br>(103-<br>UT1) | The button<br>battery 3.0 V,<br>210mAh | Equivalent per<br>UL 1642 5th<br>Edition | |
| Reuse | Yes | No | Yes | Equivalent | |
| | | | | is demonstrated<br>to not raise<br>questions of<br>safety and<br>efficacy through<br>functional<br>verification and<br>cleaning testing. | |
| Measurement Range | 35 ~ 42°C | 30 ~ 42.4°C | 25 ~ 45° C | Equivalent<br>All three devices<br>cover the needed<br>range per<br>ASTM_1112<br>Temperature<br>range. | |
| Accuracy | ±0.1°C<br>From 37 ~<br>39°C, ±0.2°C<br>from 35 ~<br>37°C and 39 ~<br>42°C | ±0.1°C<br>between 30<br>~ 42.4°C | ±0.05° C (35 -<br>38.5° C);<br>±0.1° C (25 -<br>34.99° C);<br>±0.1° C<br>(38.51 -45° C) | Equivalent<br>All three devices<br>meet the<br>maximum error<br>temperature<br>ranges per<br>ASTM_1112. | |
| Signal Transmission | Wireless 2.4G<br>Bluetooth<br>BLE | | | Identical | |
| Receiver | Wireless 2.4G<br>Bluetooth<br>BLE enabled<br>smart devices<br>running Apple<br>operating<br>system<br>iPhone 5S+ or<br>newer. | Wireless<br>2.4G<br>Bluetooth<br>BLE<br>enabled<br>smart<br>devices<br>running<br>Apple<br>operating<br>system iOS<br>7.1 through<br>8.1 or<br>Android<br>operating<br>system 4.3<br>through<br>4.4.4 | Wireless 2.4G<br>Bluetooth<br>BLE enabled<br>smart devices<br>running Apple<br>operating<br>system iPhone<br>4S, iPhone 5, iPad<br>(3rd<br>generation),<br>iPad (4th<br>generation),<br>iPad mini,<br>iPod (5th<br>generation) | Equivalent<br>All three devices<br>support 2.4G<br>BLE enabled<br>devices. The<br>difference in<br>supported<br>operating<br>systems doesn't<br>impact safety<br>and efficacy. | |
| Valid Transmission | Up to 40<br>meters (with<br>relay) | Up to 40<br>feet | Up to 5 meters | Equivalent<br>The device is<br>demonstrated to | |
| Operating Condition | 10~40°C<br>15-85%<br>humidity | 16~40°C<br>15 -95%<br>humidity | 5~40 °C<br>15-85% humidity | intended.<br>Equivalent<br><br>The operating<br>range is<br>compliant with<br>ASTM_1112. | |
| Anatomical Application | Armpit<br>peel-and-stick contact thermometer sensor | | | Identical/<br>Equivalent | |
| Temperature Measurement<br>Interval | Continuous<br>transmitter<br>measures body<br>temperature<br>every 15<br>seconds | Continuous<br>transmitter<br>measures<br>body<br>temperature<br>every 10<br>seconds | Continuous<br>transmitter<br>measures body<br>temperature every<br>4 seconds | Equivalent<br><br>The maximum<br>difference in<br>temperature<br>measurements is<br>11 seconds,<br>which does not<br>raise questions<br>of safety and<br>efficacy. | |
| Safety and<br>Performance | Biocompatibility | Conformed to ISO 10993-1, ISO 10993-5, and ISO 10993-10 | | Identical/<br>Equivalent<br><br>Test against the<br>same standards<br>for safety and<br>performance | |
| | Electrical Safety | Conformed to IEC 60601-1 | | Identical/<br>Equivalent<br><br>Test against the<br>same standard<br>for safety and<br>performance | |
| | Electromagnetic<br>Compatibility | Conformed to IEC 60601-1-2 and FCC | | Identical/<br>Equivalent<br><br>Test against the<br>same standard<br>for safety and<br>performance | |
| | Performance | Conformed to ASTM E1112 | | Identical/<br>Equivalent<br><br>Test against the<br>same standard<br>for safety and<br>performance | |

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| Technological Characteristics: | Fever Scout Continuous<br>Monitoring thermometer is technologically substantially equivalent<br>to the predicate device. Both devices use equivalent temperature<br>technology to sense, process and transmit temperature data<br>continuously from the patch affixed to the skin under the armpit to<br>a mobile application. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | The substantially equivalent performance of Fever Scout<br>Continuous Monitoring thermometer has been demonstrated by<br>product verification, software verification, user/usability validation,<br>biocompatibility test, mechanical hazards test, EMC test and IEC<br>60601-1 safety compliance test. |
| | Performance data demonstrates conformance with 21 CFR Part<br>1020 or compliance with voluntary standards includes but not<br>limited to the following: |
| | IEC 60601-1:2005/(R) 2012: Medical Electrical Equipment -- Part 1:<br>General Requirements For Basic Safety And Essential Performance |
| | IEC 60601-1-2:2014: Medical Electrical Equipment - Part 1-2: General<br>Requirements For Basic Safety And Essential Performance - Collateral<br>Standard: Electromagnetic Compatibility – Requirements And Tests |
| | IEC 60601-1-11: 2015 Medical electrical equipment - Part 1-11:<br>General requirements for basic safety and essential performance -<br>Collateral standard: Requirements for medical electrical equipment and<br>medical electrical systems used in the home healthcare environment |
| | IEC 62304:2006 Medical Device Software – Software lifecycle Processes |
| | ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing Within a Risk Management Process |
| | ASTM E1112-2000 (Reapproved 2011), standard specification for<br>electronic thermometer for intermittent determination of patient<br>temperature. |
| Conclusion: | VivaLnk concludes that the device is substantially equivalent to<br>the currently legally marketed predicate devices. Fever Scout<br>Continuous Monitoring thermometer has equivalent indications for<br>use and technological characteristics, and does not introduce<br>different questions of safety and effectiveness. |