Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard continuous temperature monitor using Bluetooth communication and a smartphone app for display and alerts. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.

Therapeutic

No.
The device is a thermometer for continuous temperature monitoring, which is a diagnostic tool, not a therapeutic intervention.

Diagnostic

Yes

Explanation: The device is a continuous monitoring thermometer that measures body temperature, which is used to diagnose fever.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is composed of a patch, a smartphone app, a charging system, and disposable adhesives, indicating it includes hardware components in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Fever Scout Continuous Monitoring thermometer measures body temperature directly from the skin (armpit). It does not analyze samples taken from the body.
Intended Use: The intended use is for "non-urgent ambulatory continuous armpit body temperature monitoring." This is a direct measurement of a physiological parameter, not an analysis of a biological sample.

Therefore, the Fever Scout is a medical device, but it falls under a different category than in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The wireless Fever ScoutTM 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.

Product codes (comma separated list FDA assigned to the subject device)

FLL

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

The Fever Scout VV-200 patch
The Smartphone app (supporting Apple iOS and Android devices)
AAA charging system with BLE relay function
Eight disposable adhesives

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Armpit (Axillary)

Indicated Patient Age Range

29 days and older.

Intended User / Care Setting

home use and in the hospital

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance data provided for Biocompatibility, Electrical Safety, Electromagnetic Compatibility, and Performance conformance tests.
Biocompatibility: Conformed to ISO 10993-1, ISO 10993-5, and ISO 10993-10
Electrical Safety: Conformed to IEC 60601-1
Electromagnetic Compatibility: Conformed to IEC 60601-1
Performance: Conformed to ASTM E1112

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: ±0.1°C From 37 ~ 39°C, ±0.2°C from 35 ~ 37°C and 39 ~ 42°C

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K162137, K160306

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.

Summary

0

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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)

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

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.
51 East Campbell Avenue Suite #160
Campbell, CA 95008 USA
Phone: 408-868-2898
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
	The Fever Scout VV-200 patchThe Smartphone app (supporting Apple iOS and Android devices)AAA charging system with BLE relay functionEight disposable adhesives
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

4

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:
Device Common Name:
Classification:
Product Code:
Classification Panel:
Class:	Fever Scout Continuous Monitoring thermometer
Armpit thermometer
21 CFR Sec. 880.2910, Clinical electronic thermometer
FLL
General Hospital
II
Summary of Substantial
Equivalence:	Fever Scout is substantially equivalent to the primary predicate
(K162137) and is the identical product as the predicates with the
expanded indications adding and a non-invasive and single patient
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
(K181013)	Primary
Predicate
(K162137)	Secondary
Predicate
(K160306)	Comparison
Product code	FLL	FLL	FLL	Identical
Regulation #	21 CFR 880.2910	21 CFR
880.2910	21 CFR
880.2910	Identical
Regulation
description	Clinical electronic
thermometer	Clinical
electronic
thermometer	Clinical
electronic
thermometer	Identical
Device class	II	II	II	Identical
Indications for 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	The wireless
Fever Scout
Continuous
Monitoring
thermometer is
a non-invasive
and re-usable
electronic
device for home
use and a non-
invasive and	The Cloud
Smart
Thermometer is
a battery-
operated
electronic
device with
intended use of
measuring and
monitoring
human axillary	Home use is
identical to primary
predicate and
comparable to
secondary predicate
(household use).

5

:

6

ﻢ

:

·

7

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).