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 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.

AI/ML Overview

The provided text describes the regulatory filing for a medical device, the Fever Scout Continuous Monitoring Thermometer (K181013), and its substantial equivalence to previously marketed predicate devices. The study detailed focuses on expanding the indications for use, particularly to include single-patient use in hospitals, rather than on proving new performance characteristics of the device itself.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

I. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Fever Scout™ Continuous Monitoring Thermometer are primarily based on its equivalence to existing predicate devices, particularly regarding its technical characteristics and compliance with recognized standards. Since the K181013 submission is for expanded indications for use (adding single-patient use in hospitals) for an identical product (VV-200) that was previously cleared (K162137), the performance acceptance criteria are implicitly those that the original predicate device met, and this submission seeks to demonstrate that the expanded use does not introduce new risks or alter its fundamental performance.

The table below summarizes the technical characteristics that serve as de facto "acceptance criteria" through comparison with predicates, along with the reported performance of the proposed device. The "Performance" section within the document refers to compliance with standards, indicating that meeting these standards serves as the primary proof of performance.

Table 1: Acceptance Criteria (Based on Predicate Equivalence) and Reported Device Performance

Characteristic	Acceptance Criteria (based on Primary Predicate K162137 and Secondary K160306)	Reported Device Performance (K181013)
Measurement Range	35 ~ 42°C (Primary Predicate); 25 ~ 45°C (Secondary Predicate)	35 ~ 42°C
Accuracy	±0.1°C From 37 ~ 39°C, ±0.2°C from 35 ~ 37°C and 39 ~ 42°C (Primary Predicate); ±0.1ºC (at 36.0 to 40.0°C), ±0.2ºC at other temp range (Secondary Predicate)	±0.1°C From 37 ~ 39°C, ±0.2°C from 35 ~ 37°C and 39 ~ 42°C
Biocompatibility	Conformed to ISO 10993-1, ISO 10993-5, and ISO 10993-10	Conformed to ISO 10993-1, ISO 10993-5, and ISO 10993-10
Electrical Safety	Conformed to IEC 60601-1	Conformed to IEC 60601-1
Electromagnetic Compatibility	Conformed to IEC 60601-1	Conformed to IEC 60601-1
Performance (General)	Conformed to ASTM E1112	Conformed to ASTM E1112
Measurement Interval	Every 15 seconds (Primary Predicate); Every 4 seconds (Secondary Predicate)	Continuous transmitter measures body temperature every 15 seconds
Anatomical Application	Axillary (armpit) temperature measuring and monitoring	Axillary (armpit) temperature measuring and monitoring
Reuse	Re-usable for home use (Primary Predicate); Reusable for household and medical institutions (Secondary Predicate)	Re-usable for home use and single patient use in the hospital
Indications for Use	Non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older, for home use (Primary Predicate) and household/medical institutions (Secondary Predicate)	Non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older, for home use and single patient use in the hospital

II. Study Details for Proving Acceptance Criteria

The document does not detail a new clinical study with a test set, expert readers, or ground truth establishment in the traditional sense of an AI model performance study. Instead, the proof of meeting acceptance criteria for this K181013 submission relies on:

Demonstrating Substantial Equivalence: The primary method is to show that the proposed device (with expanded indications) is identical to a previously cleared predicate (K162137) for home use and comparable to a secondary predicate (K160306) for institutional use.
Compliance with Recognized Consensus Standards: The document explicitly states that the device "Conformed to" or "Complied with" various international and ASTM standards (ISO 10993 series for biocompatibility, IEC 60601-1 for electrical safety and electromagnetic compatibility, and ASTM E1112 for performance of clinical thermometers). Adherence to these standards is considered sufficient evidence of safety and basic performance.
Risk Management for Expanded Use: For the expanded "single patient use in the hospital," the submission addresses potential new risks (specifically cross-contamination) through a "Fever Scout Risk Management Report" and proposed procedural controls (labeling and IFU precautions). This is a mitigation strategy rather than a performance study.

Given this context, many of the requested details for a typical AI model study are not applicable or explicitly stated in this regulatory submission document.

Sample size used for the test set and data provenance: Not explicitly detailed as a separate clinical test set for performance validation in this submission. The validation is through comparison to predicates and compliance with standards. If a test set was used for the original predicate's clearance (K162137) to meet ASTM E1112, those details are not provided here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical thermometer performance is typically established through a known temperature reference (e.g., black body calibrators for laboratory accuracy tests, or controlled clinical studies comparing to a gold standard thermometer), as part of compliance with standards like ASTM E1112. The document doesn't describe the expert consensus process for a test dataset.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a thermometer, not an AI diagnostic tool primarily assisting human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is "standalone" in continuously measuring temperature. Its performance is measured against established accuracy standards (ASTM E1112), not comparative human interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For thermometer performance, the ground truth is typically a highly accurate reference thermometer or a controlled temperature environment, as per standards like ASTM E1112. The document doesn't detail how ground truth was established for a specific "test set" in this submission.
The sample size for the training set: Not applicable. This is not an AI model that undergoes a "training" phase with a dataset.
How the ground truth for the training set was established: Not applicable.

In summary, the device's acceptance is based on its demonstrated substantial equivalence to predicate devices and its compliance with relevant performance and safety consensus standards, rather than a new, extensive clinical study detailing specific test sets, expert ground truth, or MRMC analyses. The expansion of indications for hospital use is addressed through a risk management approach for cross-contamination.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K181013

Device Name

Fever ScoutTM Continuous Monitoring thermometer

Indications for Use (Describe)

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.51 East Campbell Avenue Suite #160Campbell, CA 95008 USAPhone: 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

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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:Device Common Name:Classification:Product Code:Classification Panel:Class:	Fever Scout Continuous Monitoring thermometerArmpit thermometer21 CFR Sec. 880.2910, Clinical electronic thermometerFLLGeneral HospitalII
Summary of SubstantialEquivalence:	Fever Scout is substantially equivalent to the primary predicate(K162137) and is the identical product as the predicates with theexpanded indications adding and a non-invasive and single patientuse 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)	PrimaryPredicate(K162137)	SecondaryPredicate(K160306)	Comparison
Product code	FLL	FLL	FLL	Identical
Regulation #	21 CFR 880.2910	21 CFR880.2910	21 CFR880.2910	Identical
Regulationdescription	Clinical electronicthermometer	Clinicalelectronicthermometer	Clinicalelectronicthermometer	Identical
Device class	II	II	II	Identical
Indications for use	The wireless FeverScout ContinuousMonitoringthermometer is anon-invasive andre-usable electronicdevice for homeuse. This product isintended for non-urgent ambulatorycontinuous armpit	The wirelessFever ScoutContinuousMonitoringthermometer isa non-invasiveand re-usableelectronicdevice for homeuse and a non-invasive and	The CloudSmartThermometer isa battery-operatedelectronicdevice withintended use ofmeasuring andmonitoringhuman axillary	Home use isidentical to primarypredicate andcomparable tosecondary predicate(household use).Hospital use:comparable tosecondary predicate(used for)
	body temperaturemonitoring fromages 29 days andolder.	single patientuse in thehospital. Thisproduct isintended fornon-urgent	temperaturecontinuously viawireless signaltransmission ofthe measuringresult.	institutions)
		ambulatorycontinuousarmpit bodytemperaturemonitoringfrom ages 29days and older.	Meanwhile, thedevice isreusable and isintended foraxillarytemperaturemonitoring forpersons overtwo years old,and it is used forhousehold andmedical
			institutions
Display UseSpecification	Apple device andAndroid devicedisplay	Apple deviceand Androiddevice display	iOS or Androiddevice display	Identical
Working Voltage	3.0 V DC	3.0 V DC	3V DC	Identical
Battery	MS LithiumRechargeableBattery 3.0V	MS LithiumRechargeableBattery 3.0V	MAXELLCR2025 Buttonbattery (3.0 V,170mAh)	Comparable
Reuse	Re-usable for homeuse and singlepatient use in thehospital	Re-usable forhome use	Reusable forhousehold andmedicalinstitutions	Comparable toprimary/secondarypredicates for homeuse;comparable tosecondary predicateforhospitable/medicalinstitution use
MeasurementRange	35 ~ 42°C	35 ~ 42°C	25 ~ 45°C	Comparable
Accuracy	±0.1°CFrom 37 ~ 39°C,±0.2°Cfrom 35 ~ 37°C and39 ~ 42°C	±0.1°CFrom 37 ~39°C, ±0.2°Cfrom 35 ~ 37°Cand 39 ~ 42°C	±0.1ºC (at 36.0to 40.0°C)±0.2ºC at othertemperaturerange	Comparable
Signal Transmission	Wireless 2.4GBluetooth BLE	Wireless 2.4GBluetooth BLE	Wireless 2.4 GBluetooth 4.0	Comparable
Receiver	Wireless 2.4GBluetoothBLE enabledsmart devices	Wireless 2.4GBluetoothBLE enabledsmart devices	iOS7.0 or abovesmartphone ortablet;	Comparable
			Android 4.3 or
	Apple devices:iPhone 5S+ or later,and iOS 8.0 orlater, and Androiddevice: 4.3 or later.	Apple devices:iPhone 5S+ orlater, and iOS8.0 or later, andAndroid device:4.3 or later.	abovesmartphone,tablet ortelevision
Valid Transmission	Up to 40 meters(with relay)	Up to 40 meters(with relay)	Up to 15 meters(under barrier-freeenvironment)	Comparable
OperatingCondition	10~40°C15-85% humidity	10~40°C15-85%humidity	0~40°C15-85% (non-condensing)	Comparable
AnatomicalApplication	Axillary (armpit)temperaturemeasuring andmonitoring	Axillary(armpit)temperaturemeasuring andmonitoring	Axillary(armpit)temperaturemeasuring andmonitoring	Identical
TemperatureMeasurementInterval	Continuoustransmittermeasures bodytemperature every15 seconds	Continuoustransmittermeasures bodytemperatureevery 15seconds	Every 4 seconds	Comparable
Performance Data: Safety and Performance
Performance	Proposed Device(K181013)	PrimaryPredicate(K162137)	SecondaryPredicate(K160306)	Comparison
Biocompatibility	Conformed to ISO10993-1, ISO10993-5, and ISO10993-10	Conformed toISO 10993-1,ISO 10993-5,and ISO 10993-10	Conformed toISO 10993-1. ISO10993-5 and ISO10993-10	Identical
Electrical Safety	Conformed to IEC60601-1	Conformed toIEC 60601-1	Complied withIEC 60601-1	Identical
ElectromagneticCompatibility	Conformed to IEC60601-1	Conformed toIEC 60601-1	Complied withIEC 60601-1	Identical
Performance	Conformed toASTM E1112	Conformed toASTM E1112	Complied withASTM 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).

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.