The Kinsa QuickCare Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is for the adult and pediatric population.

Device Description

The Kinsa QuickCare Thermometer is a battery powered, thermistor based predictive Bluetooth low energy (BLE) enabled thermometer used for the measurement and monitoring of human body temperature. Body temperature can be measured with the Kinsa QuickCare Thermometer orally, axillary (under the arm), and rectally. The thermometer is reusable for clinical and/or home use on people of all ages with adult supervision. The device can be used with as a standalone device or in conjunction with the Kinsa App on a compatible BLE enabled smartphone.

AI/ML Overview

The Kinsa QuickCare Thermometer is a clinical electronic thermometer. The provided document is a 510(k) summary for its premarket notification to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets individual acceptance criteria in the manner one might expect for a new algorithmic device with novel performance claims.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Compliance)
Accuracy (Temperature Measurement)	± 0.2°C within measurement range of 32 to 42.8°C (89.6 to 109.2°F)
ISO 80601-2-56:2009 (Medical Electrical Equipment – Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement)	Design Verification results confirmed the device meets the product requirements set by Kinsa and the performance standard requirements of ISO 80601-2-56:2009. Performance comparison with the predicate device demonstrates laboratory accuracy of the subject device is the same as the predicate device over the same temperature range.
Biocompatibility (AAMI/ANSI/ISO 10993-5:2009 /(R)2014 for cytotoxicity; ISO 10993-10:2010 for irritation and sensitization)	All skin contacting materials have been tested successfully for biocompatibility.
Electrical and Mechanical Safety & Essential Performance (AAMI/ANSI ES 60601-1:2005/(R)2012; IEC 60601-1-11:2015)	Electrical and Mechanical Safety as well as essential performance was confirmed through compliance testing.
Electromagnetic Compatibility (IEC 60601-1-2:2014)	Electromagnetic Compatibility was confirmed through compliance testing.
Software Verification and Validation (FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005))	Software Verification and Validation results confirmed the firmware and software units meet the software requirements specifications and the system performs as intended.
Labeling Verification (FDA "Guidance on the Content of Premarket Notification [510(k)] Submission for Clinical Electronic Thermometers)	Labeling verification per the recommendations.
Cybersecurity Management (FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2, 2014)")	Cybersecurity management has been addressed.

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" in the context of clinical studies for performance metrics like sensitivity, specificity, or predictive values. The testing described is primarily design verification and validation against established standards.

For accuracy, which is the most relevant performance metric here, the document states: "Performance comparison with the predicate device demonstrates laboratory accuracy of the subject device is the same as the predicate device over the same temperature range." It does not provide the sample size of individuals or the number of measurements taken during this laboratory accuracy comparison. The data provenance is implied to be laboratory testing rather than real-world clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable or provided. The device measures a physical parameter (temperature), and the "ground truth" for accuracy is established by a reference thermometer in a laboratory setting, not by human expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Temperature measurement accuracy is not typically adjudicated by expert consensus in this manner.

5. 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. The Kinsa QuickCare Thermometer is a direct measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with or without AI assistance. The Bluetooth functionality is for data transmission, not for an AI-powered interpretive aid.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device itself is a "standalone" measurement device. The performance data presented (accuracy, safety, EMC, etc.) relates to the device's intrinsic operation. While it can connect to an app, its core function of temperature measurement and predictive algorithm acts "stand-alone" in terms of measurement generation. No specific "algorithm only" study report is detailed beyond stating that "Software Verification and Validation results confirmed the firmware and software units meet the software requirements specifications and the system performs as intended."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For accuracy, the ground truth is established by reference temperature measurements in a laboratory setting, typically using a calibrated high-precision thermometer. For other aspects like safety and EMC, the ground truth is compliance with the specified international standards.

8. The sample size for the training set

This is not applicable as the Kinsa QuickCare Thermometer is a traditional electronic thermometer that uses a thermistor and a predictive algorithm, not a machine learning or AI model that requires a "training set" in the typical sense for image interpretation or pattern recognition. The predictive algorithm is likely based on mathematical modeling and calibration, not statistical learning from a large dataset.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" cited for a machine learning model. The predictive algorithm's parameters would have been established through engineering design, calibration against known temperature references, and validation against a variety of temperature profiles.

Summary

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January 17, 2018

KINSA, Inc. % Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041

Re: K173730

Trade/Device Name: Kinsa QuickCare Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: January 1, 2018 Received: January 3, 2018

Dear Dave Yungvirt:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-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.

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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510(k) Summary

K173730

I. SUBMITTER

Submitter's Name:	KINSA, Inc.
Address:	535 Mission St, 18th FloorSan Francisco, CA 94105
Telephone:	917-426-3860
Contact Name:	David Gal
Telephone:	510-508-2700
Email:	david.gal@kinsahealth.com
Date Prepared:	26 December 2017

II. DEVICE

Trade Name	Kinsa QuickCare Thermometer
Model Name	KSA-110
Common or Usual Name:	Oral, rectal and axillary digital electronic thermometer
Classification Number:	21 CFR 880.2910
Classification Name:	Clinical electronic thermometer
Product Code:	FLL
Product Class:	II
Classification Panel:	General Hospital

III. PREDICATE DEVICE

Predicate device:

K Number	K043110
Trade Name	Vick, Vicks
Current 510(k) Holder	Kaz USA Inc., a Helen of Troy Company
Device Name:	Microlife Instant Digital Thermometer, Model MT1811
Classification Number:	21 CFR 880.2910
Classification Name:	Clinical electronic thermometer
Product Code:	FLL

This predicate device has not been subject to a design-related recall.

Reference device: K152975 VDT985US Vicks SmartTemp Thermometer from KAZ USA, Inc.

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The VDT985US thermometer provides an example of a cleared device that communicates wireless to a smart phone application as the receiver in support of the BLE wireless technological characteristic available in the proposed Kinsa QuickCare Thermometer.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The proposed device has the identical intended use as the predicate device and both are indicated for Over-the-Counter use.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technology of the Kinsa QuickCare Thermometer is identical to the predicate device in terms of its principle of operation, thermistor, prediction algorithm, probe tip design and materials. The industrial design is similar to the predicate except for the outer shell form. The Bluetooth feature is an additional feature similar to the reference device.

Element ofcomparison	Subject DeviceKinsa QuickCareThermometer	Predicate DeviceMicrolife MT18I1 InstantDigital Thermometer(V966 Vicks)K043110	Analysis
Thermometer type	Predictive digital	Predictive digital	Same
Fundamentaltechnology &Operatingprinciple	Utilizes an NTC thermistorlocated in the probe tip tosense human bodytemperature when placedin the desired measuringsite (mouth, underarm, andrectum). The resultingchange in resistance is	Based on conduction ofheat to a thermistor basedsensor anduse of predictivealgorithms to estimate thebody temperature	Same

	sensed and monitored inorder to through use ofpredictive algorithmsestimate human bodytemperature
Operation	Handheld device containinguser facing button, sensorhead, microcontroller,display	Handheld devicecontaining an On/Offswitch, sensor head,microcontroller anddisplay	Similar
Sensor	Thermistor based	Thermistor based	Same
Signalprocessing anddisplay	- Internal firmware andlocal LCD display- Also able to transfertransmit data to anauxiliary device forsecondary display	Internal firmware andlocal LCD display	Same primary display.The secondary displayoption in the subjectdevice achieved viaBluetooth wirelesscommunication to asmart device is not anew technology and ispresent in manymedical devicesincludingthermometers. Kinsahas included theK152975 thermometeras an example of sucha device. Thisdifference does notraise new questions ofsafety andeffectiveness and thesubject device remainssubstantiallyequivalent to thepredicate device.
WirelessInterface	Bluetooth Low Energy (BLE)	None	Different technologyincluded in the subjectdevice. Same rationaleapplies as above.
Powerrequirements	Battery powered CR2032(3V)	Battery powered	Same
Battery duration	More than 600measurements orapproximately 2 years ifused every day.	More than 200 hours ofcontinuous operation or 2years if used 10 min perday	Similar, batteryperformance testedsupports the batteryduration of the subjectdevice
Materials	Biocompatible metals andresins	Biocompatible metals andresins	Same
Scale	°F / °C	°F / °C	Same
Measurementlocations	Oral, Axillary and Rectal	Oral, Axillary and Rectal	Same
MeasurementRange	32°C to 42.8°C(89.6 to 109.2°F)	32 °C to 42.9 °C(89.6 °F to 109.2 °F)	Same
OperatingEnvironment	15 to 35°C15-85% relative humidity,non-condensing	Unknown	Tested and complieswith IEC 60601-1, IEC60601-1-11 and ISO80601-2-56
StorageEnvironment	-25 to 70 °CUp to 90% Relativehumidity, non-condensing,up to 50 hPa	Unknown	Tested and complieswith IEC 60601-1 andIEC 60601-1-11
Accuracy	± 0.2°C withinmeasurement range of 32to 42.8°C (89.6 to 109.2°F)	± 0.2 °F (± 0.1 °C) withinmeasurement range 96 to107°F	Difference inspecification butsubject devicecomplies with devicespecific FDA recognizedthermometer standardISO 80601-2-56 and incomparison, evaluationwith the predicatedevice theperformance is thesame. Therefore, thisis not considered adifference since theperformance is thesame as the predicateand the difference inthe specification doesnot raise differentquestions of safety andeffectiveness. Thesubject substantiallyequivalent to thepredicate in laboratoryaccuracy.
Response Time	8 sec nominally	±8 sec	Same
Resolution ofDisplay	0.1 °C / 0.1°F	0.1 °C / 0.1°F	Same
Performance	Meets ISO 80601-2-56	Meets ASTM E1112	Similar, both devicespecific FDA recognizedthermometer standardhave similar
			requirements andacceptance criteria.Performancecomparison with thepredicate devicedemonstrateslaboratory accuracy ofthe subject device isthe same as thepredicate device overthe same temperaturerange.
Biocompatibility	Meets ISO 10993-1	Meets ISO 10993-1	Same
Electrical Safety	Meets ES 60601-1	Meets IEC 60601-1	Same
ElectromagneticDisturbances	Meets IEC 60601-1-2	Meets IEC 60601-1-2	Same

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VII. PERFORMANČE DATA

Non-clinical

Non-clinical performance reports were provided to document verification and validation activities intended to demonstrate substantial equivalence of the subject device to the predicate device:

1. Design Verification results confirmed the device meets the product requirements set by Kinsa and the performance standard requirements of ISO 80601-2-56:2009, Medical Electrical Equipment – Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement.
1. Software Verification and Validation results confirmed the firmware and software units meet the software requirements specifications and the system performs as intended. Software documentation is provided in accordance with the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
1. Labeling verification per the recommendations within the FDA "Guidance on the Content of Premarket Notification [510(k)] Submission for Clinical Electronic Thermometers.
1. All skin contacting materials have been tested successfully for biocompatibility: cytotoxicity in accordance with AAMI/ANSI/ISO 10993-5:2009 /(R)2014, Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity, as well as irritation and sensitization in accordance with ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization.
1. Electrical and Mechanical Safety as well as essential performance was confirmed through compliance testing to AAMI/ANSI ES 60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance and IEC 60601-1-11:2015, Medical Electrical Equipment Part 1-11: Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.

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1. Electromagnetic Compatibility was confirmed through compliance testing to IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: Electromagnetic Disturbances -Requirements and Tests.
1. Cybersecurity management has been addressed in accordance with the recommendations in the relevant FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2, 2014)"

Clinical

There is no difference in the intended use, operating principle, and technology, in comparison to the predicate device, thus clinical testing in accordance with ISO 80601-2-56 was deemed unnecessary. The Bluetooth feature, similar to the reference predicate, is an additional feature solely for wireless transmission of data and does not affect measurements, calculations or local display of measurements on the LCD displays of the thermometer.

VII. CONCLUSIONS

Based on the testing and compliance with acceptable voluntary FDA recognized consensus standards, we believe that the KINSA QuickCare Thermometer is substantially equivalent to the predicate Microlife MT18/1 Instant Digital Thermometer and is as safe and as effective as this predicate.

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.