The Kinsa Smart Thermometer is intended to measure the human body temperature orally, rectally, or under the arm, and the devices are reusable for clinical or home use on people of all ages.

Device Description

The Kinsa Smart Thermometer product is a thermometer that connects to a Smartphone or another mobile device (e.g. an iPod Touch). The product will read body temperature the same way a clinical digital thermometer does by being placed under the tongue in the mouth, rectum or alternatively, or under the arm. Like other clinical digital thermometers, the Kinsa Smart Thermometer is a thermistor-based product; however, it has the advantage of being read on a mobile device display. Unlike other clinical digital thermometers, the Kinsa Smart Thermometer product requires no batteries or LCD displays. The Kinsa Smart Thermometer is reusable for clinical or home use on people of all ages.

The Kinsa Smart Thermometer will connect to Smartphones or other mobile devices via a headphone jack that accepts a microphone input. In this document the terms Smartphone, smartohone and mobile device are used interchangeably and are defined to include the following products: Apple iPhones 5, 4S and the Apple iPod Touch 5.

The Kinsa Smart Thermometer consists of four components:

A. Thermometer (probe).
B. An adapter to setup each Smartphone for temperature reading (only needed once per Smartphone).
C. An optional, flexible extension cord that can be used to lengthen the distance between the thermometer and Smartphone so users can see the Smartphone screen while taking a temperature.
D. Software.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Kinsa Smart Thermometer, based on the provided text:

Key Takeaway: The provided 510(k) summary focuses primarily on equivalence to a predicate device and compliance with established standards (ASTM E1112-00) for clinical electronic thermometers. It does not detail a specific study proving the device meets novel acceptance criteria in the way one might expect for a new AI/ML-driven medical device. Instead, the acceptance criteria are largely implied by compliance with the ASTM standard and comparison to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given that the document emphasizes compliance with ASTM E1112-00 (reapproved 2011), the acceptance criteria are drawn from general requirements for clinical electronic thermometers specified in this standard and the performance metrics compared to the predicate device.

Metric (Acceptance Criterion implied by ASTM/Predicate)	Reported Device Performance (Kinsa Smart Thermometer)
Measurement Range	35.0 to 42.0°C
Accuracy	95.0°F - 107.6°F/±0.2°F (35.0°C - 42.0°C/±0.1°C)
Response Time	15 seconds
Compliance with ASTM E1112-00	Compliant with ASTM E1112-00 (Reapproved 2011)
Compliance with AAMI/IEC 60601-1:2005+A1:2012(E)	Compliant
Compliance with AAMI/ANSI/IEC 60601-1-2:2007	Compliant

Note: The document explicitly states, "The Kinsa Smart Thermometer meets and exceeds ASTM standards for accuracy and meets ISO standards for accuracy." This indicates that the ASTM E1112-00 standard itself defines the primary acceptance criteria for accuracy.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a separate test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for a study demonstrating performance against acceptance criteria. The information focuses on compliance with standards rather than a clinical validation study with a defined patient cohort.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided in the document. The regulatory pathway for this device, a Class II thermometer, relies on established physical measurement standards (like ASTM E1112-00) and comparison to a predicate device, not on expert adjudication of diagnostic outputs from images or complex data. Therefore, "ground truth" in the context of expert consensus, as might be used for AI/ML imaging devices, is not relevant here.

4. Adjudication Method for the Test Set

Not applicable and not provided. As explained above, the assessment relies on metrological standards, not expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret data, often with AI assistance. The Kinsa Smart Thermometer is a direct measurement device; its function is to provide a temperature reading, not to assist humans in interpreting complex diagnostic information.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a measurement instrument. Its "standalone" performance is its ability to accurately measure temperature according to the specified standards, which is what the compliance with ASTM E1112-00 addresses. However, it's important to note that the device relies on a mobile device for display and processing, so it's not truly "standalone" in operation like a conventional digital thermometer. The "algorithm only" aspect refers to the software that processes the signal from the thermistor to display the temperature. The document states this software "displays the precise temperature on the screen" and implicitly meets the ASTM accuracy standards.

7. The Type of Ground Truth Used

The "ground truth" for the Kinsa Smart Thermometer's performance is established through metrological reference standards and calibrated instruments as defined by standards like ASTM E1112-00. This standard specifies the test methods and performance requirements for electronic thermometers, which would involve comparing the device's readings against highly accurate, traceable temperature references. It does not involve expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic system would.

8. The Sample Size for the Training Set

The document does not specify a "training set" sample size. The Kinsa Smart Thermometer is a sensor-based device with a processing algorithm, not a machine learning model developed through training data in the conventional sense. Its "training" would be more akin to calibration and engineering development to ensure accurate signal processing, rather than learning from a large dataset of patient temperatures.

9. How the Ground Truth for the Training Set Was Established

Not applicable in the context of "training set" for a machine learning model. The fundamental "ground truth" for its development would be the physical principles of thermistor operation and the metrological standards for temperature measurement. Engineers would have designed and calibrated the device and its processing software to adhere to these known physical laws and the accuracy requirements of ASTM E1112-00 using reference thermometers.

Summary

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SECTION 5: 510(K) PREMARKET NOTIFICATION

Summary of Safety and Effectiveness Information

K132514 Kinsa Smart Thermometer August 6, 2013

Regulatory authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1) Device name

Trade name:

Kinsa Smart Thermometer

Common name:

DEC 02 2013

Thermometer

Classification Number/ Classification name/Product code:

Clinical electronic thermometers are class II devices under 21 CFR § 880.2910 (product code FLL) and are classified by the General Hospital Panel.

2) Submitter

Kinsa, Inc. 603 Greenwich Street #101B New York, NY 10014

3) Company contact

Lael J. Pickett Kinsa, Inc. 603 Greenwich Street #101B ' New York, NY 10014 Telephone: 651-900-5460/Fax: 917-210-4288 Email: ljp1286@yahoo.com

4) Classification

Device class:

Class II

Classification panel:

General Hospital

Product code:

FLL

Special Controls:

Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers

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5) Legally Marketed Device to which Equivalence is Claimed

Fudakang Digital Thermometer (K101387)

6) Comparison to Predicate Device

Feature	Fudakang DigitalThermometer (K101387)	Kinsa Smart Thermometer(KXXXXXX)
Intended Use	Measurement and monitoring ofhuman body temperature	Same
Indications for Use	Intended for the measurement andmonitoring of human bodytemperature by doctor orconsumers in the hospital orhome.BT-A11CN, BT-A21CN and BT-A41CN can be used axillarymeasurement, oral measurementsand rectal measurement.	The Kinsa Smart Thermometer isintended to measure the humanbody temperature orally, rectally,or under the arm, and the devicesare reusable for clinical or homeuse on people of all ages.
Tip	Stainless Steel	Same
Tip Housing	Thermoplastic rubber	Same
Body Housing	Acrylonitrile butadiene styrene	Same
Size	4.9" long x 0.74" wide x 0.35" thick	Approximately 4.25" long x 0.5"wide x 0.3" thick
Weight	11 grams	4.4 grams
Flex Tip	Yes	Same
Power Source	Battery	Mobile device battery
Principles ofOperation	Thermosensor/ASIC (Thermistorused as themosensor)	Same
Compatible withMobile Device (e.g.Smartphone)	No	Yes
Display °F or °C	Yes	Same
Reusable	Yes	Same
Measurement Range	32.0°C - 42.9°C	35.0 to 42.0ºC
Accuracy	95.0°F - 102.0°F/±0.2°F	95.0°F - 107.6°F/±0.2°F
	35.0°C - 39.0°C/±0.1°C	35.0°C - 42.0°C/±0.1°C
Response Time	60 seconds	15 seconds
ASTM E1112-00	Compliant with ASTM E1112-00(2006)	Compliant with ASTM E1112-00(Reapproved 2011)
AAMI/IEC 60601-1:2005+A1:2012(E)	Compliant with IEC 60601-1	Compliant with AAMI/IEC 60601-1:2005+A1:2012(E)
AAMI/ANSI/IEC60601-1-2:2007	Compliant with IEC 6061-1-2	Compliant with AAMI/ANSI/IEC60601-1-2:2007

7) Device description

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being read on a mobile device display. Unlike other clinical digital thermometers, the Kinsa Smart Thermometer product requires no batteries or LCD displays. The Kinsa Smart Thermometer is reusable for clinical or home use on people of all ages.

The Kinsa Smart Thermometer consists of four components:

A. Thermometer (probe).
B. An adapter to setup each Smartphone for temperature reading (only needed once per Smartphone).
C. An optional, flexible extension cord that can be used to lengthen the distance between the thermometer and Smartphone so users can see the Smartphone screen while taking a temperature.
D. Software.

8) Summary of technologies

The Kinsa Smart Thermometer works by sending out an audio signal. This signal crosses the thermistor in the metal tip of the thermometer and is altered based on the temperature. The device reads back the signal change through the mobile device's microphone input. The Kinsa Smart Thermometer app (application) has software to process the signal and displays the precise temperature on the screen. The Kinsa Smart Thermometer meets and exceeds ASTM standards for accuracy and meets ISO standards for accuracy.

The Kinsa Smart Thermometer has no batteries, processor or LCD display, instead leveraging the power, processor and display of the user's Smartphone.

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Public Health Service

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

December 2, 2013

Kinsa, Incorporated C/O Lael J. Pickett 603 Greenwich Street, #101B New York, NY 10014

Re: K132514

Trade/Device Name: Kinsa Smart Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: September 2, 2013 Received: September 4, 2013

Dear Mr. Pickett:

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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for

Erin I. Keith M.S. Acting Division 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) K132514

Device Name

Kinsa Smart Thermometer

Indications for Use (Describe)

The Kinso Smart Thermometer is intended to measure orally, rectally, or under the am, and the devices are reusable for clinical or home use on people of all ages.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

[x] Over-The-Counter Use (21 CFR 801 Subpart C)

Please do not write below this line -- continue on a separate page if needed.

1999 THE FOR FOR FOR CONNECT AFFOR FOR USE ONLY SOUTH STORES AND PORT THE STORES THE FOR THE STORE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman Date: 2013.11.29 12:42:36 -05'00'

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on fast page.

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.