Kinsa QuickCare Thermometer

K173730 · Kinsa, Inc. · FLL · Jan 17, 2018 · General Hospital

Device Facts

• Record ID: K173730
• Device Name: Kinsa QuickCare Thermometer
• Applicant: Kinsa, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Jan 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

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 Story

Battery-powered, thermistor-based digital thermometer; measures human body temperature orally, axillary, or rectally. Uses NTC thermistor in probe tip to sense resistance changes; internal microcontroller applies predictive algorithms to estimate body temperature. Displays results on local LCD; supports Bluetooth Low Energy (BLE) wireless transmission to Kinsa App on compatible smartphones. Used in clinical or home settings by patients of all ages (with adult supervision). Healthcare providers or patients view temperature data on device LCD or smartphone app; facilitates monitoring of temperature trends. Benefits include rapid, accurate temperature measurement with optional digital logging for health tracking.

Clinical Evidence

Bench testing only. No clinical data provided. Verification included ISO 80601-2-56 performance testing, biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety (ES 60601-1, IEC 60601-1-11), and electromagnetic compatibility (IEC 60601-1-2).

Technological Characteristics

NTC thermistor-based sensing; predictive algorithm; battery-powered (CR2032). Materials: biocompatible metals and resins. Connectivity: BLE. Standards: ISO 80601-2-56, AAMI/ANSI ES 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 10993-5/10.

Indications for Use

Indicated for intermittent measurement and monitoring of human body temperature via oral, rectal, or axillary routes in adult and pediatric populations.

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

• Microlife Instant Digital Thermometer, Model MT1811 (K043110)

Reference Devices

• Vicks SmartTemp Thermometer (K152975)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the text "ADMINISTRATION".

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 ([e-mail]) or phone [phone] 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 Floor<br>San Francisco, CA 94105 |
| Telephone: | 917-426-3860 |
| Contact Name: | David Gal |
| Telephone: | 510-508-2700 |
| Email: | [e-mail] |
| 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

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.

# V. INDICATIONS FOR USE

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.

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 of<br>comparison | Subject Device<br>Kinsa QuickCare<br>Thermometer | Predicate Device<br>Microlife MT18I1 Instant<br>Digital Thermometer<br>(V966 Vicks)<br>K043110 | Analysis |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thermometer type | Predictive digital | Predictive digital | Same |
| Fundamental<br>technology &<br>Operating<br>principle | Utilizes an NTC thermistor<br>located in the probe tip to<br>sense human body<br>temperature when placed<br>in the desired measuring<br>site (mouth, underarm, and<br>rectum). The resulting<br>change in resistance is | Based on conduction of<br>heat to a thermistor based<br>sensor and<br>use of predictive<br>algorithms to estimate the<br>body temperature | Same |
| | | | |
| | sensed and monitored in<br>order to through use of<br>predictive algorithms<br>estimate human body<br>temperature | | |
| Operation | Handheld device containing<br>user facing button, sensor<br>head, microcontroller,<br>display | Handheld device<br>containing an On/Off<br>switch, sensor head,<br>microcontroller and<br>display | Similar |
| Sensor | Thermistor based | Thermistor based | Same |
| Signal<br>processing and<br>display | - Internal firmware and<br>local LCD display<br>- Also able to transfer<br>transmit data to an<br>auxiliary device for<br>secondary display | Internal firmware and<br>local LCD display | Same primary display.<br>The secondary display<br>option in the subject<br>device achieved via<br>Bluetooth wireless<br>communication to a<br>smart device is not a<br>new technology and is<br>present in many<br>medical devices<br>including<br>thermometers. Kinsa<br>has included the<br>K152975 thermometer<br>as an example of such<br>a device. This<br>difference does not<br>raise new questions of<br>safety and<br>effectiveness and the<br>subject device remains<br>substantially<br>equivalent to the<br>predicate device. |
| Wireless<br>Interface | Bluetooth Low Energy (BLE) | None | Different technology<br>included in the subject<br>device. Same rationale<br>applies as above. |
| Power<br>requirements | Battery powered CR2032<br>(3V) | Battery powered | Same |
| Battery duration | More than 600<br>measurements or<br>approximately 2 years if<br>used every day. | More than 200 hours of<br>continuous operation or 2<br>years if used 10 min per<br>day | Similar, battery<br>performance tested<br>supports the battery<br>duration of the subject<br>device |
| Materials | Biocompatible metals and<br>resins | Biocompatible metals and<br>resins | Same |
| Scale | °F / °C | °F / °C | Same |
| Measurement<br>locations | Oral, Axillary and Rectal | Oral, Axillary and Rectal | Same |
| Measurement<br>Range | 32°C to 42.8°C<br>(89.6 to 109.2°F) | 32 °C to 42.9 °C<br>(89.6 °F to 109.2 °F) | Same |
| Operating<br>Environment | 15 to 35°C<br>15-85% relative humidity,<br>non-condensing | Unknown | Tested and complies<br>with IEC 60601-1, IEC<br>60601-1-11 and ISO<br>80601-2-56 |
| Storage<br>Environment | -25 to 70 °C<br>Up to 90% Relative<br>humidity, non-condensing,<br>up to 50 hPa | Unknown | Tested and complies<br>with IEC 60601-1 and<br>IEC 60601-1-11 |
| Accuracy | ± 0.2°C within<br>measurement range of 32<br>to 42.8°C (89.6 to 109.2°F) | ± 0.2 °F (± 0.1 °C) within<br>measurement range 96 to<br>107°F | Difference in<br>specification but<br>subject device<br>complies with device<br>specific FDA recognized<br>thermometer standard<br>ISO 80601-2-56 and in<br>comparison, evaluation<br>with the predicate<br>device the<br>performance is the<br>same. Therefore, this<br>is not considered a<br>difference since the<br>performance is the<br>same as the predicate<br>and the difference in<br>the specification does<br>not raise different<br>questions of safety and<br>effectiveness. The<br>subject substantially<br>equivalent to the<br>predicate in laboratory<br>accuracy. |
| Response Time | 8 sec nominally | ±8 sec | Same |
| Resolution of<br>Display | 0.1 °C / 0.1°F | 0.1 °C / 0.1°F | Same |
| Performance | Meets ISO 80601-2-56 | Meets ASTM E1112 | Similar, both device<br>specific FDA recognized<br>thermometer standard<br>have similar |
| | | | requirements and<br>acceptance criteria.<br>Performance<br>comparison with the<br>predicate device<br>demonstrates<br>laboratory accuracy of<br>the subject device is<br>the same as the<br>predicate device over<br>the same temperature<br>range. |
| Biocompatibility | Meets ISO 10993-1 | Meets ISO 10993-1 | Same |
| Electrical Safety | Meets ES 60601-1 | Meets IEC 60601-1 | Same |
| Electromagnetic<br>Disturbances | 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.
- 2. 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).
- 3. Labeling verification per the recommendations within the FDA "Guidance on the Content of Premarket Notification [510(k)] Submission for Clinical Electronic Thermometers.
- 4. 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.
- 5. 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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- 6. Electromagnetic Compatibility was confirmed through compliance testing to IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: Electromagnetic Disturbances -Requirements and Tests.
- 7. 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.