(42 days)
No
The summary describes a standard digital thermometer with Bluetooth connectivity and a predictive function, but there is no mention of AI or ML in the device description, performance studies, or key metrics. The "predictive" function likely refers to a standard algorithm for estimating the final temperature based on the initial reading, not an ML model.
No.
The device is used for measuring and monitoring human body temperature, which is a diagnostic function, not a therapeutic one.
No
The device is a thermometer used for the intermittent measurement and monitoring of human body temperature. While temperature can be an indicator of illness, the device itself only measures temperature and does not provide a diagnosis of a medical condition.
No
The device description explicitly states it is a "battery powered, thermistor based predictive Bluetooth low energy (BLE) enabled thermometer," indicating it is a hardware device with integrated software.
Based on the provided information, the Kinsa QuickCare Thermometer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Kinsa QuickCare Thermometer directly measures human body temperature. It does not analyze any biological specimens.
The description clearly states its purpose is the "intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm." This is a direct physiological measurement, not an in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally, rectally and under the arm
Indicated Patient Age Range
adult and pediatric population
Intended User / Care Setting
clinical and/or home use
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
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:
- 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.
- 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).
- Labeling verification per the recommendations within the FDA "Guidance on the Content of Premarket Notification [510(k)] Submission for Clinical Electronic Thermometers.
- 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.
- 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.
- Electromagnetic Compatibility was confirmed through compliance testing to IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: Electromagnetic Disturbances -Requirements and Tests.
- 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.
Key Metrics
Accuracy: ± 0.2°C within measurement range of 32 to 42.8°C (89.6 to 109.2°F);
Response Time: 8 sec nominally;
Resolution of Display: 0.1 °C / 0.1°F
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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 Floor |
| San 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.
4
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
comparison | Subject Device
Kinsa QuickCare
Thermometer | Predicate Device
Microlife MT18I1 Instant
Digital Thermometer
(V966 Vicks)
K043110 | Analysis |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thermometer type | Predictive digital | Predictive digital | Same |
| Fundamental
technology &
Operating
principle | Utilizes an NTC thermistor
located in the probe tip to
sense human body
temperature when placed
in the desired measuring
site (mouth, underarm, and
rectum). The resulting
change in resistance is | Based on conduction of
heat to a thermistor based
sensor and
use of predictive
algorithms to estimate the
body temperature | Same |
| | | | |
| | sensed and monitored in
order to through use of
predictive algorithms
estimate human body
temperature | | |
| Operation | Handheld device containing
user facing button, sensor
head, microcontroller,
display | Handheld device
containing an On/Off
switch, sensor head,
microcontroller and
display | Similar |
| Sensor | Thermistor based | Thermistor based | Same |
| Signal
processing and
display | - Internal firmware and
local LCD display
- Also able to transfer
transmit data to an
auxiliary device for
secondary display | Internal firmware and
local LCD display | Same primary display.
The secondary display
option in the subject
device achieved via
Bluetooth wireless
communication to a
smart device is not a
new technology and is
present in many
medical devices
including
thermometers. Kinsa
has included the
K152975 thermometer
as an example of such
a device. This
difference does not
raise new questions of
safety and
effectiveness and the
subject device remains
substantially
equivalent to the
predicate device. |
| Wireless
Interface | Bluetooth Low Energy (BLE) | None | Different technology
included in the subject
device. Same rationale
applies as above. |
| Power
requirements | Battery powered CR2032
(3V) | Battery powered | Same |
| Battery duration | More than 600
measurements or
approximately 2 years if
used every day. | More than 200 hours of
continuous operation or 2
years if used 10 min per
day | Similar, battery
performance tested
supports the battery
duration of the subject
device |
| Materials | Biocompatible metals and
resins | Biocompatible metals and
resins | Same |
| Scale | °F / °C | °F / °C | Same |
| Measurement
locations | Oral, Axillary and Rectal | Oral, Axillary and Rectal | Same |
| Measurement
Range | 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 |
| Operating
Environment | 15 to 35°C
15-85% relative humidity,
non-condensing | Unknown | Tested and complies
with IEC 60601-1, IEC
60601-1-11 and ISO
80601-2-56 |
| Storage
Environment | -25 to 70 °C
Up to 90% Relative
humidity, non-condensing,
up to 50 hPa | Unknown | Tested and complies
with IEC 60601-1 and
IEC 60601-1-11 |
| Accuracy | ± 0.2°C within
measurement range of 32
to 42.8°C (89.6 to 109.2°F) | ± 0.2 °F (± 0.1 °C) within
measurement range 96 to
107°F | Difference in
specification but
subject device
complies with device
specific FDA recognized
thermometer standard
ISO 80601-2-56 and in
comparison, evaluation
with the predicate
device the
performance is the
same. Therefore, this
is not considered a
difference since the
performance is the
same as the predicate
and the difference in
the specification does
not raise different
questions of safety and
effectiveness. The
subject substantially
equivalent to the
predicate in laboratory
accuracy. |
| Response Time | 8 sec nominally | ±8 sec | Same |
| Resolution of
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
specific FDA recognized
thermometer standard
have similar |
| | | | requirements and
acceptance criteria.
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 | Meets ISO 10993-1 | Meets ISO 10993-1 | Same |
| Electrical Safety | Meets ES 60601-1 | Meets IEC 60601-1 | Same |
| Electromagnetic
Disturbances | Meets IEC 60601-1-2 | Meets IEC 60601-1-2 | Same |
5
6
7
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:
-
- 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.
-
- 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).
-
- Labeling verification per the recommendations within the FDA "Guidance on the Content of Premarket Notification [510(k)] Submission for Clinical Electronic Thermometers.
-
- 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.
-
- 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.
8
-
- Electromagnetic Compatibility was confirmed through compliance testing to IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: Electromagnetic Disturbances -Requirements and Tests.
-
- 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.