(151 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a straightforward process of collecting and analyzing temperature data to approximate rectal temperature. There is no mention of training sets, complex algorithms, or other indicators of AI/ML.
No.
The device is intended for the "intermittent determination of human body temperature," which is a diagnostic function, not a therapeutic one. It measures temperature but does not treat any condition.
Yes
The device intermittently determines human body temperature, which is a physiological measurement used in the diagnosis of various medical conditions.
No
While the device is described as "software-only," its functionality is explicitly tied to and relies on a "general purpose infrared sensor built into the smartphone" to collect temperature data. This indicates a dependency on specific hardware for its core function, preventing it from being purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Body Temperature Software (BTS) App measures human body temperature using an infrared sensor. This is a measurement taken directly from the body (specifically, the forehead and temple), not from a sample taken from the body.
- Intended Use: The intended use is for the intermittent determination of human body temperature. This is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, the BTS App falls under the category of a medical device that performs a physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Body Temperature Software (BTS) App is a software-only mobile medical application intended for over-the-counter (OTC) use with compatible mobile computing platforms that includes a general purpose infrared sensor for the intermittent determination of human body temperature on people of all ages.
Product codes (comma separated list FDA assigned to the subject device)
QZA
Device Description
The Body Temperature Software (BTS) is a mobile medical application available to its intended users via their mobile device. The Body Temperature Software (BTS) collects and analyzes temperature data obtained via the infrared sensor built into the smartphone to approximate the user's rectal temperature which is then displayed on the application's user interface. The Body Temperature Software (BTS) is a pre-installed application on the Pixel 8 Pro with Android 14 operating system release or higher.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
all ages. The feature has not been tested for and is not intended to be used to measure the body temperature of a premature baby (defined as less than or equal to 37 calendar weeks gestational age at birth).
Intended User / Care Setting
over-the-counter (OTC) 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
Clinical Study
The Sponsor provided data from a clinical study as well as literature to support the clinical accuracy of the Body Temperature Software (BTS). This study used data collected from a subset of participants enrolled in a prospective. single-arm, multi-center observational study conducted to demonstrate the Body Temperature Software (BTS) produces temperature measurements within the specified clinical accuracy criteria when compared to a legally marketed comparator device in conformance with ISO 80601-2-56:2017 Medical electrical equipment - Part2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
A total of 145 racially and ethnically diverse subjects were enrolled in the clinical study, including 37 newborns and infants (0 to
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR BODY TEMPERATURE SOFTWARE (BTS)
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Body temperature sensing software. Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.
NEW REGULATION NUMBER: 21 CFR 880.2915
CLASSIFICATION: Class II
PRODUCT CODE: QZA
BACKGROUND
DEVICE NAME: Body Temperature Software (BTS)
SUBMISSION NUMBER: DEN230050
DATE DE NOVO RECEIVED: July 17, 2023
CONTACT: Fitbit LLC 199 Fremont Street San Francisco, CA 94105
INDICATIONS FOR USE
The Body Temperature Software (BTS) App is a software-only mobile medical application intended for over-the-counter (OTC) use with compatible mobile computing platforms that includes a general purpose infrared sensor for the intermittent determination of human body temperature on people of all ages.
LIMITATIONS
The feature has not been tested for and is not intended to be used to measure the body temperature of a premature baby (defined as less than or equal to 37 calendar weeks gestational age at birth).
Use of the BTS App is not intended to diagnose or monitor a serious medical condition or disease and is not a substitute for a consultation with a healthcare professional. Don't interpret or take clinical action based on the device output without consulting a qualified healthcare professional.
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This device CANNOT detect illnesses.
This device DOES NOT replace the advice of your healthcare provider.
This device should be operated by persons over 18 years of age.
DO NOT use this device to measure body temperature when exposed to the following conditions:
- . Excessive motion (e.g., operating machinery, walking), and/or
- Direct sun or near radiant heat sources (e.g., heaters). .
DO NOT use this device to measure body temperature when the smartphone is visibly damaged, or has sensors or ports obstructed. Reference manufacturer instructions for maintenance.
DO NOT use this device to measure body temperature when the external environmental temperature is outside of 15°C - 35°C (59°F - 95°F).
DO NOT use this device to measure body temperature if you suspect hypothermia.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Body Temperature Software (BTS) is a mobile medical application available to its intended users via their mobile device. The Body Temperature Software (BTS) collects and analyzes temperature data obtained via the infrared sensor built into the smartphone to approximate the user's rectal temperature which is then displayed on the application's user interface. The Body Temperature Software (BTS) is a pre-installed application on the Pixel 8 Pro with Android 14 operating system release or higher.
| Software | Body Temperature Software (BTS) |
|---|---|
| Hardware | Pixel 8 Pro (Android 14 operating system release or higher) |
| Intended Users | All users over the age of 18 |
| Intended Patient Population | General population excluding premature/preterm infants |
Users must opt-in and go through an onboarding process prior to use of the Body Temperature Software (BTS) application. The Body Temperature Software (BTS) onboarding process consists of a pop-up screen requiring user acknowledgement of the intended use, patient population, and user population followed by a video walkthrough demonstrating the kev steps necessary to obtain a temperature measurement. These steps include (1) identifying the sensor on the back of the phone, (2) removal of accessories that cover the forehead and temple, (3) place the sensor as close to the center of the forehead without touching, and (4) conducting the measurement sweep from the center of the forehead to the temple within four (4) seconds. The hardware platform provides audible, visual, and tactile feedback in addition to voice assist during these steps. The
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audible, visual, and tactile feedback are intended to communicate the process steps (e.g., appropriate distance to forehead, counting of seconds of the forehead sweep) related to obtaining a temperature measurement during the forehead sweep. The voice assist is intended to provide audio guidance supplementary to the existing feedback.
After the four (4) second forehead sweep, the temperature data is then used as an input into the Body Temperature Software (BTS) algorithm to convert the measured skin temperature data into a body temperature value representative of an approximation of rectal temperature results are able to be stored in the mobile application for seven (7) days. This information includes the time and date of the measurement, age range associated with the temperature guidance if enabled, and the temperature result.
Within the Body Temperature Software (BTS) mobile application, a user may enable the Temperature Guide that informs users whether their temperature measurement indicates a normal, elevated, or high temperature based on medical literature. The results of this functionality are based on the age range chosen prior to taking a measurement. The age ranges include 0-3 months. 3-36 months, 3+ years.
The application performs a series of checks prior to launching the application, during the measurement sweep, and during the processing of the signal to ensure that the temperature data collected is valid for processing. Using this valid collected data, the algorithm processes the sensor data collected during the sweep and displays a measurement to the user that approximates rectal temperature.
To enable the mobile application to obtain a temperature measurement, the systems check, proximity detection, and infrared sensor checks must pass. If the signal quality checks are deemed acceptable, following additional proximity and internal infrared sensor ambient temperature checks, additional signal quality checks are performed upon signal ingestion to the algorithm and again at subsequent points throughout the algorithm analysis to verify that the signal received by the sensor is accurate and reliable.
If these checks fail, error messages are intended to inform the user when the collected signal is not of sufficient quality. The potential error messages include 'Sensor out of range', 'Unable to start measurement', 'Measurement failed', 'Temperature sensor is too warm/too cool', and 'Temperature sensor unavailable'.
In addition to the signal quality checks implemented within the Body Temperature Software (BTS) process flow to obtain an accurate temperature measurement, pre-specified requirements for the hardware platform (e.g., operating system, processor speed, memory, etc.), sensor (e.g., sensor type, sensitivity, accuracy, etc.), and signal quality (e.g., maximum forehead temperature, infrared sensor internal temperature, estimated body temperature, sensor to sensor window difference, proximity, system check) must be met.
SUMMARY OF NONCLINICAL/BENCH STUDIES
SOFTWARE
The Body Temperature Software has a Moderate Level of Concern (LOC). Appropriate documentation was provided to support the validation of the software for a Moderate LOC in
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accordance with FDA's 2005 guidance titled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
PERFORMANCE TESTING - BENCH
The Body Temperature Software (BTS) was subjected to a series of bench tests to assess its functional performance under nominal conditions and conditions exposing the device to factors that may impact signal quality. These tests were performed in conformance with ISO 80601-2-56:2017 Medical electrical equipment - Part2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement using the final version of the device or a version of the device that was sufficiently representative of the final version of the device. The bench testing summarized in the table below was performed to demonstrate acceptable performance of the device for its intended use.
| Test | Description |
|---|---|
| Range Check Flag | Demonstrate that the range enable flag correctly captures |
| distance and gates forehead temperature measurement | |
| signals when within a specified range from the user's | |
| forehead. | |
| Infrared Sensor Internal | |
| (Ambient) Temperature (TA) | |
| Check Flag | Demonstrate that internal temperature of the infrared sensor |
| can sufficiently and correctly measure the internal | |
| temperature and sensor window temperature and gates | |
| forehead temperature within a specified range. | |
| Robustness to External | |
| Aggressors | Demonstrate that variations in the inputs due to a variety of |
| common and/or expected behavioral and physiological | |
| conditions do not affect the performance of the algorithm | |
| significantly. These conditions include motion artifacts, | |
| environment, and wear condition/position of the device. | |
| Fitzpatrick/Monk Level | |
| Performance | Demonstrate that the infrared sensor signal quality does not |
| vary significantly across various skin tones, and skin tone | |
| emissivity does not impact algorithm performance. | |
| Hardware Equivalency | Demonstrate that variations of the hardware and software |
| components found on compatible Pixel mobile devices have | |
| no significant effect on the signal quality of the data | |
| provided as inputs for the algorithm. | |
| Skin Temperature Range | |
| Check | Demonstrate that the filtered maximum forehead |
| temperature must be in the range of 30°C to 40°C, which is | |
| inclusive of the human body temperature range. | |
| Body Temperature Check | Demonstrate that the calculated maximum temperature must |
| be in the range of 34.5°C to 43°C which is inclusive of the | |
| human body core temperature range. |
Performance/Input Signal Testing (Bench) Summary
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| Test | Description |
|---|---|
| Window & Sensor | |
| Temperature Differences | |
| Check | Demonstrate that the sensor-to-sensor window temperature |
| difference is $\leq$ 2°C. |
SUMMARY OF CLINICAL INFORMATION
Clinical Study
The Sponsor provided data from a clinical study as well as literature to support the clinical accuracy of the Body Temperature Software (BTS). This study used data collected from a subset of participants enrolled in a prospective. single-arm, multi-center observational study conducted to demonstrate the Body Temperature Software (BTS) produces temperature measurements within the specified clinical accuracy criteria when compared to a legally marketed comparator device in conformance with ISO 80601-2-56:2017 Medical electrical equipment - Part2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
A total of 145 racially and ethnically diverse subjects were enrolled in the clinical study, including 37 newborns and infants (0 to