(66 days)
Not Found
No
The description focuses on standard infrared measurement technology and a polynomial function for temperature conversion, with no mention of AI or ML terms or concepts.
No.
This device is for the intermittent determination of human body temperature and does not mention any therapeutic functions or treatments.
No
The device is intended for the "intermittent determination of human body temperature," which is a measurement function, not a diagnostic one. While it provides a "color-coded temperature guide to indicate if the measurement falls within normal limits or indicative of an elevated state," this is an aid for interpretation, not a diagnosis of a specific condition.
Yes
The device is explicitly described as a "software-only mobile medical application" and "Software as a Medical Device (SaMD)" that leverages an infrared sensor from a "general purpose computing platform" (smartphone). It does not include or require dedicated medical device hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This device measures body temperature on the human body using an infrared sensor. It does not analyze blood, urine, tissue, or any other biological sample.
- The intended use is for intermittent determination of human body temperature. This is a direct physiological measurement, not an analysis of a sample.
- The device description focuses on the measurement process using an infrared sensor and converting skin temperature to an estimated body temperature. This is a physical measurement process, not a laboratory analysis of a biological sample.
Therefore, the Body Temperature Software (BTS) App, as described, falls under the category of a medical device that performs a direct physiological measurement, not an In Vitro Diagnostic.
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
QZA
Device Description
The Body Temperature Software ("BTS") mobile application ("App"), is a Software as a Medical Device (SaMD) that leverages an infrared sensor from qualified compatible general computing platforms (i.e. Google Pixel Smartphone) to provide on-demand body temperature measurements. The BTS App is based on well understood infrared measurement technology. The app leverages consumer general purpose computing platforms to collect the inputs for measurement.
The BTS App is intended to be operated by users above 18 years of age and can be used to measure body temperature for themselves or other individuals. To collect the input temperature data, the user is guided to conduct a non-contact forehead sweep starting at the center of the forehead and ending at the temple, thereby passing over the temporal artery, which corresponds to the highest temperature point on the forehead. This temperature data is then used as an input into the BTS App to convert the measured skin temperature data into a body temperature value. Before and during this measurement process, the BTS App performs a series of signal quality checks to ensure the validity of the temperature data collected. Additionally, to aid users with the interpretation of their measurements, the BTS App also has the option to present users with a color-coded temperature quide to indicate if the measurement falls within normal limits or indicative of an elevated state based on well-recognized body temperature ranges for the specified age of the individual being measured.
The BTS App collects the temporal artery temperature, which is processed using a polynomial function to approximate a rectal temperature. The following are the key performance specifications for the BTS App:
- Human Body Temperature Measurement Range: 94.1°F-109.4°F (34.5°C-43°C) ●
- o Laboratory Accuracy (Max): ±0.5°F (±0.3°C)
Operating Ambient Temperature:
- Temperature: 59.0°F-95°F (15°C-35°C)
- Humidity: Humidity Per ASTM E1965-98, up to 95% non-condensing ●
- Display Resolution: 0.1℃ / 0.1°F ●
- Temperature Scales: Degrees °C / °F ●
- Storage Conditions (temperature/humidity): -20°C 40°C (-4°F 113°F); Humidity ● up to 95% non-condensing
- Display Modes: Displayed temperature is the temperature of the temporal artery plus a mathematical adjustment to approximate rectal temperature.
The changes subject to this special 510k are the pre-measurement checks and values that are replaced by binary flags to ensure a body temperature measurement is only enabled when the appropriate conditions are met. These flags are:
-
- Sensor too warm flag
-
- Sensor too cold flag
-
- Difference too high flaq
-
- Skin too warm flag
-
- Skin too cold flag
Additionally, the range for the sensor too warm/too cold flag is hardware dependent and no longer a set value.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
infrared sensor
Anatomical Site
Forehead
Indicated Patient Age Range
people of all ages / General population excluding premature/preterm infants
Intended User / Care Setting
Intended User: users above 18 years of age
Care Setting: Home/General 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
The device demonstrated a laboratory accuracy of ±0.3°C per ISO 80601-2-56. Risk management was conducted in accordance with ISO 14971.
The following testing was conducted to demonstrate that the modifications to the subject device are as safe and effective as the predicate:
- Validation Testing
Results of these tests demonstrate that the functionality, safety, and effectiveness of the subject device are adequate for their intended use, indications for use and support a determination of substantial equivalence.
Clinical testing was not required for this Special 510(k).
Key Metrics
Laboratory Accuracy (Max): ±0.5°F (±0.3°C)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 13, 2025
Fitbit LLC Nathan Austin Lead Regulatory Affairs Technical Program Manager 215 Fremont St San Francisco, California 94105
Re: K243778
Trade/Device Name: Body Temperature Software (BTS) Regulation Number: 21 CFR 880.2915 Regulation Name: Body Temperature Sensing Software Regulatory Class: Class II Product Code: QZA Dated: December 4, 2024 Received: December 9, 2024
Dear Nathan Austin:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Porsche Bennett
Porsche Bennett For David Wolloscheck Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243778
Device Name Body Temperature Software (BTS)
Indications for Use (Describe)
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.
| 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)
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K243778- 510k Summary
This Premarket Notification is submitted by:
Fitbit, LLC. 215 Fremont Street, San Francisco, CA 94105
Contact Information:
Contact Person: Nathan Austin Phone: (650) 447-9336 Email: nathanaustin@google.com Date Prepared: February 13, 2025
Device Trade Name: Body Temperature Software (BTS)
| Subject Device Information | |
|---|---|
| Device Classification Name | Body temperature sensing software |
| Review Panel | General Hospital |
| Product Code & Regulation Number | QZA - 21 CFR 880.2915 |
| Regulatory Class | Class II |
| 510k Number | K243778 |
Predicate Device:
The legally marketed predicate for the subject device is detailed in the table below.
| Predicate Device
| Trade Name | De Novo | Product Code | Manufacturer |
|---|---|---|---|
| Body Temperature | |||
| Software (BTS) | DEN230050 | QZA | Fitbit LLC |
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.
Device Description:
The Body Temperature Software ("BTS") mobile application ("App"), is a Software as a Medical Device (SaMD) that leverages an infrared sensor from qualified compatible general computing platforms (i.e. Google Pixel Smartphone) to provide on-demand body temperature measurements. The BTS App is based on well understood infrared measurement technology. The app leverages consumer general purpose computing platforms to collect the inputs for measurement.
5
The BTS App is intended to be operated by users above 18 years of age and can be used to measure body temperature for themselves or other individuals. To collect the input temperature data, the user is guided to conduct a non-contact forehead sweep starting at the center of the forehead and ending at the temple, thereby passing over the temporal artery, which corresponds to the highest temperature point on the forehead. This temperature data is then used as an input into the BTS App to convert the measured skin temperature data into a body temperature value. Before and during this measurement process, the BTS App performs a series of signal quality checks to ensure the validity of the temperature data collected. Additionally, to aid users with the interpretation of their measurements, the BTS App also has the option to present users with a color-coded temperature quide to indicate if the measurement falls within normal limits or indicative of an elevated state based on wellrecognized body temperature ranges for the specified age of the individual being measured.
The BTS App collects the temporal artery temperature, which is processed using a polynomial function to approximate a rectal temperature. The following are the key performance specifications for the BTS App:
- Human Body Temperature Measurement Range: 94.1°F-109.4°F (34.5°C-43°C) ●
- o Laboratory Accuracy (Max): ±0.5°F (±0.3°C)
Operating Ambient Temperature:
- Temperature: 59.0°F-95°F (15°C-35°C)
- Humidity: Humidity Per ASTM E1965-98, up to 95% non-condensing ●
- Display Resolution: 0.1℃ / 0.1°F ●
- Temperature Scales: Degrees °C / °F ●
- Storage Conditions (temperature/humidity): -20°C 40°C (-4°F 113°F); Humidity ● up to 95% non-condensing
- Display Modes: Displayed temperature is the temperature of the temporal artery plus a mathematical adjustment to approximate rectal temperature.
The changes subject to this special 510k are the pre-measurement checks and values that are replaced by binary flags to ensure a body temperature measurement is only enabled when the appropriate conditions are met. These flags are:
-
- Sensor too warm flag
-
- Sensor too cold flag
-
- Difference too high flaq
-
- Skin too warm flag
-
- Skin too cold flag
Additionally, the range for the sensor too warm/too cold flag is hardware dependent and no longer a set value.
Comparison of Technological Characteristics:
A summary of substantial equivalence between the subject device and predicate device included in the scope of this Special 510(k) is included in the table below.
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Table 1: Summary of Substantial Equivalence
| | Subject Device
Body Temperature Software | Predicate Device
Body Temperature Software
(DEN230050) | Equivalence Discussion |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | Same |
| Intended User | The BTS App is intended to be
operated by users above 18 years of
age. | The BTS App is intended to be
operated by users above 18 years of
age. | Same |
| Device
Classification | Class II | Class II | Same |
| FDA Product
Code and
Regulatory
Classification | QZA - 21 CFR 880.2915
Body temperature sensing software | QZA - 21 CFR 880.2915
Body temperature sensing software | Same |
| Patient
Population | General population excluding
premature/preterm infants | General population excluding
premature/preterm infants | Same |
| Prescription | OTC | OTC | Same |
| or OTC | | | |
| Anatomical
Site | Forehead using a compatible
consumer smartphone with IR
sensors. | Forehead using a compatible
consumer smartphone with IR sensors. | Same |
| Use
Environment | Home/General Use | Home/General Use | Same |
| Compatible
devices | Pixel 8 Pro and other consumer Pixel
smartphone devices deemed
compatible with Android 14 operating
system release or higher | Pixel 8 Pro with Android 14 operating
system release or higher | Different
The BTS App is deemed
compatible with additional
hardware platforms that meet the
pre-specified requirements. This
addition is to include additional
consumer Pixel smartphones
as compatible devices and
does not raise new questions of
safety and effectiveness. |
| Inputs to BTS | 1. Range flag and IR sensor check
2. A temperature signal that qualified
smartphone devices generate.
a. The Sensor Ambient
Temperature is set to
Hardware specific
ranges.
b. Skin too warm/cold
checks are binary
flags.
c. Window temperature
difference too high
check is a binary flag. | 1. Range flag and IR sensor check
2. A temperature signal that qualified
smartphone devices generate.
a. The Sensor Ambient
Temperature parameter
is set at 15°C to 35°C | Different
The subject device uses binary
flags to check for suitable pre-
measurement phone hardware
conditions. These functions occur
outside the SaMD and are
maintained in a hardware
specification table.
The Sensor Ambient
Temperature is set to Hardware |
| | | | specific ranges with the subject
device instead of a defined range.
Validated laboratory accuracy
testing for the sensor ambient
temperature range supports the
change not raising new questions
of safety and effectiveness.
The skin too warm/cold and
the difference too high flags
have been modified to be
binary flags instead of
specified ranges. This
difference is evaluated using
software verification and does
not raise new questions of
safety and effectiveness. |
| Principle of
operation | A user's temperature is measured
when a forehead measurement
sweep is performed with the infrared
sensor and the signal input data is
provided by the platform to the BTS
App algorithm.
The BTS App performs a series of
checks prior to launching, during the
sweep and during the processing of
the signal to ensure that the
temperature data collected is valid for
processing. Using this valid collected | A user's temperature is measured
when a forehead measurement sweep
is performed with the infrared sensor
and the signal input data is provided by
the platform to the BTS App algorithm.
The BTS App performs a series of
checks prior to launching, during the
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 BTS App algorithm | Same |
| | data, the BTS App algorithm
processes the sensor data collected
during the sweep and determines the
body temperature.
The displayed temperature is that of
the temporal artery which is
processed using a polynomial
function to approximate a rectal
temperature. | processes the sensor data collected
during the sweep and determines the
body temperature.
The displayed temperature is that of
the temporal artery which is processed
using a polynomial function to
approximate a rectal temperature. | |
| Specifications | | | |
| Human body
temperature
Measurement
Range
(Min/Max
Accuracy) | 94.1°F-109.4°F (34.5°C-43.0°C) | 94.1°F-109.4°F (34.5°C-43.0°C) | Same |
| Laboratory
Accuracy (Max) | ±0.5°F (±0.3°C) | ±0.5°F (±0.3°C) | Same |
| Measurement
Site | Temporal Artery | Temporal Artery | Same |
| Reference Body Rectal
Site | Rectal | Rectal | Same |
| Human body
temperature
Measurement
Range
(Min/Max
Accuracy) | 94.1°F-109.4°F (34.5°C-43.0°C) | 94.1°F-109.4°F (34.5°C-43.0°C) | Same |
| Operating Ambient Ranges | | | |
| Temperature | 59.0°F-95.0°F (15.0°C-35.0°C) | 59.0°F-95.0°F (15.0°C-35.0°C) | Same |
| Display
Resolution | 0.1°F/0.1°C | 0.1°F/0.1°C | Same |
| Temperature
Scales | Degrees °F/°C | Degrees °F/°C | Same |
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Summary of Non-Clinical Testing:
The intended use of the subject device and predicate are identical, and their technological characteristics are similar. The subject device is a modification of the predicate device and utilizes the same design and operating principles. The device modifications have been verified and do not raise any new or different questions of safety and effectiveness.
The device demonstrated a laboratory accuracy of ±0.3°C per ISO 80601-2-56. Risk management was conducted in accordance with ISO 14971.
The following testing was conducted to demonstrate that the modifications to the subject device are as safe and effective as the predicate.
- Validation Testing .
Results of these tests demonstrate that the functionality, safety, and effectiveness of the subject device are adequate for their intended use, indications for use and support a determination of substantial equivalence.
Summary of Clinical Testing:
Clinical testing was not required for this Special 510(k).
Conclusion:
The proposed modifications to the subject device do not alter the indications for use, intended use, user interface or its core algorithm. There are no differences in the indications for use and intended use between the subject and predicate devices.
One of the technological differences is that pre-measurement checks related to 'Sensor Ambient Temperature', 'Skin temperature', and 'Sensor Window Temperature' values are replaced by binary flags that function similarly to proximity flag check in that a body temperature measurement is only enabled when the appropriate conditions are met. Additionally, the Sensor Ambient Temperature range is being set to hardware specific range instead of a predefined range.
Laboratory accuracy testing and software verification show that the modifications to the software do not raise new or different questions of safety and effectiveness and the device demonstrates substantial equivalence to the predicate device.
The subject device is substantially equivalent to the predicate device, Body Temperature Software (BTS), DEN230050.