(156 days)
Unknown
The document describes an "algorithm" for analyzing ECG data and detecting AFib, but it does not explicitly state whether this algorithm utilizes AI or ML techniques. The lack of mention of AI, DNN, or ML, and the absence of details about training sets or model architecture, make it impossible to definitively confirm the presence of AI/ML.
No.
The "Intended Use / Indications for Use" section explicitly states that "The ECG data displayed by the Fitbit ECG App is intended for informational use only. The user is not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment." This indicates it is for information and diagnosis support, not direct therapy.
Yes
The device determines the presence of atrial fibrillation (AFib) or sinus rhythm and provides an ECG waveform, which are used to aid in the diagnosis of AFib. Although it states the data is for informational use and not intended to replace traditional diagnosis, it clearly facilitates the diagnostic process by detecting and reporting a medical condition.
Yes
The device is explicitly described as a "software-only mobile medical application" and a "software-only medical device." While it utilizes data from a Fitbit wrist-worn product, the submission focuses on the software's function and analysis, not the hardware itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Fitbit ECG App function: The Fitbit ECG App works by measuring electrical signals from the user's body through sensors on the wrist-worn device. It analyzes these electrical signals to determine heart rhythm (AFib or sinus rhythm). It does not analyze samples taken from the body.
The Fitbit ECG App is a software-only medical device that performs an in vivo measurement (measurement taken from a living organism).
N/A
Intended Use / Indications for Use
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AFib detection feature is not recommended for users with other known arrhythmias.
The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the Fitbit ECG App is intended for informational use only. The user is not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old.
Product codes
ODA, QDA
Device Description
The Fitbit ECG App is a software-only medical device used to create, record, display, store and analyze a single channel ECG. The Fitbit ECG App consists of a Device application ("Device app") on a consumer Fitbit wrist-worn product and a mobile application tile ("mobile app") on Fitbit's consumer mobile application. The Device app uses data from electrical sensors on a consumer Fitbit wrist-worn product to create and record an ECG. The algorithm on the Device app analyzes a 30 second recording of the ECG and provides results to the user. Users are able to view their past results as well as a pdf report of the waveform similar to a Lead I ECG on the mobile app.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left hand fingers to right wrist or vice versa on a consumer grade electronic.
Indicated Patient Age Range
Individuals (22 years or older)
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
Not Found
Summary of Performance Studies
Clinical testing was performed similar to the predicate device. 475 subjects, with and without a known diagnosis of AFib, were recruited to participate across 9 US sites. Eligible subjects underwent a 10-second screening using a 12-lead ECG. Subjects with a known history of AFib were screened for AFib by a single qualified physician and assigned to the AFib cohort. Subjects without a known history of AFib were screened for NSR and assigned to the NSR cohort. Subsequently, subjects underwent a simultaneous 30-second 12-lead ECG and Fitbit ECG App test. The Fitbit ECG App's single lead waveform was deemed morphologically equivalent to the Lead I of a 12-Lead ECG waveform overall for 95.0% of AF and SR tracings reviewed qualitatively. The qualitative and quantitative results of the clinical study demonstrated substantial equivalence.
Key results: The Fitbit ECG App software algorithm was able to detect AF with the sensitivity and specificity of 98.7% and 100%, respectively.
Key Metrics
AFib detection: Sensitivity 98.7%, Specificity 100%
Predicate Device(s):
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2345 Electrocardiograph software for over-the-counter use.
(a)
Identification. An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing under anticipated conditions of use must demonstrate the following:
(i) The ability to obtain an electrocardiograph of sufficient quality for display and analysis; and
(ii) The performance characteristics of the detection algorithm as reported by sensitivity and either specificity or positive predictive value.
(2) Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs.
(3) Non-clinical performance testing must validate detection algorithm performance using a previously adjudicated data set.
(4) Human factors and usability testing must demonstrate the following:
(i) The user can correctly use the device based solely on reading the device labeling; and
(ii) The user can correctly interpret the device output and understand when to seek medical care.
(5) Labeling must include:
(i) Hardware platform and operating system requirements;
(ii) Situations in which the device may not operate at an expected performance level;
(iii) A summary of the clinical performance testing conducted with the device;
(iv) A description of what the device measures and outputs to the user; and
(v) Guidance on interpretation of any results.
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September 11, 2020
Fitbit, Inc. Shruti Rajagopalan Medical Regulatory Compliance Manager 199 Fremont Street San Francisco, California 94105
Re: K200948
Trade/Device Name: Fitbit ECG App Regulation Number: 21 CFR 870.2345 Regulation Name: Electrocardiograph software for over-the-counter use Regulatory Class: Class II Product Code: ODA Dated: August 10, 2020 Received: August 11, 2020
Dear Shruti Rajagopalan:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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).
Sincerely,
for
Jennifer Shih Kozen Acting Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200948
Device Name Fitbit ECG App
Indications for Use (Describe)
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AFib detection feature is not recommended for users with other known arrhythmias.
The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the Fitbit ECG App is intended for informational use only. The user is not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old.
| 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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Image /page/3/Picture/0 description: The image shows the Fitbit logo. The logo consists of a stylized, geometric shape made up of small circles on the left side. To the right of the shape is the word "fitbit" in a sans-serif font. There is a registered trademark symbol to the right of the word.
510(k) SUMMARY
| Submitter | Fitbit, Inc
199 Fremont Ave, 14th Floor,
San Francisco, CA 94105 |
|-----------------------|------------------------------------------------------------------------|
| Contact Person: | Shruti Rajagopalan |
| Phone: | 408-242-2515 |
| Email: | shruti.rajagopalan@fitbit.com |
| Date Prepared: | 09 September 2020 |
| Name of Device: | Fitbit ECG App |
| Common or Usual Name: | Heart Rhythm Assessment, ECG |
| Regulation Number: | 21 CFR§870.2345 |
| Regulation Name: | Electrocardiograph software for over-the-counter use |
| Regulatory Class: | Class II |
| Product Code: | QDA |
| Submission Number | K200948 |
Predicate Device Information:
| Name of Device: | ECG App |
|---|---|
| Manufacturer: | Apple, Inc. |
De Novo Petition Number: DEN180044
Indications for Use
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel
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Image /page/4/Picture/0 description: The image shows the Fitbit logo. The logo consists of a stylized, geometric shape made up of small circles arranged in a pattern resembling a stylized "F". To the right of the geometric shape is the word "fitbit" in a sans-serif font. The logo is simple, modern, and easily recognizable.
electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias.
The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the Fitbit ECG App is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old.
Device Description
The Fitbit ECG App is a software-only medical device used to create, record, display, store and analyze a single channel ECG. The Fitbit ECG App consists of a Device application ("Device app") on a consumer Fitbit wrist-worn product and a mobile application tile ("mobile app") on Fitbit's consumer mobile application. The Device app uses data from electrical sensors on a consumer Fitbit wrist-worn product to create and record an ECG. The algorithm on the Device app analyzes a 30 second recording of the ECG and provides results to the user. Users are able to view their past results as well as a pdf report of the waveform similar to a Lead I ECG on the mobile app.
Summary of Technological Characteristics
| | Subject Device
Fitbit ECG App | Predicate Device
Apple ECG app |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K200948 | DEN180044 |
| Indications for
Use | The Fitbit ECG App is a
software-only mobile medical
application intended for use with
Fitbit wrist-wearable devices to
create, record, store, transfer, and
display a single channel
electrocardiogram (ECG)
qualitatively similar to a Lead I
ECG. The Fitbit ECG App
determines the presence of atrial | The ECG app is a software-only
mobile medical application
intended for use with the Apple
Watch to create, record, store,
transfer, and display a single
channel electrocardiogram (ECG)
similar to a Lead I ECG. The ECG
app determines the presence of
atrial fibrillation (AFib) or sinus
rhythm on a classifiable waveform. |
| | fibrillation (AFib) or sinus rhythm
on a classifiable waveform. The
AFib detection feature is not
recommended for users with other
known arrhythmias.
The Fitbit ECG App is intended for
over-the-counter (OTC) use. The
ECG data displayed by the Fitbit
ECG App is intended for
informational use only. The user is
not intended to interpret or take
clinical action based on the device
output without consultation of a
qualified healthcare professional.
The ECG waveform is meant to
supplement rhythm classification
for the purposes of discriminating
AFib from normal sinus rhythm
and not intended to replace
traditional methods of diagnosis or
treatment. The Fitbit ECG App is
not intended for use by people
under 22 years old. | The ECG app is not recommended
for users with other known
arrhythmias
The ECG app is intended for
over-the-counter (OTC) use. The
ECG data displayed by the ECG
app is intended for informational
use only. The user is not intended
to interpret or take clinical action
based on the device output without
consultation of a qualified
healthcare professional. The ECG
waveform is meant to supplement
rhythm classification for the
purposes of discriminating AFib
from normal sinus rhythm and not
intended to replace traditional
methods of diagnosis or treatment.
The ECG app is not intended for
use by people under 22 years old. |
| Mechanism of
Operation | Uses input from consumer
wrist-worn devices to detect the
electrical potential differences
between the electrical sensors and
generate an ECG waveform. | Uses input from consumer
wrist-worn devices to detect
electrical potential differences
between the electrodes and the
crown and generate an ECG
waveform. |
| Device
Classification | Class II | Class II |
| FDA Product
Code and
Regulatory
Classification | QDA
21 CFR 870.2345 | QDA
21 CFR 870.2345 |
| Anatomical sites | Left hand fingers to right wrist or
vice versa on a consumer grade
electronic. | Left hand fingers to right wrist or
vice versa on a consumer grade
electronic. |
| Patient
population | Individuals (22 years or older) | Individuals (22 years or older) |
| Data storage | ECG data stored locally on
wrist-worn device until
transmission to a server. | ECG data stored locally on
wrist-worn device until
transmission to a server. |
| Prescription/OTC | OTC | OTC |
| ECG Channels | Single Channel, Lead I | Single Channel, Lead I |
| User Interface | Device app and Mobile app | Device app and Mobile app |
| Use Method | Record a 30 second ECG on the
wrist-worn device and receive
results determining the presence of
Atrial Fibrillation or Normal Sinus
Rhythm. | Record a 30 second ECG on the
wrist-worn device and receive
results determining the presence of
Atrial Fibrillation or Normal Sinus
Rhythm. |
| Results of the
algorithm | Atrial Fibrillation
Normal Sinus Rhythm
Inconclusive | Atrial Fibrillation
Normal Sinus Rhythm
Inconclusive |
| ECG Waveform
Display | Qualitatively similar to a Lead I
ECG waveform displayed as a pdf
on the Mobile app | Similar to a Lead I ECG displayed
as a pdf on the Mobile app |
Table 1. Subject and Predicate Device Comparison
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Image /page/5/Picture/0 description: The image shows the Fitbit logo. The logo consists of a stylized, geometric shape made up of small circles on the left side. To the right of the shape is the word "fitbit" in a sans-serif font.
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Image /page/6/Picture/0 description: The image shows the Fitbit logo. The logo consists of a stylized, geometric shape to the left of the word "fitbit." The geometric shape is made up of a collection of dots arranged in a pattern. The word "fitbit" is written in a sans-serif font.
Non-clinical Testing
All necessary performance testing was conducted on the Fitbit ECG App to support a determination of substantial equivalence to the predicate device. This testing included testing of input signal quality as per IEC 60601-2-47:2012 Medical Electrical Equipment -Ambulatory Electrocardiographic Systems. Testing was conducted using appropriate databases from ANSI/AAMI EC57:2012.
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Image /page/7/Picture/0 description: The image shows the Fitbit logo. The logo consists of a stylized, geometric shape made up of small circles arranged in a pattern resembling a stylized letter 'F' or a diamond shape. To the right of the geometric shape is the word "fitbit" in a sans-serif font. A small circle with an 'R' inside is located to the right of the word.
Human Factors Testing
Human Factors testing was performed to demonstrate that the user can correctly use the device by solely reading the device labeling and also correctly interpret the device output and understand when to seek medical care. This testing satisfies the special control requirements of the predicate device and provides evidence of substantial equivalence.
Clinical Testing
Clinical testing was performed similar to the predicate device. 475 subjects, with and without a known diagnosis of AFib, were recruited to participate across 9 US sites. Eligible subjects underwent a 10-second screening using a 12-lead ECG. Subjects with a known history of AFib were screened for AFib by a single qualified physician and assigned to the AFib cohort. Subjects without a known history of AFib were screened for NSR and assigned to the NSR cohort. Subsequently, subjects underwent a simultaneous 30-second 12-lead ECG and Fitbit ECG App test. The Fitbit ECG App software algorithm was able to detect AF with the sensitivity and specificity of 98.7% and 100%, respectively. The Fitbit ECG App's single lead waveform was deemed morphologically equivalent to the Lead I of a 12-Lead ECG waveform overall for 95.0% of AF and SR tracings reviewed qualitatively. The qualitative and quantitative results of the clinical study demonstrated substantial equivalence.
Conclusions
The Fitbit ECG App is similar in technological characteristics and has the same intended use as the Apple ECG app. Differences in technological characteristics have been evaluated through performance testing including the special controls requirements of the predicate which has shown that the minor technological differences between the Fitbit ECG App and the predicate device raise no new issues of safety or effectiveness. Bench and clinical data demonstrate that the Fitbit ECG App is substantially equivalent to the Apple ECG App.