Fitbit ECG App

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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). 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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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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There is a registered trademark symbol to the right of the word. # 510(k) SUMMARY | Submitter | Fitbit, Inc<br>199 Fremont Ave, 14th Floor,<br>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 {4}------------------------------------------------ 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<br>Fitbit ECG App | Predicate Device<br>Apple ECG app | |---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K200948 | DEN180044 | | Indications for<br>Use | The Fitbit ECG App is a<br>software-only mobile medical<br>application intended for use with<br>Fitbit wrist-wearable devices to<br>create, record, store, transfer, and<br>display a single channel<br>electrocardiogram (ECG)<br>qualitatively similar to a Lead I<br>ECG. The Fitbit ECG App<br>determines the presence of atrial | The ECG app is a software-only<br>mobile medical application<br>intended for use with the Apple<br>Watch to create, record, store,<br>transfer, and display a single<br>channel electrocardiogram (ECG)<br>similar to a Lead I ECG. The ECG<br>app determines the presence of<br>atrial fibrillation (AFib) or sinus<br>rhythm on a classifiable waveform. | | | fibrillation (AFib) or sinus rhythm<br>on a classifiable waveform. The<br>AFib detection feature is not<br>recommended for users with other<br>known arrhythmias.<br>The Fitbit ECG App is intended for<br>over-the-counter (OTC) use. The<br>ECG data displayed by the Fitbit<br>ECG App is intended for<br>informational use only. The user is<br>not intended to interpret or take<br>clinical action based on the device<br>output without consultation of a<br>qualified healthcare professional.<br>The ECG waveform is meant to<br>supplement rhythm classification<br>for the purposes of discriminating<br>AFib from normal sinus rhythm<br>and not intended to replace<br>traditional methods of diagnosis or<br>treatment. The Fitbit ECG App is<br>not intended for use by people<br>under 22 years old. | The ECG app is not recommended<br>for users with other known<br>arrhythmias<br>The ECG app is intended for<br>over-the-counter (OTC) use. The<br>ECG data displayed by the ECG<br>app is intended for informational<br>use only. The user is not intended<br>to interpret or take clinical action<br>based on the device output without<br>consultation of a qualified<br>healthcare professional. The ECG<br>waveform is meant to supplement<br>rhythm classification for the<br>purposes of discriminating AFib<br>from normal sinus rhythm and not<br>intended to replace traditional<br>methods of diagnosis or treatment.<br>The ECG app is not intended for<br>use by people under 22 years old. | | Mechanism of<br>Operation | Uses input from consumer<br>wrist-worn devices to detect the<br>electrical potential differences<br>between the electrical sensors and<br>generate an ECG waveform. | Uses input from consumer<br>wrist-worn devices to detect<br>electrical potential differences<br>between the electrodes and the<br>crown and generate an ECG<br>waveform. | | Device<br>Classification | Class II | Class II | | FDA Product<br>Code and<br>Regulatory<br>Classification | QDA<br>21 CFR 870.2345 | QDA<br>21 CFR 870.2345 | | Anatomical sites | Left hand fingers to right wrist or<br>vice versa on a consumer grade<br>electronic. | Left hand fingers to right wrist or<br>vice versa on a consumer grade<br>electronic. | | Patient<br>population | Individuals (22 years or older) | Individuals (22 years or older) | | Data storage | ECG data stored locally on<br>wrist-worn device until<br>transmission to a server. | ECG data stored locally on<br>wrist-worn device until<br>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<br>wrist-worn device and receive<br>results determining the presence of<br>Atrial Fibrillation or Normal Sinus<br>Rhythm. | Record a 30 second ECG on the<br>wrist-worn device and receive<br>results determining the presence of<br>Atrial Fibrillation or Normal Sinus<br>Rhythm. | | Results of the<br>algorithm | Atrial Fibrillation<br>Normal Sinus Rhythm<br>Inconclusive | Atrial Fibrillation<br>Normal Sinus Rhythm<br>Inconclusive | | ECG Waveform<br>Display | Qualitatively similar to a Lead I<br>ECG waveform displayed as a pdf<br>on the Mobile app | Similar to a Lead I ECG displayed<br>as a pdf on the Mobile app | ### Table 1. Subject and Predicate Device Comparison {5}------------------------------------------------ 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ 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.