Garmin ECG App by Garmin International, Inc.

The Garmin ECG app is a software-only, mobile medical application intended for use with compatible Garmin smartwatches to create, record, store, transfer, and display a single-channel electrocardiograph similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm (SR) on a classifiable waveform. 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 SR, and it is not intended to replace traditional methods of diagnosis or treatment.

The ECG app is not intended for use by people under 22 years old.

Device Description

The Garmin ECG App (ECG App) is a software-only, mobile medical application that has two components: (1) the Watch ECG App for compatible Garmin smartwatches ("Watch" or "Watches"), and (2) the Smartphone ECG App included within Garmin's consumer health and fitness application ecosystem, Garmin Connect allows users to store, manage, and share their respective health and fitness data.

The ECG App is intended to create, record, store, transfer, and display a single lead ECG signal similar to a Lead | ECG. The Watch ECG App acquires and analyzes the single lead ECG signal from electrodes built into each Watch and detects the presence of atrial fibrillation (AFib) or normal sinus rhythm (SR) in the adult wearer of the Watch ECG App then calculates the average heart rate and displays that value, along with the rhythm classification result, to the user on the Watch screen. The user may annotate the result by choosing from a provided list of symptoms.

Optionally, and only when directed by the user, the Watch ECG App can securely transmit the result to the Smartphone ECG App for the purposes of storing and viewing a history of ECG App results. The user may also export ECG App results as a PDF for easy sharing.

AI/ML Overview

The Garmin ECG App is a software-only, mobile medical application intended for use with compatible Garmin smartwatches to detect the presence of atrial fibrillation (AFib) or sinus rhythm (SR) from a single-channel electrocardiograph (similar to Lead I ECG).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Garmin ECG App's clinical performance were based on its ability to accurately detect AFib and sinus rhythms. The reported device performance is presented in the table below:

Acceptance Criteria	Reported Device Performance
Atrial Fibrillation Sensitivity	99.5%
Sinus Rhythm Specificity	100%
AFib Detection (including inconclusive recordings)	86.5%
Sinus Rhythm Detection (including inconclusive recordings)	91.1%

2. Sample Size and Data Provenance

Test Set Sample Size: Approximately 590 subjects.
Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, it describes a "clinical study," which typically implies a prospective design.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not explicitly stated, but the ground truth for the test set was established by "board-certified cardiologists."
Qualifications of Experts: Board-certified cardiologists.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly detailed beyond stating that "12-Lead ECG rhythm classifications performed by board-certified cardiologists" were used as the comparison for the ECG app's classifications. It implies that these expert classifications served as the gold standard for comparison.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted to assess how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the Garmin ECG App compared to expert-classified 12-Lead ECGs.

6. Standalone Performance (Algorithm Only)

Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was done. The reported sensitivities and specificities (99.5% AFib sensitivity, 100% SR specificity for classifiable waveforms, and 86.5% AFib detection, 91.1% SR detection overall) are for the device's algorithmic classification.

7. Type of Ground Truth Used

The ground truth used was expert consensus based on 12-Lead ECG rhythm classifications performed by board-certified cardiologists.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set for the ECG app's algorithm. The provided information specifically refers to the clinical validation study (test set).

9. How Ground Truth for the Training Set Was Established

The document does not explicitly describe how the ground truth for the training set was established. It mentions that "Garmin conducted database testing using a previously adjudicated dataset as per ANSI/AAMI EC57:2012" under "Non-Clinical Testing." While this indicates the use of adjudicated data for some form of testing, it doesn't specify if this was the training dataset or how that adjudication was performed (e.g., expert review, specific criteria).

Summary

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January 12, 2023

Garmin International, Inc. Travis Johnson Product and Strategy Director, Medical Devices 1200 East 151st Street Olathe, Kansas 66062

Re: K221774

Trade/Device Name: Garmin ECG App Regulation Number: 21 CFR 870.2345 Regulation Name: Electrocardiograph Software For Over-The-Counter Use Regulatory Class: Class II Product Code: QDA Dated: December 9, 2022 Received: December 9, 2022

Dear Travis Johnson:

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 statutes and regulations administered by other Federal agencies.

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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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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).

Sincerely,

Shruti N. Mistry -S
for

Jennifer Shih Kozen 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) K221774

Device Name Garmin ECG App

Indications for Use (Describe)

The 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)
Over-The-Counter Use (21 CFR 801 Subpart C)

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K221774 - 510(k) Summary

This summary of 510(k) substantial equivalence information is submitted in accordance with the requirements of 21 C.F.R. § 807.92.

। Submitter

Applicant	Garmin International, Inc.1200 East 151st StreetOlathe, KS, 66062
Contact Person	Travis JohnsonProduct and Strategy Director, Medical DevicesPhone: 913-440-2624Email: travis.johnson@garmin.com
Date Prepared:	June 17th, 2022

2 Device Names and Classifications

Subject Device:

Name of Device	Garmin ECG App
Common Name	ECG App
Classification Name	Electrocardiograph Software for Over-the-Counter Use
Regulation Number	21 C.F.R. § 870.2345
Product Code	QDA
Regulatory Class	Class II

Predicate Device:

Predicate Manufacturer	Apple Inc.
Predicate Trade Name	Apple ECG App
Predicate 510(k)	DEN180044

3 Device Description

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user on the Watch screen. The user may annotate the result by choosing from a provided list of symptoms.

Indications for Use す

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 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 SR, and it is not intended to replace traditional methods of diagnosis or treatment.

The ECG app is not intended for use by people under 22 years old.

5 Comparison of Predicate and Subject Device Technological Characteristics

The predicate and subject devices have equivalent indications for use. The devices have equivalent technological characteristics and operating principles. Clinical, usability, and bench testing show performance equivalence and raise no new questions of safety or effectiveness. Table 1 provides a detailed comparison of the devices.

Specification	Garmin ECG App(Subject Device)	Apple ECG App - DEN180044(Predicate Device)
Manufacturer	Garmin International, Inc.	Apple Inc.
Device Classification	Class II	Class II
FDAProduct Code	QDA	QDA
RegulationNumber	21 C.F.R. § 870.2345	21 C.F.R. § 870.2345
Type of Use	OTC	OTC
Patient population	Adults 22 years or older	Adults 22 years or older
Specification	Garmin ECG App(Subject Device)	Apple ECG App - DEN180044(Predicate Device)
Indicationsfor Use	The Garmin ECG app is a software-only, mobile medical applicationintended for use with compatibleGarmin smartwatches to create,record, store, transfer, and display asingle-channel electrocardiographsimilar to a Lead I ECG. The ECG appdetermines the presence of atrialfibrillation (AFib) or sinus rhythm (SR)on a classifiable waveform. The ECGapp is not recommended for users withother known arrhythmias.	The Apple ECG app is a software-onlymobile medical application intendedfor use with the Apple Watch tocreate, record, store, transfer anddisplay a single channelelectrocardiogram (ECG) similar to alead I ECG. The ECG app determinesthe presence of atrial fibrillation (AF)or sinus rhythm on a classifiablewaveform. The ECG app is notrecommended for users with otherknown arrhythmias.
	The ECG app is intended for over-the-counter (OTC) use. The ECG datadisplayed by the ECG app is intendedfor informational use only. The user isnot intended to interpret or takeclinical action based on the deviceoutput without consultation of aqualified healthcare professional. TheECG waveform is meant to supplementrhythm classification for the purposesof discriminating AFib from normal SR,and it is not intended to replacetraditional methods of diagnosis ortreatment.	The ECG app is intended for over-the-counter (OTC) use. The ECG datadisplayed by the ECG app is intendedfor informational use only. The user isnot intended to interpret or takeclinical action based on the deviceoutput without consultation of aqualified healthcare professional. TheECG waveform is meant tosupplement rhythm classification forthe purposes of discriminating AFfrom normal sinus rhythm and notintended to replace traditionalmethods of diagnosis or treatment.
	The ECG app is not intended for use bypeople under 22 years old.	The ECG app is not intended for useby people under 22 years old.
Principleof Operation	The ECG app acquires the electricalpotential between electrodes built intocompatible Garmin smartwatches.After acquisition, the ECG app analyzesthe signal, generates an ECGwaveform, and classifies the rhythm todisplay to the user.	The ECG app acquires the electricalpotential difference betweenelectrodes built into the AppleWatch. After acquisition, the ECG appanalyzes the signal, generates an ECGwaveform, and classifies the rhythmto display to the user.
Mechanismof Action	While at rest, users complete circuitwith skin contact from two fingers onsmartwatch bezel while wearing thesmartwatch on their wrist.	While at rest, users completes circuitwith skin contact from a single fingeron a button on the side of device.
SmartwatchPlatform Sensor	A single channel electrocardiogram(ECG) similar to a Lead I ECG takenfrom electrodes on the back of thewatch on one wrist and the bezelwhere the fingers are placed.	A single channel electrocardiogram(ECG) similar to a Lead I ECG takenfrom electrodes on the back of thewatch on one wrist and the digitalcrown where the finger is placed.
Specification	Garmin ECG App(Subject Device)	Apple ECG App - DEN180044(Predicate Device)
AnatomicalSites	Left hand fingers to right wrist or viceversa on a consumer grade electronic.	Left hand fingers to right wrist or viceversa on a consumer gradeelectronic.
ECG Channels	A single channel electrocardiogramsimilar to a Lead I ECG.	A single channel electrocardiogramsimilar to a Lead I ECG.
RhythmClassificationResults	Low Heart Rate (< 50 bpm) Sinus Rhythm (50-100 bpm) Atrial Fibrillation (50-120 bpm) Inconclusive (Other) Inconclusive - Poor Recording High Heart Rate (> 120 bpm)	Low Heart Rate (< 50 bpm) Sinus Rhythm (50-100 bpm) Atrial Fibrillation (50-120 bpm) Inconclusive (Other) Inconclusive - Poor Recording High Heart Rate (> 120 bpm)
Platforms	Watch ECG App:Compatible Garmin Smartwatchesrunning GarminOS	Watch ECG App:Compatible Apple Watch modelsrunning WatchOS
	Smartphone ECG App:Garmin Connect mobile application forAndroid and iOS smartphones	Smartphone ECG App:Apple Health mobile application foriOS smartphones (iPhones)
Data storage	ECG data stored locally on smartwatch(Watch ECG App) until transmission toSmartphone ECG App.	ECG data stored locally onsmartwatch (Watch ECG App) untiltransmission to Smartphone ECGApp.
User Interface	Garmin watch screen for taking an ECGrecording, viewing signal duringacquisition (not diagnosis quality),providing rhythm classification,viewing average heart rate, andentering symptoms.	Apple watch screen for taking an ECGrecording, viewing signal duringacquisition (not diagnosis quality),providing rhythm classification,viewing average heart rate, andentering symptoms.
	Smartphone screen for:1) ECG app activation; and2) Secondary display of ECG app resultsand export of results as a PDF reportthat includes the ECG waveform andrhythm classification.	Smartphone screen for:1) ECG app activation; and2) Secondary display of ECG appresults and export of results as a PDFreport that includes the ECGwaveform and rhythm classification.
ECGWaveform Display	Similar to a Lead I ECG displayed as aPDF on the Smartphone ECG App.	Similar to a Lead I ECG displayed as aPDF on the Smartphone ECG App.
ClinicalPerformance	Atrial Fibrillation Sensitivity: 99.5%Sinus Rhythm Specificity: 100%	Atrial Fibrillation Sensitivity: 98.3%Sinus Rhythm Specificity: 99.6%

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Table 1 – Comparison of Subject and Predicate Device Technological Characteristics

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Image /page/7/Picture/0 description: The image shows the word "GARMIN." in all capital letters. The font is a bold sans-serif typeface. A small registered trademark symbol is located to the right of the period.

ട Performance Data

Garmin conducted all the necessary non-clinical and clinical performance testing on the ECG App to support a determination of substantial equivalence to the predicate device.

Non-Clinical Testing 6.1

Software Verification Testing

Garmin conducted software verification testing and provided documentation as recommended by FDA Guidance, "Content of Premarket Submissions for Software Contained in Medical Devices."

Human Factors Validation

Garmin conducted a human factors validation study to verify the ECG App is substantially equivalent for the intended users, uses, and use environments. Results demonstrated that users can correctly use the device by solely reading the device labeling, correctly interpret the device output, and understand when to seek medical care. This testing satisfies the FDA special controls established for the predicate device.

ECG Database Testing

In compliance with special controls established under 21 C.F.R. § 870.2345, Garmin conducted database testing using a previously adjudicated dataset as per ANSI/AAMI EC57:2012.

Platform Compliance

Input Signal Quality Testing per IEC 60601-2-47:2012 Medical Electrical Equipment Ambulatory ECG Systems
Applicable RF and EMC requirements under ETSI EN 301 489-1 V2.2.3 (2019-11), 301 489-3 V2.1.1 (2019-03), and 301 489-17 V3.2.4 (2020-09) and FCC Part 15
Thermal and Electrical safety requirements under IEC 62368-1:2014

6.2 Clinical Testing

The ECG App's ability to accurately detect AFib and sinus rhythms in an ECG recording was validated in a clinical study involving approximately 590 subjects. ECG app rhythm classifications were compared to 12-Lead ECG rhythm classifications performed by board-certified cardiologists. The ECG App was able to correctly identify AFib 99.5% of the time and correctly identify SR 100% of the time in the recordings that could be classified.

During this study, the ECG App determined 11.5% of recordings were inconclusive, including those which were deemed of too poor quality for analysis. When inclusive recordings, the probability that the ECG App would return an AFib result for a subject in AFib was 86.5%, and 91.1% for a SR result for subjects in sinus rhythm. Real-world performance may have a higher rate of inconclusive and poor recording results.

Accuracy of the ECG App PDF reports was assessed by comparing to a simultaneously recorded standard Lead I ECG. Key characteristics of the ECG waveforms such as PR and RR intervals, QRS duration, and amplitude, and P wave presence and amplitude were compared and found to be statistically equivalent within an acceptable margin of error. Comparison of the board-certified cardiologists' rhythm classifications of simultaneously recorded 12-Lead ECG App recordings had 96% agreement. No adverse events were observed during the clinical study. The results of the clinical study demonstrated substantial equivalence with the predicate device.

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Statement of Substantial Equivalence 7

The Garmin ECG App has the same indications for use and similar technological characteristics as its predicate Apple ECG app. The Garmin ECG App was assessed and evaluated through extensive non-clinical and clinical performance testing. The testing results demonstrate that the minor differences between the subject and predicate device do not raise new questions of safety and effectiveness and support a substantial equivalence determination. The Garmin ECG App is substantially equivalent to the Apple ECG app.

Regulation Number and Section

§ 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.