(205 days)
Not Found
Unknown
The document describes an algorithm that classifies ECG waveforms but does not explicitly state whether AI/ML is used in this classification process. The "Mentions AI, DNN, or ML" section is marked as "Not Found", and there is no description of training or test sets in the context of AI/ML model development. While the performance metrics are provided, they don't inherently indicate the use of AI/ML.
Yes
The device is intended to monitor heart rhythm and classify it as AFib or sinus rhythm, helping users detect a potential medical condition (AFib), which aligns with the definition of a therapeutic device designed to manage or mitigate a health issue, even if it does not directly treat it.
Yes
The device is intended to "determine the presence of atrial fibrillation (AFib) or sinus rhythm (SR) on a classifiable waveform" and displays rhythm classification results, which are diagnostic functions. While it states the data is for "informational use only" and "not intended to replace traditional methods of diagnosis," the core functionality of classifying a medical condition (AFib or SR) aligns with the definition of a diagnostic device.
No
While the summary states the device is "software-only," it explicitly mentions that the software acquires and analyzes signals from "electrodes built into each Watch." This indicates a dependency on specific hardware components (the electrodes within the smartwatch) for its core function of acquiring the ECG signal, which goes beyond being purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Garmin ECG app acquires and analyzes an electrical signal directly from the user's body (via electrodes on the smartwatch) to determine heart rhythm. It does not analyze a sample taken from the body.
Therefore, while it is a medical device that provides diagnostic information, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
QDA
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.
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
Adults 22 years or older. Not intended for use by people under 22 years old.
Intended User / Care Setting
Over-The-Counter Use (OTC). The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Atrial Fibrillation Sensitivity: 99.5%
Sinus Rhythm Specificity: 100%
For inclusive recordings:
Probability of AFib result for subject in AFib: 86.5%
Probability of SR result for subject in sinus rhythm: 91.1%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
Indications for Use
510(k) Number (if known) K221774
Device Name Garmin ECG App
Indications for Use (Describe)
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.
| 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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3
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 Street
Olathe, KS, 66062 |
|----------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Travis Johnson
Product and Strategy Director, Medical Devices
Phone: 913-440-2624
Email: 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
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
4
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.
Indications for Use す
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 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 |
| FDA
Product Code | QDA | QDA |
| Regulation
Number | 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) |
| Indications
for Use | 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 Apple 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 (AF)
or sinus rhythm 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 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 AF
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. | The ECG app is not intended for use
by people under 22 years old. |
| Principle
of Operation | The ECG app acquires the electrical
potential between electrodes built into
compatible Garmin smartwatches.
After acquisition, the ECG app analyzes
the signal, generates an ECG
waveform, and classifies the rhythm to
display to the user. | The ECG app acquires the electrical
potential difference between
electrodes built into the Apple
Watch. After acquisition, the ECG app
analyzes the signal, generates an ECG
waveform, and classifies the rhythm
to display to the user. |
| Mechanism
of Action | While at rest, users complete circuit
with skin contact from two fingers on
smartwatch bezel while wearing the
smartwatch on their wrist. | While at rest, users completes circuit
with skin contact from a single finger
on a button on the side of device. |
| Smartwatch
Platform Sensor | A single channel electrocardiogram
(ECG) similar to a Lead I ECG taken
from electrodes on the back of the
watch on one wrist and the bezel
where the fingers are placed. | A single channel electrocardiogram
(ECG) similar to a Lead I ECG taken
from electrodes on the back of the
watch on one wrist and the digital
crown where the finger is placed. |
| Specification | Garmin ECG App
(Subject Device) | Apple ECG App - DEN180044
(Predicate Device) |
| 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. |
| ECG Channels | A single channel electrocardiogram
similar to a Lead I ECG. | A single channel electrocardiogram
similar to a Lead I ECG. |
| Rhythm
Classification
Results | Low Heart Rate ( 120 bpm) | Low Heart Rate ( 120 bpm) |
| Platforms | Watch ECG App:
Compatible Garmin Smartwatches
running GarminOS | Watch ECG App:
Compatible Apple Watch models
running WatchOS |
| | Smartphone ECG App:
Garmin Connect mobile application for
Android and iOS smartphones | Smartphone ECG App:
Apple Health mobile application for
iOS smartphones (iPhones) |
| Data storage | ECG data stored locally on smartwatch
(Watch ECG App) until transmission to
Smartphone ECG App. | ECG data stored locally on
smartwatch (Watch ECG App) until
transmission to Smartphone ECG
App. |
| User Interface | Garmin watch screen for taking an ECG
recording, viewing signal during
acquisition (not diagnosis quality),
providing rhythm classification,
viewing average heart rate, and
entering symptoms. | Apple watch screen for taking an ECG
recording, viewing signal during
acquisition (not diagnosis quality),
providing rhythm classification,
viewing average heart rate, and
entering symptoms. |
| | Smartphone screen for:
- ECG app activation; and
- Secondary display of ECG app results
and export of results as a PDF report
that includes the ECG waveform and
rhythm classification. | Smartphone screen for: - ECG app activation; and
- Secondary display of ECG app
results and export of results as a PDF
report that includes the ECG
waveform and rhythm classification. |
| ECG
Waveform Display | Similar to a Lead I ECG displayed as a
PDF on the Smartphone ECG App. | Similar to a Lead I ECG displayed as a
PDF on the Smartphone ECG App. |
| Clinical
Performance | 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
7
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.
8
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.