ECG Monitor App

K201168 · Samsung Electronics Co., Ltd. · QDA · Aug 4, 2020 · Cardiovascular

Device Facts

• Record ID: K201168
• Device Name: ECG Monitor App
• Applicant: Samsung Electronics Co., Ltd.
• Product Code: QDA · Cardiovascular
• Decision Date: Aug 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2345
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

The Samsung ECG Monitor Application is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. The app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG, for informational use only in adults 22 years and older. Classifiable traces are labeled by the app as either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

Device Story

Samsung ECG Monitor Application is a software-only mobile medical app operating on compatible Samsung Galaxy Watch and Phone. Device captures bioelectrical signals via watch electrodes (wrist and top button) to generate 30-second single-lead ECG (Lead I). App processes signals to calculate heart rate and classify rhythm as AFib, sinus rhythm, or inconclusive. Data transmits to phone app for storage, display, and PDF generation. Used by patients in home/non-clinical settings for informational purposes. Output aids heart rhythm identification; not for diagnosis or treatment. Users must consult healthcare professionals before clinical action. Benefits include patient-initiated rhythm monitoring.

Clinical Evidence

Clinical study (n=544) compared Samsung ECG Monitor App to 12-lead ECG reference. Subjects included 268 AFib, 261 SR, 15 other arrhythmias. Primary endpoints: rhythm classification accuracy and signal quality. AFib sensitivity 98.1% (95% CI: 96.3%, 99.9%), specificity 100%. Inconclusive rate 2.9%. Cardiologist interpretation concordance 99.4%. Secondary endpoints: fiducial point annotation (QRS amplitude, RR interval, QRS duration, PR interval) met non-inferiority margins. Bench testing included IEC 60601-2-47 database testing, heart rate accuracy, and platform-specific safety/robustness testing.

Technological Characteristics

Software-only mobile application (SaMD). Operates on Samsung Galaxy Watch (Tizen OS) and Samsung Galaxy Phone (Android OS). Single-channel Lead I ECG acquisition via watch electrodes. Connectivity: Bluetooth/wireless transmission between wearable and phone. Software performs signal processing and rhythm classification. Safety testing includes electrical, thermal, and electromagnetic compatibility. No specific ASTM material standards cited, but skin contact safety verified.

Indications for Use

Indicated for adults 22 years and older, not previously diagnosed with other known arrhythmias, for informational use to record and display a single-channel Lead I ECG and aid in identifying atrial fibrillation or sinus rhythm.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the electrocardiograph software for over-the-counter use is subject to the following special controls:

*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.

Predicate Devices

• Apple ECG App (DEN180044)

Submission Summary (Full Text)

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August 4, 2020

Samsung Electronics Co., Ltd Matthew Wiggins, Ph.D. Director, Medical Device Team 665 Clyde Avenue Mountain View. California 94043

Re: K201168

Trade/Device Name: Samsung ECG Monitor Application Regulation Number: 21 CFR 870.2345 Regulation Name: Electrocardiograph software for over-the-counter use Regulatory Class: Class II Product Code: ODA Dated: July 14, 2020 Received: July 15, 2020

Dear Matthew Wiggins:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Jennifer Shih 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) K201168

Device Name Samsung ECG Monitor Application

#### Indications for Use (Describe)

The Samsung ECG Monitor Application is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. The app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG, for informational use only in adults 22 years and older. Classifiable traces are labeled by the app as either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

| 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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### Samsung ECG Monitor Application 510(k) Summary

#### Applicant Information

| Manufacturer: | Samsung Electronics Co., Ltd<br>129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do 16677, Korea |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Matthew Wiggins, Ph.D.<br>Samsung Research America<br>665 Clyde Avenue, Mountain View, CA 94043<br>770-596-1765<br>[e-mail] |
| Date Prepared: | August 4th, 2020 |

#### Device Information

| Proprietary Name: | Samsung ECG Monitor Application |
|-------------------|------------------------------------------------------------------------------|
| Common Name: | ECG Monitor App |
| Classification: | QDA - Electrocardiograph software for over-the-counter use (21 CFR 870.2345) |
| Predicate Device: | Apple ECG App (DEN180044) |

#### Device Description

The Samsung ECG Monitor Application consists of a pair of mobile medical apps: one on a compatible Samsung wearable and the other on a compatible Samsung phone. The compatible Samsung wearable application captures bioelectrical signals from the user and generates single lead ECG signals, calculates average heart rate and classifies the rhythm. The wearable application securely transmits the obtained data to the phone application on the paired phone device. The phone application shows the ECG measurement history and generates the PDF file for the received ECG signals which can be shared by the user.

#### Intended Use/Indications for Use

The Samsung ECG Monitor Application is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. The app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG, for informational use only in adults 22 years and older. Classifiable traces are labeled by the app as either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

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#### Comparison of Technological Characteristics

- The predicate and the subject device have an equivalent intended use, ●
- The operating principle and specifications are equivalent, and ●
- Clinical and Usability validation testing, as well as bench testing, show performance equivalence . and bring up no new safety or effectiveness questions.

A more detailed comparison of the devices is provided below in Table 1.

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Table 1. Technological Comparison

| Specification | Predicate SaMD<br>Apple ECG App (DEN 180044) | Samsung ECG Monitor App | Difference |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The ECG app is a software-only mobile<br>medical application intended for use with<br>the Apple Watch to create, record, store,<br>transfer, and display a single channel<br>electrocardiogram (ECG) similar to a<br>Lead I ECG. The ECG app determines the<br>presence of atrial fibrillation (AFib) or<br>sinus rhythm on a classifiable waveform.<br>The ECG app is not recommended for<br>users with other known arrhythmias.<br>The ECG app is intended for over-the-<br>counter (OTC) use. The ECG data<br>displayed by the ECG app is intended for<br>informational use only. The user is not<br>intended to interpret or take clinical action<br>based on the device output without<br>consultation of a qualified healthcare<br>professional. The ECG waveform is meant<br>to supplement rhythm classification for<br>the purposes of discriminating AFib from<br>normal sinus rhythm and not intended to<br>replace traditional methods of diagnosis or<br>treatment.<br>The ECG app is not intended for use by<br>people under 22 years old. | The Samsung ECG Monitor Application is<br>an over-the-counter (OTC) software-only,<br>mobile medical application operating on a<br>compatible Samsung Galaxy Watch and<br>Phone. The app is intended to create,<br>record, store, transfer, and display a single<br>channel electrocardiogram (ECG), similar<br>to a Lead I ECG, for informational use only<br>in adults 22 years and older. Classifiable<br>traces are labeled by the app as either atrial<br>fibrillation (AFib) or sinus rhythm with the<br>intention of aiding heart rhythm<br>identification; it is not intended to replace<br>traditional methods of diagnosis or<br>treatment. The app is not intended for users<br>with other known arrhythmias and users<br>should not interpret or take clinical action<br>based on the device output without<br>consultation of a qualified healthcare<br>professional. | Equivalent |
| Patient population | Adults not previously diagnosed with<br>other known arrhythmias | Adults not previously diagnosed with<br>other known arrhythmias | Equivalent |
| Prescription Use/OTC | OTC | OTC | Equivalent |
| Lead | A single channel electrocardiogram<br>(ECG) similar to a Lead I ECG. | A single channel electrocardiogram<br>(ECG) similar to a Lead I ECG. | Equivalent |
| ECG duration | 30 seconds | 30 seconds | Equivalent |
| Rhythms detected | Atrial Fibrillation (HR between 50-120<br>BPM)<br>Sinus Rhythm (HR between 50-100 BPM)<br>Inconclusive (Any Other Rhythm and HR<br><50 BPM) OR (AFib and HR >120<br>BPM) OR (Not SR or AFib and HR 50-<br>100 BPM) OR (SR and HR >100 BPM) | Atrial Fibrillation (HR between 50-120<br>BPM)<br>Sinus rhythm (HR between 50-100 BPM)<br>Inconclusive (Any Other Rhythm and HR<br><50 BPM) OR (AFib and HR >120<br>BPM) OR (Not SR or AFib and HR 50-<br>100 BPM) OR (SR and HR >100 BPM) | Equivalent |
| Heart Rate | Yes | Yes | Equivalent |
| Key Platform Sensor | A single channel electrocardiogram<br>(ECG) similar to a Lead I ECG taken from<br>electrodes on the back of the watch on one<br>wrist and the digital crown where the<br>finger is placed | A single channel electrocardiogram<br>(ECG) similar to a Lead I ECG taken from<br>electrodes on the back of the watch on one<br>wrist and the top button where the<br>finger is placed | Placement of the finger<br>electrode on the top button of<br>the Samsung watch vs. the<br>predicate's digital crown. |
| Platforms | Wearable: Apple Watch with watch OS<br>Phone: Apple iPhones with iOS | Wearable: Samsung Galaxy Watch running<br>Tizen OS<br>Phone: Samsung Galaxy phones with<br>Android OS | Different hardware and OS for<br>both wearable and phone<br>platforms, both offering<br>similar communications and<br>sensor capabilities and<br>features. |
| User Interface | Apple watch screen for initiating spot<br>checks, viewing signal during<br>acquisition (user engagement feature,<br>not diagnosis quality), delivering<br>rhythm classification, and capturing<br>symptomsPhone screen for viewing and sharing<br>ECG spot check results, viewing | Samsung wearable screen for initiating<br>spot checks, viewing signal during<br>acquisition (user engagement feature,<br>not diagnosis quality), delivering<br>rhythm classification, and capturing<br>symptomsPhone screen for viewing and sharing<br>ECG spot check results, viewing | Equivalent |
| | historic data and PDF report including<br>recorded ECG and algorithmic rhythm<br>classification | historic data and PDF report including<br>recorded ECG and algorithmic rhythm<br>classification | |
| Algorithms | ECG Lead I Rhythm Classification for<br>Sinus Rhythm, Atrial Fibrillation,<br>Inconclusive (includes poor<br>recording), High/Low Heart Rate Heart Rate | ECG Lead I Rhythm Classification for<br>Sinus Rhythm, Atrial Fibrillation,<br>Inconclusive, Poor Recording (for low<br>quality or other reasons) Heart Rate | All rhythms classified are the<br>same as the predicate device<br>except:<br>Predicate device classifies<br>low signal quality as<br>Inconclusive- Poor<br>Recording while Samsung<br>classifies it as Poor<br>Recording. Predicate device has a<br>High/Low Heart Rate<br>classification, whereas<br>Samsung device outputs<br>Inconclusive in this case. Both devices provide Heart<br>Rate. |
| Rhythm Classification<br>Performance | Atrial Fibrillation Sensitivity: 98.3%<br>Sinus Rhythm Specificity: 99.6% | Atrial Fibrillation Sensitivity: 98.1%<br>Sinus Rhythm Specificity: 100% | Equivalent |

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#### Performance Data

The following clinical, usability, and bench testing was conducted with the Samsung Galaxy Watch Active2, showing the SaMD meets predetermined acceptance criteria to demonstrate safety, effectiveness, and substantial equivalence to the previously cleared Apple ECG App device. No new safety issues were found during this testing.

- . Clinical validation showing non-inferiority to the predicate in clinical performance in terms of
- с ECG signal quality sufficiency
- Rhythm classification accuracy o
- Human Factors Validation ●
- IEC 60601-2-47 ECG Database Testing ●
- Heart Rate Accuracy Bench Testing
- SW Verification Testing .

In addition, testing was performed on the platforms, showing they meets all necessary specifications to safely and effectively host the subject SaMD. This included the following:

- ECG Signal Quality and Lead Detection Bench Testing ●
- Platform Interface SW Testing (for both platforms) ●
- . Platform Interface HW Testing
- General safety tests: Electrical safety, electromagnetic compatibility, radio frequency o emissions, material safety for skin contact, thermal safety for skin contact tests
- Device robustness tests: Resistance to electrostatic discharge, water ingress and breakage o tests

#### Clinical Study

The Samsung ECG Monitor App was proven to be non-inferior to the predicate in terms of rhythm classification accuracy and ECG signal quality sufficiency. No adverse events were observed.

The study enrolled 544 subjects, among whom 268 were AFib patients, 261 had sinus rhythm (SR), and 15 had other arrhythmias. The ECG App algorithm detection of AFib and SR was compared to cardiologists' read of 12-lead ECG reference strip. Among the recordings where the algorithm output a rhythm classification, AFib was correctly indicated with 98.1% sensitivity (95%CI: 96.3%, 99.9%) and 100% specificity (95% CI: 100%) in the Samsung ECG Monitor App, while the predicate showed 99.6% sensitivity (95% CI: 98.7%, 100%) and 99.6% specificity (95% CI: 98.8%, 100%) in the comparison study. As a result, the sensitivity and specificity of the Samsung ECG Monitor App were within the pre-determined non-inferiority margin, thus the primary endpoint was met.

The ratio of readings that were deemed inconclusive (or unclassifiable) by the Samsung ECG Monitor App when the truth was either AFib or SR was 2.9% (95% CI: 1.1%, 4.7%) while the predicate was 2.2% (95% CI: 0.7%, 3.7%), which met the non-inferiority margin.

To assess the signal quality of the ECG Monitor App recording, cardiologists' interpretation of the ECG Monitor App strips was compared to the paired reference 12-lead ECG. Cardiologists were able to interpret 98.5% (95% CI: 97.4%, 99.5%) of ECG recordings on the Samsung ECG Monitor App and 99.4% (95% CI: 98.8%, 100%) on the predicate App. The results showed good concordance between the interpretation of the ECG Monitor App strip and the reference 12-lead ECG, 99.4% (95%CI: 98.7%,

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100%) on Samsung ECG Monitor App and 99.8% (95%CI: 99.4%, 100%) on the predicate ECG App. Both of the interpretation and agreement met the pre-determined non-inferiority margin.

To further assess the ECG waveform accuracy, a total of 140 subjects (AFib cohort: 70, SR cohort: 70) were randomly selected for fiducial point annotation. Three blinded, independent ECG technicians marked the fiducial points for key ECG features (QRS amplitude, RR interval, QRS duration, PR interval) in comparison between the ECG Monitor App strip and the reference 12-lead ECG. The key ECG features of Samsung ECG Monitor App were all within non-inferiority margin with statistical significance. Thus the secondary endpoints were met.

#### Conclusion

The Samsung ECG Monitor Application is substantially equivalent to the Apple ECG App (DEN180044). The devices have the same intended use, the same key technological characteristics, and the same signal acquisition capabilities. In a clinical testing, the Samsung ECG Monitor app demonstrated that it is noninferior to the predicate in quantitative ECG measurement and rhythm analysis accuracy.