ECG Monitor App by Samsung Electronics Co., Ltd

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 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.

AI/ML Overview

The Samsung ECG Monitor Application was proven to be non-inferior to the predicate (Apple ECG App, DEN180044) in terms of rhythm classification accuracy and ECG signal quality sufficiency.

Here's the breakdown of the acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Acceptance Criteria (Non-inferiority Margin)	Reported Device Performance (Samsung ECG Monitor App)	Reference (Predicate Device)
AFib Sensitivity	Within pre-determined non-inferiority margin compared to predicate	98.1% (95% CI: 96.3%, 99.9%)	99.6% (95% CI: 98.7%, 100%)
Sinus Rhythm Specificity	Within pre-determined non-inferiority margin compared to predicate	100% (95% CI: 100%)	99.6% (95% CI: 98.8%, 100%)
Inconclusive Rate (AFib or SR truth)	Within pre-determined non-inferiority margin compared to predicate	2.9% (95% CI: 1.1%, 4.7%)	2.2% (95% CI: 0.7%, 3.7%)
Cardiologist Interpretability of ECG Recordings	Within pre-determined non-inferiority margin compared to predicate	98.5% (95% CI: 97.4%, 99.5%)	99.4% (95% CI: 98.8%, 100%)
Concordance between App Strip and 12-lead ECG	Within pre-determined non-inferiority margin compared to predicate	99.4% (95% CI: 98.7%, 100%)	99.8% (95% CI: 99.4%, 100%)
Fiducial Point Annotation (Key ECG Features)	All key ECG features (QRS amplitude, RR interval, QRS duration, PR interval) within non-inferiority margin with statistical significance compared to 12-lead ECG.	Met non-inferiority margin with statistical significance.	N/A (compared to 12-lead reference)

2. Sample size used for the test set and the data provenance

Sample Size: 544 subjects.
- 268 AFib patients
- 261 Sinus Rhythm (SR) patients
- 15 with other arrhythmias
Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is Samsung Electronics Co., Ltd in Korea. The study structure implies prospectively collected data for this clinical validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Unspecified number of cardiologists and three blinded, independent ECG technicians.
Qualifications of Experts:
- Cardiologists: Used for comparing the ECG App algorithm detection of AFib and SR to 12-lead ECG reference strips, and for interpreting the ECG Monitor App strips. No specific experience level provided.
- ECG Technicians: Three blinded, independent ECG technicians were used for fiducial point annotation. No specific experience level provided.

4. Adjudication method for the test set

For rhythm classification, the ground truth was established by cardiologists' read of 12-lead ECG reference strips. This implies a consensus or authoritative read by these experts.
For signal quality interpretability and concordance, cardiologists' interpretation served as the reference.
For fiducial point annotation, three blinded, independent ECG technicians marked the points, implying their individual annotations were compared against the reference or potentially against each other for a form of consensus, though this is not explicitly detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document describes a clinical study where the algorithm's performance (Samsung ECG Monitor App) was compared to a reference standard (cardiologist-read 12-lead ECG), and also against a predicate device (Apple ECG App). It does not describe an MRMC comparative effectiveness study evaluating how human readers improve with AI vs without AI assistance. The focus was on the algorithm's standalone performance compared to expert ground truth and its non-inferiority to an existing cleared device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The clinical study directly evaluated the Samsung ECG Monitor App algorithm's performance in detecting AFib and Sinus Rhythm against a cardiologist-read 12-lead ECG reference strip. The reported sensitivity, specificity, and inconclusive rates are for the algorithm's performance alone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth used was expert consensus / expert interpretation from:

Cardiologists (for rhythm classification based on 12-lead ECG reference strips and for interpretability and concordance studies).
Blinded, independent ECG technicians (for fiducial point annotation).

8. The sample size for the training set

The document does not specify the sample size for the training set. It only details the clinical validation study (test set).

9. How the ground truth for the training set was established

The document does not provide information on how the ground truth for the training set was established, as it focuses solely on the clinical validation (test set) and device performance evaluation.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
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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., Ltd129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do 16677, Korea
Contact Person:	Matthew Wiggins, Ph.D.Samsung Research America665 Clyde Avenue, Mountain View, CA 94043770-596-1765m.wiggins@samsung.com
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

Intended Use/Indications for Use

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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 SaMDApple ECG App (DEN 180044)	Samsung ECG Monitor App	Difference
Indications for Use	The ECG app is a software-only mobilemedical application intended for use withthe Apple Watch to create, record, store,transfer, and display a single channelelectrocardiogram (ECG) similar to aLead I ECG. The ECG app determines thepresence of atrial fibrillation (AFib) orsinus rhythm on a classifiable waveform.The ECG app is not recommended forusers with other known arrhythmias.The ECG app is intended for over-the-counter (OTC) use. The ECG datadisplayed by the ECG app is intended forinformational use only. The user is notintended to interpret or take clinical actionbased on the device output withoutconsultation of a qualified healthcareprofessional. The ECG waveform is meantto supplement rhythm classification forthe purposes of discriminating AFib fromnormal sinus rhythm and not intended toreplace traditional methods of diagnosis ortreatment.The ECG app is not intended for use bypeople under 22 years old.	The Samsung ECG Monitor Application isan over-the-counter (OTC) software-only,mobile medical application operating on acompatible Samsung Galaxy Watch andPhone. The app is intended to create,record, store, transfer, and display a singlechannel electrocardiogram (ECG), similarto a Lead I ECG, for informational use onlyin adults 22 years and older. Classifiabletraces are labeled by the app as either atrialfibrillation (AFib) or sinus rhythm with theintention of aiding heart rhythmidentification; it is not intended to replacetraditional methods of diagnosis ortreatment. The app is not intended for userswith other known arrhythmias and usersshould not interpret or take clinical actionbased on the device output withoutconsultation of a qualified healthcareprofessional.	Equivalent
Patient population	Adults not previously diagnosed withother known arrhythmias	Adults not previously diagnosed withother known arrhythmias	Equivalent
Prescription Use/OTC	OTC	OTC	Equivalent
Lead	A single channel electrocardiogram(ECG) similar to a Lead I ECG.	A single channel electrocardiogram(ECG) similar to a Lead I ECG.	Equivalent
ECG duration	30 seconds	30 seconds	Equivalent
Rhythms detected	Atrial Fibrillation (HR between 50-120BPM)Sinus Rhythm (HR between 50-100 BPM)Inconclusive (Any Other Rhythm and HR<50 BPM) OR (AFib and HR >120BPM) OR (Not SR or AFib and HR 50-100 BPM) OR (SR and HR >100 BPM)	Atrial Fibrillation (HR between 50-120BPM)Sinus rhythm (HR between 50-100 BPM)Inconclusive (Any Other Rhythm and HR<50 BPM) OR (AFib and HR >120BPM) OR (Not SR or AFib and HR 50-100 BPM) OR (SR and HR >100 BPM)	Equivalent
Heart Rate	Yes	Yes	Equivalent
Key Platform Sensor	A single channel electrocardiogram(ECG) similar to a Lead I ECG taken fromelectrodes on the back of the watch on onewrist and the digital crown where thefinger is placed	A single channel electrocardiogram(ECG) similar to a Lead I ECG taken fromelectrodes on the back of the watch on onewrist and the top button where thefinger is placed	Placement of the fingerelectrode on the top button ofthe Samsung watch vs. thepredicate's digital crown.
Platforms	Wearable: Apple Watch with watch OSPhone: Apple iPhones with iOS	Wearable: Samsung Galaxy Watch runningTizen OSPhone: Samsung Galaxy phones withAndroid OS	Different hardware and OS forboth wearable and phoneplatforms, both offeringsimilar communications andsensor capabilities andfeatures.
User Interface	Apple watch screen for initiating spotchecks, viewing signal duringacquisition (user engagement feature,not diagnosis quality), deliveringrhythm classification, and capturingsymptomsPhone screen for viewing and sharingECG spot check results, viewing	Samsung wearable screen for initiatingspot checks, viewing signal duringacquisition (user engagement feature,not diagnosis quality), deliveringrhythm classification, and capturingsymptomsPhone screen for viewing and sharingECG spot check results, viewing	Equivalent
	historic data and PDF report includingrecorded ECG and algorithmic rhythmclassification	historic data and PDF report includingrecorded ECG and algorithmic rhythmclassification
Algorithms	ECG Lead I Rhythm Classification forSinus Rhythm, Atrial Fibrillation,Inconclusive (includes poorrecording), High/Low Heart Rate Heart Rate	ECG Lead I Rhythm Classification forSinus Rhythm, Atrial Fibrillation,Inconclusive, Poor Recording (for lowquality or other reasons) Heart Rate	All rhythms classified are thesame as the predicate deviceexcept:Predicate device classifieslow signal quality asInconclusive- PoorRecording while Samsungclassifies it as PoorRecording. Predicate device has aHigh/Low Heart Rateclassification, whereasSamsung device outputsInconclusive in this case. Both devices provide HeartRate.
Rhythm ClassificationPerformance	Atrial Fibrillation Sensitivity: 98.3%Sinus Rhythm Specificity: 99.6%	Atrial Fibrillation Sensitivity: 98.1%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.

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.