The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) softwareonly, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present, rather the feature is intended to opportunistically acquire pulse rate data when the data when determined sufficient toward surfacing a notification.

Following this prompt, or based on the user's own initiative, the app is intended to create, record, store, transfer, and display a single-channel ECG. similar to a Lead I ECG. Classifiable traces are labeled by the app as either AFib or sinus rhythm with the intention of aiding heart rhythm identification.

The app is not intended for users with other known arrhythmias, and it is not intended to replace traditional methods of diagnosis or treatment. Users should not interpret or take clinical action based on the device of the of a qualified healthcare professional.

Device Description

The Samsung ECG Monitor App with Irregular Heart Rhythm Notification (IHRN) Feature is a software as a medical device (SaMD) that consists of a pair of mobile medical apps: one app on a compatible Samsung wearable and the other on a compatible Samsung phone, both general-purpose computing platforms.

When enabled, the wearable application of the SaMD uses a wearable photoplethysmography (PPG) sensor to background monitor bio-photonic signals from the user. The application examines beat-to-beat intervals and generates an irregular rhythm notification indicative of atrial fibrillation (AFib). Upon receiving an irregular rhythm notification or at their discretion, the user can record a single-lead ECG using the same wearable. The wearable application then calculates the average heart rate from the ECG recording and produces a rhythm classification. The wearable application also securely transmits the data to the ECG phone application on the paired phone device. The phone application shows a time-stamped irregular rhythm notification history with heart rate information; ECG measurement history; and generates a PDF file of the ECG signal, which the user can share with their healthcare provider.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification Feature, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Targeted Performance)	Reported Device Performance (Samsung IHRN Feature)
Subject Level:
Sensitivity (for irregular rhythm notification)	68.0% (C.I. 60.5 - 75.5)
Specificity (for irregular rhythm notification)	98.8% (C.I. 98.0 - 99.6)
Tachogram Level:
Positive Predictive Value (PPV)	95.7% (C.I. 94.7 - 96.7)
ECG Function (inherited from K201168):
Atrial Fibrillation Sensitivity	98.1%
Sinus Rhythm Specificity	100%

The document states that Samsung's algorithm performance for the IHRN function is substantially equivalent to the predicate device (Apple IRN Feature DEN180042) at both subject and tachogram levels, indicating these reported values met the acceptance criteria. For the ECG function, the device inherited the performance from the previously cleared Samsung ECG Monitor App (K201168) and thus the reported values were assumed to meet their prior acceptance criteria.

Study Details

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

IHRN Clinical Validation (PPG-based notification):
- Analyzable Dataset for primary and secondary endpoints: 810 subjects (from 888 enrolled).
- Tachogram-level assessment: 98 subjects with AFib episodes (over an hour) and 101 subjects with less than an hour of AFib or no AFib were randomly selected from the cardiologist-reviewed subjects. Up to 25 positive tachograms with reference ECG data were randomly selected from these subjects.
- Data Provenance: The document does not explicitly state the country of origin, but it is a clinical study. The phrasing "All recruited subjects were at risk for AFib and had experienced symptoms..." suggests prospective data collection.
ECG Function (on-demand):
- No new clinical, human factors, or ECG database tests were conducted as the function was unchanged from the K201168 clearance. Therefore, a new test set was not used for this specific clearance.

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

IHRN Clinical Validation:
- Subject-level ground truth: "clinician-adjudicated and cardiologist-reviewed patch ECG data." The exact number of clinicians/cardiologists for this overarching adjudication is not specified, but it implies multiple experts.
- Tachogram-level ground truth: "Two board-certified cardiologists reviewed each reference ECG for annotation with a third cardiologist serving as tie-breaker."
- Qualifications: "Board-certified cardiologists."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Tachogram-level ground truth: 2+1 (Two board-certified cardiologists reviewed, with a third serving as a tie-breaker).
Subject-level ground truth: Not explicitly stated as a specific numerical method (e.g., 2+1), but referred to as "clinician-adjudicated and cardiologist-reviewed," implying a consensus or expert-driven process.

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:

No MRMC comparative effectiveness study involving human readers with and without AI assistance was mentioned or conducted. The study evaluated the device's performance (IHRN feature) against a clinical ground truth, not the improvement of human readers using the device.

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

Yes, the clinical validation study for the Irregular Heart Rhythm Notification (IHRN) feature primarily assesses the standalone performance of the PPG-based algorithm in identifying irregular rhythms and generating notifications. The "subject-level irregular rhythm notification accuracy" and "tachogram-level positive predictive value" are metrics of the algorithm's performance without direct human interpretation being part of the primary output.

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

IHRN Clinical Validation: Expert consensus using reference ECG patch data reviewed and adjudicated by clinicians and board-certified cardiologists.

8. The sample size for the training set:

The document does not specify the sample size for the training set. It focuses on the validation study.

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

The document does not specify how the ground truth for the training set (if any) was established. It only details the ground truth establishment for the test/validation set.

Summary

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May 2, 2023

Samsung Electronics Co., Ltd % Matthew Wiggins MPS-HSL Lab Head Samsung Research America 665 Clyde Avenue Mountain View, California 94043

Re: K230292

Trade/Device Name: Samsung ECG Monitor Application with Irregular Heart Rhythm Notification Feature Regulation Number: 21 CFR 870.2790 Regulation Name: Photoplethysmograph Analysis Software For Over-The-Counter Use Regulatory Class: Class II Product Code: QDB, QDA Dated: February 1, 2023 Received: February 2, 2023

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.

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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. 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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230292

Device Name

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (IHRN) Feature

Indications for Use (Describe)

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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Samsung ECG Monitor Application with Irregular Heart Rhythm Notification Feature 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 94043650-770-5804m.wiggins@samsung.com
Date Prepared:	May 1st, 2023

Device Information

Proprietary Name:	Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationFeature
Common Name:	ECG Monitor App with IHRN Feature
Classification:	• QDA - Electrocardiograph software for over-the-counter use (21 CFR 870.2345)• QDB - Photoplethysmograph Analysis Software For Over-The-Counter Use (21 CFR 870.2790)
Predicate Device:	• Primary: Apple Irregular Rhythm Notification Feature (DEN180042)• Secondary: Samsung ECG Monitor App (K201168)

Device Description

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Intended Use/Indications for Use

The subject device's indications for use are a combination of the predicate devices' indications (K201168 and DEN180042), reflecting its background AFib monitoring and ECG classification purposes. This combination did not change the use population or application of the device and yielded no new questions of safety or effectiveness. The indications for use are provided below.

The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-thecounter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when is still and analyze the data when determined sufficient toward surfacing a notification.

Following this prompt, or based on the user's own initiative, the app is intended to create, record, store, transfer, and display a single channel ECG, similar to a Lead I ECG. Classifiable traces are labeled by the app as either AFib or sinus rhythm with the intention of aiding heart rhythm identification.

The app is not intended for users with other known arrhythmias and it is not intended to replace traditional methods of diagnosis or treatment. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

Comparison of Technological Characteristics

The IHRN feature of the subject device uses Photoplethysmograph (PPG) technology to extract rhythm information. A PPG array on the back side of the Galaxy Watch wearable device, in contact with the dorsal side of the wrist, collects data as tachograms of specific frequencies. The algorithm classifies the collected tachogram as either AFib or Sinus. Accelerometer and other sensor data also inform the algorithm to exclude tachograms from classification due to noise. The user is then notified on the wearable when consistent tachograms are classified as AFib. The process of collecting tachograms, classifying them, and notifying the user of an irregular rhythm is functionally equivalent to the primary predicate device: Apple Irregular Rhythm Notification Feature (DEN180042).

A more detailed comparison between the IHRN Feature of the subject device and Apple's Irregular Rhythm Notification Feature is provided in Table 1.

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Specification	Samsung ECG Monitor Appwith IHRN Feature	Primary PredicateApple IRN Feature (DEN180042)	Difference
Key PlatformSensor	Green wavelength PPG on the back side of thewatch for contact with the dorsal side of the wrist.	Green wavelength PPG on the back side of thewatch for contact with the dorsal side of the wrist.	EquivalentThe Apple and Samsung sensorfunctions in the same method.
Platform(s)	Wearable: Samsung Galaxy Watch4 or laterrunning Wear OSPhone: Samsung Galaxy phones withAndroid OS	Wearable: Apple Watch with watch OSPhone: Apple iPhones with iOS	EquivalentDifferent hardware and OS for bothwearable and phone platforms, bothoffering equivalent communicationsand sensor capabilities and features
UserInterface	Samsung wearable screen for notifying theuser when irregular rhythm is detectedPhone screen for onboarding, turning thefeature ON/OFF, and viewing notificationhistory and historic data including time-stamped heart rate information	Apple watch screen for notifying the userwhen irregular rhythm is detectedPhone screen for onboarding, turning thefeature ON/OFF viewing details about thetachograms that resulted in notification,viewing historic data including time-stampedheart rate information	EquivalentBoth user interfaces offer the same keyfunctions.
Algorithms	PPG signal quality assessment algorithm(includes motion rejection)PPG-based algorithm to extract tachogramsIrregular rhythm detection algorithm todetect AFib using tachogramsNotification generation algorithm to let userknow about presence of AFib based onsuccessive positive tachograms	PPG signal quality assessment algorithm(includes motion rejection)PPG-based algorithm to extract tachogramsIrregular rhythm detection algorithm todetect AFib using tachogramsNotification generation algorithm to let userknow about presence of AFib based onsuccessive tachograms	EquivalentHigh level algorithm is based on thesame premise and basic steps thoughthe details regarding parameters andsampling periods are different.

Table 1. Technological Comparison of IHRN Function

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Specification	Samsung ECG Monitor Appwith IHRN Feature	Primary PredicateApple IRN Feature (DEN180042)	Difference
NotificationPerformance	Subject Level:Sensitivity - 68% (95% CI:59.9%, 75.4%) Specificity - 98.8% (95% CI:97.6%, 99.5%) Tachogram level: PPV - 95.7% (95% CI: 94.7%, 96.7%)	Subject Level:Sensitivity - 47.9% (95% CI:37.5%, 58.5%) Specificity - 90.9% (95% CI:84.7%, 95.2%) Tachogram Level: PPV - 66.6% (97.5% CI lower bound 63%)	EquivalentSamsung's subject-level endpoints aresensitivity and specificity to removethe positive/negative populationdependence inherent to PPV, which theIRN predicate used. Samsung'salgorithm performance is substantiallyequivalent to the predicate device atboth subject level and tachogram level.

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The on-demand ECG capability of Samsung ECG Monitor App with IHRN Feature has not been functionally changed since the original clearance as Samsung ECG Monitor App (K201168). A detailed comparison between the subject device's ECG function and the predicate Samsung ECG Monitor App is presented in Table 2.

Specification	Samsung ECG Monitor Appwith IHRN Feature	Secondary PredicateSamsung ECG Monitor App (K201168)	Difference
Lead	A single channel electrocardiogram (ECG) similar to aLead I ECG.	A single channel electrocardiogram (ECG) similar to aLead I ECG.	Same
ECG duration	30 seconds	30 seconds	Same
Rhythmsdetected	Atrial Fibrillation (HR between 50-120 BPM) Sinus rhythm (HR between 50 – 100 BPM) Inconclusive (Any Other Rhythm and HR <50 BPM) OR (AFib and HR >120 BPM) OR (NOT SR or AFib and HR 50-100 BPM) OR (SR and HR >100 BPM)	Atrial Fibrillation (HR between 50-120 BPM) Sinus rhythm (HR between 50 - 100 BPM) Inconclusive (Any Other Rhythm and HR <50 BPM) OR (AFib and HR >120 BPM) OR (NOT SR or AFib and HR 50-100 BPM) OR (SR and HR >100 BPM)	Same
Heart Rate	Yes	Yes	Same
Key PlatformSensor	A single channel electrocardiogram (ECG) similar to aLead I ECG taken from electrodes on the back of thewatch on one wrist and the top button where the finger isplaced	A single channel electrocardiogram (ECG) similar to aLead I ECG taken from electrodes on the back of thewatch on one wrist and the top button where the finger isplaced	Same
Algorithms	ECG Lead I Rhythm Classification for Sinus Rhythm, Atrial Fibrillation, Inconclusive, Poor Recording (for low quality or other reasons) Heart Rate	ECG Lead I Rhythm Classification for Sinus Rhythm, Atrial Fibrillation, Inconclusive, Poor Recording (for low quality or other reasons) Heart Rate	Same
RhythmClassificationPerformance	Atrial Fibrillation Sensitivity: 98.1% Sinus Rhythm Specificity: 100%	Atrial Fibrillation Sensitivity: 98.1% Sinus Rhythm Specificity: 100%	Same

Table 2. Technological Comparison of ECG Function

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Performance Data

As the on-demand ECG capability of the subject device has not been functionally changed since the original clearance as Samsung ECG Monitor App (K201168), clinical, human factors, ECG database (IEC 60601-2-47), and ECG heart rate accuracy tests were not repeated.

The following clinical, usability, and bench testing were conducted, showing that the IHRN function of the subject SaMD meets predetermined acceptance criteria to demonstrate substantial equivalence to the previously cleared Apple Irregular Rhythm Notification device. No new safety issues were found during this testing.

Clinical Validation showing non-inferiority to the predicate in clinical performance in terms of
- Subject-level irregular rhythm notification accuracy, measured by sensitivity and O specificity
- Tachogram-level positive predictive value о
. Human Factors Validation
Bench Verification Testing covering potential confounder conditions
Software Verification Testing
Labeling Verification Testing ●

In addition, testing was performed on the platform, showing it meets all necessary specifications to adequately host the subject SaMD. This included the following:

Sensor Suite Testing
. Platform Interface Software Testing
Platform Interface Hardware 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 о tests

Clinical Study

Our clinical validation testing results indicate that the PPG-based notification of the Samsung ECG Monitor App with IHRN Feature has substantially equivalent classification accuracy compared to the predicate device. Classification accuracy is measured in sensitivity and specificity.

A total of 888 subjects were enrolled. All recruited subjects were at risk for AFib and had experienced symptoms such as palpitations lasting at least several minutes or a feeling of their heart beating quickly or irregularly while at rest. Subjects who did not have a previous diagnosis of AFib had risk factors for AFib with a CHADS2 score ≥2 or CHADS2VASc score ≥3. Of all enrolled subjects, 810 were included in the analyzable dataset for primary and secondary endpoints. All subjects wore a reference ECG patch and the watch simultaneously for approximately seven days. IHRN notifications were compared against clinician-adjudicated and cardiologist-reviewed patch ECG data. Samsung IHRN Feature's subject-level sensitivity is 68.0% (C.I. 60.5 -75.5) and the specificity is 98.8% (C.I. 98.0 - 99.6).

Since irregular rhythm notifications are aggregates of several PPG tachograms, tachogram classification accuracy was also assessed during the study. 98 subjects who had an AFib episode(s)

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over the span of an hour and 101 subjects who had less than an hour of AFib or no AFib were randomly selected by biostatisticians from all of the cardiologist-reviewed subjects. Up to 25 positive tachograms with reference ECG data were randomly selected from these subjects. Two boardcertified cardiologists reviewed each reference ECG for annotation with a third cardiologist serving as tie-breaker. Based on this data, Samsung IHRN Feature's tachogram level positive predictive value is 95.7% (C.I. 94.7 - 96.7).

Conclusion

The subject device and combined predicate devices have intended use, the same key technological characteristics, and the same signal-acquisition capabilities. In clinical testing, the Samsung IHRN Feature demonstrated that it is capable of substantially equivalent irregular rhythm notification accuracy. Therefore, Samsung ECG Monitor App with Irregular Heart Rhythm Notification Feature is substantially equivalent to the Apple Irregular Rhythm Notification Feature (DEN180042) and the Samsung ECG Monitor App (K201168).

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.