(122 days)
No
The document describes analysis of pulse rate data and ECG signals using algorithms to identify irregular rhythms and classify ECG traces. While this involves complex data processing, the summary does not explicitly mention the use of AI, ML, or related terms like DNN, nor does it describe training or test sets in a way that strongly suggests a machine learning approach. The performance metrics and validation study are consistent with traditional algorithmic methods.
No.
The device is intended for informational use only and explicitly states it is "not intended to replace traditional methods of diagnosis or treatment," and users "should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional." This indicates it does not provide therapy.
Yes
The device analyzes pulse rate data to identify irregular heart rhythms suggestive of AFib, creates and displays a single channel ECG, and labels traces as sinus rhythm, AFib, high heart rate (non-AFib), or AFib with high heart rate, all of which are activities associated with diagnosing a medical condition.
No
While the device is described as "software as a medical device (SaMD)" and operates on general-purpose computing platforms (Samsung Galaxy Watch and Phone), its functionality relies on and utilizes hardware components (wearable photoplethysmography (PPG) sensor and ECG electrodes) to acquire the necessary physiological data (pulse rate and ECG signal). The software processes this data, but the device's operation is intrinsically linked to the hardware sensors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device function: The Samsung ECG app with IHRN analyzes physiological signals directly from the user's body (pulse rate via PPG and electrical signals via ECG). It does not analyze specimens taken from the body.
- Intended Use: The intended use describes the device as analyzing pulse rate data and recording ECGs to aid in heart rhythm identification. This is a direct measurement of the body's electrical activity and pulse, not an analysis of a biological sample.
Therefore, while it is a medical device, it falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Samsung ECG app with IHRN is an over-the-counter (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 the user 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 sinus rhythm. AFib. high heart rate (non-AFib), or AFib with high heart rate 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.
Product codes (comma separated list FDA assigned to the subject device)
QDA, QDB
Device Description
The Samsung ECG App v1.3 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 cardiac 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dorsal side of the wrist
Indicated Patient Age Range
Adults 22 years and older
Intended User / Care Setting
Over-the-counter (OTC)
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
Our clinical validation testing results indicate that the ECG rhythm classification of the Samsung ECG App v1.3 has comparable classification accuracy compared to the reference device. Classification accuracy is measured in sensitivity and specificity.
The updated ECG function was validated in a multi-center study with 1.013 subjects who were 22 years old or older. The subject demographics is summarized in Table 2 below. The study enrolled 446 subjects diagnosed with AFib, 536 subjects without AFib, and 31 subjects diagnosed with another type of irregular rhythm. These enrolled subjects contributed to 453 AFib recordings (heart rate 50 to 150 BPM) and 691 Sinus rhythm recordings (heart rate 50 to 150 BPM) for the primary endpoint analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following clinical, usability, and bench testing were conducted, showing that the updated ECG function of the subject SaMD meets predetermined acceptance criteria to demonstrate safety, effectiveness, and substantial equivalent to the reference Apple ECG 2.0 App. No new safety issues were found during this testing.
- Clinical Validation showing comparable clinical performance in terms of:
- Subject-level ECG classification accuracy, measured by sensitivity and specificity, for all classifiable heart rates (50-150 beats per minute) and high heart rate (100-150 beats per minute)
- ECG signal quality sufficiency
- Human Factors Validation
- IEC 60601-2-47 ECG Database Testing
- Heart Rate Accuracy Bench Testing
- Artifact Detection Bench Testing
- Software Verification Testing
- Labeling Verification Testing
In addition, testing was performed on the commercial platform, showing it meets all necessary specifications to safely and effectively host the subject SaMD. This included the following:
- ECG Signal Quality, Sampling Rate, Operating Conditions, and Lead Detection Bench Testing
- Platform Interface Software Testing (Android and WearOS)
- Platform Interface Hardware Testing
- General safety tests: Electrical safety, electromagnetic compatibility, radio frequency emissions, material safety for skin contact, thermal safety for skin contact tests
- Device robustness tests: Resistance to electrostatic discharge, water ingress and breakage tests
As the IHRN function of the subject device has not been functionally changed since the predicate device clearance as Samsung ECG Monitor App with IHRN Feature (K230292), clinical, human factors, and PPG confounder testing were not repeated.
Clinical Study:
Our clinical validation testing results indicate that the ECG rhythm classification of the Samsung ECG App v1.3 has comparable classification accuracy compared to the reference device. Classification accuracy is measured in sensitivity and specificity.
The updated ECG function was validated in a multi-center study with 1.013 subjects who were 22 years old or older. The study enrolled 446 subjects diagnosed with AFib, 536 subjects without AFib, and 31 subjects diagnosed with another type of irregular rhythm. These enrolled subjects contributed to 453 AFib recordings (heart rate 50 to 150 BPM) and 691 Sinus rhythm recordings (heart rate 50 to 150 BPM) for the primary endpoint analysis.
The ECG function accurately classified 435 out of the 453 AFib recordings with a sensitivity of 96.0% and classified 682 out of the 691 Sinus rhythm recordings with a specificity of 98.7%. There were no clinically meaningful difference in classification performance for age and gender demographic groups. The ECG App version 1.3 also produced visually interpretable waveforms in 98.7% of the cases. Furthermore, the key intervals (RR, PR, QRS) and R-wave amplitude of the waveforms were accurately measured when compared against the standard Lead I ECG.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ECG Rhythm Classification Performance:
HR 50-150 BPM
- Sinus rhythm
- Specificity: 98.7% (95% CI 94.0%, 97.8%)
- Atrial Fibrillation
- Sensitivity: 96.0% (95% CI 94.0%, 97.8%)
HR 100-150 BPM
- Sensitivity: 96.0% (95% CI 94.0%, 97.8%)
- Sinus rhythm
- Specificity: 96.3% (95% CI 93.5%, 98.9%)
- Atrial fibrillation
- Sensitivity: 93.6% (95% CI 88.5%, 97.5%)
Clinical Study:
- Sensitivity for AFib recordings: 96.0% (435 out of 453)
- Specificity for Sinus rhythm recordings: 98.7% (682 out of 691)
- ECG App version 1.3 produced visually interpretable waveforms in 98.7% of the cases.
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.
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
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August 2, 2024
Samsung Electronics Co., Ltd % Matthew Wiggins Sr. Director of Digital Health Commercialization Samsung Research America Inc. 665 Clyde Avenue Mountain View, California 94043
Re: K240909
Trade/Device Name: Samsung ECG App v 1.3 (ECG) Regulation Number: 21 CFR 870.2345 Regulation Name: Electrocardiograph Software For Over-The-Counter Use Regulatory Class: Class II Product Code: QDA, QDB Dated: July 3, 2024 Received: July 3, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Kimberly Crowley
For: Jennifer Shih Kozen Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Samsung ECG App v 1.3 (ECG)
Indications for Use (Describe)
The Samsung ECG app with IHRN is an over-the-counter (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 the user 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 sinus rhythm. AFib. high heart rate (non-AFib), or AFib with high heart rate 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.
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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4
K240909 - Samsung ECG App v1.3
| Applicant Information | |
|---|---|
| Manufacturer: | Samsung Electronics Co., Ltd |
| 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do 16677, Korea | |
| Contact Person: | Matthew Wiggins, Ph.D. |
| Samsung Research America | |
| 665 Clyde Avenue, Mountain View, CA 94043 | |
| 1-650-770-5804 | |
| m.wiggins@samsung.com | |
| Date Prepared: | July 3rd, 2024 |
| Device Information | |
| Trade/Device Name: | Samsung ECG App v1.3 |
| 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: Samsung ECG Monitor App with Irregular Heart Rhythm Notification Feature (K230292) |
| Reference Device | Apple ECG 2.0 App (K201525) |
Device Description
The Samsung ECG App v1.3 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 cardiac 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. 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.
5
Intended Use/Indications for Use
The subject device's indications for use include the new classifiable ECG rhythms, High heart rate and Atrial fibrillation with high heart rate, while maintaining its background AFib monitoring and on-demand ECG classification intended uses. The updated indications for use are provided below.
The Samsung ECG with IHRN 2.0 is an over-the-counter (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 analvzes pulse rate data to identify episodes of irregular heart rhvthms 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 user 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 sinus rhythm, AFib, high heart rate (non-AFib), or AFib with high heart rate 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 ECG function of the subject device is substantially equivalent to the predicate and reference devices. Using the dry electrodes on the Galaxy Watch wearable, the user can record an on-demand ECG recording, similar to Lead I ECG, without requiring a physician visit. This function enables users to easily and more frequently record their ECG, and consult with their qualified healthcare provider. The updates to the ECG function primarily consist of expansion of classifiable ECG heart rates up to 150 beats per minutes, consistent with the reference Apple ECG 2.0 App (K201525).
The IHRN function of the subject device, including user workflow, sensor and algorithm function, and device output remains substantially equivalent to the predicate device, where it uses Photoplethysmograph (PPG) technology to extract rhythm information and notify the user when consistent tachograms are classified as a rhythm suggestive of Atrial Fibrillation.
A more detailed comparison between the subject device, the predicate device (Samsung ECG Monitor App with IHRN Feature, K230292), and the reference device (Apple's ECG 2.0 App, K201525) is provided in Table 1.
6
| Table 1. Technological Comparison of Subject Device, Predicate Device, and Reference Device | ||||||||
|---|---|---|---|---|---|---|---|---|
| -- | --------------------------------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- |
| | Subject Device:
Samsung ECG App v1.3 | Predicate Device:
Samsung ECG Monitor App with IHRN
Feature (K230292) | Reference Device:
ECG 2.0 App (K201525) | Differences and Discussion |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Key Platform
Sensor (ECG) | Lead I Electrocardiogram (ECG) acquired
from the dorsal side of the wrist to the
opposing hand's finger, which is placed on
the watch body. | Lead I Electrocardiogram (ECG) acquired
from the dorsal side of the wrist to the
opposing hand's finger which is placed on
the watch body. | A single channel
electrocardiogram (ECG) similar
to a Lead I ECG. Taken from
electrodes on the back of the
watch on one had to the digital
crown where the finger is placed | Identical to the Predicate Device. |
| Key Platform
Sensor (IHRN) | Green wavelength PPG on the back side of
the watch for contact with the dorsal side of
the wrist. | Green wavelength PPG on the back side of
the watch for contact with the dorsal side of
the wrist. | N/A | Identical to the Predicate Device. |
| Platform(s) | • Samsung Galaxy Watch5 wearable
running Wear OS version 4.0.
• Galaxy phones with Android 9 (Pie). | • Samsung Galaxy Watch4 wearable or
later running Wear OS version 4.0.
• Samsung Galaxy phones with Android 9
(Pie) and beyond | • Apple Watch Series 4 with
watch OS 7.0 or later
• Apple iPhone 6s with iOS 14 or
later | Substantially equivalent to the
Predicate Device. |
| User Interface | • Wearable screen for initiating ECG
recording, viewing signal during acquisition
(user engagement feature, not diagnostic
quality), delivering rhythm classification,
and capturing user reported symptoms
• Phone screen for viewing and sharing ECG
recoding results and PDF report including
recorded ECG and algorithmic rhythm
classification
• Phone screen for onboarding and education
materials | • Wearable screen for initiating ECG
recording, viewing signal during
acquisition (user engagement feature, not
diagnostic quality), delivering rhythm
classification, and capturing user reported
symptoms.
• Phone screen for viewing and sharing
ECG recoding results and PDF report
including recorded ECG and algorithmic
rhythm classification
• Phone screen for onboarding and
education materials | • Apple watch screen for initiating
spot checks, viewing signal
during acquisition (user
engagement feature, not
diagnostic quality), and delivering
rhythm classification and
capturing symptoms
• Phone screen for viewing and
sharing ECG spot check results,
viewing historic data and PDF
report including recorded ECG
and algorithmic rhythm
classification | Substantially equivalent to the
Predicate Device for ECG and
IHRN function. |
| Rhythm
Classification
Results | • ECG Lead I Rhythm Classification for
Sinus rhythm, Atrial fibrillation, Atrial
fibrillation with high heart rate, High
heart rate (non-AF), Inconclusive (inc.
heart rate out of range), or Poor
recording
• ECG signal quality assessment for
sufficient for analysis
• Average heart rate | • ECG Lead I Rhythm Classification for
Sinus rhythm, Atrial fibrillation,
Inconclusive (heart rate out of range),
or Poor recording (poor signal quality)
• ECG signal quality assessment for
sufficient for analysis
• Average heart rate | • ECG Lead I Rhythm
Classification for Sinus Rhythm,
Atrial Fibrillation, High heart
rate, Inconclusive, Poor
Recording
• Heart Rate High/Low Indicator | Substantially equivalent to the
Reference Device.
Due to expanded heart rate range
in the subject device, new
classifications for high heart rate
(≥100 BPM and ≤ 150 BPM) are
created [high heart rate (non-
AFib), and AFib with high heart
rate]. |
| | Subject Device:
Samsung ECG App v1.3 | Predicate Device:
Samsung ECG Monitor App with IHRN
Feature (K230292) | Reference Device:
ECG 2.0 App (K201525) | Differences and Discussion |
| ECG Rhythm
Classification
Performance | HR 50-150 BPM
• Sinus rhythm
■ Specificity: 98.7% (95% CI 94.0%,
97.8%)
• Atrial Fibrillation
■ Sensitivity: 96.0% (95% CI 94.0%,
97.8%)
HR 100-150 BPM
• Sinus rhythm
■ Specificity: 96.3% (95% CI 93.5%,
98.9%)
• Atrial fibrillation
■ Sensitivity: 93.6% (95% CI 88.5%,
97.5%) | • Sinus rhythm (HR 50-100 BPM)
■ Specificity: 100% (95% CI 100%,
100%)
• Atrial fibrillation (HR 50-120 BPM)
■ Sensitivity: 98.1% (95% CI 96.3%,
99.9%)
Note: ECG performance was established
in K201168 and maintained in K230292 as
the ECG capability is equivalent between
devices. | HR 50-150 BPM
• Sinus Rhythm
■ Specificity: 99.3% (95%
CI 98.4%, 100%)
• Atrial Fibrillation
■ Sensitivity: 98.5% (95% CI
97.3%, 99.6%)
HR 100-150 BPM
• Sinus Rhythm
■ Specificity: 83% (95% CI
77.8%, 88%)
• Atrial Fibrillation
■ Sensitivity: 90.7% (95% CI
86.7%, 94.6%) | AF sensitivity and SR specificity
with all heart rate and high heart
rate is substantially equivalent to
the Reference Device's point
estimate level and lower
confidence bound performance.
The IHRN function's performance
has not changed from the Predicate
Device. |
7
8
Performance Data
The following clinical, usability, and bench testing were conducted, showing that the updated ECG function of the subject SaMD meets predetermined acceptance criteria to demonstrate safety, effectiveness, and substantial equivalent to the reference Apple ECG 2.0 App. No new safety issues were found during this testing.
- Clinical Validation showing comparable clinical performance in terms of: ●
- Subject-level ECG classification accuracy, measured by sensitivity and specificity, for all o classifiable heart rates (50-150 beats per minute) and high heart rate (100-150 beats per minute)
- ECG signal quality sufficiency o
- Human Factors Validation
- IEC 60601-2-47 ECG Database Testing
- Heart Rate Accuracy Bench Testing
- Artifact Detection Bench Testing
- Software Verification Testing
- Labeling Verification Testing ●
In addition, testing was performed on the commercial platform, showing it meets all necessary specifications to safely and effectively host the subject SaMD. This included the following:
- ECG Signal Quality, Sampling Rate, Operating Conditions, and Lead Detection Bench Testing ●
- Platform Interface Software Testing (Android and WearOS) ●
- 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 o tests
As the IHRN function of the subject device has not been functionally changed since the predicate device clearance as Samsung ECG Monitor App with IHRN Feature (K230292), clinical, human factors, and PPG confounder testing were not repeated.
Clinical Study
Our clinical validation testing results indicate that the ECG rhythm classification of the Samsung ECG App v1.3 has comparable classification accuracy compared to the reference device. Classification accuracy is measured in sensitivity and specificity.
The updated ECG function was validated in a multi-center study with 1.013 subjects who were 22 years old or older. The subject demographics is summarized in Table 2 below. The study enrolled 446 subjects diagnosed with AFib, 536 subjects without AFib, and 31 subjects diagnosed with another type of irregular rhythm. These enrolled subjects contributed to 453 AFib recordings (heart rate 50 to 150 BPM) and 691 Sinus rhythm recordings (heart rate 50 to 150 BPM) for the primary endpoint analysis.
9
| Parameter | Description | Percentage |
|---|---|---|
| Age | Mean | 57.6 |
| Age | Standard Deviation | 18.3 |
| Gender | Female | 46.1% |
| Gender | Male | 53.9% |
| Ethnic Group | Hispanic or Latino | 6.4% |
| Ethnic Group | Non-Hispanic or Latino | 93.6% |
| Race | American Indian or Alaska Native | 0.4% |
| Race | Asian | 2.2% |
| Race | Black or African American | 8% |
| Race | Pacific Islander | 0.2% |
| Race | Caucasian | 87.7% |
| Race | Other | 1.5% |
| Table 2. Clinical Validation Testing Subject Demographics | ||
|---|---|---|
The ECG function accurately classified 435 out of the 453 AFib recordings with a sensitivity of 96.0% and classified 682 out of the 691 Sinus rhythm recordings with a specificity of 98.7%. There were no clinically meaningful difference in classification performance for age and gender demographic groups. The ECG App version 1.3 also produced visually interpretable waveforms in 98.7% of the cases. Furthermore, the key intervals (RR, PR, QRS) and R-wave amplitude of the waveforms were accurately measured when compared against the standard Lead I ECG.
Conclusion
The subject device and combined predicate and reference devices have intended use, the same key technological characteristics, and the same signal-acquisition capabilities. In clinical testing, the Samsung's updated ECG function demonstrated that it has comparable ECG rhythm classification accuracy performance as the Apple ECG 2.0 App. Therefore, Samsung ECG v1.3 is substantially equivalent to the Samsung ECG Monitor App with IHRN Feature (K230292) and the Apple ECG 2.0 App (K201525).