The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib), sinus rhythm, and high heart rate (no detected AF with heart rate 100-150 bpm) on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.

The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment.

The ECG app is not intended for use by people under 22 years old.

Device Description

The ECG 2.0 app comprises a pair of mobile medical apps - one on Apple Watch and the other on the iPhone.

The ECG Watch app analyzes data collected by the integrated electrical sensors on a compatible Apple Watch to generate an ECG waveform similar to a Lead I. calculate average heart rate, and provide a rhythm classification to the user for a given 30 second session. When a user opens the ECG Watch app while wearing the Watch on one wrist, and places the finger of the opposite hand on the digital crown, they are completing the circuit across the heart which begins a recording session.

Once the recording session is complete, the ECG Watch app performs signal processing, feature extraction and rhythm classification to generate a session result.

The resulting classification and average heart rate for the session, along with educational information, will be displayed to the user within the ECG Watch app.

The ECG iPhone app contains the on-boarding and educational materials that a user must review prior to taking an ECG reading. The ECG iPhone app is included in the Health App, which allows users to store, manage, and share health and fitness data, and comes pre-installed on every iPhone. The ECG 2.0 app expands the classifiable heart range, introduces new classification results, and introduces minor, non-userfacing algorithm updates. These changes will be reflected in both the Apple Watch app, and also on the corresponding iPhone app within the Health App.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Device Performance (ECG 2.0 App)
AFib Classification Sensitivity (HR 50-150 bpm)	98.5%
Sinus Rhythm Classification Specificity (HR 50-150 bpm)	99.3%
PQRST Waveform Visual Acceptability	100% pass rating
R-wave Amplitude Assessment	97.2% total pass rating

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

Sample size: Approximately 546 subjects.
- 305 subjects were in the Atrial Fibrillation cohort.
- 241 subjects were in the normal sinus rhythm cohort.
Data provenance: Prospective, multi-center clinical trial. The country of origin is not explicitly stated, but it is a "multi-center" trial, implying diverse participant recruitment.

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

Number of experts: Not explicitly stated, but the ground truth was established by "a cardiologist." This implies at least one, likely a panel or multiple, to ensure robustness, though the exact number isn't quantified.
Qualifications of experts: "Cardiologist." Years of experience are not specified.

4. Adjudication method for the test set

The text states: "Rhythm classification of a 12-lead ECG by a cardiologist was compared to the rhythm classification of a simultaneously collected ECG from the ECG 2.0 app." This indicates that the cardiologist's interpretation of a 12-lead ECG served as the ground truth. It does not explicitly describe an adjudication method like 2+1 or 3+1 if multiple cardiologists were involved. It implies a single definitive classification by the cardiologist.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not conducted or reported in the provided text. The study focused on the standalone performance of the ECG 2.0 app against a cardiologist's interpretation.

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

Yes, a standalone performance study was done. The reported performance metrics (sensitivity, specificity, waveform acceptability) reflect the algorithm's direct classification capabilities compared to the ground truth established by a cardiologist. The device is intended for over-the-counter use, and its performance in classifying AFib and sinus rhythm was assessed directly.

7. The type of ground truth used

The ground truth used was expert consensus / diagnosis from a cardiologist's interpretation of a 12-lead ECG.

8. The sample size for the training set

The document does not explicitly state the sample size for the training set. It only mentions the test set (clinical trial of 546 subjects).

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

The document does not explicitly describe how the ground truth for the training set was established. It primarily focuses on the validation study. However, given that it states "Apple conducted database testing using a previously adjudicated dataset" for "ECG Database Testing per EC57," it is highly probable that the training data's ground truth was also established by expert cardiologists adjudicating ECGs in a similar manner to the test set, but this is not explicitly detailed for the training set.

Summary

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October 8, 2020

Apple Inc. Luke Olson Regulatory Affairs Associate One Apple Park Way Cupertino, California 94015

Re: K201525

Trade/Device Name: ECG 2.0 App Regulation Number: 21 CFR 870.2345 Regulation Name: Electrocardiograph Software for Over-The-Counter Use Regulatory Class: Class II Product Code: QDA Dated: September 8, 2020 Received: September 9, 2020

Dear Luke Olson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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

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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 Kozen Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: 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) K201525

Device Name ECG 2.0 App

Indications for Use (Describe)

The ECG app is not intended for use by people under 22 years old.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

5.1 Submitter

Applicant	Apple Inc.One Apple Park WayCupertino, CA 95014
SubmissionCorrespondent	Luke OlsonRegulatory Affairs AssociatePhone: (408) 608-2001Email: luke_olson@apple.com
Contact	David AmorSr Manager, Quality and Regulatory AffairsPhone: (786) 546-1806Email: damor@apple.com
Date Prepared	October 6, 2020

5.2 Device Names and Classifications

Subject Device:

Name of Device	ECG App (2.0)
Classification Name	Electrocardiograph Software For Over-The-Counter Use, 21 CFR 870.2345
Regulatory Class	Class II
Product Code	QDA
510(k) Review Panel	Cardiovascular

Predicate Device:

Predicate Manufacturer	Apple Inc.
Predicate Trade Name	ECG App
Predicate 510(k)	DEN180044

5.3 Device Description

The ECG 2.0 app comprises a pair of mobile medical apps - one on Apple Watch and the other on the iPhone.

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Once the recording session is complete, the ECG Watch app performs signal processing, feature extraction and rhythm classification to generate a session result.

The resulting classification and average heart rate for the session, along with educational information, will be displayed to the user within the ECG Watch app.

5.4 Indications for Use

The ECG app is not intended for use by people under 22 years old.

5.5 Comparison with the Predicate Device

Item	Subject Device	Predicate Device
	ECG 2.0 App	ECG App
Manufacturer	Apple Inc.	Apple Inc.
SubmissionReference	K201525	DEN180044
Item	Subject Device	Predicate Device
	ECG 2.0 App	ECG App
Intended Use	An electrocardiograph software devicefor over-the-counter use creates,analyzes, and displayselectrocardiograph data, and canprovide information for identifyingcardiac arrhythmias. This device is notintended to provide a diagnosis.	An electrocardiograph software device forover-the-counter use creates, analyzes, anddisplays electrocardiograph data, and canprovide information for identifying cardiacarrhythmias. This device is not intended toprovide a diagnosis.
Indications forUse	The ECG app is a software-only mobilemedical application intended for usewith the Apple Watch to create, record,store, transfer, and display a singlechannel electrocardiogram (ECG)similar to a Lead I ECG. The ECG appdetermines the presence of atrialfibrillation (AFib), sinus rhythm, andhigh heart rate (no detected AF withheart rate 100-150 bpm) on aclassifiable waveform. The ECG app isnot recommended for users with otherknown arrhythmias.The ECG app is intended for over-the-counter (OTC) use. The ECG datadisplayed by the ECG app is intendedfor informational use only. The user isnot intended to interpret or take clinicalaction based on the device outputwithout consultation of a qualifiedhealthcare professional. The ECGwaveform is meant to supplementrhythm classification for the purposesof discriminating AFib from sinusrhythm and is not intended to replacetraditional methods of diagnosis ortreatment.The ECG app is not intended for use bypeople under 22 years old.	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 a LeadI ECG. The ECG app determines thepresence of atrial fibrillation (AF) or sinusrhythm on a classifiable waveform. TheECG app is not recommended for userswith 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 for thepurposes of discriminating AF from normalsinus rhythm and not intended to replacetraditional methods of diagnosis ortreatment.The ECG app is not intended for use bypeople under 22 years old.
Principle ofOperation	The ECG 2.0 app acquires platformsensor data from Apple Watch. Afteracquisition, the ECG 2.0 appalgorithms process and classify thesignal and display the classification tothe user.	The ECG app acquires platform sensordata from Apple Watch. After acquisition,the ECG app algorithms process andclassify the signal and display theclassification to the user.
Item	Subject Device	Predicate Device
	ECG 2.0 App	ECG App
ECG SessionClassificationResults	- Low Heart Rate (< 50 bpm)	- Low Heart Rate (< 50 bpm)
	- Sinus Rhythm (50-99 bpm)	- Sinus Rhythm (50-100 bpm)
	- High Heart Rate (No AFib) (100-150 bpm)	- Atrial Fibrillation (50-120 bpm)
	- Atrial Fibrillation (50-99 bpm)	- Inconclusive
	- Atrial Fibrillation High Heart Rate (100-150 bpm)	- Inconclusive - Poor Recording
	- Inconclusive	- High Heart Rate (> 120 bpm)
	- Poor Recording
	- High Heart Rate (> 150 bpm)

ClinicalApplication	The ECG 2.0 app is intended tosupplement rhythm classification forthe purposes of discriminating Afibfrom normal rhythms. The device is notintended to replace traditional methodsor diagnosis.	The ECG app is intended to supplementrhythm classification for the purposes ofdiscriminating Afib from normal rhythms.The device is not intended to replacetraditional methods or diagnosis.
Compatibilitywith IntendedPlatforms	iOS version 14.0WatchOS version 7.0Apple Watch Series 4, Apple WatchSeries 5iPhone 6s - iPhone 11 models	iOS 12.1.1 - 14.0.1WatchOS 5.1.2 - 7.0.1Apple Watch Series 4, Apple Watch Series5, Apple Watch Series 6iPhone 5s - iPhone 11 models

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Performance Data

Apple conducted all necessary clinical and non-clinical performance testing on the ECG 2.0 app to support a determination of substantial equivalence to the predicate device.

Non-Clinical Testing Summary

Apple conducted the necessary non-clinical testing on the ECG 2.0 app with passing results supporting a determination of substantial equivalence. Non-clinical testing conducted included the following:

Software Verification Testing
Software verification testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Human Factors Validation

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Apple conducted a human factors validation study to verify the ECG 2.0 app is safe and effective for the intended users, uses, and use environments.

ECG Database Testing per EC57 In compliance with special controls established under 21 CFR 870.2345, Apple conducted database testing using a previously adjudicated dataset.
Platform compliance with the following standards:
- Thermal safety requirements under IEC-60950
- Applicable RF and EMC requirements under EN 301-489-17 v 3.2.0 and FCC Part 15

Clinical Testing Summary

The ECG app's ability to accurately classify an ECG recording into AFib and sinus rhythm was extensively tested in a pivotal, prospective, multi-center clinical trial of approximately 546 subjects -305 were enrolled in the Atrial Fibrillation cohort, 241 were enrolled in the normal sinus rhythm cohort. The mean age of enrolled subjects was 58. Rhythm classification of a 12-lead ECG by a cardiologist was compared to the rhythm classification of a simultaneously collected ECG from the ECG 2.0 app. The ECG app demonstrated 98.5% sensitivity in classifying AFib (HR 50-150 bpm) and 99.3% specificity in classifying sinus rhythm (HR 50-150 bpm) in classifiable recordings. Subgroup analysis indicated sensitivity ranged from 98.3% - 100% across all age groups, and specificity ranged from 99.0% - 100.0%. Specificity and sensitivity estimates were slightly higher for females (99.6% and 99.2%, respectively) than for males (99.1% and 98.3%, respectively). Specificity and sensitivity estimates for subjects identifying as White were 99.1% and 98.5%, respectively, and were 100.0% each for subjects identifying as Asian, Black or African American, and Other.

In addition, The morphology of the waveform was also tested in this clinical trial by visual assessment of the PQRST wave and R wave amplitude in comparison to a reference. The ECG 2.0 app produced a visually acceptable PQRST waveform with a pass rating of 100% compared to the reference waveform. Additionally, the total pass rating for R-wave amplitude assessment was 97.2% compared to the reference.

Conclusion

The Apple ECG 2.0 app is substantially equivalent to the Apple ECG app as they are identical with respect to intended use and share very similar technological characteristics. The differences in technological characteristics were assessed and testing through extensive non-clinical testing. The testing results demonstrate that the differences between the subject and predicate device do not raise new questions of safety and effectiveness. The Apple ECG 2.0 app is substantially equivalent to the Apple ECG app.

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.