(122 days)
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Unknown
The document mentions "signal processing, feature extraction and rhythm classification" and "minor, non-userfacing algorithm updates," which are common components of ML systems, but it does not explicitly state that AI or ML is used. The lack of mention of training or test sets for an AI/ML model also contributes to the uncertainty.
No
The device is intended for informational use only and is not intended for diagnosis or treatment, which are functions of a therapeutic device.
Yes
The device is described as determining the presence of atrial fibrillation (AFib) and sinus rhythm, which are diagnostic classifications of heart rhythm.
No
While the device is described as a "software-only mobile medical application," its functionality is explicitly tied to and relies on the integrated electrical sensors and hardware of the Apple Watch to collect the data (ECG waveform) that the software then processes and classifies. The description details how the user completes a circuit across the heart using the Apple Watch hardware. Therefore, it is not purely software independent of specific medical device hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This device analyzes electrical signals from the heart, but it does not analyze biological samples like blood, urine, or tissue.
- The intended use is for creating, recording, storing, transferring, and displaying an ECG. While it performs rhythm classification, this is based on the electrical signal itself, not on the analysis of a biological sample.
- The device description focuses on the electrical sensors and signal processing. There is no mention of reagents, assays, or other components typically associated with IVDs.
Therefore, this device falls under the category of a medical device that measures physiological signals, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
QDA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The ECG app is not intended for use by people under 22 years old.
Intended User / Care Setting
over-the-counter (OTC) use
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
Not Found
Summary of Performance Studies
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:
- 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: 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.
Key Metrics
Sensitivity: 98.5% (for AFib, HR 50-150 bpm in classifiable recordings)
Specificity: 99.3% (for sinus rhythm, HR 50-150 bpm in classifiable recordings)
Subgroup analysis sensitivity: 98.3% - 100% (across all age groups)
Subgroup analysis specificity: 99.0% - 100.0% (across all age groups)
Female sensitivity: 99.2%
Female specificity: 99.6%
Male sensitivity: 98.3%
Male specificity: 99.1%
White sensitivity: 98.5%
White specificity: 99.1%
Asian, Black or African American, and Other sensitivity: 100.0%
Asian, Black or African American, and Other specificity: 100.0%
PQRST waveform visual acceptability pass rating: 100%
R-wave amplitude assessment total pass rating: 97.2%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
Indications for Use
510(k) Number (if known) K201525
Device Name ECG 2.0 App
Indications for Use (Describe)
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.
| 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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3
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 Way
Cupertino, CA 95014 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------|
| Submission
Correspondent | Luke Olson
Regulatory Affairs Associate
Phone: (408) 608-2001
Email: luke_olson@apple.com |
| Contact | David Amor
Sr Manager, Quality and Regulatory Affairs
Phone: (786) 546-1806
Email: 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.
4
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.
5.4 Indications for Use
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.
5.5 Comparison with the Predicate Device
| Item | Subject Device | Predicate Device |
|---|---|---|
| ECG 2.0 App | ECG App | |
| Manufacturer | Apple Inc. | Apple Inc. |
| Submission | ||
| Reference | K201525 | DEN180044 |
| Item | Subject Device | Predicate Device |
| ECG 2.0 App | ECG App | |
| Intended Use | 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. | 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. | ||
| Indications for | ||
| Use | 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. | 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 (AF) or sinus | ||
| rhythm 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 AF from normal | ||
| sinus rhythm and not intended to replace | ||
| traditional methods of diagnosis or | ||
| treatment. | ||
| The ECG app is not intended for use by | ||
| people under 22 years old. | ||
| Principle of | ||
| Operation | The ECG 2.0 app acquires platform | |
| sensor data from Apple Watch. After | ||
| acquisition, the ECG 2.0 app | ||
| algorithms process and classify the | ||
| signal and display the classification to | ||
| the user. | The ECG app acquires platform sensor | |
| data from Apple Watch. After acquisition, | ||
| the ECG app algorithms process and | ||
| classify the signal and display the | ||
| classification to the user. | ||
| Item | Subject Device | Predicate Device |
| ECG 2.0 App | ECG App | |
| ECG Session | ||
| Classification | ||
| Results | - Low Heart Rate ( 120 bpm) | |
| - Poor Recording | ||
| - High Heart Rate (> 150 bpm) | ||
| Clinical | ||
| Application | The ECG 2.0 app is intended to | |
| supplement rhythm classification for | ||
| the purposes of discriminating Afib | ||
| from normal rhythms. The device is not | ||
| intended to replace traditional methods | ||
| or diagnosis. | The ECG app is intended to supplement | |
| rhythm classification for the purposes of | ||
| discriminating Afib from normal rhythms. | ||
| The device is not intended to replace | ||
| traditional methods or diagnosis. | ||
| Compatibility | ||
| with Intended | ||
| Platforms | iOS version 14.0 | |
| WatchOS version 7.0 | ||
| Apple Watch Series 4, Apple Watch | ||
| Series 5 | ||
| iPhone 6s - iPhone 11 models | iOS 12.1.1 - 14.0.1 | |
| WatchOS 5.1.2 - 7.0.1 | ||
| Apple Watch Series 4, Apple Watch Series | ||
| 5, Apple Watch Series 6 | ||
| iPhone 5s - iPhone 11 models |
5
6
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
7
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.