The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when prescribed or used under the care of a physician). The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and it is not intended for pediatric use.

Device Description

The AliveCor Heart Monitor (the device) is the next generation of trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorders. The device utilizes the processing power of a mobile computing platform (MCP) while reducing the complexity of the electronics hardware associated with data acquisition and transmission. The AliveCor Heart Monitor can also analyze ECG signals and indicate the presence of atrial fibrillation for each ECG recording.

AI/ML Overview

The provided document is a 510(k) premarket notification for the AliveCor Heart Monitor. It addresses the substantial equivalence of the device to a previously cleared predicate device, but it does not contain the detailed information required to fully answer the request regarding acceptance criteria and the study proving the device meets those criteria.

Specifically, the document states:

"All necessary performance testing was conducted on the AliveCor Heart Monitor to support a determination of substantial equivalence to the predicate devices."
"The non-clinical testing included ECG performance evaluation in accordance with IEC 60601-2-47, electrical safety and EMC testing in accordance with IEC 60601-1 and 60601-1-2, and internal verification and validation testing."
"The collective results of the non-clinical testing demonstrate that the AliveCor Heart Monitor meets the established specifications and complies with the aforementioned standards."

However, it does not provide:

A table of specific acceptance criteria (e.g., sensitivity, specificity for AF detection) and reported device performance against those criteria.
Details about a clinical study for the AF detection feature, such as sample size, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone performance metrics.
Information on the training set for any algorithms, including its size or how its ground truth was established.

Based on the provided text, here's what can be extracted and what is missing:

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

Information in document: The document references compliance with "established specifications" and standards like IEC 60601-2-47 for ECG performance. However, it does not list specific acceptance criteria (e.g., "AF detection sensitivity > X%") or the exact reported performance values. The primary claim for this 510(k) is substantial equivalence to a predicate device that was "redesigned for aesthetic appeal and functions to the same specifications." This implies that the performance metrics of the new device are expected to be the same as the predicate and meet the standards, but the specific numerical criteria and results are not presented here.

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

Information in document: Not explicitly stated for any clinical performance testing related to the AF detection algorithm. The document focuses on non-clinical engineering and safety testing.

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

Information in document: Not stated.

4. Adjudication method for the test set

Information in document: Not stated.

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

Information in document: No MRMC study is mentioned. The device "detects the presence of atrial fibrillation (when prescribed or used under the care of a physician)" and also allows for human interpretation. This document doesn't detail studies on human reader improvement with AI assistance.

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

Information in document: The document states, "The AliveCor Heart Monitor can also analyze ECG signals and indicate the presence of atrial fibrillation for each ECG recording." This implies a standalone algorithm for AF detection. However, the specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) and the study that produced them are not included in this summary.

7. The type of ground truth used

Information in document: Not stated. For AF detection, this would typically involve expert cardiologist over-reads of the ECGs.

8. The sample size for the training set

Information in document: Not stated.

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

Information in document: Not stated.

In summary, this document is a regulatory submission focused on substantial equivalence based on non-clinical engineering and safety testing, confirming the device meets established specifications and regulatory standards. It does not provide the detailed clinical performance study results (especially for the AF detection feature) that would answer questions 1-9 comprehensively. Such details would typically be found in a more extensive clinical study report or a different section of the 510(k) submission, not summarized in the provided text.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 3, 2014

Alivecor, Inc. Albert Boniske Director of Regulatory Affairs 30 Maiden Lane, 6th Floor San Francisco, California 94108

K142672 Re:

Trade/Device Name: Alivecor Heart Monitor Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DXH, DPS Dated: November 3, 2014 Received: November 4, 2014

Dear Albert Boniske.

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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K142672

Device Name: AliveCor Heart Monitor

Indications For Use:

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) SUMMARY

510(k) Notification K142672

General Information

Applicant: AliveCor, Inc. 30 Maiden Lane, 6th Floor San Francisco, CA 94108

Contact Person:

Albert Boniske Director of Regulatory Affairs AliveCor, Inc. Phone: 415-795-9811 Fax: 415-397-0440

Date Prepared: September 18, 2014

DEVICE INFORMATION

Trade Name: Alive Cor Heart Monitor

Generic/Common Name: Telephone electrocardiograph transmitter and receiver

Classification: 21 CFR§870.2920, Transmitters and Receivers, Electrocardiograph, Telephone, Class II

Product Code: DXH, DPS

PREDICATE DEVICE(S)

. K140933 – AliveCor Heart Monitor

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INDICATIONS FOR USE

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The new AliveCor Heart Monitor is substantially equivalent to the original cleared AliveCor Heart Monitor. The new AliveCor Heart Monitor has been redesigned for aesthetic appeal and functions to the same specifications for the same intended use as the predicate device.

NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary performance testing was conducted on the AliveCor Heart Monitor to support a determination of substantial equivalence to the predicate devices. The non-clinical testing included ECG performance evaluation in accordance with IEC 60601-2-47, electrical safety and EMC testing in accordance with IEC 60601-1 and 60601-1-2, and internal verification and validation testing. The collective results of the non-clinical testing demonstrate that the AliveCor Heart Monitor meets the established specifications and complies with the aforementioned standards.

CONCLUSION

The results of the nonclinical testing demonstrate that the AliveCor Heart Monitor is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).