ALIVECOR HEART MONITOR OTC

K130921 · AliveCor, Inc. · DPS · Feb 6, 2014 · Cardiovascular

Device Facts

• Record ID: K130921
• Device Name: ALIVECOR HEART MONITOR OTC
• Applicant: AliveCor, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Feb 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The AliveCor Heart Monitor is intended to record, display (when prescribed or used under the care of a physician), store and transfer single-channel electrocardiogram (ECG) rhythms.

Device Story

AliveCor Heart Monitor records single-channel ECG rhythms; device captures electrical signals via electrodes; data transmitted to mobile device for display, storage, and transfer. Used by patients (OTC) or clinicians (prescription) to monitor cardiac activity. Output allows healthcare providers to review ECG data to assist in clinical decision-making regarding cardiac health. Benefits include accessible, portable ECG monitoring for patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use identical to the predicate device.

Technological Characteristics

Single-channel ECG monitor; mobile-integrated; records electrical cardiac signals; software-based display and storage; intended for OTC and prescription use.

Indications for Use

Indicated for recording, displaying, storing, and transferring single-channel ECG rhythms. Intended for use by patients or clinicians in prescription or OTC settings.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• AliveCor Heart Monitor (K122753)

Submission Summary (Full Text)

{0}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

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

February 6, 2014

Alivecor, Inc. Michael Righter Director, Regulatory Affairs 30 Maiden Lane, 6th Floor San Francisco, CA 94108 US

Re: K130921

> Trade/Device Name: Alivecor Heart Monitor OTC Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: January 10, 2014 Received: January 15, 2014

Dear Michael Righter:

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

{1}------------------------------------------------

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 (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 Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Owen P. Faris -S

for

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

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for AliveCor. The logo consists of a geometric shape on the left and the word "AliveCor" on the right. The geometric shape is a three-dimensional cube-like structure with a series of V-shaped patterns inside. The word "AliveCor" is written in a bold, sans-serif font.

K130921 Page 1 of 1

### 510(k) PREMARKET NOTIFICATION

#### INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Names: · AliveCor Heart Monitor

## Indications for Use:

The AliveCor Heart Monitor is intended to record, display (when prescribed or used under the care of a physician), store and transfer single-channel electrocardiogram (ECG) rhythms.

Prescription Use _ _ _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by