ALIVECOR HEART MONITOR FOR IPHONE

K122356 · AliveCor, Inc. · DPS · Nov 19, 2012 · Cardiovascular

Device Facts

• Record ID: K122356
• Device Name: ALIVECOR HEART MONITOR FOR IPHONE
• Applicant: AliveCor, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Nov 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The AliveCor Heart Monitor for iPhone is intended for use by licensed medical professionals or patients to record, display, store and transfer single-channel electrocardiogram (ECG) rhythms.

Device Story

The AliveCor Heart Monitor for iPhone is a mobile-based ECG recording system. It captures single-channel ECG signals via electrodes; data is transmitted to an iPhone for display, storage, and transfer. Used by clinicians or patients in various settings; facilitates remote monitoring and clinical review of cardiac rhythms. Output allows healthcare providers to assess heart rhythm, aiding in clinical decision-making and patient management.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological and intended use comparisons.

Technological Characteristics

Single-channel ECG monitor; mobile-integrated form factor; electrodes for signal acquisition; software-based display and storage; connectivity via iPhone interface.

Indications for Use

Indicated for use by licensed medical professionals or patients to record, display, store, and transfer single-channel ECG rhythms.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

# NOV 1 9 2012

Alivecor, Inc. c/o Mr. Michael Righter Director, Regulatory Affairs 140 Geary Street, Suite 500 San Francisco, CA 94108

#### Re: K122356

Trade/Device Name: Alivecor heart monitor for iphone Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: October 18, 2012 Received: October 20, 2012

#### Dear Mr. 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.

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Page 2 - Mr. Michael Righter

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actives that I Dr o levice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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

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# 510(k) PREMARKET NOTIFICATION

# INDICATIONS FOR USE STATEMENT

122356 510(k) Number:

AliveCor Heart Monitor for iPhone Device Names:

### Indications for Use:

The AliveCor Heart Monitor for iPhone is intended for use by licensed medical professionals or patients to record, display, store and transfer single-channel electrocardiogram (ECG) rhythms.

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

AND/OR

Over-The-Counter Use (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)

Civerti

Owen P. Faris -S 2012.11.19 16:09:42 -05'00'