(309 days)
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No
The provided 510(k) summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices (like training/test sets, AUC, etc.).
No
The device is intended to "record, display, store and transfer single-channel electrocardiogram (ECG) rhythms," which are diagnostic functions, not therapeutic ones.
Yes
The device is described as an ECG monitor which records, displays, stores, and transfers rhythms, indicating its role in providing data relevant for diagnosis.
No
The summary describes a "Heart Monitor" which is typically a hardware device that records ECG rhythms. While it mentions displaying, storing, and transferring data, the core function of recording ECG rhythms strongly implies a hardware component is involved. The lack of a "Device Description" section prevents definitive confirmation, but the term "Heart Monitor" is the primary indicator.
Based on the provided information, the AliveCor Heart Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for recording, displaying, storing, and transferring single-channel electrocardiogram (ECG) rhythms. This is a physiological measurement of electrical activity in the heart, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on analysis of biological samples.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The AliveCor Heart Monitor directly measures a physiological signal from the body's surface.
N/A
Intended Use / 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.
Product codes
DPS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.2340 Electrocardiograph.
(a)
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.(b)
Classification. Class II (performance standards).
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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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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