(199 days)
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Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
No
The device is intended to monitor and record ECG rhythms, which is a diagnostic function, not a therapeutic one. It does not provide any treatment or therapy.
Yes
The device records ECG rhythms, which are used to assess the heart's electrical activity and diagnose cardiac conditions.
Unknown
The provided 510(k) summary is incomplete and lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. The "Intended Use" mentions recording, displaying, storing, and transferring ECG rhythms, which could be achieved with software, but it doesn't explicitly state that the device is solely software. Without a device description, it's impossible to definitively classify it.
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 used to "record, display, store and transfer single-channel electrocardiogram (ECG) rhythms." This involves measuring electrical activity of the heart, which is a physiological process within the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples taken from the body (like blood, urine, tissue).
- Detecting or measuring substances in those samples.
- Providing information about a physiological or pathological state based on the analysis of those samples.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. The AliveCor Heart Monitor directly measures a physiological signal from the body itself.
N/A
Intended Use / Indications for Use
The AliveCor Heart Monitor is intended for use by licensed medical professionals or patients to record, display, 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
licensed medical professionals or patients
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
Public Health Service
September 6, 2013 ·
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Alivecor, Inc. Michael Righter 30 Maiden Lane, 6th Floor San Francisco, CA 94108 US
Re: K130409 Trade/Device Name: Alivecor Heart Monitor Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: July 30, 2013 Received: August 6, 2013.
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 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 (2) 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 contact 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
1
http://www.fda.gov/MedicalDevices/Resources.forYou/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/Resourcesfor You/Industry/default.htm.
for
Sincerely yours,
Owen P. Faris -S
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 AliveCor logo. 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 heart-like shape inside. The word "AliveCor" is written in a bold, sans-serif font.
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 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)
Clue Z.
Digitally signed by Owen P. Faris -S Date: 2013.09.06 16:06:29 -04'00'