(126 days)
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Yes
The device description mentions an "atrial fibrillation algorithm" that "analyzes" the ECG waveform and was "validated" using "ECGs that were previously recorded... and labeled by cardiologists." This strongly suggests a machine learning approach for pattern recognition (atrial fibrillation detection) based on a labeled dataset.
No
The device records, stores, and transfers ECG rhythms and detects atrial fibrillation; it does not explicitly state that it provides therapy or treatment.
Yes
The device records, stores, transfers, and displays ECG rhythms, which are diagnostic indicators. It also specifically states that it "detects the presence of atrial fibrillation," which is a diagnostic function.
No
The device description explicitly states it is a "next generation of trans-telephonic single-lead ECG event recorders" and "utilizes the processing power of a mobile computing platform (MCP) while reducing the complexity of the electronics hardware associated with data acquisition and transmission." It also mentions the device is "placed on the chest or held by the user's hands to provide a single-channel ECG rhythm strip" and uses "acoustic waves to communicate with the MCP." This clearly indicates the presence of hardware components for data acquisition and transmission, making it a hardware device with accompanying software.
Based on the provided information, the AliveCor Heart Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- AliveCor Heart Monitor Function: The AliveCor Heart Monitor directly measures electrical activity of the heart (ECG rhythms) from the body surface (chest or hands). It does not examine specimens derived from the human body in vitro.
- Intended Use: The intended use is to record, store, transfer, and display ECG rhythms and detect atrial fibrillation. This is a direct physiological measurement and analysis, not an in vitro examination of a specimen.
Therefore, the AliveCor Heart Monitor falls under the category of a medical device that performs a direct physiological measurement, rather than an In Vitro Diagnostic device.
No
The provided text does not explicitly state that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
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.
Product codes
DXH, DPS
Device Description
The AliveCor Heart Monitor (the device) is the next generation of trans-telephonic (transmission by telephone) single-lead 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 device is placed on the chest or held by the user's hands to provide a single-channel ECG rhythm strip. Similar to other mobile ECG devices, the AliveCor Heart Monitor uses a proprietary method of data transmission using acoustic waves to communicate with the MCP where the waveform is stored, displayed, and analyzed for the presence of atrial fibrillation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
healthcare professionals, patients with known or suspected heart conditions and health conscious individuals
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
The AF algorithm was tested in accordance with AAMI/ANSI EC57. ECGs that were previously recorded using the AliveCor Heart Monitor and labeled by cardiologists were used to validate the performance of the AF algorithm.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 software verification and atrial fibrillation (AF) algorithm validation. The AF algorithm was tested in accordance with AAMI/ANSI EC57. ECGs that were previously recorded using the AliveCor Heart Monitor and labeled by cardiologists were used to validate the performance of the AF algorithm. The collective results of the non-clinical testing demonstrate that the AliveCor Heart Monitor meets the established specifications necessary for consistent performance for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2014
Alivecor, Inc. Albert Boniske Director of Regulatory Affairs 30 Maiden Lane, 6th Floor San Francisco, California 94108
Re: K140933
Trade/Device Name: Alivecor Heart Monitor Regulation Number: 21 CFR 870.2920 Regulation Name: Transmitters and Receivers, Electrocardiograph, Telephone Regulatory Class: Class II Product Code: DXH, DPS Dated: July 9, 2014 Received: July 10, 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
1
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 (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 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.
Mitchell Stein
forBram 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 contains the logo for AliveCor. The logo consists of a blue geometric shape resembling a cube with a heart-like shape inside, followed by the text "AliveCor" in a bold, sans-serif font. The logo is clean and modern, suggesting a focus on technology and health.
SECTION 4
INDICATIONS FOR USE STATEMENT
K140933 510(k) Number:
AliveCor Heart Monitor Device Names:
Indications for Use:
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.
Prescription Use _ (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)
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Image /page/3/Picture/0 description: The image shows the AliveCor logo. The logo consists of a blue geometric shape on the left and the word "AliveCor" in black on the right. The geometric shape is made up of lines that form a cube-like structure. The word "AliveCor" is written in a sans-serif font, and the letters are connected to each other.
SECTION 5
510(k) SUMMARY
510(k) Notification K140933
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: April 9, 2014
Device Information
Trade Name: AliveCor Heart Monitor
Generic/Common Name: Electrocardiograph
Classification: 21 CFR§870.2340, Electrocardiograph, Class II
Product Code:
DPS, DXH
PREDICATE DEVICE(S)
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Image /page/4/Picture/0 description: The image shows the AliveCor logo. The logo consists of a blue geometric shape on the left and the word "AliveCor" in black on the right. The geometric shape is a stylized cube with an "M" shape inside. The word "AliveCor" is written in a sans-serif font, with the "TM" symbol in superscript after the "r".
INDICATIONS FOR US
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.
Device Description
The AliveCor Heart Monitor (the device) is the next generation of trans-telephonic (transmission by telephone) single-lead 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 device is placed on the chest or held by the user's hands to provide a single-channel ECG rhythm strip. Similar to other mobile ECG devices, the AliveCor Heart Monitor uses a proprietary method of data transmission using acoustic waves to communicate with the MCP where the waveform is stored, displayed, and analyzed for the presence of atrial fibrillation.
SUBSTANTIAL EQUIVALENCE
The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the AliveCor Heart Monitor. The AliveCor Heart Monitor operates using the same technological characteristics for the same intended use as its predicate devices record and store ECGs and indicate the presence of abnormalities in the recording. The nonclinical testing results demonstrate that any differences in the technological characteristics between the subject and predicate devices do not raise any new issues of safety or effectiveness. Thus, the AliveCor Heart Monitor is substantially equivalent to the predicate devices.
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 software verification and atrial fibrillation (AF) algorithm validation. The AF algorithm was tested in accordance with AAMI/ANSI EC57. ECGs that were previously recorded using the AliveCor Heart Monitor and labeled by cardiologists were used to validate the performance of the AF algorithm. The collective results of the non-clinical testing demonstrate that the AliveCor Heart Monitor meets the established specifications necessary for consistent performance for its intended use.
CONCLUSION
The results of the nonclinical testing demonstrate that the AliveCor Heart Monitor is substantially equivalent to the predicate devices.