(75 days)
Not Found
Yes
The device description explicitly states that the device "can also analyze ECG signals and indicate the presence of atrial fibrillation," which is a common application of AI/ML in medical devices. While the terms AI/ML are not explicitly used, the analytical function described strongly suggests the use of such technology for pattern recognition in ECG data.
No.
The device is for recording and monitoring ECG rhythms and detecting atrial fibrillation, not for therapy or treatment.
Yes
The device is described as detecting the presence of atrial fibrillation and indicating the presence of atrial fibrillation for each ECG recording, which implies a diagnostic function.
No
The device description explicitly states it utilizes "electronics hardware associated with data acquisition and transmission," indicating it includes hardware components beyond just software.
Based on the provided text, the AliveCor Heart Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- AliveCor Heart Monitor function: The text clearly states the device "record[s], store[s] and transfer[s] single-channel electrocardiogram (ECG) rhythms." ECGs are recordings of the electrical activity of the heart, obtained by placing electrodes on the surface of the body. This is an in vivo measurement (taken from a living organism), not an in vitro measurement (taken from a specimen outside the body).
Therefore, the AliveCor Heart Monitor falls under the category of a medical device that performs physiological measurements directly on the patient, not an IVD.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked as "Not Found".
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. The device has not been tested and it is not intended for pediatric use.
Product codes (comma separated list FDA assigned to the subject device)
DXH, DPS
Device Description
The AliveCor Heart Monitor (the device) is the next generation of trans-telephonic (transmission by telephone) 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 AliveCor Heart Monitor can also analyze ECG signals and indicate the presence of atrial fibrillation for each ECG recording.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The device has not been tested and it is not intended for pediatric use.
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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 ECG performance evaluation in accordance with IEC 60601-2-47, electrical safety and EMC testing in accordance with IEC 60601-1 and 60601-1-2, and internal verification and validation testing. The collective results of the non-clinical testing demonstrate that the AliveCor Heart Monitor meets the established specifications and complies with the aforementioned standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2014
Alivecor, Inc. Albert Boniske Director of Regulatory Affairs 30 Maiden Lane, 6th Floor San Francisco, California 94108
K142672 Re:
Trade/Device Name: Alivecor Heart Monitor Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DXH, DPS Dated: November 3, 2014 Received: November 4, 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 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 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,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K142672
Device Name: AliveCor Heart Monitor
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. The device has not been tested and it is not intended for pediatric use.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) SUMMARY
510(k) Notification K142672
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: September 18, 2014
DEVICE INFORMATION
Trade Name: Alive Cor Heart Monitor
Generic/Common Name: Telephone electrocardiograph transmitter and receiver
Classification: 21 CFR§870.2920, Transmitters and Receivers, Electrocardiograph, Telephone, Class II
Product Code: DXH, DPS
PREDICATE DEVICE(S)
- . K140933 – AliveCor Heart Monitor
4
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. The device has not been tested and it is not intended for pediatric use.
DEVICE DESCRIPTION
The AliveCor Heart Monitor (the device) is the next generation of trans-telephonic (transmission by telephone) 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 AliveCor Heart Monitor can also analyze ECG signals and indicate the presence of atrial fibrillation for each ECG recording.
SUBSTANTIAL EQUIVALENCE
The new AliveCor Heart Monitor is substantially equivalent to the original cleared AliveCor Heart Monitor. The new AliveCor Heart Monitor has been redesigned for aesthetic appeal and functions to the same specifications for the same intended use as the predicate device.
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 ECG performance evaluation in accordance with IEC 60601-2-47, electrical safety and EMC testing in accordance with IEC 60601-1 and 60601-1-2, and internal verification and validation testing. The collective results of the non-clinical testing demonstrate that the AliveCor Heart Monitor meets the established specifications and complies with the aforementioned standards.
CONCLUSION
The results of the nonclinical testing demonstrate that the AliveCor Heart Monitor is substantially equivalent to the predicate device.