(351 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related technologies, and the described function is a basic heart rate monitor with alerts.
No
The device is described as a heart tachometer to be used before, during, and after exercise or at rest, with the ability to alert the user if presets are exceeded. This functionality aligns with monitoring rather than treating a disease or condition, which is characteristic of therapeutic devices.
No
The device is described as a Heart Tachometer for use during exercise and rest, which measures heart rate but does not appear to provide a medical diagnosis. The alerts for exceeded presets are warnings, not diagnostic outputs.
Unknown
The provided text does not contain a "Device Description" section, which is crucial for determining if the device is software-only. Without this description, it's impossible to ascertain if the device includes any hardware components or relies solely on software for its intended function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on monitoring heart rate during and after exercise, at rest, and providing alerts based on preset limits. This is a physiological monitoring function, not a diagnostic test performed on samples taken from the body (like blood, urine, etc.).
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on analysis of biological samples.
The device functions as a heart rate monitor, which falls under the category of physiological monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
To be used before, during and after exercise. To be used while at rest. The primary function is as a Heart Tachometer. The user also can be alerted if various presets have been exceeded.
Product codes
74 DRT
Device Description
Not Found
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
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct lines forming its body and wings. The bird is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Rockville MD 20857
DEC - 9 1997
Mr. Ken Nusbaum N.P.N.T., Inc. 111 Martin Ross Avenue, Unit 4 Downsview, Ontario Canada, M3J-2M1
Re: K965158 Heart Protector Requlatory Class: II (two) Product Code: 74 DRT Dated: October 14, 1997 Received: November 19, 1997
Dear Mr. Nusbaum:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Ken Nusbaum
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K-965158 |
|---|---|
| Device Name: | HEART PROTECTOR |
Indications For Usc:
To be used before, during and after exercise. To be used while at rest. The primary function is as a Heart Tachometer. The user also can be alerted if various presets have been exceeded.
(PLEASE DO NOT WRITE BELOW THIS-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
S10(k) Number_
Prescription Disc: OR (Per 21 CFR 801:1091
Over The Counter Use: (Optional Format 1-2-96)