(256 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The "Intended Use / Indications for Use" section is nonsensical and does not describe any therapeutic purpose. The "Device Description" is simply "TRACER", which provides no information about a therapeutic function.
No
The "Intended Use / Indications for Use" section is nonsensical and appears to be gibberish ("PATICATS WIS TARY BE EXCERIENCING For હર CARDIAC EVENTS SymfromMic Purse RATE ABACAITAL"), offering no information to determine if the device is diagnostic.
Unknown
The provided 510(k) summary is extremely sparse and lacks sufficient detail about the device's nature and components to definitively determine if it is software-only. The description "TRACER" is not informative enough.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Lack of Key IVD Indicators: The provided text does not mention any of the typical characteristics of an IVD. IVDs are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Focus on Cardiac Events and Pulse Rate: The "Intended Use" mentions "CARDIAC EVENTS" and "SymfromMic Purse RATE ABACAITAL". This suggests the device is likely measuring physiological signals directly from the patient, rather than analyzing a sample.
- Device Description "TRACER": While vague, "TRACER" doesn't inherently point to an IVD. It could refer to a device that tracks or monitors something.
- Absence of Specimen Information: There is no mention of collecting or analyzing any type of biological specimen.
In summary, the information provided points towards a device that likely interacts directly with the patient to monitor physiological parameters related to cardiac function, which is not the typical function of an IVD.
N/A
Intended Use / Indications for Use
For patient’s who may be experiencing cardiac events symptomatic pulse rate abnormalities.
Product codes
MJW
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The central image is a stylized depiction of an eagle with three lines above it, representing the department's mission to promote health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ਰ 1999 APR
Mr. John A. Humphrey President Heartland Medical Systems, Inc. 725 Pickford Court Newbury Park, CA 91320
Re: K982617 Tracer Regulatory Class: II (two) Product Code: MJW Dated: February 15, 1999 March 4, 1999 Received:
Dear Mr. Humphrey:
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 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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 Druq 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 Reqister. Please note: this response to your premarket notification submission does not affect any
1
Page 2 - Mr. Edward F. Waddell
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.
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, 2 Misbranding by reference to premarket notification? (21CFR 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Page | |
|---|---|
| of |
| 510(k) Number (if known): | K982617 |
|---|---|
| Device Name: | TRACER |
| Indications For Use: |
PATICATS WIS TARY BE EXCERIENCING For હર CARDIAC EVENTS SymfromMic Purse RATE ABACAITAL
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number
Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109) OR
(Optional Format 1-2-96)