(117 days)
None
Not Found
No
The summary describes a standard heart rate variability analysis technique (Frequency Domain HRV) based on established guidelines, with no mention of AI or ML.
No
The device is described as an "aid to other clinical diagnostic techniques" for quantifying and displaying heart rate variability, indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section states that the device is "an aid to other clinical diagnostic techniques," which indicates it contributes to the diagnostic process.
No
The summary describes a "Biosensor Holter Monitor System" which implies a hardware component (the Holter monitor) that collects data. The software component is an "analysis option" incorporated into this system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as analyzing heart rate variability from a Holter Monitor System. This involves analyzing physiological signals from the patient's body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, this device falls under the category of a medical device that analyzes physiological data, but not an IVD.
N/A
Intended Use / Indications for Use
The Biosensor Frequency Domain Heart Rate Variability . (FD HRV), analysis option is being incorporated into the Biosensor Holter Monitor System for quantification and graphical displays of heart rate changes over a specific monitoring period as an aid to other clinical diagnostic techniques.
The FD HRV graph is modeled after the recommendations of the Task Force of the European Society of Cardiology (Circulation. 1996;93: 1042-1065). FD HRV is intended to provide HRV spectra for any selected time segment of 5 minutes of duration or longer, at the physician's discretion.
Product codes
74 DQK
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
physician
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)
Validation data for FD HRV will be made available upon request.
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
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(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 with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1998
Mr. Darren D. Dershem Biosensor Corporation 7001 East Fish Lake Road Maple Grove, MN 55311-2833
Re: K974192 Biosensor Holter Monitor System Requlatory Class: II (two) Product Code: 74 DQK February 12, 1998 Dated: Received: February 17, 1998
Dear Mr. Dershem:
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 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 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.
.
1
Page 2 - Mr. Darren D. Dershem
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 f. 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): | K974192 |
|---|---|
| Device Name: | BIOSENSOR HOLTOR MONITOR SYSTEM |
Indications For Use:
The Biosensor Frequency Domain Heart Rate Variability . (FD HRV), analysis option is being incorporated into the Biosensor Holter Monitor System for quantification and graphical displays of heart rate changes over a specific monitoring period as an aid to other clinical diagnostic techniques.
The FD HRV graph is modeled after the recommendations of the Task Force of the European Society of Cardiology (Circulation. 1996;93: 1042-1065). FD HRV is intended to provide HRV spectra for any selected time segment of 5 minutes of duration or longer, at the physician's discretion.
Precaution:
Computerized ECG analysis should not replace diagnosis by a qualified physician. The physician should verify that the reported data is accurate before applying clinical conclusions.
Since various neural, respiratory, and endocrine factors are known to affect heart rate variability, the significance of the data must be determined by a physician.
FD HRV analysis may differ among devices from different manufacturers since methods and algorithms may vary. Caution should be used in applying conclusions drawn from studies with other devices.
Validation data for FD HRV will be made available upon request.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ర్ Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)