(73 days)
Biofeedback is to be used for muscle re-education and relaxation training
Not Found
I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria and the study that proves the device meets them. The text is a 510(k) clearance letter from the FDA for a device named "BioTrol," indicating it's cleared for marketing.
While it mentions the device's intended use (muscle re-education and relaxation training via biofeedback) and its classification, it does not include any details about:
- Acceptance criteria: What specific performance metrics were set for the device.
- Device performance: The actual results achieved by the device in testing.
- Study design details:
- Sample size for test set or training set.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used or how it was established.
This document is primarily an administrative clearance letter, not a technical report detailing the device's validation studies.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
OCT - 2 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Allen Director MindMedia Labs, Inc. 1036 Willa Lake Circle Oveida, Florida 32765
K972723 Re: Trade Name: BioTrol Requlatory Class: II 84HCC Product Code: April 3, 1997 Dated: Received: July 21, 1997
Dear Mr. Allen:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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. Tom Allen
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 requlation (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. 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
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number: K972723
Device Name: BioTrol
Indications For Use:
Biofeedback is to be used for muscle re-education and relaxation training ,
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 2723 510(k) Number .
Prescription Use_X (Per 21 CFR 801.109)
Over-The-Gounter Use-0
(Optional Format 1-2-96)
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.