(376 days)
The Sportstim 2.0 can only be used upon the prescription of a physician for the symptomatic relief of chronic intractable pain, including the relief of post-traumatic and post-surgical pain.
Not Found
The provided text is related to the FDA clearance of a TENS device (Sportstim Model 2.0 TENS Device, K962951). However, it does not contain any information about acceptance criteria, device performance studies, or clinical trial specifics as requested.
The document is a clearance letter stating that the device is substantially equivalent to predicate devices and can be marketed. It discusses regulatory classifications, general controls, and contact information for compliance.
Therefore, I cannot provide the requested information based on the given text. The text does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth establishment.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for the training set or how its ground truth was established.
This is a regulatory clearance document, not a study report or clinical evidence summary.
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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
:
Mr. Bryan D. Adams Technalithics, Inc. 7003 Woodway Drive, Suite 315 Waco, Texas 76712 1. 1. 1.
AUG - 6 1997
Re: K962951 Trade Name: Sportstim Model 2.0 TENS Device Requlatory Class: TI Product Code: 84GZJ Dated: May 22, 1997 Received: May 23, 1997
Dear Mr. Adams:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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. Bryan D. Adams
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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INDICATIONS FOR USE STATEMENT
510(k) Number: K962951
Device Name: Sportstim Model 2.0 TENS Device
Indications For Use:
The Sportstim 2.0 can only be used upon the prescription of a physician for the symptomatic relief of chronic intractable pain, including the relief of post-traumatic and post-surgical pain.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED ) Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahan
Prescription Use (Per 21 CFR §801.109)
Over-The-Counter Use
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).