(287 days)
MEDIPOINT is intended for relief of chronic or acute pain.
MEDIPOINT is an electronic pulse generator that has been designed to provide in MEDIPOINT IS an electionic pulse generator that has has has and post-traumatic acute pain (TENS).
MEDIPOINT is a portable hand held battery operated micro current pulse generator Pusing a very minute biphasic DC current.
The provided text is a 510(k) Premarket Notification for the MEDIPOINT Microcurrent Therapy device. It does not contain information about specific acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics.
Instead, the document focuses on:
- Device Identification: Trade name (MEDIPOINT), common name (Microcurrent Therapy), and classification name (Transcutaneous electrical nerve stimulator for pain relief).
- Predicate Device: Identifies SOLITENS™ (K913522) as the predicate device.
- Device Description: A portable hand-held, battery-operated micro current pulse generator using a very minute biphasic DC current.
- Intended Use: For relief of chronic or acute pain.
- FDA Clearance: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
- Indications For Use: Specifically states "MEDIPOINT is an electronic pulse generator that has been designed to provide in MEDIPOINT IS an electronic pulse generator that has has has and post-traumatic acute pain (TENS)." (There appears to be a transcription error in the original document's "Indications For Use" statement, with repeated words).
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study evaluating its performance against such criteria, as this information is not present in the provided text. The 510(k) pathway primarily demonstrates substantial equivalence to a predicate device, rather than requiring extensive performance studies against pre-defined acceptance criteria in the same way a PMA (Premarket Approval) might.
The other requested information (sample size, data provenance, expert details, adjudication, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are also not found in this document, as they would typically be part of detailed clinical or performance studies, which are not outlined here.
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Medipoint Ltd. 12 Wolfe Close Parkgate Business Park, Knutsford Cheshire, WA16 8XJ, UK
MEDIPOINT 510(K) Premarket Notification Dated: August 5, 1998
510(k) Summary 10.
MEDIPOINT, MICROCURRENT THERAPY
Contact: Larry Ratliff Medipoint USA Pocatella, Idaho 83204
Tel: (208) 232-2941
Sponsor: Medipoint Ltd. 12 Wolfe Close Parkgate Business Park, Knutsford Chesire, WA16 8XJ, UK
Tel: 01565 632000
Notice: This document is propriety and its contents are the exclusive property of Medipoint Ltd. This ડી document may not be reproduced in any form without the specific permission of Medipoint Ltd.
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MEDIPOINT 510(K) Premarket Notification Dated: August 5, 1998
10. 1. Device Name
MEDIPOINT is provided as follows:
- a. Trade Name MEDIPOINT
- b. Common Name Microcurrent Therapy
- c. Classification Name
- 21 CFR Sec. 882.5890 Transcutaneous electrical nerve stimulator . for pain relief
10. 2. Predicate Device / Company Names and Addresses
The predicate device is listed below with its 510(k) clearance number.
| SOLITENS™ | K(913522) | INNOVATIVE DESIGNER PRODUCTS, INC.Saul Liss175 Rock RoadGlen Rock, NJ 07452 |
|---|---|---|
| ----------- | ----------- | ----------------------------------------------------------------------------------------- |
10. 3. Description of Device
MEDIPOINT is a portable hand held battery operated micro current pulse generator Pusing a very minute biphasic DC current.
10. 4. Intended Use
MEDIPOINT is intended for relief of chronic or acute pain.
Notice: This document is propriety and its contents are the exclusive property of Medipoint Ltd. This ട് 2 document may not be reproduced in any form without the specific permission of Medipoint Ltd.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three lines extending from its head, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 7 1999
Jules T. Mitchel, Ph.D. Target Health Inc. Representing Medipoint_Limited Representing nearpoint 22mlood New York, New York 10017
K982961 Re: Medipoint Trade Name: Requlatory Class: II Product Code: GZJ March 9, 1999 Dated: March 10, 1999 Received:
Dear Dr. Mitchel:
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 The general controls provisions of the Act 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 requirement, 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 In addition, FDA may publish further announcements action. 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 - Jules T. Mitchel, Ph.D.
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) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note one 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,
Celia M. Witten, PH.D., M.D.
Director
Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment I b
Page / of /
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K982961 |
| Device Name: | Mediprint |
Indications For Use:
MEDIPOINT is an electronic pulse generator that has been designed to provide in MEDIPOINT IS an electionic pulse generator that has has has and post-traumatic acute pain (TENS).
(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 of General Restorative Devices
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K98296
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).