(63 days)
Stimus latio OV INTERFERENTIAL
Not Found
The provided text is an FDA 510(k) clearance letter for MSB (Electrical Stimulation) Electrodes from 1999. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information based on the given text.
The document primarily focuses on regulatory approval based on substantial equivalence, not on the detailed technical data or clinical study results that would typically include acceptance criteria and performance metrics.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 1999
Mr. Peter D. Marks Quality Manager MSB Limited Ramsbury Marlborough, Wiltshire SN8 2RB, United Kingdom
K990370 Re: MSB (Electrical Stimulation) Electrodes Trade Name: (Disposable) (TENS/FES/NMES) Regulatory Class: II Product Code: GXY December 22, 1998 Dated: February 8, 1999 Received:
Dear Mr. Marks:
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 Requlations, 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 Requlation (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.
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Page 2 - Mr. Peter D. Marks
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 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,
Celia M. Witten Ph.D. M.D.
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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Allachinent I b
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l Jevice Name:
Indications For Usc:
510(k) Number (if known):
Stimus latio OV INTERFERENTIAL ﻠ
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Concurrence of (DRH, Office of Device Evaluation (C
luation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990370
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter I Ise
(Optional Format 1-2-96)
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).