(88 days)
Peripheral nerve stimulate electrically a peripheral nerve in patients to relieve severe intractable pain. In order to maintain consistency between products, this indication will be used for all Medicated devices.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a Peripheral Nerve Stimulator for Pain. It outlines the regulatory approval for marketing the device based on substantial equivalence to predicate devices.
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The letter is a regulatory approval, not a technical report detailing the performance evaluation of the device.
Therefore, I cannot provide the requested information from the given input.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with three waving lines emanating from it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 10 1998
Mr. David H. Mueller Requlatory Affairs Manager Medtronic, Inc. Neurological Division 800 53rd Avenue, N.E. Minneapolis, Minnesota 55421
K982902 Re :
Trade Names: Model 3425 X-trel Transmitter, Model 3465 RF Receiver/Extension, Model 3586 Lead, Model 3625 Screener, Model 3470 X-trel Receiver, Model 7495 Extension, Model 7496 Extension, Model 3587A Lead, Models 3987/3988 On-Point Lead, Model 3080 Lead, Model 3990 Half-Cuff Lead, Model 3272 Mattrix Receiver, Model 3210 Mattrix Transmitter, Model 3627 Screener, 100% Ethylene Oxide Sterilization, Model 3650 Adapter, Model 3628 Screener, Models 3273/3274 RF Receiver, and Models 3629/3630 Screener Requlatory Class: II Product Code: GZF Dated: August 13, 1998 August 14, 1988 Received:
Dear Mr. Mueller:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 aqainst misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major requlations affecting your devices 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug
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Paqe 2 - Mr. David H. Mueller
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 devices 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.
This letter will allow you to begin marketing your devices as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Scotty
Colin M. Wittner, Ph.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
Enclosures
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1582902 510(k) Number (if known)
Device Name:_Peripheral Nerve Stimulator for Pain - Multiple Devices
Indications for Use:
Peripheral nerve stimulate electrically a peripheral nerve in patients to relieve severe intractable pain. In order to maintain consistency between products, this indication will be used for all Medicated devices.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1/2/96)
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icolleto
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number Kg 82902
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).