PERIPHERAL NERVE STIMULATION

K982902 · Medtronic Vascular · GZF · Nov 10, 1998 · Neurology

Device Facts

• Record ID: K982902
• Device Name: PERIPHERAL NERVE STIMULATION
• Applicant: Medtronic Vascular
• Product Code: GZF · Neurology
• Decision Date: Nov 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

System comprises various peripheral nerve stimulation components including transmitters, receivers, extensions, leads, screeners, and adapters. Devices function by delivering electrical stimulation to peripheral nerves to manage severe intractable pain. Operated by clinicians in a medical setting; components are implanted or connected to facilitate stimulation therapy. System provides electrical output to target nerves; intended to alleviate patient pain. Sterilization via 100% ethylene oxide.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device characteristics and intended use.

Technological Characteristics

Peripheral nerve stimulation system components including transmitters, receivers, leads, and screeners. Sterilization: 100% Ethylene Oxide. Regulatory Class: II. Product Code: GZF.

Indications for Use

Indicated for patients suffering from severe intractable pain requiring electrical stimulation of a peripheral nerve.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number Kg 82902