MAGSTIM RAPID

K992911 · Magstim Corporation US · GWF · Jan 7, 2000 · Neurology

Device Facts

• Record ID: K992911
• Device Name: MAGSTIM RAPID
• Applicant: Magstim Corporation US
• Product Code: GWF · Neurology
• Decision Date: Jan 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stimulation of peripheral nerves.

Device Story

Magstim Rapid is a magnetic stimulator system used for peripheral nerve stimulation. The device generates magnetic pulses delivered via a Dual 70-mm coil or Circular 90-mm coil to induce electrical currents in nerve tissue. Operated by clinical professionals in a medical setting, the device provides non-invasive stimulation to assist in diagnostic or therapeutic nerve assessment. The output is controlled by the clinician to elicit nerve responses, aiding in the evaluation of peripheral nerve function. The system is designed for clinical use under prescription.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Magnetic stimulator system; includes Dual 70-mm coil and Circular 90-mm coil. Operates via electromagnetic induction to stimulate peripheral nerves. Class II device.

Indications for Use

Indicated for stimulation of peripheral nerves. Prescription use only.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2000

Reza Jalinous, Ph.D. Technical & Clinical Director Magstim Corporation US 730 Fifth Avenue, 9th Floor New York, New York 10019-4105

Re: K992911

> Trade Name: Magstim Rapid (Standard and Super versions) with Dual 70-mm Coil and Circular 90-mm Coil Regulatory Class: II Product Codes: 84 GWF and 84 JXE Dated: December 2, 1999 Received: December 3, 1999

Dear Dr. Jalinous:

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 legally marketed predicate 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 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 - Reza Jalinous, 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 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 device, 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Russell Sage

dro James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(K) Number (if known): K9929 | l Device Name: Magstim Rapid

## Indications for Use:

Stimulation of peripheral nerves.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lennell/m

General

Prescription Use: (Per 21 CFR 801.109)

OR

Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________