NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800

K053141 · The Magstim Company , Ltd. · ETN · Dec 14, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K053141
• Device Name: NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800
• Applicant: The Magstim Company , Ltd.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Dec 14, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

To locate and identify cranial motor nerves during ENT and intra-cranial procedures.

Device Story

Neurosign 400 and 800 are motor nerve monitors used during ENT and intra-cranial surgeries. Device functions by providing electrical stimulation to tissues to locate and identify cranial motor nerves; monitors resulting muscle activity. Used by surgeons in the operating room to assist in nerve preservation during procedures. Output provided to the clinician to guide surgical decision-making and prevent nerve damage.

Clinical Evidence

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

Technological Characteristics

Surgical nerve stimulator/locator; electrical stimulation output; monitors muscle response; intended for ENT and intra-cranial procedures. Class II device.

Indications for Use

Indicated for use in locating and identifying cranial motor nerves during ENT and intra-cranial surgical procedures. Prescription use only.

Regulatory Classification

Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized symbol featuring three abstract, curved shapes that resemble an abstract caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2005

The Magstim Company LTD c/o Mr. Chris Lewis Spring Gardens Whitland, Dyfed Wales United Kingdom SA34 OHR

Re: K053141

Trade/Device Name: Neurosign Nerve Monitor, Models Neurosign 400 and Neurosign 800 Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: November 1, 2005 Received: November 9, 2005

Dear Mr. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Chris Lewis

This letter will allow you to begin marketing your device as described in your Section 510(k) I his ictier will anow you to ogin maneness your alence of your device of your device to a legally prematics notification: "The PDF intemsgssification 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), please If you desire spocents at [phone]. Also, please note the regulation entitled, Comation of Compilance and (set notification" (21CFR Part 807.97). You may obtain Milsoranding of reference to premiers on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Neurosign Motor Nerve Monitor Special 510(k)

## Indications for Use

510(k) Number (if known): K053141

Device Name: ___ Neurosign Motor Nerve Monitor

Indications for Use:

To locate and identify cranial motor nerves during ENT and intra-cranial procedures.

Prescription Use _ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

. . . . . ... . . . . . . . . . . . Section and the considered Concurrence of CDRH, Office of Device Evaluation (ODE)

and and the security the country and the comments of

**Prescription Use**
(Per 21 CFR 801.109)

*(Division Sign-Off)*

sion of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K053171