NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR

K991583 · The Magstim Company , Ltd. · ETN · May 19, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K991583
• Device Name: NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
• Applicant: The Magstim Company , Ltd.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: May 19, 1999
• 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 is an EMG machine and nerve stimulator used to monitor and stimulate cranial motor nerves during ENT and intra-cranial procedures. System comprises a central control unit, pre-amplifier pod, and intramuscular or surface electrodes for EMG recording; includes a stimulator pod with a probe for delivering current to nerve tissue. Operated by clinicians in surgical settings. Device detects EMG activity in muscles innervated by cranial nerves to assist surgeons in nerve identification and localization. Output provides real-time monitoring of nerve activity, aiding clinical decision-making during surgery to potentially benefit patients by preserving nerve function.

Clinical Evidence

No clinical data provided. Safety and effectiveness established through in-house and on-site clinical evaluations and the historical performance of predicate devices.

Technological Characteristics

EMG machine and nerve stimulator. Components: central control unit, pre-amplifier pod, stimulator pod, and electrodes (intramuscular or surface). Sensing principle: EMG recording of muscle activity. Actuation principle: electrical stimulation of nerve tissue via probe. Connectivity: not specified. Sterilization: not specified.

Indications for Use

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

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.

Predicate Devices

• Neurosign 800 Nerve Monitor (K964869)
• Neurosign 100 Nerve Monitor (K923056/A)

Submission Summary (Full Text)

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Neurosign 400 Motor Nerve Monitor Special 510(k)

## Section 3: Summary of Safety and Effectiven

## Neurosign 400 Motor Nerve Monitor

The Neurosign 400 is an EMG machine and nerve stimulator. The machine consists of a central control unit to which a pre-amplifier pod and intramuscular, or surface, electrodes are attached for EMG recordings. Additionally, connected to the main unit is a stimulator pod to which a stimulating probe, which delivers current to nerve tissue, may be connected.

The Neurosign 400 is intended to monitor and to stimulate cranial motor nerves. Cranial motor nerves are monitored by detecting EMG activity in the muscles they innervate.

The Neurosign 400 is similar to the following products which are currently in commercial distribution in the U.S.A.

Neurosign 800 Nerve Monitor, The Magstim Company, K964869 Neurosign 100 Nerve Monitor. The Magstim Company. K923056/A

The safety and effectiveness of the Neurosign 400 has been established through various techniques. The history of the similar products listed above lacks complaints related to safety and effectiveness, and as far as we are aware there have been no reports of adverse effects or reportable incidents connected with them, or in any published papers on nerve monitoring.

The Magstim Company performs extensive in-house an on-site clinical evaluation of all its products, both prior to, and after product release for distribution. Our methods and procedures for acceptance of products as well as our techniques for clinical evaluation are performed using team participation. Team members include, but are not limited to, Marketing, Manufacturing, Engineering and Quality Assurance. The Neurosign 400 has met all the specifications and expectations for its intended use based on the evaluations conducted thus far.

The materials and methods used to manufacture the Neurosign 400 do not vary from the current materials and methods used by the Magstim Company in the manufacture of the Neurosign 800. We will incorporate new, proven technologies as they become available; however, these improvements support product performance through greater reliability.

The Magstim Company concludes that the Neurosign 400 is safe and effective for its intended use. Clinical evidence in support of this statement is presented in Section 9 of this application.

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Image /page/1/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 a stylized image of an eagle with three stripes representing the bird's wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 1999

Dr. Reza Jalinous The Magstim Co. Ltd. 730 Fifth Ave., 9th Floor New York, New York 10019

Re: K991583 Trade Name: Neurosign 400 Motor Nerve Monitor Regulatory Class: II Product Code: 77 ETN Dated: April 29, 1999 Received: May 7, 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 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 - Dr. Reza Jalinous

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/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal. M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## CATION CALINDICATIONS FOR USE

510(k) Number (if known): 12991583

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1. Sales of the same

Device Name:

Neurosign 400, 4 channel Motor Nerve Monitor

11. 11. 11. Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------|---------|
| Division of Ophthalmic Devices | |
| 510(k) Number | K991583 |

| Prescription Use:<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use: |
|-------------------------------------------|----|-----------------------|
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Prescription Use:
(Per 21 CFR 801.109)