NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR

K980148 · The Magstim Company , Ltd. · ETN · Aug 5, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K980148
• Device Name: NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
• Applicant: The Magstim Company , Ltd.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Aug 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

To locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots.

Device Story

Neurosign 800 is an 8-channel motor nerve monitor used during surgery. It functions by detecting and monitoring electrical activity associated with motor nerves to assist surgeons in locating and identifying cranial and peripheral nerves, including spinal nerve roots. The device provides real-time feedback to the surgeon, allowing for nerve preservation during procedures. It is intended for use by trained medical professionals in an operating room environment. By providing continuous monitoring, the device helps reduce the risk of iatrogenic nerve injury, potentially improving patient outcomes by minimizing post-operative neurological deficits.

Clinical Evidence

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

Technological Characteristics

8-channel motor nerve monitor; electronic device for nerve stimulation and signal detection; intended for surgical use; class II device (Product Code: ETN).

Indications for Use

Indicated for use in surgical settings to locate and identify cranial and peripheral motor nerves, including spinal nerve roots, in patients undergoing 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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 5 1998

Mr. Chris Hovey Product Manager The Magstim Company, Ltd. Spring Gardens, Whitland Carmarthenshire, SA34 OHR Wales, United Kingdom

Re: K980148 Trade Name: Neurosign 800. 8 Channel Motor Nerve Monitor Regulatory Class: II Product Code: ETN Dated: July 29, 1998 Received: July 29, 1998

Dear Mr. Chris Hovey:

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 requirement, as set forth in the Quality System Regulation (OS) 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.

{1}------------------------------------------------

Page 2 - Chris Hovey

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,

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page 1 of 1

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Neurosign_800

Indications For Use:

To locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots.

(PLEASE UU NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEFDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|--------|
| Division of General Restorative Devices | |
| 510(k) Number | K98048 |

| Prescription Use <span style="text-decoration: underline;">✓</span><br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use <span style="text-decoration: underline;">_</span><br>(Optional Format 1-2-96) |
|---------------------------------------------------------------------------------------------|----|-----------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------|----|-----------------------------------------------------------------------------------------------------|