This device is intended for use in surgical procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves. This device is indicated for locating and identifying cranial and peripheral motor nerves during surgery, including spinal nerve roots.

Device Description

NIM Spine is a multi-channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying electrical stimulus for evoked responses. The monitoring console uses both video and audio output. Responses monitored with the device may originate from operator applied electrical stimulus or from direct or indirect mechanical stimulus occurring during the course of the surgery. Acquired data may be stored on various types of durable media, and hard copy may be obtained via an optional printer.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Xomed NIM Spine device, an intraoperative neurophysiological monitor. It aims to establish substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or a study demonstrating that the device meets such criteria.

The 510(k) summary focuses on device description, indications for use, and a comparison to predicate devices to prove substantial equivalence. It does not detail performance metrics, study designs, sample sizes, or ground truth establishment relevant to the questions asked.

Therefore, I cannot provide the requested information from the given text. A 510(k) summary often summarizes performance data presented in the full 510(k) submission, but this particular summary does not include that level of detail.

Summary

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JUN 1 8 2003

510(k) Summary

Date Prepared 1.0

March 22, 2003

Submitter (Contact) 2.0

Martin D. Sargent Regulatory Affairs Manager Medtronic Xomed Jacksonville, FL (904) 279-7586

3.0 Device Name

Proprietary Name:	NIM Spine (The tradename has not been finalized at this time)
Common Name(s):	Nerve Integrity Monitor, Intraoperative Electromyographic(EMG) Monitor, Nerve locator / stimulator
Classification Name(s):	Nerve locator / stimulator, Electromyographic (EMG) Monitor

4.0 Device Classification

Classification Name:	Nerve locator / stimulator,	Electromyographic (EMG) Monitor
Procode 77ETN	Class II	21 CFR § 874.1820
Procode 89IKN	Class II	21 CFR § 890.1375
Procode 84GWF	Class II	21 CFR § 882.1870

5.0 Device Description

6.0 Indications for Use

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510(k) Summary (continued)

7.0 Substantial Equivalence

The indications, basic instrumentation, design, technology, system features, functions, and principle of operation of the NIM Spine are substantially equivalent to the Nicolet Viking IV, (K923315, 890495, K880573,K842956) described as used with the Nicolet Bravo system, (K991054) and Neurosign 800 devices.

The Monopolar Stimulating Instrumentation is equivalent to Medtronic Xomed's Stimulus / Dissection Instrumentation, cleared via K014165.

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Image /page/2/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name encircling a stylized eagle-like symbol. The symbol is composed of three curved lines that suggest the shape of a bird in flight.

Public Health Service

JUN 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Xomed c/o Mr. Robert Mosenkis Citech 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K031510

Trade/Device Name: NIM Spine Regulation Number: 21 CFR 874.1820, 21 CFR 890.1375, 21 CFR 882.1870 Regulation Name: Surgical nerve stimulator/locator Diagnostic electromyography Evoked response electrical stimulator Regulatory Class: II Product Code: ETN, IKN, GWF Dated: June 9, 2003 Received: June 9, 2003

Dear Mr. Mosenkis:

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 (OS) 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. Robert Mosenkis

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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Ko31510 510(k) Number (if known): NIM Spine Device Name: Indications for Use:

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

General. Restorative and Neurological Devices

510(k) Number K031510

Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
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.(b)
Classification. Class II.