NIM-SPINE

K031510 · Medtronic Xomed · ETN · Jun 18, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K031510
• Device Name: NIM-SPINE
• Applicant: Medtronic Xomed
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Jun 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 Story

NIM Spine is a multi-channel intraoperative neurophysiological monitor; used in surgical settings by surgeons/clinicians. Device inputs include EMG signals from patient-connected electrodes and electrical stimuli (applied by operator or mechanical stimulus during surgery). System processes these inputs to provide real-time monitoring of nerve integrity. Outputs include audio and video signals representing nerve activity; data can be stored on durable media or printed. Device assists surgeons in identifying and mapping motor nerves; helps prevent nerve damage during procedures. Clinical benefit includes improved surgical precision and nerve preservation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Multi-channel intraoperative neurophysiological monitor; includes electrical stimulator and EMG monitoring capabilities. Features video and audio output interfaces. Supports connection of various patient-monitoring electrodes. System allows for data storage and printing. Operates as a nerve locator/stimulator and EMG monitor.

Indications for Use

Indicated for patients undergoing surgery requiring intraoperative monitoring of cranial and peripheral motor nerves, including spinal nerve roots, to assist surgeons in nerve location and mapping.

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

• Nicolet Viking IV (K923315, 890495, K880573, K842956)
• Nicolet Bravo system (K991054)
• Neurosign 800
• Medtronic Xomed Stimulus / Dissection Instrumentation (K014165)

Submission Summary (Full Text)

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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 [phone]

#### 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<br>(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

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.

# 6.0 Indications for Use

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.

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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 [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" (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 [phone] or [phone] 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:

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.

(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

Or

510(k) Number K031510

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

(Optional Format 1-2-96)