NIM-PRS

K024316 · Medtronic Xomed, Inc. · IKN · Jan 6, 2003 · Physical Medicine

Device Facts

• Record ID: K024316
• Device Name: NIM-PRS
• Applicant: Medtronic Xomed, Inc.
• Product Code: IKN · Physical Medicine
• Decision Date: Jan 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

This device is indicated 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.

Device Story

NIM PRS is multi-channel intraoperative neurophysiological monitor; used in surgical settings by surgeons/clinical staff. Device inputs: EMG signals from patient-connected electrodes; electrical stimulus applied by operator or mechanical stimulus during surgery. Device transforms inputs into real-time audio/video alerts indicating nerve activity. Output: visual/auditory feedback to surgeon; data storage on durable media; optional hard copy printouts. Clinical utility: assists in nerve identification/mapping; helps prevent nerve damage during surgery. System features 8 monitoring channels and 2 stimulators (0-30 mA and 0-120 mA).

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing, including compliance with IEC 60601-1 electrical safety standards.

Technological Characteristics

Multi-channel intraoperative neurophysiological monitor; 8 EMG channels; 2 electrical stimulators (0-30 mA and 0-120 mA); audio/video output; durable media storage; optional printer; complies with IEC 60601-1 electrical safety standards.

Indications for Use

Indicated for patients undergoing surgical procedures requiring intraoperative nerve monitoring to assist surgeons in locating and mapping motor nerves via EMG signals and electrical nerve stimulation.

Regulatory Classification

Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

Predicate Devices

• Medtronic Xomed NIM-4 (K982595)

Submission Summary (Full Text)

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# 510(k) Summary

#### 1.0 Date Prepared

January 2, 2003

#### 2.0 Submitter (Contact)

Martin D. Sargent Regulatory Affairs Manager Medtronic Xomed Jacksonville, FL [phone]

#### 3.0 Device Name

| Proprietary Name: | NIM PRS (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 |

#### Device Classification 4.0

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

#### 5.0 Device Description

NIM PRS 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 to alert the user of EMG responses during a surgical procedure. EMG responses monitored with the device may originate from operator applied electrical stimulus or from direct 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.

#### Indications for Use 6.0

This device is indicated 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.

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# 510(k) Summary (continued)

### 7.0 Substantial Equivalence

The basic instrumentation, design, technology, system features, functions, and the principle of operation of the NIM-PRS are substantially equivalent to the Medtronic Xomed NIM-4 (K982595).

| Characteristic | NIM-4 (K982595)<br>(Tradename NIM-Response) | NIM-PRS<br>(Proposed device) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|------------------------------------------------------------------|
| Multi-channel intraoperative<br>neurophysiological monitor | Yes<br>(4 channels) | Yes<br>(8 channels) |
| Indicated for use in surgical<br>procedures for patient-connected<br>intraoperative nerve monitoring,<br>i.e. assisting the surgeon in<br>locating and mapping motor<br>nerves through the use of elec-<br>tromyographic (EMG) signals and<br>electrical stimulus of nerves | Yes | Yes |
| Complies with IEC 60601-1<br>electrical safety standards | Yes | Yes |
| Capable of connecting various<br>styles of patient monitoring<br>electrodes | Yes | Yes |
| Capable of supplying electrical<br>stimulus for evoked responses | Yes<br>(1 stimulator 0 - 3 mA) | Yes<br>(2 stimulators 0 - 30 mA and<br>0 - 120 mA) |
| Capable of connecting various<br>styles of patient stimulating<br>electrodes | Yes | Yes |
| Uses both video and audio output<br>to alert the user of EMG responses<br>during a surgical procedure | Yes | Yes |
| Monitors EMG responses origi-<br>nating from operator applied<br>electrical stimulus | Yes | Yes |
| Monitors EMG responses origi-<br>nating from direct or indirect<br>mechanical stimulus | Yes | Yes |
| Acquired data may be printed on<br>hard copy via an optional printer | Yes | Yes<br>(May also be stored on various<br>types of durable media) |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 6 2003

Medtronic Xomed c/o Robert Mosenkis CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298

Re: K024316

Trade/Device Name: NIM-PRS Regulation Number: 21 CFR 874.1820; 21CFR890.1375 Regulation Name: Stimulator, Nerve; Electromyograph, Diagnostic Regulatory Class: Class II Product Code: ETN; IKN Dated: December 24, 2002 Received: December 26, 2002

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

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### Page 2 - Robert Mosenkis

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. 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). 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,
A. Ralph Rosenthal

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

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510(k) Number (if known): < O 2 4 3 16 NIM PRS Device Name: Indications for Use:

> This device is indicated 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.

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

Euch. Thum, m.

**510(k) Number** K024316

Prescription Use (Per 21 CFR 801.109)

Or

Over-the-Counter Use __

(Optional Format 1-2-96)