K Number
K024316
Device Name
NIM-PRS
Date Cleared
2003-01-06

(11 days)

Product Code
Regulation Number
890.1375
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

No
The summary describes a standard intraoperative neurophysiological monitor using EMG signals and electrical stimulus, with no mention of AI or ML capabilities.

No
The device is used for monitoring nerve activity during surgery to assist the surgeon, not for treating a condition or disease.

Yes

The device aids in locating and mapping motor nerves using electromyographic (EMG) signals and electrical stimulus, providing information to assist the surgeon during procedures.

No

The device description explicitly states it is a "multi-channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying electrical stimulus for evoked responses," indicating it includes hardware components beyond just software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "patient-connected intraoperative nerve monitoring" and assists in "locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves." This involves monitoring physiological signals directly from the patient during surgery.
  • Device Description: The description reinforces this by mentioning connecting "patient monitoring electrodes" and supplying "electrical stimulus for evoked responses." It focuses on monitoring electrical activity within the patient's body.
  • IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not analyze samples taken from the body; it monitors signals within the body.

Therefore, this device falls under the category of a medical device used for physiological monitoring and nerve stimulation during surgery, not an in vitro diagnostic device.

N/A

Intended Use / 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."

Product codes (comma separated list FDA assigned to the subject device)

77ETN, 89IKN

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."

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

"surgical procedures"

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K982595

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 890.1375 Diagnostic electromyograph.

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

0

510(k) Summary

1.0 Date Prepared

January 2, 2003

2.0 Submitter (Contact)

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

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
(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
ProcodeClass
77ETNII21 CFR § 874.1820
89IKNII21 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.

1

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

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

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

3

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 (301) 594-4692. 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). 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,
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

4

510(k) Number (if known): 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)