(35 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard neurophysiological monitoring techniques (EMG, electrical stimulus).
No
The device is used for monitoring and locating nerves during surgery, not for treating a disease or condition.
No
This device is for monitoring nerve activity during surgery to assist the surgeon in locating and mapping motor nerves. While it provides information, its primary role is not to diagnose a patient's condition or disease but rather to guide surgical 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." This indicates the presence of 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" during surgical procedures. This involves monitoring physiological signals directly from the patient's body.
- Device Description: The description details a "multi-channel intraoperative neurophysiological monitor" that connects to patient electrodes and provides electrical stimulus. This is consistent with a device used for in-vivo monitoring.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body. IVDs are specifically designed for testing these types of samples.
Therefore, this device falls under the category of a medical device for in-vivo monitoring and stimulation, not an in-vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ETN, IKN, GWF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal nerve roots, cranial and peripheral motor nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, 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.
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.
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
§ 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.
0
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
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.
1
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.
2
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.
3
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
4
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)