(39 days)
No
The summary describes improvements focused on user interface, signal quality, documentation options, and cost reduction using state-of-the-art components. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No.
The device's intended use is for nerve monitoring to assist surgeons in locating and mapping motor nerves using EMG signals, which is a diagnostic/monitoring function, not a therapeutic intervention.
Yes
This device assists the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals, which is a diagnostic function to monitor nerve integrity during surgical procedures.
No
The device description explicitly states it is a "Nerve Integrity Monitor" and describes changes to "componentry," indicating it is a hardware device with software components, not a software-only device.
Based on the provided text, 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 direct interaction with a living patient during surgery.
- 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 operate on such samples.
- Device Description: The description focuses on the device's function in monitoring nerve signals and providing documentation options, all within the context of a surgical procedure on a patient.
Therefore, the device described is a medical device used for intraoperative nerve monitoring, 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
77 ENT, 89 CAB
Device Description
The purpose of this 510(k) is to notify the FDA of changes that are intended to be made to the currently marketed NIM-2XL Nerve Integrity Monitor. As previously mentioned, these changes serve to improve the NIM-2XL even further: to make the device more "user friendly" and simplify its use, provide a cleaner, higher quality signal, provide additional options for documentation (printer, disk drive, and video-out) and to lower the overall cost of the system through the use of state-of-the-art componentry. Other than the changes specifically described in this notification, the device remains the same as previously provided in K934426.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary NIM Monitor
-
1.0 Date Prepared July 22, 1998
SEP - 4 1998 -
2.0 Submitter (Contact) David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532
3.0 Device Name
Proprietary Name:
NIM4 (The product's trade name has not been finalized and may be changed at a later date.)
Nerve Integrity Monitor, Intraoperative Electromyographic (EMG) Common Name(s): Monitor. Nerve locator / stimulator
Nerve locator / stimulator, Electromyographic (EMG) Monitor Classification Name:
Device Classification 4.0
Nerve locator / stimulator Procode 77 ENT Class II ; 21 CFR 874.1820
Electromyographic (EMG) Monitor 21 CFR 874.4140 Procode 89 CAB Class II :
5.0 Device Description
The purpose of this 510(k) is to notify the FDA of changes that are intended to be made to the currently marketed NIM-2XL Nerve Integrity Monitor. As previously mentioned, these changes serve to improve the NIM-2XL even further: to make the device more "user friendly" and simplify its use, provide a cleaner, higher quality signal, provide additional options for documentation (printer, disk drive, and video-out) and to lower the overall cost of the system through the use of state-of-the-art componentry. Other than the changes specifically described in this notification, the device remains the same as previously provided in K934426.
6.0 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.
1
7.0 Substantial Equivalence
The added features described in this notification do not present any significant differences when compared to the currently marketed NIM-2XL Nerve Integrity Monitor. They do not change the intended use of the device and only serve to compliment the current system operation. The Hazard Analysis, included with the software validation, confirms that the proposed modifications present no greater risks than those associated with the current system. If anything, it is expected that the majority of the changes will aid in lowering the risk through simplification of use and cleaner signals.
Conclusion: The proposed NIM4 Nerve Integrity Monitor that is described in this notification, has the same intended use and the same basic technological characteristics as the previously cleared device; and, does not raise any new issues of safety or effectiveness.
2 2 8
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David Timlin Manager, Regulatory Affairs Xomed. Inc. 6743 Southpoint Drive, N. Jacksonville, Florida 32216-0980 Re:
K982595 NIM (Nerve Integrity Monitor) Dated: July 24, 1998 Received: July 27, 1998 Regulatory Class: II 21 CFR 874.1820/Procode: 77 ETN
Dear Mr. Timlin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510%) premarket notification. The FDA finding of substantial oquivalence 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".
Sincerely yours,
Kilian Yi
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/2/Picture/14 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The letters "SEP" are in the bottom right corner of the image.
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
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)
Elvin L. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982595
Or Over-t
Prescription Use _ (Per 21 CFR 801.109) Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)