(128 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard neurophysiological monitoring techniques without mentioning AI/ML capabilities.
No
The device is described as a monitor intended for locating and identifying nerves and monitoring responses during surgery, not for treating a condition.
No
Explanation: The device is described as an intraoperative neurophysiological monitor used for locating and identifying nerves and monitoring evoked responses during surgery. Its primary function is to assist surgeons by providing real-time information about nerve function and location, rather than diagnosing a disease or condition. The "Indications for Use" specify procedures where it's used for monitoring, not for diagnostic purposes.
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, the NIM 3.0 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- NIM 3.0 Function: The NIM 3.0 is described as an intraoperative neurophysiological monitor that uses electrical stimulation and monitors electrical responses from nerves within the patient's body during surgery. It is used for locating and identifying nerves in vivo.
- Lack of Specimen Analysis: There is no mention of the NIM 3.0 analyzing any specimens derived from the human body. Its function is based on direct interaction with the patient's nervous system during a surgical procedure.
Therefore, the NIM 3.0 falls under the category of a medical device used for monitoring and guidance during surgery, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NIM 3.0 is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.
Indications for NIM 3.0 EMG Monitoring Procedures include: Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities
Indications for Spinal procedures which may use NIM 3.0 EMG monitoring include:
Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures, and Thoracic Surgical Procedures.
Product codes
GWF, ETN
Device Description
NIM 3.0 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial, peripheral (motor and mixed motor-sensory nerves), spinal cord, spinal nerve roots, Intracranial, Extracranial, Intratemporal, Extratemporal, Neck, Thoracic, Upper and Lower Extremities, Lumbar, Cervical
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
FEB 2 7 2009
C083124/
510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS FOR
Nerve Integrity Monitor 3.0
510(k) Owner
Medtronic Xomed, Inc 6743 Southpoint Drive North Jacksonville, Florida 32216-0980 USA 904-296-9600 904-296-2386 (FAX)
Contact Name
Jayme Wilson Senior Regulatory Affairs Specialist Medtronic Xomed, Inc
Date Summary Prepared
October 21, 2008
Nerve Stimulator
Proprietary Name
Common Name
Classification Name
Evoked response electrical stimulator (21 CFR 882.1870. Product Code GWF. Class II) Surgical nerve stimulator/locator (21 CFR 874.1820. Product Code ETN. Class II)
Nerve Integrity Monitor 3.0 (Final name TBD)
Marketed device claiming equivalence to
The Medtronic Nerve Integrity Monitor 3,0 and accessories are substantially equivalent to the Medtronic NIM Spine (K031510) and the NIM PRS (K024316).
Device Description
NIM 3.0 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.
Intended Use
The NIM 3.0 is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.
1
Indications for Use
Indications for NIM 3.0 EMG Monitoring Procedures include: Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities
Indications for Spinal procedures which may use NIM 3.0 EMG monitoring include:
Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures, and Thoracic Surgical Procedures.
Substantial Equivalence
The indications, design, technology, functions, and principle of operation of the NIM 3.0 are substantially equivalent to the NIM Spine (K031510) and the NIM PRS (K024316).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem of an eagle.
Public Health Service
FEB 2 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Xomed, Inc. % Ms. Jayme Wilson Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, FL 32216-0980
Re: K083124
Trade/Device Name: Xomed Nerve Integrity Monitor 3.0 Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF. ETN Dated: February 17, 2009 Received: February 18, 2009
Dear Ms. Wilson:
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 (QS) 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
3
Page 2 - Ms. Jayme Wilson
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
. Pik Dothan Ave D.e
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Nerve Integrity Monitor 3.0 (Final name to be determined)
Indications for Use:
The NIM 3.0 is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.
Indications for NIM 3.0 EMG Monitoring Procedures include: Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities
Indications for Spinal procedures which may use NIM 3.0 EMG monitoring include:
Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures, and Thoracic Surgical Procedures.
Prescription Use X AND/OR
Over-The-Counter Use
4 - 1
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dlo. Thim Ruma
(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of General Devices 160 83124
510(k) Number