(128 days)
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.
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.
This is an FDA 510(k) summary for the Medtronic Nerve Integrity Monitor 3.0. A 510(k) summary is submitted to demonstrate substantial equivalence to a predicate device, not necessarily to provide detailed performance data from a clinical study proving specific acceptance criteria.
Based on the provided text, a formal study with detailed acceptance criteria and reported device performance metrics in the format requested was not provided in this 510(k) summary. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting the results of a primary clinical study against specific, quantified acceptance criteria.
The following information is what can be extracted or inferred from the provided text, along with what is explicitly not present.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated or quantified in this 510(k) summary. The summary focuses on demonstrating substantial equivalence based on indications, design, technology, functions, and principle of operation to predicate devices (Medtronic NIM Spine K031510 and NIM PRS K024316).
- Reported Device Performance: Not provided in terms of quantitative metrics against specific acceptance criteria. The narrative indicates the device's capabilities (locating and identifying nerves, monitoring responses from applied electrical or mechanical stimulus), but no performance outcomes (e.g., sensitivity, specificity, accuracy, or other quantifiable measures) from a study are included.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided.
- Data Provenance: A specific test set or study data is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Experts and Qualifications: Not applicable, as a test set requiring ground truth establishment by experts is not described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable, as a test set or study requiring adjudication is not described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not applicable. This device is a nerve integrity monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" in the context of imaging. It's an intraoperative neurophysiological monitor.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an "algorithm only" study as might be conducted for AI software. The device is a hardware system with integrated monitoring capabilities. Its performance is inherent to its function, but a "standalone" study in the AI sense is not described. The device's operation is intended for use by a clinician during surgery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable, as a formal study requiring ground truth for performance evaluation is not described. The device's function involves real-time physiological monitoring, where the "truth" is the presence or absence of nerve activity in response to stimulation, directly observed or inferred by the operating surgeon based on the monitor's output.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning algorithm requiring a "training set" in the typical sense for AI development.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Summary of what is present:
The 510(k) summary indicates that the Medtronic Nerve Integrity Monitor 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." It claims substantial equivalence to two predicate devices (Medtronic NIM Spine K031510 and NIM PRS K024316) based on "indications, design, technology, functions, and principle of operation." This suggests that the "acceptance criteria" and "proof" are based on the device's similarity to already cleared devices, rather than a new de novo clinical study with quantified performance metrics against explicit acceptance criteria.
{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
§ 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).