NIM Vital Nerve Integrity Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200759 FDA 510(k)
- FDA Product Code
- GWF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1870 FDA 510(k)
- Regulation Number
- 882.1870 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NIM Vital Nerve Integrity Monitor is an Electrical Stimulator, Evoked Response device designed to assess nerve function intraoperatively. It stimulates peripheral nerves to elicit muscle contractions, then records and displays the resulting electrical signals as graphical and auditory outputs. This enables real-time confirmation of nerve integrity during surgical procedures, particularly in high-risk areas such as spinal, peripheral, or cranial nerve surgeries.
The system is supplied as a reusable medical device and is intended for use in operating room environments. It includes stimulation probes and electrodes for nerve localization and monitoring, with outputs displayed on a dedicated console. The device is classified as Class II under FDA regulations and holds a 510(k) clearance for substantial equivalence. No MRI safety classification or sterility specifications are provided in the data.
Frequently asked questions
What types of surgical procedures is the NIM Vital Nerve Integrity Monitor primarily used for during surgery?
The NIM Vital is designed to assess nerve function intraoperatively in high-risk surgical areas, particularly during spinal, peripheral, or cranial nerve surgeries. It stimulates peripheral nerves to elicit muscle contractions and records the resulting electrical signals, allowing real-time confirmation of nerve integrity during these procedures.
Is the NIM Vital Nerve Integrity Monitor a single-use or reusable device, and how is it supplied?
The NIM Vital is supplied as a reusable medical device. It includes a dedicated console for displaying outputs, along with stimulation probes and electrodes for nerve localization and monitoring, all intended for use in operating room environments.
What regulatory pathway was followed for the FDA clearance of the NIM Vital, and what does this mean for its intended use?
The NIM Vital received FDA clearance through a 510(k) pathway, specifically under the Traditional review process with a decision of Substantially Equivalent (SESE). This means the device was determined to be substantially equivalent to a legally marketed predicate device in terms of technology and safety, confirming its compliance with FDA regulations for electrical stimulators and evoked response devices. The clearance does not specify clinical indications but confirms its regulatory status for nerve monitoring.
Does the NIM Vital come with specific electrode or probe sizes, and how might this affect its use in different surgical cases?
The device includes stimulation probes and electrodes for nerve localization and monitoring, though the exact sizes or models are not detailed in the provided data. These components are likely designed to accommodate various anatomical and surgical needs, including spinal, peripheral, and cranial nerve procedures. Clinicians should refer to the manufacturer’s instructions for compatibility with specific surgical cases.
How is the NIM Vital intended to be stored, and are there any special handling requirements mentioned?
The NIM Vital is a reusable device intended for operating room use, but specific storage instructions (e.g., temperature, humidity, or cleaning protocols) are not provided in the data. Standard medical device storage practices—such as keeping it in a clean, dry environment and following manufacturer guidelines for maintenance—should be followed to ensure proper functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NIM Vital™ nerve monitoring system - Medtronic, NIM Vital™ nerve monitoring system - Medtronic, Medtronic Nerve Integrity Monitor User Manual: NIM Vital Console..., PDF Nerve Integrity Monitor - FCC ID Search
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200759 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA 510(k) K200759 24 fields · synced Oct 6, 2026