C2 NerveMonitor System

• 2 recalls, same reason

  • Terminated Z-0024-2020 FDA Class II ·initiated 31 Jul 2019
  • Terminated Z-0023-2020 FDA Class II ·initiated 31 Jul 2019

  Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.

510(k) Number

K152505 ↗

FDA product code

ETN

Device class

Class II

Regulation

21 CFR Part 874.1820

Advisory committee

Ear, Nose, Throat

FDA decision

SESE Substantially Equivalent

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• What types of surgical procedures is the C2 NerveMonitor System primarily used for, and how does it help during these procedures?

  The C2 NerveMonitor System is designed for intraoperative neuromonitoring, specifically to monitor motor and sensory nerve function during surgical procedures. It provides real-time feedback to assess nerve integrity and response to stimulation, helping surgeons prevent intraoperative nerve injury by ensuring precise monitoring of neural pathways. This is particularly useful in procedures where nerve pathways are at risk, such as in ear, nose, and throat surgeries, as indicated by its regulatory classification.

• Is the C2 NerveMonitor System intended for single-use or reusable applications, and what maintenance considerations should be taken into account?

  The C2 NerveMonitor System is supplied as a reusable medical device. As such, it requires adherence to standard protocols for maintenance, calibration, and cleaning as outlined by the manufacturer. Proper storage and handling, following guidelines for non-sterile reusable surgical equipment, are essential to ensure its reliability and longevity in clinical settings.

• What regulatory pathway was followed for the C2 NerveMonitor System, and what does this mean for its use in clinical settings?

  The C2 NerveMonitor System received FDA clearance through a 510(k) submission (K152505), classified as a Class II medical device. This means it has been determined to be substantially equivalent to a legally marketed device and meets regulatory standards for safety and effectiveness. Clinicians can rely on its compliance with FDA requirements, ensuring it is suitable for use in operating rooms where intraoperative neuromonitoring is necessary.

• Does the C2 NerveMonitor System include any specific features that simplify its use during surgery?

  Yes, the C2 NerveMonitor System includes integrated stimulators, a loudspeaker for auditory feedback, a foot switch for hands-free operation, and a mains lead for power. These features are designed to enhance ease of use and real-time monitoring during surgical procedures, allowing surgeons to focus on the operation while maintaining continuous assessment of nerve function.

• What medical specialties are most likely to benefit from using the C2 NerveMonitor System, based on its regulatory classification?

  The C2 NerveMonitor System is most relevant to medical specialties involving procedures where nerve pathways are at risk of injury, particularly those listed under the Ear, Nose, and Throat (ENT) specialty. This classification reflects its primary use in surgeries where precise neuromonitoring is critical, such as those performed by otolaryngologists or neurosurgeons in high-risk anatomical regions.