Neuralytix iD3 System (NTX-9001)
Neuralytix LLCThe Neuralytix iD3 System is a surgical nerve stimulator and locator that helps surgeons find and monitor motor nerves during surgery by measuring muscle responses to electrical stimulation. It uses mechanomyographic signals to assess nerve function in real-time, enabling safer and more effective surgical interventions involving nerve mapping and monitoring.
Intended Use
This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure. The device identifies relative changes in the conduction and neural transmission ability of the nerve by measuring minimum electrical stimulation current (mA) needed to induce a measurable MMG response.
Technology
The Neuralytix iD3 System is a multichannel device that uses electrical stimulation and mechanomyographic sensors (accelerometers) to detect muscle activity in response to nerve stimulation. It provides real-time visual and auditory alerts to the surgeon through a touchscreen graphical user interface, measuring nerve response thresholds with digitally controlled stimulation currents. The device includes disposable sensor patches and stimulation probes made of biocompatible materials, functioning through constant current monophasic rectangular pulses.
Performance
Non-clinical testing was conducted including design controls, risk management, electrical safety, software validations, biocompatibility, and comparative performance against predicate device Sentio MMG Gen 2. The device demonstrated >99% agreement in MMG signal detection with the predicate, passed sterility and packaging integrity tests, and met all acceptance criteria for electrical, environmental, and user interface performance, confirming substantial equivalence and safe function.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/25/2024
7 months - 2
FDA Approval
6/26/2025
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