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510(k) Data Aggregation

    K Number
    K243636
    Device Name
    Neuralytix iD3 System (NTX-9001)
    Manufacturer
    Neuralytix LLC
    Date Cleared
    2025-06-26

    (213 days)

    Product Code
    PDQ, ETN
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neuralytix LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 is intended to identify relative changes in the conduction and neural transmission ability of the nerve throughout a surgical procedure by measuring and comparing the minimum amount of electrical stimulation current (mA) required to induce a measurable MMG response (MMG nerve response threshold). Examples of surgical applications which may require mechanomyographic (MMG) monitoring: - Minimally invasive and open spinal surgery involving spinal fusion cages, screws, rods, plates, discs and biologics. - Minimally invasive, open and endoscopic, direct and indirect nerve decompressions, discectomies, laminectomies, laminotomies, facetectomies, foraminotomies. - Treatment of nerve compression, stenosis, degenerative disc disease, disc herniation, spondylolisthesis.
    Device Description
    The Neuralytix iD3 System is a multichannel device for locating, mapping and assessing the status of motor nerves during surgical procedures. Neuralytix alerts the user of recorded mechanical activity (termed mechanomyography, or MMG) from muscles innervated by affected nerves, which may originate from operator applied electrical stimulus. The device will assist with nerve identification and assessment by alerting the surgeon when monitored nerves are activated. The device will also assist with tracking the status of monitored nerves throughout the course of surgical intervention. Neuralytix is especially useful in helping assess a patient's neurophysiologic status by measuring and identifying nerve response thresholds, or the minimum amount of electrical current (mA) necessary to elicit an MMG response. Neuralytix enables intuitive controls for measuring, recording and comparing nerve response thresholds throughout a surgical procedure to provide insights to the user as to how the conduction and neural transmission ability of a nerve may change throughout surgery.
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