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510(k) Data Aggregation

    K Number
    K192873
    Device Name
    SX-One MicroKnife
    Manufacturer
    Sonex Health, Inc.
    Date Cleared
    2019-12-20

    (73 days)

    Product Code
    LXH
    Regulation Number
    888.4540
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K080158,K943873
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sonex Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SX-One MicroKnife is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.

    Device Description

    The Sonex Health SX-One MicroKnife is a mechanical device that uses a blade to manually transect the transverse carpal ligament. The device is provided sterile and intended for single use.

    The SX-One MicroKnife® consists of a thin stainless-steel shaft connected to a handpiece that is designed to be ambidextrous. A lever on the handle is activated to unlock the blade actuator and inflate the two balloons located on the lateral sides of the tip of the device. The blade actuator is used to activate a cutting blade that transects the TCL. The cutting blade is manually moved proximally and distally along a track. The purpose of the blade is to transect the transverse carpal ligament to treat carpal tunnel syndrome.

    AI/ML Overview

    This document describes the Sonex Health SX-One MicroKnife, a manual surgical instrument for carpal tunnel release. The information provided is primarily related to its regulatory clearance (510(k) submission) and does not contain details about acceptance criteria, clinical study results, or AI/software performance.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC studies, as the provided text explicitly states "No clinical data was required" and describes a mechanical device with no mention of AI or software.

    The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance testing related to sterilization, biocompatibility, and shelf life for a mechanical surgical instrument.

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