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510(k) Data Aggregation

    K Number
    K242304
    Device Name
    RED
    Manufacturer
    NeurAxis, Inc
    Date Cleared
    2024-12-06

    (123 days)

    Product Code
    KLA
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeurAxis, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RED is used to evaluate the neuromuscular function of the patient's ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity. RED helps identify patients with rectal hypersensitivity who experience desire or urge-to-defecate at lower volumes of distension. RED is intended to be used in a clinical setting by trained health care providers in adult populations.
    Device Description
    RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. The RED catheter consists of an open-cell foam ball encased inside of a balloon, coupled to a hollow catheter. The insertion end of the device has a rounded tip for comfortable insertion through the anus. Once inserted and opened, the catheter normalizes to atmospheric pressure which allows the foam to passively and safely expand to its original size. The volume of air it displaces when inflated in room air is 52ml. This passive expansion provides the same function as filling an empty balloon with water or air. When expanded, the volume of material inside the patient's rectum is perceived by the patient similar to how patients perceive stool, and this may trigger the desire to defecate. This is measured by asking patients the questions on perceived desire to defecate according to the London Classification that define the evaluation of rectal sensation. After the sensation evaluation, while in the seated or left lateral decubitus position, the patient is instructed to attempt to expel the device in a set amount of time. If the patient is unable to expel the device, the practitioner may gently remove the balloon manually.
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