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510(k) Data Aggregation

    K Number
    K150625
    Device Name
    Morrison Steerable Needle
    Manufacturer
    APRIOMED AB
    Date Cleared
    2015-06-09

    (90 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K980122,K970872
    Why did this record match?
    Device Name :

    Morrison Steerable Needle

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

    The Morrison Steerable Needle is intended for percutaneous injection and aspiration procedures, and tissue sampling in kidney, liver, muscle and subcutaneous tissue.

    Device Description

    The sterile, single use, Morrison Steerable Needle consists of the housing, a rotating lever which controls the deflection of the needle tip, the slide, the collar which transfers tensile force from the slide to the core wire; the tendon wire (core wire) which transfers tensile force from the collar to distal tip of the tubing; the stainless steel tubing which ends in a Menghini like needle tip on the distal end and a luer lock fitting on the proximal end.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the Morrison Steerable Needle, asserting its substantial equivalence to previously marketed predicate devices. It covers the device's description, indications for use, comparison with predicate devices, and performance data, but it does not contain the specific information requested in the prompt regarding acceptance criteria for an AI/CAD/software device, or a study proving that the device meets such criteria.

    The document is for a physical medical device (a steerable needle), not an AI/CAD/software product. Therefore, it does not discuss topics such as:

    1. Acceptance criteria for an AI/CAD/software device: The document focuses on regulatory equivalence based on design, materials, intended use, and performance of a physical needle, not performance metrics like sensitivity, specificity, or F1-score for an algorithm.
    2. Study proving the device meets AI/CAD/software acceptance criteria: There is no mention of such a study. The performance testing described is for biocompatibility, needle advancement, injection/aspiration, tissue sampling, and animal safety for a physical needle.
    3. Sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, training set size, or how ground truth for training set was established: These are all concepts relevant to the evaluation of AI/CAD/software devices, which are not applicable to the physical device described in this document.

    In summary, the provided text does not contain any of the information requested in the prompt as it pertains to an AI/CAD/software device.

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