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510(k) Data Aggregation

    K Number
    K172729
    Device Name
    Polypectomy Snare
    Manufacturer
    Hangzhou AGS MedTech CO., Ltd
    Date Cleared
    2018-05-21

    (252 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K133987
    Predicate For
    K183289,K192342,K220790,K221713
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Polypectomy Snare is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.

    Device Description

    The polypectomy snare consists of handle, sheath, flexible wire and electrode that is used to remove polys utilizing monopolar RF energy under endoscopic visualization. The rotary snares' cable and polypectomy can be rotated using the rotation actuator on the handle. Polypectomy snare is sterile for single use with no delayed hypersensitivity and no intracutaneous reactivity, have no animal or human origin substance. The electrode of polypectomy snare has five shapes to be used in clinical practice: Oval, Polygon, Duck Bill, Hexagonal and Round, and the electrode can extend, retract from the snare's flexible outer sheath.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device called "Polypectomy Snare." This type of document is a premarket notification to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.

    The information requested pertains to the acceptance criteria and study for an AI/ML powered medical device. Based on the content of this document, the device in question is a Polypectomy Snare, which is a physical medical device and NOT an AI/ML powered device.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies as these are specific to the evaluation of AI/ML software.

    The document primarily focuses on:

    • Biocompatibility Testing: Evaluating the device's interaction with biological systems using ISO standards.
    • Performance Testing (Bench Tests): Assessing physical attributes like appearance, size, material, usability, and electric properties.
    • Substantial Equivalence: Comparing the proposed device to a predicate device (Captivator II, Single-Use Polypectomy Snares, K133987) to show it meets the same safety and effectiveness standards.

    There is no mention of an algorithm, AI, machine learning, or software performance in the document. The statement "No Clinical Study is included in this submission" further reinforces that this submission does not involve clinical performance data that would be relevant to an AI/ML device.

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