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510(k) Data Aggregation

    K Number
    K070924
    Device Name
    FLEXGUARD
    Manufacturer
    ALLMED SYSTEMS INC.
    Date Cleared
    2007-06-21

    (79 days)

    Product Code
    GEX,FED
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FLEXGUARD

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

    The FlexGuard Family of sheath's are intended for use in surgical procedures using flexible scopes and other approved flexible or rigid fiber optic delivery devices, to protect the working channel from damage when a laser fiber is introduced and also to provide irrigation to the surgical site when used for incision, ablation, vaporization and coagulation of soft tissue with any approved laser with a wavelength from 532nm to 2100nm in medical specialties including: Urology, Gasteroenterology, Thoracic, Head and Neck, Pulmonary, Gynecology, ENT and General Surgery

    Device Description

    The FlexGuard is a family of flexible sheaths that are used to protect the working channel of a flexible scope or surgical device from mechanical damage when the laser fiber is introduced into the working channel. The tip of the FlexGuard is allowed to protrude approx 3mm beyond the laser fiber, this assembly is then inserted into the working channel of the scope. The FlexGuard Family is designed to work with a range of laser fibers from 200 micron to 600 micron diameter. It consists of: Flexible Sheath Fiber clamp/Yee piece

    AI/ML Overview

    The provided text is a 510(k) summary for the FlexGuard device and a clearance letter from the FDA. It does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML device.

    The FlexGuard is a family of flexible sheaths designed to protect flexible scopes or surgical devices from mechanical damage when a laser fiber is introduced. It is a physical medical device, not an AI/ML diagnostic or prognostic tool. Therefore, the questions about acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment (pathology, outcomes data) as they relate to AI/ML device performance are not applicable to this submission.

    The document discusses the device's intended use, its components, and its substantial equivalence to a predicate device, which is typical for a 510(k) submission for a non-AI/ML device.

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