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510(k) Data Aggregation

    K Number
    K980400
    Device Name
    PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
    Manufacturer
    PEREGRINE SURGICAL LTD.
    Date Cleared
    1998-04-30

    (87 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the Peeling and Vertical Cutting of Preretinal Membranes.

    Device Description

    The PVRS - Peregrine Vitreoretinal Scissor is vertical cutting, provided sterile and consists of the following: A 6' length of (pneumatical) tubing with a luer connector at the proximal end to fit into a surgical console. A Delrin handpiece with a 20 GA stainless steel shaft and scissor tip at the distal end.

    AI/ML Overview

    The provided text describes a 510(k) submission for the PVRS - Peregrine Vitreoretinal Scissor, a medical device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    The document primarily focuses on:

    • Device Description: What the device is and what it does (vertical cutting, preretinal membranes).
    • Substantial Equivalence Comparison: Comparing the PVRS to predicate devices (Grieshaber MPC and Sutherland Instruments) based on features like cutting type, drive mechanism, shaft size, and insertion method.
    • Sterility Validation: Mentioning ETO sterilization and the AAMI Overkill Method for validation.
    • FDA Communication: The FDA's letter of substantial equivalence.
    • Indications for Use: Explicitly stating "For the Peeling and Vertical Cutting of Preretinal Membranes."

    Therefore, I cannot provide the requested information in the format you specified, as the source material does not contain it.

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