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510(k) Data Aggregation

    K Number
    K033390
    Device Name
    COLIBRI DISPOSABLE VITRECTOMY CUTTER
    Manufacturer
    MICROWORLD MEDICAL INSTRUMENTS, INC.
    Date Cleared
    2003-11-04

    (12 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROWORLD MEDICAL INSTRUMENTS, INC.

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

    The COLIBRI Disposable Vitrectomy Cutter is intended to be used for the removal of vitreous and vitreal membranes during ophthalmic surgery.

    Device Description

    The COLIBRI Disposable Vitrectomy Cutter is a quillotine-style pneumatic handbiece for use during ophthalmic surgery. TThe main components of the device are the handle, diaphragm, inner spring, stainless steel inner and outer cutters, and attached tubing and connectors. The device provides cutting and aspiration functions during removal of vitreous and vitreal membranes in anterior and posterior segment surgeries. It is designed to be used with 20 psi and 30 psi ophthalmic surgical systems.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device (COLIBRI Disposable Vitrectomy Cutter) and its substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

    The document primarily focuses on:

    • Identifying the device and its manufacturer.
    • Stating the device's indications for use.
    • Listing predicate devices.
    • Asserting that the technical characteristics are "similar if not identical" to predicate devices.
    • The FDA's letter of substantial equivalence determination.

    Therefore, I cannot fulfill your request for the specific details outlined (table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) because this information is not present in the provided text.

    The 510(k) summary provided, in this case, relies on a comparison to predicate devices rather than directly presenting performance study results against predefined acceptance criteria.

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