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510(k) Data Aggregation

    K Number
    K030054
    Device Name
    DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    2003-02-26

    (51 days)

    Product Code
    HJK,HMX,HNN
    Regulation Number
    886.1385
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES

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

    The disposable Vitrectorny Set is used in the context of vitrectorny procedures. The self-blocking infusion cannula with infusion tubing provides the saline solution or balanced saline solution throughout the procedure, ensuring that the eye retains its tonicity. No sutures are required. The knife is used for making a calibrated and non-leaking incision into which the self-blocking infusion cannula is inserted. The lens, used with microscope, facilitates visualization of the retina by canceling the corneal diopter. An edge, which has a frosted ring on its upper side to avoid edge glare effects, allows users to position and move the lens on the cornea with forceps.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to FCI Ophthalmics, Inc., regarding several ophthalmic devices: Disposable Vitrectomy Lenses, Disposable Infusion Cannula, and Surgical Knife.

    This document confirms substantial equivalence of these devices to previously marketed predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is an administrative notification of regulatory clearance, not a performance study report.

    Therefore, I cannot provide the requested information from this document. The document primarily focuses on:

    1. Regulatory Clearance: Granting permission to market the devices based on substantial equivalence.
    2. Device Classification: Class II, Class I, and Class I for the respective devices.
    3. Indications for Use: Describing the intended purpose of each component within the vitrectomy set.
    4. General Regulatory Requirements: Reminding the manufacturer of ongoing obligations like registration, labeling, and good manufacturing practices.

    Crucially, there is no mention of specific acceptance criteria (metrics, thresholds), study designs, sample sizes, expert ground truth establishment, or any performance data that would answer the questions posed.

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