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510(k) Data Aggregation

    K Number
    K091777
    Device Name
    ALCON ULTRACHOPPER
    Manufacturer
    ALCON RESEARCH, LTD.
    Date Cleared
    2009-10-20

    (125 days)

    Product Code
    HQC,HOC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K041998,K021566,K063583
    Why did this record match?
    Device Name :

    ALCON ULTRACHOPPER

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

    The ALCON® UltraChopper is indicated to be used with an Ultrasonic Phacofragmentation Handpiece to separate a cataractous lens into smaller pieces.

    Device Description

    The ALCON® UltraChopper tip is a modified ultrasonic tip that will be added to the existing ALCON® Phaco tip family. The ALCON® UltraChopper tip is of a similar size and shape as existing Alcon phaco tips and is made with the same material (Titanium 6AL-4V alloy) as the Alcon phaco tips currently used on the INFINITI® System and CONSTELLATION® System. The ALCON® UltraChopper tip will utilize existing packaging configurations and have the same shelf life as existing phaco tips. It can be used with the same ultrasonic handpieces (INFINITI®, INFINITI® NeoSonix® or INFINITI® OZil) currently used on the Alcon systems such as the INFINITI® System and CONSTELLATION® System.

    To use the ALCON® UltraChopper as intended, no modification to the existing INFINITI® System and CONSTELLATION® System software is required.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document describes a 510(k) premarket notification for the ALCON® UltraChopper, a phacofragmentation tip. It includes:

    • Device Description: What the device is, its materials, and compatibility with existing systems.
    • Indications for Use: The intended purpose of the device.
    • Brief Summary of Non-clinical test and Results: This section details biocompatibility evaluations and sterilization validation, stating that "Non-clinical testing has demonstrated that the functional requirements have been met and that the device is equivalent to the predicate devices."

    However, it does not provide specific acceptance criteria (e.g., performance metrics, thresholds) or detailed study results that would allow me to fill out the requested table and answer the specific questions about sample sizes, expert qualifications, adjudication methods, or comparative effectiveness studies. The primary purpose of this document is to establish substantial equivalence to predicate devices, not to present a detailed performance study against predefined acceptance criteria.

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