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510(k) Data Aggregation

    K Number
    K200207
    Device Name
    xPORT S Lens Fragmentation System
    Manufacturer
    Carl Zeiss Meditec Cataract Technology Inc.
    Date Cleared
    2020-10-15

    (261 days)

    Product Code
    HQC,MLZ
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    xPORT S Lens Fragmentation System

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

    The intended use of the xPORT S Lens Fragmentation System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation, as well as ancillary functions such as vitreous aspiration and cutting

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) clearance letter for the Carl Zeiss Meditec xPORT S Lens Fragmentation System does not contain any information regarding acceptance criteria, device performance studies, or details about AI model validation.

    The document is a standard 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices for its indicated use (fragmentation and removal of cataracts, etc.). It outlines the regulatory classification, product codes, and general controls the device is subject to.

    Therefore, I cannot provide the details you requested because the source material does not contain that information. To answer your request, I would need a document that describes the clinical performance testing, validation studies, or technical specifications of an AI-powered medical device.

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