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510(k) Data Aggregation

    K Number
    K101774
    Device Name
    MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Date Cleared
    2011-10-13

    (476 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K063155
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This MONARCH® III P Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.

    Device Description

    The Monarch® III IOL Delivery System (P Cartridge), hereafter referred to as the Monarch® III P Cartridge, is a modification to the previously cleared Alcon Monarch® III IOL Delivery System (D Cartridge) consisting of a disposable polypropylene cartridge and reusable titanium handpiece. The Monarch® III P Cartridge features nozzle tip sizing like the currently marketed Monarch® III D Cartridge and is intended to fold and deliver Alcon AcrySof® intraocular lenses into the anterior chamber of the eye. It is designed to work with the currently marketed Monarch® III handpiece.

    AI/ML Overview

    The provided document describes the predicate device and the new device (Monarch® III IOL Delivery System (P Cartridge)) and concludes with an assessment of substantial equivalence. The document does not contain the acceptance criteria and performance data in the format requested. It states: "The Monarch® III P Cartridge, in conjunction with the currently marketed Monarch® III handpiece, has been tested and found to deliver Alcon IOL in conformance with the requirements set forth in ISO 11979-3, section 5." However, the specific acceptance criteria from ISO 11979-3, section 5, and the detailed results of the testing (actual performance metrics) are not provided in the document.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from the text. I also cannot fulfill the requests for sample size, data provenance, number or qualifications of experts, adjudication method, MRMC study details, standalone performance, training set details, or ground truth establishment, as this information is not present in the provided 510(k) summary.

    The document primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and conformity to a standard (ISO 11979-3, section 5) rather than a detailed report of clinical study results against specific criteria.

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