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510(k) Data Aggregation

    K Number
    K022043
    Device Name
    SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503
    Manufacturer
    MEDENNIUM, INC.
    Date Cleared
    2002-10-18

    (116 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    K040912,K053333
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SmartPlug™ is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blocking of the punctum.

    SmartPlug™ may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases.

    When indicated, SmartPlug™ may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by SmartPlug™.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to Medennium Inc. regarding their SmartPlug™ Model 500 device. This document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and does not contain information about acceptance criteria, performance studies, or details relevant to artificial intelligence/machine learning (AI/ML) device evaluation.

    Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from this specific document. The document confirms the FDA clearance for marketing but does not detail the technical performance evaluation or clinical study results that would typically include the requested metrics.

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