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510(k) Data Aggregation

    K Number
    K150986
    Device Name
    Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
    Manufacturer
    MEDDEV CORPORATION
    Date Cleared
    2015-08-17

    (125 days)

    Product Code
    MML
    Regulation Number
    886.5700
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K011740
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDDEV CORPORATION

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

    The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.

    Device Description

    MedDev Contour™ and ThinProfile™ Eyelid Weight Implants were designed for the treatment of lagophthalmos, i.e. the inability of the eyelid to fully close. This condition is typically due to a degree of facial paralysis. The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are passive implants surgically placed in the eyelid. The density of their construct material (pure gold or platinum) provides the weight necessary to close the eyelid over the eye. The patient can use their functional orbital musculature to keep their eyes open, but have the gravitational assist from the Implant to close the eyelid.

    AI/ML Overview

    The provided text describes the acceptance criteria and a study for the MedDev Contour™ and ThinProfile™ Eyelid Weight Implants.

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestAcceptance CriteriaReported Device Performance
    MRI Safety ReviewMR-Conditional for static magnetic fields of 3-Tesla or less.Successfully demonstrated MR-Conditional claim.
    MRI Related force (Torque)Minimal to no deflection/torque in a 3-Tesla MRI. (Implied: Acceptable deflection for safety, which for this device was 2 degrees, and torque rating of 0 for both axis, indicating no movement after initial 2 degree deflection)2° deflection for both gold and platinum samples (2.8g), with a torque rating of 0 (no torque) in both long and short axis for 2.8g Gold and Platinum Contour™ Eyelid Weight Implants.
    MRI Related HeatingMaximum temperature change (over 15 minutes in a 3T field) within safe limits. (Implied: Typically
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