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510(k) Data Aggregation

    K Number
    K151918
    Device Name
    Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Date Cleared
    2016-02-11

    (213 days)

    Product Code
    LPL,MVN
    Regulation Number
    886.5925
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K113703,K132715,K143632
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Spherical:
    The Bausch + Lomb Lomb Biotrue® ONEday (nesofilcon A) Contact Lens with NaturMoist is indicated for the daily wear correction of refractive ametropia (myopia, astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism up to 2.00 diopters or less, that does not interfere with visual acuity. The lens is to be prescribed in spherical powers ranging from +20.00D to -20.00D.

    Multifocal:
    The Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lens with NaturMoist is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D.

    Toric:
    The Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens with NaturMoist is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters for daily wear.

    The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

    Device Description

    The Biotrue ONEday Contact Lens with NaturMoist is a soft hydrophilic contact lens. The lenses are made from the nesofilcon A material, a hydrophilic copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and is 78% water by weight when immersed in a sterile borate buffered saline solution with poloxamine and sodium hyaluronate. A UV-absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380mm. This lens is tinted blue with Reactive Blue Dye 246. The color additive conforms to 21 CFR Part 73.3106.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for contact lenses. It does not contain information about the acceptance criteria or a study proving that an AI-powered device meets specific acceptance criteria.

    The document discusses the substantial equivalence of the "Biotrue ONEday Contact Lenses with NaturMoist" to its predicate devices, highlighting that no clinical studies were required to demonstrate the safety or effectiveness of the subject device because its technological characteristics, formulation, manufacturing, and sterilization processes are the same as the predicate device.

    Therefore, I cannot provide the requested information regarding an AI device's acceptance criteria and associated studies from this document.

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