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    K Number
    K221768
    Device Name
    Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
    Manufacturer
    Paragon Vision Sciences, Inc.
    Date Cleared
    2023-05-05

    (322 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K171404
    Why did this record match?
    Applicant Name (Manufacturer) :

    Paragon Vision Sciences, Inc.

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

    The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non aphakic persons with nondiseased eyes. The lenses may be disinfected using a chemical disinfection system only.

    Device Description

    The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut into the following designs: Spherical, Aspherical, Toric, Mulifocal, Scleral, Semi-scleral. Oxfore100 (hexafocon A) may incorporate an ultraviolet light absorber and is available in a variety of tints. The material (hexafocon A) from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO (hexafocon A) Material and Contact Lenses described in K171404. These devices will not be marketed with multiple components or any required accessories.

    AI/ML Overview

    This document describes a 510(k) premarket notification for a new rigid gas permeable (RGP) contact lens, Oxfore®100 (hexafocon A), seeking to establish substantial equivalence to a predicate device, the Boston XO™ (hexafocon A) Daily Wear Contact Lens (K171404).

    Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission does not explicitly present a table of "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, it compares the characteristics of the new device (Oxfore®100) directly against its predicate device (Boston XO™), concluding they are "substantially equivalent." The implicit acceptance criterion is that the new device's material and physical properties should be comparable to or meet the established standards of the predicate device and relevant guidance documents.

    CharacteristicOxfore®100 (hexafocon A) RGP Lens (New Device)Boston XO™ (hexafocon A) RGP Lens (Predicate Device)Implicit Acceptance Criteria (Achieved)
    Materialhexafocon Ahexafocon ASame material (hexafocon A)
    Production methodLathe CutLathe CutSame production method
    Actions/Operational PrinciplesWhen placed on the eye the Rigid Gas Permeable Contact Lens acts as a refracting medium to focus light rays on the retina to improve visual acuityWhen placed on the eye the Rigid Gas Permeable Contact Lens acts as a refracting medium to focus light rays on the retina to improve visual acuitySame fundamental mechanism of action
    Product CodeHQDHQDSame FDA product code
    Common NameContact Lens, Rigid Gas PermeableContact Lens, Rigid Gas PermeableSame classification
    Device ClassIIIISame device class
    CFR Reference21 CFR 886.591621 CFR 886.5916Same regulatory classification
    FDA Group #Group # 3 Fluoro Silicone AcrylateGroup # 3 Fluoro Silicone AcrylateSame FDA material group
    Indications for UseCorrection of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non aphakic persons with non-diseased eyes. Disinfected using chemical disinfection system only.Correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia), management of irregular corneal conditions (keratoconus, etc.), and therapeutic use for ocular surface disease. Disinfected using chemical disinfection system only.Partially equivalent, with predicate having broader therapeutic indications not claimed by the new device. However, the core refractive correction indication is equivalent.
    Refractive Index (RGP)1.4151.415Identical
    Oxygen Permeability (RGP Center)100100Identical
    Specific Gravity (RGP)1.271.27Identical
    Hardness (Shore D)8181Identical
    Modulus (MPa)15001500Identical
    TintVisibility Tints – various (D&C Green No. 6, D&C Violet No. 2, D&C Yellow No. 18, D&C Red No. 17)Visibility Tints – various (D&C Green No. 6, D&C Violet No. 2, D&C Yellow No. 18)Largely similar, with new device having one additional tint (D&C Red No. 17). This is considered a minor difference.
    Water Content (Soft Skirt)
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