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510(k) Data Aggregation

    K Number
    K182304
    Device Name
    Hyper GP (tisilfocon A) Daily Wear Contact Lens
    Manufacturer
    CONTAMAC LTD.
    Date Cleared
    2018-11-23

    (91 days)

    Product Code
    HQD,MUW
    Regulation Number
    886.5916
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K103561,K160859,K161100
    Predicate For
    K202860,K212631,K242393
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Hyper GP (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia.

    The Hyper GP (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

    The Hyper GP (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

    The Hyper GP (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eves that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

    The Hyper GP (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

    Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

    Device Description

    The Hyper GP (tisilfocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process.

    In the Hyper GP (tisilfocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block >99% of UV radiation in the UVB range (280nm = 315nm) and >85% in the UVA range (316 - 380nm).

    The Hyper GP (tisilfocon A) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17.

    The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes.

    The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material (tisilfocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness.

    The Hyper GP (tisilfocon A) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters: Base Curve, Center Thickness, Chord Diameter, Spherical Power, Cylindrical Power, Cylindrical Axis, Multifocal Power.

    The Hyper GP (tisilfocon A) Daily Wear Contact Lens for daily wear orthokeratology is available in following lens parameters: Base Curve (BC), Center Thickness, Diameter, Secondary Curves, Peripheral Curves, Spherical Power.

    The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the Hyper GP (tisilfocon A) Daily Wear Contact Lens is the Poly Vial Contact Lens Case. When shipped "wet", the Hyper GP (tisilfocon A) Daily Wear Contact Lens may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.

    AI/ML Overview

    This document describes the Hyper GP (tisilfocon A) Daily Wear Contact Lens and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and a detailed analysis of device performance against those criteria as would be found in a typical AI/ML medical device submission.

    However, based on the provided text, I can infer the "acceptance criteria" and "reported device performance" are related to a comparison of technical characteristics and the successful completion of non-clinical and clinical studies for a contact lens.

    Here's an interpretation of the requested information based on the provided document:

    Acceptance Criteria and Reported Device Performance

    The document does not explicitly list "acceptance criteria" in the typical format of quantitative thresholds for a specific study. Instead, it demonstrates acceptance primarily through substantial equivalence to predicate devices and through a series of non-clinical (in vitro and in vivo toxicology/biocompatibility) and clinical studies. The reported device performance is presented as meeting safety and effectiveness expectations, aligning with previously established performance for similar materials and designs.

    The key "performance data" highlights can be interpreted as demonstrating the device meets the implied acceptance criteria for a contact lens, specifically in terms of material properties, safety, and physical compatibility.

    Table of "Acceptance Criteria" (Implied) and "Reported Device Performance":

    Implied Acceptance CriterionReported Device Performance
    I. Substantial Equivalence to Predicate Devices:
    - Intended use and indications for useSubstantially equivalent to "Rigid Gas Permeable Contact Lenses (tisilfocon A)" by Menicon Co., Ltd. (K103561) for daily wear and general indications.
    - Orthokeratology indicationsSubstantially equivalent to "OPTIMUM GP OK Daily Wear Contact Lens" (roflufocon D & E) by Contamac Ltd. (K160859) for daily wear orthokeratology.
    - Material composition (USAN)Hyper GP (tisilfocon A) is made of tisilfocon A, similar to predicate K103561. (Predicate K160859 and K161100 use roflufocon D & E, and roflufocon C, D, and E respectively, with the new device asserting equivalence in the "fluoro silicone acrylate" material group).
    - Classification (21 CFR 886.5916)Class II, consistent with predicate devices.
    - FDA material groupGroup #3 fluoro silicone acrylate, consistent with predicate K103561. (Predicate K160859 and K161100 are also in this group).
    - Production methodLathe-cut, custom manufactured, consistent with predicate devices.
    - Surface coating (Tangible™ Hydra-PEG)The ability to be optionally surface coated with Tangible™ Hydra-PEG is substantially equivalent to predicate K161100 which also has this option.
    - Optical and physical parameters (e.g., UV blocking, Dk)Comparable or improved parameters: - Average Sessile Drop Contact Angle (coated): 37.34° (improved from 106.2° uncoated) - Oxygen Permeability (Dk): $180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) - Higher Dk than both predicate roflufocon materials, and predicate K103561 at $160 \times 10^{-11}$ - UV blocking (optional) and other physical attributes found to be acceptable and within range typically for RGP lenses.
    II. Safety and Effectiveness (Non-Clinical Studies):
    - Biocompatibility (non-toxic, non-irritating)Finished lenses (uncoated and coated with Tangible™ Hydra-PEG) are not toxic and not irritating.
    - Physicochemical, mechanical, and optical propertiesSubstantially equivalent to the predicate device.
    - Bioburden levelsBelow acceptance criteria (<100 cfu/lens) initially and after 30 days storage.
    - Stability of physical parametersStable after 30 days of storage.
    - Physical compatibility with care solutionsTangible™ Hydra-PEG coated lenses are physically compatible with currently marketed care solutions.
    III. Clinical Performance:
    - Safety and effectiveness of tisilfocon A materialClinical performance data for contact lenses manufactured from tisilfocon A has been previously addressed. (This indicates prior clearance of the material).

    Additional Requested Information:

    Since this document is a 510(k) summary for a contact lens, it details substantial equivalence to predicates rather than presenting a performance study with specific AI/ML metrics, test sets, or ground truth establishment methods typically associated with AI-driven devices. Therefore, many of the requested points below are not applicable or explicitly stated in this type of submission.

    1. Sample size used for the test set and the data provenance:

      • Test Set (Non-Clinical):
        • For Average Sessile Drop Contact Angle: n=30 lenses were tested for both uncoated and Tangible™ Hydra-PEG coated lenses.
        • For Bioburden levels: Not explicitly stated, but tests were conducted.
        • For Stability of physical parameters: Not explicitly stated, but tests were conducted.
        • Data Provenance: Not specified, but likely from in-house or contracted laboratory testing as part of the regulatory submission process.
      • Test Set (Clinical): The document states that "Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from tisilfocon A has been previously addressed." This implies that new clinical trials were not conducted for this specific 510(k) submission, but rather referenced existing data for the material. Therefore, no new sample size or provenance for a new clinical test set is provided here.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and submission. "Ground truth" in this context refers to standard measurements, not expert annotations of images or other data. Non-clinical tests follow established protocols and standards.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Standardized laboratory testing methods were used, not expert adjudication panels.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a contact lens, not an AI-assisted diagnostic tool.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a contact lens.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

      • For non-clinical tests (e.g., Dk, contact angle, toxicity, bioburden), the "ground truth" is defined by established physical, chemical, and biological testing standards and measurements.
      • For clinical performance, it refers to previously collected outcomes data and clinical experience with the tisilfocon A material, which established its safety and effectiveness.

    7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

    8. How the ground truth for the training set was established: Not applicable.

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