(91 days)
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.
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%.
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 Criterion | Reported Device Performance |
|---|---|
| I. Substantial Equivalence to Predicate Devices: | |
| - Intended use and indications for use | Substantially equivalent to "Rigid Gas Permeable Contact Lenses (tisilfocon A)" by Menicon Co., Ltd. (K103561) for daily wear and general indications. |
| - Orthokeratology indications | Substantially 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 group | Group #3 fluoro silicone acrylate, consistent with predicate K103561. (Predicate K160859 and K161100 are also in this group). |
| - Production method | Lathe-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 properties | Substantially equivalent to the predicate device. |
| - Bioburden levels | Below acceptance criteria (
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.