(48 days)
OPTIMUM GP (roflufocon D. roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery.
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. OPTIMUM GP (roflufocon D) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
- cannot be adequately corrected with spectacle lenses
- requires a rigid gas permeable contact lens surface to improve vision
- is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses may concurrently provide correction of refractive error.
The lenses may be disinfected using a chemical disinfection (not heat) system only.
The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, or hexafocon A-with the following properties: Refractive Index, Light Transmission (clear), Light Transmission (tinted), Water Content, Specific Gravity, Shore D Hardness, Oxygen Permeability (Dk) ISO/FATT Method, Contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D, UV Light Blocking (UVB - 280nm – 315nm; UVA 316nm – 380nm). The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are available with or without 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 is encapsulated in a thin layer of polymer that results in measurable improvement of wettability compared to untreated lenses. The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the lenses 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%. The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Spherical Power, Cylindrical Power, Cylindrical Axis, Multifocal Power.
This document is a 510(k) premarket notification for Contamac, Ltd.'s OPTIMUM GP and HEXA100 Daily Wear Contact Lenses. It seeks to demonstrate substantial equivalence to a predicate device and expand the indications for use to include therapeutic applications.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantified, pass/fail manner for the device's therapeutic indication. Instead, it relies on demonstrating substantial equivalence to a predicate device and referencing previously established safety and effectiveness.
The comparison is primarily based on:
- Material properties: Refractive Index, Light Transmission, Water Content, Specific Gravity, Shore D Hardness, Oxygen Permeability (Dk), Color additives, UV Light Blocking.
- General characteristics: Intended use, indications for use, actions, classification, FDA material group, production method.
- Surface treatment: The new device offers Tangible™ Hydra-PEG surfacing, which the predicate did not. This is presented as an improvement in wettability.
Therefore, the "acceptance criteria" appear to be implicit: the device's materials and characteristics must be comparable to or better than the predicate, and its therapeutic indications must be sufficiently similar to those previously cleared.
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance (OPTIMUM GP/HEXA100) |
|---|---|
| Intended Use: Daily wear contact lenses | Same as predicate |
| Indications for Use: Therapeutic (scleral) | Same as predicate (with expanded details for specific conditions, but fundamentally similar therapeutic rationale) |
| Classification: Class II, Rigid Gas Permeable, Daily Wear | Same as predicate |
| FDA Material Group: Group #3 Fluoro Silicone Acrylate | Same as predicate |
| Production Method: Lathe-cut | Same as predicate |
| Specific Gravity: Comparable ranges | roflufocon D: 1.166; roflufocon E: 1.155; hexafocon A: 1.266 (Predicate: hexafocon A: 1.266, hexafocon B: 1.190) - All within similar range. |
| Shore D Hardness: Comparable ranges | roflufocon D: 75; roflufocon E: 77; hexafocon A: 80 (Predicate: hexafocon A: 80, hexafocon B: 78) - All within similar range. |
| Oxygen Permeability (Dk): Comparable to predicate | roflufocon D: 100 x 10⁻¹¹; roflufocon E: 125 x 10⁻¹¹; hexafocon A: 111 x 10⁻¹¹ (Predicate: hexafocon A: 111 x 10⁻¹¹, hexafocon B: 141 x 10⁻¹¹) - All within similar range, some materials even higher Dk than predicate materials. |
| Refractive Index: Comparable ranges | roflufocon D: 1.433; roflufocon E: 1.433; hexafocon A: 1.415 (Predicate: hexafocon A: 1.415, hexafocon B: 1.424) - All within similar range. |
| Water Content: |
§ 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.