(322 days)
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.
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.
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.
| Characteristic | Oxfore®100 (hexafocon A) RGP Lens (New Device) | Boston XO™ (hexafocon A) RGP Lens (Predicate Device) | Implicit Acceptance Criteria (Achieved) |
|---|---|---|---|
| Material | hexafocon A | hexafocon A | Same material (hexafocon A) |
| Production method | Lathe Cut | Lathe Cut | Same production method |
| Actions/Operational Principles | When 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 acuity | When 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 acuity | Same fundamental mechanism of action |
| Product Code | HQD | HQD | Same FDA product code |
| Common Name | Contact Lens, Rigid Gas Permeable | Contact Lens, Rigid Gas Permeable | Same classification |
| Device Class | II | II | Same device class |
| CFR Reference | 21 CFR 886.5916 | 21 CFR 886.5916 | Same regulatory classification |
| FDA Group # | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone Acrylate | Same FDA material group |
| Indications for Use | Correction 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) | 1.415 | 1.415 | Identical |
| Oxygen Permeability (RGP Center) | 100 | 100 | Identical |
| Specific Gravity (RGP) | 1.27 | 1.27 | Identical |
| Hardness (Shore D) | 81 | 81 | Identical |
| Modulus (MPa) | 1500 | 1500 | Identical |
| Tint | Visibility 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) |
§ 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.