(148 days)
The Acuity 58™ (en:flufocon B) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear. The lenses may be prescribed for daily wear 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 (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only.
The Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:
- in the power range of -20.00 to +20.00 diopters for sphere
- with base curves of 4.0 mm to 11.50 mm
- with base curve chord of 6.0 mm to 6.5 mm
- with diameter of 7.0 to 21.0 mm
The lens material (enflufocon B) incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston EO Material and Contact Lenses (enflufocon B) described K980741.
The provided text describes the Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lens and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria in the form of specific performance metrics with numerical thresholds that the device must meet, nor does it describe a study specifically designed to prove the device meets such criteria in a comparative fashion. Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Boston EO Contact Lens, K980741) by showing that the new device has identical or highly similar material, design, and indications for use.
Here's an attempt to extract the requested information based on the provided text, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission asserts "substantial equivalence" as its primary acceptance criterion. The performance is demonstrated by comparing the new device's characteristics to those of the predicate device.
| Characteristic | Acceptance Criteria (based on predicate) | Reported Device Performance (Acuity 58™ enflufocon B) |
|---|---|---|
| Material | enflufocon B | enflufocon B (identical) |
| Production Method | Lathe Cut | Lathe Cut (identical) |
| UV Blocking | Yes | Yes (identical) |
| Base Curves | 4.0 mm to 11.5 mm | 4.0 mm to 11.5 mm (identical) |
| Base Curve Chord | 6.0 mm to 6.5 mm | 6.0 mm to 6.5 mm (identical) |
| Design | Standard & reverse geometry with anterior aspheric surface | Standard & reverse geometry with anterior aspheric surface (identical) |
| Diameters | 7.0-21.0 mm | 7.0-21.0 mm (identical) |
| Power Range | -20.00D to +20.00D | -20.00D to +20.00D (identical) |
| Astigmatism range corrected | Up to 9.00 D | Up to 9.00 D (identical) |
| Add Powers (multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D (identical) |
| Indications for Use | Effectively identical scope (myopia, hyperopia, presbyopia, astigmatism in aphakic/non-aphakic non-diseased eyes, irregular corneal conditions) | Effectively identical scope as predicate |
| Refractive Index | 1.429 | 1.429 (identical) |
| Oxygen Permeability | 58 | 58 (identical) |
| Specific Gravity | 1.23 | 1.24 (very close) |
| Hardness | 114 (Rockwell R) | 81 (Shore D) (Note: Different scales, not directly comparable without conversion. The document states "materials values meet minimum values required for use.") |
| Modulus | 1500 MPa | 1568 MPa (very close) |
| Tint | Visibility tints (D&C Green #6, D&C Violet #2, Solvent Yellow 18) | Visibility tints (D&C Green #6, D&C Violet #2, Solvent Yellow 18) (identical) |
| 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.