(123 days)
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 4.00mm to 11.5mm | ± 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | ± 0.02 mm |
| Diameter | 7.0mm to 21.0mm | ±0.10mm |
| Spherical Power | -20.00D to +20.00D | ± 0.12 (0 to = 5D) |
| ± 0.18 (5 to = 10.0D) | ||
| ± 0.25 (10 to = 15D) | ||
| ± 0.37 (15 to = 20D) | ||
| ± 0.50 (over 20D) | ||
| Cylindrical Power | Up to 9.00D | ± 0.25 (0 to = 2D) |
| ± 0.37 (2 to = 4D) | ||
| ± 0.50 (over 4D) | ||
| Multifocal Power | +1.00D to 4.00D | ± 0.25D |
| Surface Appearance | Lenses should be clear with no surface | |
| defect |
The following table depicts the physical properties of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens:
| Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | |
|---|---|
| Refractive Index | 1.430 |
| Modulus (MPa) | 1194 |
| Hardness (Shore D) | 78 |
| Specific Gravity | 1.18 |
| Oxygen Permeability | |
| (Dk) | 200 x 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35 °C) |
| Color Additives | Visibility Tints – D&C Green #6, D&C Violet #2, Solvent Yellow 18, D&C Red #17 |
This document describes the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens and its substantial equivalence to predicate devices, focusing on its expanded indications for use.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity, as it's a 510(k) submission for a medical device (contact lens) and not an AI/software device. The primary "acceptance criteria" for such a device effectively revolve around demonstrating substantial equivalence to legally marketed predicate devices and proving its safety and effectiveness for its intended use and expanded indications.
The reported device performance is primarily qualitative and based on the outcomes of a retrospective clinical study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness for Original Indications | Demonstrated through previous 510(k) clearances. Substantial equivalence to predicate for its original indications (correction of refractive error in non-diseased eyes). |
| Safety and Effectiveness for Expanded Indications | In a retrospective clinical study (41 patients, 66 eyes), "irregular corneal conditions and vision remained stable or improved during treatment with the Acuity 200 (fluoroxyfocon A) contact lenses." No serious adverse reactions reported over 13,760 total days of wear. This demonstrates safety and effectiveness for management of irregular corneal conditions. |
| Physical and Chemical Properties Equivalence | Refractive Index, Modulus, Hardness, Specific Gravity, and Oxygen Permeability (Dk) are provided for the Acuity 200 and are comparable to predicate devices in terms of material group. |
| Manufacturing and Design Equivalence | Lathe-cut production method, daily wear intended use, |
§ 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.