(52 days)
Acuity 200™ with Tangible® Hydra PEG® (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 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 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Acuity 200™ with Tangible® Hydra PEG® (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. Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is treated to incorporate Hydra-PEG Technology developed by Tangible Sciences. This PEG polymer is permanently attached to the surface and is designed to enhance surface (wetting) properties while not affecting the mechanical or optical properties of the underlying material.
Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) 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 spheres .
- with base curves of 4.0 mm to 11.50 mm ●
- with base curve chord of 6.0 mm to 6.5 mm ●
- with diameters of 7.0 to 21.0 mm
The lens material incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, scleral and aspheric surfaces in visibility tinted material.
The provided text describes the regulatory clearance of a medical device, the Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, based on substantial equivalence to predicate devices, rather than a direct study validating specific acceptance criteria against reported performance in a clinical setting.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly stated in the provided text in the format you requested, as the submission relies on demonstrating similarity to already approved devices.
However, I can extract information related to the performance data mentioned and the basis for determining substantial equivalence.
Here's an analysis based on the provided text, addressing your points as much as possible:
1. Table of acceptance criteria and the reported device performance:
The document states that the new device has been shown to be "substantially equivalent" to predicate devices. This implies that the acceptance criteria are met if the new device's performance is comparable to the predicate devices across various characteristics. The "Comparison of Characteristics with the Predicate Device" table serves as the primary evidence for this.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Acuity 200™ with Tangible® Hydra PEG®) |
|---|---|---|
| Material | fluoroxyfocon A (matching predicate K201194, K203571) | fluoroxyfocon A |
| Production Method | Lathe Cut (matching predicate devices) | Lathe Cut |
| UV Blocking | Yes (matching predicate devices) | Yes |
| Base Curves | 4.0 mm to 11.5 mm (matching predicate K201194, K203571, within range of K161100) | 4.0 mm to 11.5 mm |
| Base Curve Chord | 6.0 mm to 6.5 mm (matching predicate devices) | 6.0 mm to 6.5 mm |
| Design | Standard geometry with anterior aspheric surface (matching predicate K201194, K203571) | Standard geometry with anterior aspheric surface |
| Diameters | 7.0-21.0 mm (matching predicate K201194, K203571, within range of K161100) | 7.0-21.0 mm |
| Power Range | -20.00D to +20.00D (matching predicate devices) | -20.00D to +20.00D |
| Astigmatism Range | Up to 9.00 D (matching predicate K201194, K203571, comparable to K161100's up to 10.00 D) | Up to 9.00 D |
| Add Powers | +1.00 D to +4.00 D (matching predicate devices) | +1.00 D to +4.00 D |
| Indications for Use | Must be for daily wear for correction of refractive error (myopia, hyperopia, presbyopia, astigmatism) in aphakic and non-aphakic persons with non-diseased eyes, and for management of irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-keratoplasty/LASIK surgery). Must also be compatible with chemical disinfection. (Matching and expanding on predicates) | Matches and expands on previous predicates. |
| Refractive Index | 1.430 (matching predicate K201194, K203571, comparable to K161100's 1.4406) | 1.430 |
| Oxygen Permeability | 200 (matching predicate K201194, K203571, superior to K161100's 65) | 200 |
| Specific Gravity | 1.18 (matching predicate K201194, K203571, comparable to K161100's 1.27) | 1.18 |
| Hardness (Shore D) | 78 (matching predicate K201194, K203571) | 78 |
| Modulus (MPa) | 1194 (matching predicate K201194, K203571) | 1194 |
| Tint | Visibility Tints (various as specified) (matching predicate devices) | Visibility Tints (various as specified) |
| 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.