(141 days)
The Acuity 100™ (hexafocon A) 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 lons 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 100™ (hexafocon 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 sphere 0
- with base curves of 4.0 mm to 11.50 mm 0
- 0 with base curve chord of 6.0 mm to 6.5 mm
- with diameter of 7.0 to 21.0 mm 0
The lens material (hexafocon A) incorporates an ultraviolet light absorber and lenses are lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material. The material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO Material and Contact Lenses (hexafocon A) described in K071043.
The provided document is a 510(k) Premarket Notification for the Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens. This type of submission establishes substantial equivalence to a legally marketed predicate device rather than independently proving performance against acceptance criteria using clinical studies.
Therefore, the main "study" proving the device meets acceptance criteria is the demonstration of substantial equivalence to the predicate device, the Boston XO (hexafocon A) Daily Wear Contact Lens (K071043), based on material properties, design, and intended use as per the FDA Daily Wear Contact Lens Guidance Document, May 1994.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, "acceptance criteria" are implicitly met by demonstrating similarity to the predicate device. The performance is reported as the characteristics of the new device compared to the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (New Device - Acuity 100™) |
|---|---|---|
| Lens Characteristics | Boston XO (hexafocon A) RGP Lens | Acuity 100™ (hexafocon A) RGP Lens |
| Material | hexafocon A | hexafocon A |
| Production method | Lathe Cut | Lathe Cut |
| UV Blocking | Yes | Yes |
| Base Curves | 4.0 mm to 11.5 mm | 4.0 mm to 11.5 mm |
| Base Curve Chord | 6.0 mm to 6.5 mm | 6.0 mm to 6.5 mm |
| Design | Standard & reverse geometry with anterior aspheric surface | Standard & reverse geometry with anterior aspheric surface |
| Diameters | 7.0-21.0 mm | 7.0-21.0 mm |
| Power Range | -20.00D to +20.00D | -20.00D to +20.00D |
| Astigmatism range corrected | Up to 9.00 D | Up to 9.00 D |
| Add Powers (for multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D |
| Indications for Use | As described for Boston XO (K071043) | As described for Acuity 100™ (identical in scope) |
| Material Properties | ||
| Refractive Index | 1.415 | 1.415 ±0.002 |
| Oxygen Permeability | 100 | 111 ±22 |
| Specific Gravity | 1.27 | 1.27 ±0.02 |
| Hardness (Shore D) | 81 | 80 ±2 |
| Modulus (MPa) | 1500 | 1496 ±200 |
| Tint | Visibility Tints - various | Visibility Tints - various |
| 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.