(58 days)
The Acuity 1800 (enflufocon 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 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 18TM (enflufocon 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
- 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 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 ES (AKA Boston 7-30) Material and Contact Lenses (enflufocon A) described K943177 and K053124.
The provided text describes a 510(k) premarket notification for the Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics, ground truth, or expert review.
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, and adjudication methods for a study proving the device meets acceptance criteria is not explicitly available in this document in the typical sense of a diagnostic or AI-driven device.
Instead, the submission relies on the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a "Side-by-Side Comparison" of the new device (Acuity 18) and its predicate device (Boston ES (enflufocon A) RGP Lens). The "acceptance criteria" here are implicitly the characteristics and values of the predicate device, which the new device aims to match or be substantially equivalent to.
| Characteristic | New Lens (Acuity 18™ enflufocon A) | Predicate Lens (Boston ES enflufocon A) |
|---|---|---|
| Manufacturer | Acuity Polymers, Inc. | Bausch + Lomb |
| Material | enflufocon A | enflufocon 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 (multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D |
| Indications for Use | Identical | Identical |
| Refractive Index (RGP) | 1.445 | 1.443 |
| Oxygen Permeability (RGP Center) | 21 | 18 |
| Specific Gravity (RGP) | 1.22 | 1.22 |
| Hardness (Shore D) | 84 | 85 |
| Modulus (MPa) | 1739 | 1900 |
| Tint | Visibility Tints - various (D&C Green #6, D&C Violet #2, D&C Yellow #18) | Visibility Tints - various (D&C Green #6, D&C Violet #2, D&C Yellow #18) |
| 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.