(53 days)
The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (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 non-diseased eyes. The lens may be prescribed in spherical and aspheric 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 lenses may be stored in a multipurpose solution (BOSTON SIMPLUS or Menicon Unique pH) solution up to 30 days.
The Acuity Polymers Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses comprised of fluoro-silicon acrylate copolymers wet shipped in Boston SIMPLUS Multi-Action Solution or Menicon Unique pH Multi-purpose solution.
The provided text describes the regulatory clearance of "The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lenses." However, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and results.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone performance studies is not found in the provided document.
The document explicitly states: "Clinical data is not necessary as the products, both RGP lenses and multi-purpose disinfection solutions are cleared for use as indicated."
Instead, the submission relies on:
- Substantial Equivalence: The primary method for demonstrating safety and effectiveness is by showing that the new device is substantially equivalent to a legally marketed predicate device (BOSTON RGP Lenses Wet Shipped in Boston SIMPLUS Multi-Action Solution, K073184).
- Prior Clearances for Materials and Solutions: The gas permeable lens materials themselves (Acuity 100, Acuity 18, Acuity 85, Acuity 58) were previously cleared under separate 510(k)s. The multi-action solutions (BOSTON SIMPLUS and Menicon Unique pH) were also previously cleared. The current submission bundles these cleared components.
- Biocompatibility Testing: The materials have been tested and found to meet biocompatibility requirements listed in the FDA Daily Wear Contact Lens Guidance Document, May 1994, and ISO 10993-1 (2009).
- Solution Compatibility Studies: Previous 510(k)s for the individual RGP lens materials included solution compatibility studies demonstrating stable lens parameters when using the specified solutions.
- Microbiological Methods (Bioburden Studies): Bioburden studies (in accordance with ISO 11737-1) were conducted to monitor lens manufacturing. These were extended to evaluate wet storage and shipping for up to 30 days, finding "no CFUs were found at any test point during the 30-day period." This represents a specific "performance" aspect, but not in the context of clinical efficacy.
- Conformance to Standards: The quality system conforms to ISO Standard 13485 (2003).
In summary, the document argues that the device meets regulatory requirements by demonstrating substantial equivalence to a predicate device and by referencing prior clearances and standard-based testing for its constituent materials and solutions, rather than presenting a new, dedicated study with specific performance acceptance criteria.
§ 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.