(87 days)
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes who may need up to 4.00D of ADD power and have 0.75D of astigmatism or less.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal-Toric), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in phakic persons with non-diseased eyes who may need up to 4.00D of ADD power and have 10.00D of astigmatism or less.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, with UV Blocker, when Cosmetically Timed, is also indicated for daily wear to enhance or alter the appearance of the eye.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear contains a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Practitioners may prescribe the ACUVUE® (etafficon A) Soft (hydrophilic) Contact Lens for Presbyopia either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement.
When prescribed for single-use disposable wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.
When prescribed for frequent/planned replacement wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be cleaned, rinsed, and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is a soft (hydrophilic) contact lens available in a multifocal and/or multifocal-toric design. The lens material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with 1,1,1-trimethylol propane trimethacrylate and ethylene glycol dimethacrylate. The composition of the lens is 42% etafilcon A and 58% water by weight when hydrated and stored in buffered saline solution with or without povidone. The lens is supplied in a sterile state.
The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Visibility Tinted with UV Blocker for Daily Wear, is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV Blocking for ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lenses for Presbyopia, Visibility Tinted with UV Blocker averages 97% in the UVB range of 280 nm to 315 nm and 82% in the UVA range of 316 nm to 380 nm.
The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Cosmetically Tinted with UV Blocker for Daily Wear, contains a pigmented area that will enhance or alter the appearance of the eye. The lens is colored with one or more of the following color additives: iron oxides, titanium dioxide, phthalocyaninato (2-) copper, phthalocyanine green, vat orange 1, and Reactive Blue Dye #4.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia:
Based on the provided FDA 510(k) summary, the device being described is a soft contact lens, and the submission is for a new multifocal design (ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear).
Crucially, the document states that clinical performance data was NOT required because the device is substantially equivalent to predicate devices. This means that there wasn't a new clinical study specifically designed to establish the performance of this particular new multifocal design against specific acceptance criteria. Instead, the substantial equivalence relies on the material, manufacturing process, and indications being similar to previously cleared devices, and on non-clinical testing to ensure the modified design meets specifications.
Therefore, many of the questions regarding a study proving acceptance criteria cannot be directly answered from this document because such a study was not conducted for this 510(k) submission.
Here's a breakdown of what information can be extracted:
1. A table of acceptance criteria and the reported device performance
Since a dedicated clinical study for this specific multifocal design was not performed to establish new acceptance criteria or performance metrics, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate devices and through non-clinical verification of specifications.
The document provides the following technical specifications for the device, which serve as performance characteristics that were verified non-clinically:
| Characteristic | Acceptance Criteria (Specification) | Reported Device Performance (Verification) |
|---|---|---|
| Water Content | 58% | 58% (Same as predicate) |
| Refractive Index (@ 20°C) | 1.40 | 1.40 (Same as predicate) |
| Oxygen Permeability (Dk, Fatt method, edge corrected) | $21.4 \times 10^{-11}$ (cm²/sec)(mL O₂/mL * mm Hg) | $21.4 \times 10^{-11}$ (Same as predicate) |
| Light Transmission - Visible | Minimum 85% | Achieved (Implied by "Same as predicate") |
| Light Transmission - UVA (316 nm to 380 nm) |
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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.