(75 days)
The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and presbyopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less.
The ACUVUE MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or nonaphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The ACUVUE Toric Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with nondiseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
Eye care practitioners may prescribe the lens for either single-use disposable wear or frequent/ planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.
The ACUVUE (etafilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, spherical multifocal lens and an astigmatic (toric) lens. 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 ACUVUE Contact Lens with visibility tint 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 average transmittance characteristics are less than 5 % in the UVB range of 280 to 315 nm and less than 30 % in the UVA range of 316 to 380 nm.
The provided text describes a 510(k) submission for ACUVUE (etafilcon A) Contact Lenses, focusing on the substantial equivalence to a predicate device rather than a new medical device requiring extensive acceptance criteria and a standalone study for performance. Here's an analysis based on the provided information:
This submission is for a contact lens, which is a medical device, but the context indicates it's an update to an existing product (ACUVUE with UV blocker) seeking substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study" are geared towards demonstrating this equivalence rather than establishing completely new performance benchmarks for a novel AI or diagnostic device.
Here's an attempt to extract and format the information as requested, acknowledging the limitations of applying these categories to a contact lens 510(k) submission:
Acceptance Criteria and Device Performance for ACUVUE (etafilcon A) Contact Lens (with UV blocker)
The primary "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to the predicate device, ACUVUE (etafilcon A) Contact Lens clear and with visibility tint. Performance is largely assessed through a comparative analysis of physical and chemical characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criterion (Predicate Device Label Claim) | Reported Device Performance (Subject Device Measured Avg) | Comparison/Outcome |
|---|---|---|---|
| % Water Content | 58% | 60% | Close to claim, slightly higher |
| Refractive Index @ 20° C | 1.40 ± 0.01 | 1.40 | Meets claim |
| Dk (Fatt method, non-edge corrected) | 28 + 5.6 x 10⁻¹¹ cm²/sec (ml O₂/ml*mmHg) | 26 x 10⁻¹¹ cm²/sec (ml O₂/ml*mmHg) | Within the range of the predicate, slightly lower than mean but within acceptable variance (implied by 5.6 variability) |
| Color | light blue | light blue | Matches predicate |
| % T @ 593 nm | 85% minimum | Conforms | Meets minimum |
| % T @ 280 - 315 nm | avg |
§ 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.