(46 days)
The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL is indicated for daily wear 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 4.00 of ADD power and have 0.75D or less of astigmatism.
The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less of astigmatism.
Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional.
When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2 weeks (14 days).
The subject device is a soft (hydrophilic) contact lens available in a multifocal and/or multifocal toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells.
The subject device is made of a silicone hydrogel material containing an internal wetting agent. The lens 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 transmittance characteristics for these lenses are less than 1.0% in the UVB range of 280 nm to 315 nm and less than 10.0% in the UVA range of 315 nm to 380 nm for the entire power range.
This document is a 510(k) summary for the ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL and ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC. It discusses the substantial equivalence of the new device to previously cleared predicate and reference devices.
Here's an analysis of the provided text in the context of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for a study endpoint. Instead, it presents physicochemical properties and parameters of the subject device, which are implicitly the performance characteristics that need to be within an acceptable range to demonstrate equivalence to the predicate and reference devices.
In this case, the "device performance" is the reported property/parameter values.
| Property / Parameter | Reported Device Performance (ACUVUE® (senofilcon A) Soft Contact Lens Multifocal) |
|---|---|
| Water Content | 38% |
| Refractive Index | 1.42 |
| Oxygen Permeability (Fatt method, edge corrected) | 103 x 10-11 (cm²/sec)(mL O2/mL * mm Hg) |
| Oxygen Permeability (Fatt method, non-edge corrected) | 122 x 10-11 (cm²/sec)(mL O2/mL * mm Hg) |
| Light Transmittance: Visible | 89% to 99% |
| Light Transmittance: UVA (315 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.