(254 days)
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Sphere designs are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and astigmatic corrections from -0.25 to -3.50 diopters.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition form +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Multifocal-Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters who may need up to +3.00 diopters of ADD power and have -3.50 diopters of astigmatism or less.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
The Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are clear, visibility-tinted, UV absorber-containing and are available in sphere, asphere, toric, multifocal and multifocal-toric designs. It is an ionic hydrogel lens derived from Etafilcon A material which is a co-polymer of 2-Hydroxyethyl Methacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) and 1,1,1-Trimethylolpropane Trimethacrylate (TMPTMA) and made by photo-polymerization. The lens consists of 42% Etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer further contains a benzotriazole, a UV absorbing monomer, thus is able to block the UV radiation to the ocular. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 315-380mm. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. Lenses are supplied sterile in the sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.
The provided document is a 510(k) premarket notification for Aquamax (Etafilcon A) soft contact lenses. It asserts substantial equivalence to existing predicate devices rather than presenting a novel device that requires a new clinical study with specific acceptance criteria and performance data. Therefore, the information typically requested regarding acceptance criteria, study design, and performance metrics for a new device's clinical efficacy is not present in this document.
Instead, the submission relies on the established safety and effectiveness of the predicate devices.
Here's an breakdown of the available information regarding testing:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria for a new clinical study. Instead, it performed non-clinical tests to demonstrate that the proposed device is comparable to the predicate devices. The "Technological characteristics studies" table (page 8) presents a comparison of the proposed device's physical properties with those of the predicate devices.
| Characteristic | Proposed Device (Aquamax) | K200296 Predicate (Pegavision) | K141670 Predicate (ACUVUE®) |
|---|---|---|---|
| Production Method | Cast-Molded | Cast-Molded | Cast-Molded |
| Lens Designs | Sphere & Asphere, Toric, Multifocal, Multifocal-Toric | Sphere & Asphere, Toric, Multifocal | Multifocal, Multifocal-Toric |
| USAN Name | Etafilcon A | Etafilcon A | Etafilcon A |
| Material Classification | Group IV high water ionic | Group IV high water ionic | Group IV high water ionic |
| Water Content (%) | 58% | 58% | 58% |
| Refractive Index | 1.402 | 1.402 | 1.402 |
| Oxygen Permeability (edge corrected) @ 35°C | $19.73 \times 10^{-11}$ (cm²/sec)(mlO2/ml-mmHg) | $19.73 \times 10^{-11}$ (cm²/sec)(mlO2/ml-mmHg) | $21.4 \times 10^{-11}$ (cm²/sec)(mlO2/ml-mmHg) |
| Cosmetically tinted | N/A | To enhance or alter the appearance of the eye | To enhance or alter the appearance of the eye |
| Percent Transmittance: | |||
| % T at 380~780nm | > 95% | > 95% | > 95% |
| % T at 315-380nm |
§ 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.