(85 days)
The Sofclear Enhance, Colors, and Comfort (methafilcon A) contact lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for 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 disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from methafilcon A, which is a hydrophilic copolymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in saline solution. The (methafilcon A) name has been adopted by the United States Adopted Names Council (USAN).
The Sofclear Enhance (methafilcon A) Daily Wear Contact Lenses are available tinted to enhance or alter the apparent color of the eye. The lenses are tinted with one or a combination of one or more of the following 'listed' color additives: Reactive Blue 21, Reactive Blue 19, Reactive Yellow 86.
The Sofclear Colors (methafilcon A) Daily Wear Contact Lenses are available printed to enhance or alter the apparent color of the eye. The lenses are printed with one or a combination of one or more of the following 'listed' color additives: Red Iron Oxide, Violet 23, Titanium Dioxide, Chromium Oxide Green, Blue 36.
The Sofclear Comfort (methafilcon A) Daily Wear Contact Lenses include a tint (1,4-Bis[4-(2methacryloxyethyl)phenylamino]-9,10-anthraquinone) in the composition of the lens for ease of handling and visibility.
The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses incorporate a UV absorbing monomer. The lenses block >88% in the UVB range (280mm - 315nm), and >68% in the UVA range (316nm - 380nm).
The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses will be manufactured in the spherical design configuration.
This document describes the pre-market notification (510(k)) for Gelflex Laboratories' Sofclear Enhance, Sofclear Colors, and Sofclear Comfort (methafilcon A) Daily Wear Contact Lenses. The submission asserts substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in a typical quantitative clinical performance metric sense (e.g., sensitivity, specificity for a diagnostic device). Instead, it demonstrates performance by comparing physicochemical and mechanical properties to the predicate devices and by demonstrating safety through non-clinical testing. The "acceptance criteria" appear to be meeting established standards for contact lenses and comparability to predicates.
| Parameter | Acceptance Criteria (implied - comparable to predicate/standards) | Reported Device Performance (Sofclear Enhance, Colors, Comfort) | Notes |
|---|---|---|---|
| Physicochemical & Mechanical Properties | Reported as demonstrated consistent material properties between subject and predicate devices.Specific values are provided in a table on page 6. | ||
| In-Vitro Cytotoxicity | Non-toxic (according to ISO 10993-5) | Non-toxic | Completed in accordance with GLP regulation. |
| Systemic Toxicity | Meet requirements of systemic injection test (ISO 10993-11) | Considered non-toxic | Completed in accordance with GLP regulation. |
| Acute Ocular Irritation | No ocular irritation (ISO 10993-10) | Produced no ocular irritation | Completed in accordance with GLP regulation. |
| Shelf Life | Stability, sterility, and package integrity over labeled expiration date | Demonstrated stability, sterility, and package integrity over labeled expiration date | Completed in accordance with GLP regulation. |
| Chord Diameter | 11.00 mm to 15.00 mm (Tolerance ±0.20 mm) | (Implicitly within range and tolerance) | Based on table on page 6, values are within range |
| Center Thickness | 0.05 mm to 0.210 mm (Tolerance based on value) | (Implicitly within range and tolerance) | Based on table on page 6, values are within range |
| Base Curve | 7.00 mm to 10.0 mm (Tolerance ±0.20 mm) | (Implicitly within range and tolerance) | Based on table on page 6, values are within range |
| Back Vertex Power (F'v) | +20.00D to -20.00D (Tolerance based on value) | (Implicitly within range and tolerance) | Based on table on page 6, values are within range |
| Surface Appearance | Clear with no surface defect | (Implicitly meets criteria) | Based on table on page 6 |
| Oxygen Permeability (Dk) | 20.4 (x 10⁻¹¹ (cm²/sec)(mlO₂)/(ml x mmHg)) (Tolerance ±20%) | 20.4 (subject device) vs. 20.7 (main predicate) | Based on table on page 8, subject device Dk is 20.4, compared to predicate's 20.7 and 19.7. |
| Light Transmission (@ 380-780nm) | >97% (Tolerance ±5%) | (Implicitly meets criteria) | Based on table on page 6 |
| Ultraviolet Radiation Transmittance |
§ 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.