(86 days)
The CONTAFLEX 38 (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The CONTAFLEX 38 Spherical Soft Contact Lenses are fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The nonionic lens material, (polymacon) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint, [phthalocyaninato (2-)] copper. The polymacon name has been adopted by the United States Adopted Names Council (USAN). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CONTAFLEX 38 (polymacon) Spherical Soft Contact Lens:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to a predicate device ("BENZ 38") rather than defining explicit, separate acceptance criteria for the new device. The "acceptance criteria" are implied by the need for the CONTAFLEX 38 to exhibit comparable pre-clinical characteristics to the BENZ 38.
| Acceptance Criteria (Implied by Predicate Equivalence) | Predicate Device (BENZ 38) Performance | CONTAFLEX 38 Performance |
|---|---|---|
| Intended Use | Daily wear for aphakic/non-aphakic persons, myopia/hyperopia correction | Daily wear for aphakic/non-aphakic persons, myopia/hyperopia correction |
| Functionality | Refractive medium focusing light rays on retina | Refractive medium focusing light rays on retina |
| Indications | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens |
| Production Method | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 1 |
§ 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.