(54 days)
The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens help protect against transmission of harmful UV radiation to the cornea and into the eye.
For Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, the eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.
The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A 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 50 % in the UVA range of 316 to 380 nm.
The lenses are tinted from edge to edge for visibility purposes with the color additive C.I. Reactive Blue No. 4 and printed with an intermittent coating containing a combination of the following approved pigments: Copper Phthalocyanine, Reactive Black 5, Iron Oxide, Titanium Dioxide, Carbazole Violet and D&C Yellow No. 10. The Lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing 0.01 % sodium hyaluronate and 0.1 % trehalose wetting agents.
The provided text details a 510(k) premarket notification for new contact lenses, asserting their substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence rather than establishing de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and specific performance metrics like sensitivity, specificity, and reader studies is not explicitly available in this document.
However, I can extract the closest available information related to the device's characteristics and the non-clinical testing performed to support its substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on demonstrating similar performance and characteristics to the predicate device (Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, K132854). The "reported device performance" are the characteristics of the new devices.
| Characteristic | Acceptance Criteria (Implied: Similar to predicate K132854) | Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Performance | Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens Performance |
|---|---|---|---|
| Regulatory Number | 886.5925 | 886.5925 | 886.5925 |
| Classification | II | II | II |
| Intended Use | Same as predicate | The same | The same |
| Prescription Use | Yes | Yes | Yes |
| Material | polymacon | polymacon | polymacon |
| Manufacturing Method | Cast Molded | Cast Molded | Cast Molded |
| Water Content | 38 % | 38 % | 38 % |
| Powers | -0.50 D ~ -12.00 D (predicate) | -0.00 D ~ -20.00 D | -0.00 D ~ -20.00 D |
| Light Transmittance | 95 % ± 5 % | 95 % ± 5 % | 95 % ± 5 % |
| UV-A |
§ 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.