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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.

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.

Device Description

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.

AI/ML Overview

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

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