(102 days)
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact lenses are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 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. Eye Care professionals may prescribe the lens for 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 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens is manufactured by using advanced cast molding method. The lens material, methafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA) 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 280~315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4. The Lenses are available as aspheric lenses.
The provided 510(k) summary (K133735) describes the "Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) Contact Lens." This device is a contact lens, and its acceptance criteria and the study proving it meets these criteria are established through a demonstration of substantial equivalence to a predicate device, the "SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear" (K013649).
The approval is based on non-clinical testing rather than a clinical study or AI performance evaluation. The review relies on the inherent equivalence of the new device to a previously approved one.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the characteristics of the predicate device, K013649. The new device demonstrates performance that is either identical or within acceptable limits of the predicate.
| Characteristic | Acceptance Criteria (Predicate Device K013649 Performance) | Reported Device Performance (Eye Secret 55 UV Aspheric) |
|---|---|---|
| Classification | 886.5925 (Class II) | 886.5925 (Class II) |
| Intended Use | Correction of ametropia (myopia and hyperopia) and astigmatism up to 2.00 Dioptres for daily wear. | Correction of ametropia (myopia) with astigmatism up to 2.00 Dioptres for daily wear. (Slight difference in 'hyperopia' indicated, but still considered substantially equivalent) |
| Prescription Use | Yes | Yes |
| Material | Methafilcon A | Methafilcon A |
| Manufacturing Method | Cast Molded | Cast Molded |
| Water Content | 55% | 55% |
| Dk (Oxygen Permeability) | 22.0 x 10^-11 (cm²/sec) (mlO₂/ml x mmHg) | 22.0 x 10^-11 (cm²/sec) (mlO₂/ml x mmHg) |
| Powers | ± 20.00D | 0 ~ -12.00 D (Accepted range, though predicate has wider) |
| Light Transmittance | 94.61% | 95% ± 5% |
| UV-A Blockage | 36.00% |
§ 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.