(60 days)
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens helps protect against transmission of harmful UV radiation to the cornea and into the eye.
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 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is manufactured by using 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 to 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. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing sodium hyaluronate and trehalose wetting agents.
The provided text is related to the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens. It serves as a 510(k) summary for premarket notification to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device (K133735) rather than acting as a traditional clinical study report for a new medical device where complex acceptance criteria related to diagnostic performance might be required.
Therefore, the requested information regarding acceptance criteria and studies (e.g., MRMC, expert ground truth, training set details) that are typical for AI/ML-driven devices with diagnostic or prognostic capabilities is not applicable to this document. This document describes a contact lens and focuses on bench testing and material safety.
However, I can extract the "acceptance criteria" through the lens of substantial equivalence and the reported device performance related to the physical and chemical properties of the contact lens, as well as the non-clinical tests performed to demonstrate its safety and effectiveness.
Here's an interpretation of the requested information based on the provided text for the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (contact lens), the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device (K133735) across various physical, chemical, and safety characteristics. The reported device performance is compared directly to the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device K133735) | Reported Device Performance (Subject Device) |
|---|---|---|
| Device Name | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens |
| Intended Use | Correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 to -12.00 diopters; for astigmatism ≤ 2.00 diopters not interfering with visual acuity. Prescribed for daily disposable or daily wear in a Frequent Replacement Program. Disinfection with chemical or hydrogen peroxide systems. | Correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes; for astigmatism ≤ 2.00 diopters not interfering with visual acuity. Helps protect against transmission of harmful UV radiation. Prescribed for single use daily disposable or daily wear in a Frequent Replacement Program. Disinfection with chemical or hydrogen peroxide systems. |
| Material | Methafilcon A | Methafilcon A |
| Manufacturing Method | Cast Molded | Cast Molded |
| Water Content | 55 % | 55 % |
| Powers | -0.00 ~ -12.00 D | -0.50 D ~ -20.00 D |
| Light Transmittance | 95 % (± 5 %) | 95 % (± 5 %) |
| UV-A 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.