(136 days)
The Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors 42 UV also acts to enhance or alter the apparent color of the eye.
The Saview-Colors 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.
The Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the corrective ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Colors 42 UV lens also acts to enhance or alter the apparent color of the eye.
Eve care practitioners may prescribe the lenses for single use disposable wear or frequent replacement. When prescribed for a Disposable Wearing Schedule, the lenses are not intended to be cleaned or disinfected and should be discarded after a single use. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.
The Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA), and using azobisisobutyronitrile (AIBN) as the initiator. A compound 22-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl] UV absorbing ethvl methacrylate is incorporated into the lens polymer. The lens contains 42% water by weight and each lens is supplied sterile in a blister container in saline solution. The lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, phthalocyanine green and carbazole violet listed in 21 CFR Part 73 and [phthalocyaninato (2-)] copper list in 21 CFR Part 74.
The Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is available as a single vision lens.
The Saview-Colors 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable.
The Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.
The provided document is a 510(k) summary for contact lenses and does not describe AI/ML device performance or acceptance criteria in the context of diagnostic accuracy. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Therefore, most of the requested information regarding AI/ML device performance and study design cannot be extracted.
However, I can extract the acceptance criteria and device performance information related to the physical and chemical properties of the contact lenses, as presented in the "Comparison Chart" (Table 1).
Here's the available information presented in the requested format, with notes indicating why certain sections are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For the purpose of this 510(k), the "acceptance criteria" appear to be meeting or being substantially equivalent to the properties of the predicate devices. The document explicitly states: "Information submitted in the 510(k) establishes that the Saview-Colors 42 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness."
| Metric | Acceptance Criteria (Predicate Device K040900) | Acceptance Criteria (Predicate Device K050213) | Reported Device Performance (Saview-Colors 42 UV) |
|---|---|---|---|
| Material (Classification) | hefilcon A (Group 1) | nelfilcon A (Group 2) | hefilcon A (Group 1) |
| Indication for use | myopia, hyperopia, presbyopia and astigmatism | myopia, hyperopia, presbyopia and astigmatism | myopia, hyperopia, presbyopia and astigmatism |
| Water content | 42 % | 69 % | 42 % |
| Visible light transmittance | 90.3 % | Clear ≥ 97 %, Vistint 96 % | 97.06 % |
| UV 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.