(108 days)
The SPHERICAL/ASPHERE Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The TORIC Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The MULTIFOCAL Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution with polymeric wetting agents. The color additive (Pathalocyaninto(2-))Copper, Iron Oxide and Reactive Yellow 15 are added to the lens material to create a light yellow-green edge-to-edge color to make it easier to see when handling, and additionally, reduce transmittance of short wavelength light in the range of 380nm to 460nm. In addition, lenses contain a benzotriazole monomer to filter UVA and UVB radiation. The (ocufilcon D) name has been adopted by the United States Adopted Names Council (USAN).
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are available tinted for visibility, and tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Reactive Yellow 15, Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green.
When producing the color lenses, the manufacturing process changes the specifications to the light yellow-green contact lens by pad-printing the color pigment(s)—entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses filter >95% in the UVB range (280nm - 315nm), and >80% in the UVA range (315nm - 380nm).
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are manufactured in the sphere/asphere, toric, and multifocal design configurations.
The provided FDA 510(k) clearance letter and associated summary pertain to a contact lens device, the Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color). It's important to note that this document describes the device as a "Soft (Hydrophilic) Contact Lens," which is a device type, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study parameters related to AI/ML device performance (such as sensitivity, specificity, MRMC studies, ground truth establishment for AI/ML, etc.) are not applicable to this type of medical device submission.
The "acceptance criteria" for a contact lens device primarily revolve around its physical, chemical, and biological properties, as well as its safety and functionality for human use, established through non-clinical (laboratory) testing and comparisons to predicate devices. The study proving these criteria are met is typically a combination of non-clinical bench testing and demonstrating substantial equivalence to an already marketed predicate device.
Here's the information based on the provided document, restructured to address your points where applicable:
1. A table of acceptance criteria and the reported device performance
For a contact lens, explicit "acceptance criteria" are often derived from recognized standards (like ANSI Z80.20 mentioned) and the performance of predicate devices. The reported device performance is compared against these and is generally expected to be within acceptable tolerances or equivalent to the predicate.
| Parameter | Acceptance Criteria (Implicitly from Standard/Predicate) | Reported Device Performance (Aurora) |
|---|---|---|
| Chord Diameter | 11.00 mm to 15.00 mm (±0.20 mm tolerance) | 11.00 mm to 15.00 mm (±0.20 mm tolerance) |
| Center Thickness | 0.05 mm to 0.15 mm (Specific tolerances) | 0.05 mm to 0.15 mm (Specific tolerances) |
| Base Curve | 7.00 mm to 10.0 mm (±0.20 mm tolerance) | 7.00 mm to 10.0 mm (±0.20 mm tolerance) |
| Back Vertex Power (F'v) | +20.00D to -20.00D (Specific tolerances) | +20.00D to -20.00D (Specific tolerances) |
| Cylinder Power (F'c) | -0.25D to -4.00D (Specific tolerances) | -0.25D to -4.00D (Specific tolerances) |
| Cylinder Axis | 10° to 180° (Specific tolerances) | 10° to 180° (Specific tolerances) |
| Multifocal Add Power | +0.25D to +4.00D (±0.37 D tolerance) | +0.25D to +4.00D (±0.37 D tolerance) |
| Surface Appearance | Clear with no surface defect | Clear with no surface defect |
| Oxygen Permeability (Dk) | 19.6 (±20% tolerance) | 19.6 (±20% tolerance) |
| Light Transmission (380-780nm) | 95% (±5% tolerance) | 95% (±5% tolerance) |
| Light Transmission (380-460nm) | >75% (>75% tolerance) | >75% (>75% tolerance) |
| UV-B 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.