(167 days)
Sphere/Asphere
Innova Vision Sphere and Asphere (Etafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuty.
Toric
Innova Vision Toric (Etafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal
Innova Vision Multifocal (Etafilcon A) Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric
Innova Vision Multifocal Toric (Etafilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eves in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.
Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.
When prescribed for frequent/planned replacement, the Innova Vision Hydrogel (Etafficon A) Soft (Hydrophilic) Contact Lens is to be cleaned. rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.
When prescribed for single-use disposable wear, Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (58% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) a via UV photo-polymerization. Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for for handling and contains 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxyl-phenyl]ethyl as an additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 30% in the UVA region.
The properties of the lens are:
Chord Diameter: 13.00 mm to 15.00 mm
Center Thickness 0.080 mm to 0.580 mm
Base Curve: 8.0 mm to 9.8 mm
Power Range
Sphere Power: -20.00 D to +20.00 D in 0.25 D steps
Cylinder Power (Toric): -0.25 D to -2.25 D in 0.25 D steps
Cylinder Axis (Toric): 10 degrees to 180 degrees in 10 degrees steps
Multifocal Power: +0.25 D to +4.00 D in 0.25 D steps
Specific Gravity: 0.98 to 1.12
Refractive Index: 1.400 plus or minus 0.005
Visible Light Transmittance: > 95%
UVA (315 nm~380 nm) Absorbance
The provided text describes the regulatory submission for the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens (K222954). The submission demonstrates substantial equivalence to predicate and reference devices, primarily through non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria in a quantitative format for all aspects. Instead, it states that "All the test results met the requirements of product specification" and "The results complied with the testing guidance." It provides specific performance characteristics for the subject device and compares them to predicate and reference devices, asserting non-significant differences.
Based on the "Description of the Device" and the comparison tables, here's a summary of performance characteristics presented as implicit acceptance criteria and reported performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens) |
|---|---|
| Geometric Parameters | |
| Chord Diameter | 13.00 mm to 15.00 mm |
| Center Thickness | 0.080 mm to 0.580 mm |
| Base Curve | 8.0 mm to 9.8 mm |
| Power Range (Sphere) | -20.00 D to +20.00 D in 0.25 D steps |
| Power Range (Cylinder, Toric) | -0.25 D to -2.25 D in 0.25 D steps |
| Cylinder Axis (Toric) | 10° to 180° in 10° steps |
| Multifocal Power | +0.25 D to +4.00 D in 0.25 D steps |
| Material Properties | |
| Specific Gravity | 0.98 to 1.12 |
| Refractive Index | 1.400 ± 0.005 |
| Visible Light Transmittance | > 95% |
| UVA (315 nm~380 nm) Absorbance |
§ 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.