(196 days)
The UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 4.00 diopters. The lens may be disinfected using a chemical disinfection system.
The UltraCon (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The UltraCon Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions: Chord Diameter: 8.5 to 10,5 mm . 0.10 mm to 0.28 mm Center Thickness: . 7.0 to 8.5 mm Base Curve: . +12.00 D to-20.00 D Powers: . The physical/optical properties of the lens are: Specific Gravity 1.105 . 1.57 at 20°C Refractive Index: . 98.5% Light Transmittance: . Hydrophobic Surface Character: . 0.5% Water Content: . 19° (CLMA method) Wetting Angle: . Oxygen Permeability (Dk) :: 44 x 10-11 (cm2/sec) (ml O2 /ml x mm Hg) . at 35°C [Fatt method used for determination of oxygen permeability] 2. UltraCon S (carbosifiocon A) Rigid Gas Permeable Contact Lens for Daily Wear The UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The diameter of the lens is larger than conventional rigid gas permeable lenses, and the UltraCon S lens extends beyond the cornea and onto the limbal region. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The UltraCon S Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions: Chord Diameter: 12.0 mm to 14.0 mm Center Thickness: 0.10 mm to 0.28 mm Base Curve: 7.0 to 8.5 mm Powers: +12.00 D to-20.00 D Peripheral Curves: C, D, and E The physical/optical properties of the lens are: Specific Gravity 1.105 Refractive Index: 1.57 at 20°C Light Transmittance: 96.5% Surface Character: Hydrophobic Water Content: 0.5% Wetting Angle: 19° (CLMA method) Oxygen Permeability (Dk): 44 x 10-11 (cm²/sec) (ml O₂ /ml x mm Hg) at 35°C *[Fatt method used for determination of oxygen permeability]
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lenses for Daily Wear.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabular format as performance metrics against predefined thresholds. Instead, it demonstrates substantial equivalence to a predicate device, implying that meeting or exceeding the predicate's characteristics constitutes acceptance. The "Comparison to Predicate Device" table serves as the primary source for this.
| Parameter | UltraCon and UltraCon S (Reported Performance) | LifeStyle GP (Predicate Device Performance) | Note |
|---|---|---|---|
| Material | carbosilfocon A | telefocon B | Different material, but same classification. Non-clinical tests confirmed safety. |
| Material Classification | Hydrophobic Lens Group 2 | Hydrophobic Lens Group 2 | Same classification. |
| Indication for Use | myopia, hyperopia, astigmatism | myopia, hyperopia, astigmatism | Identical indications. |
| Water Content | 0.5% | less than 0.5% | Comparable. |
| Light Transmittance | 96.5% | 96% | Comparable, slightly better. |
| Dk (35° C) | 44 x 10⁻¹¹ | 43.5 x 10⁻¹¹ | Comparable, slightly better. |
| Powers | +20.00 to -20.00 Diopters | +20.00 to -20.00 Diopters | Identical. |
| Color | blue visibility | blue, green, brown, and gray | Different color options, but for visibility tint, not clinical performance. |
| Specific Gravity | 1.105 | 1.126 | Comparable. |
| Refractive Index | 1.57 at 20° C | 1.480 at 20° C | Different, but considered acceptable within the context of substantial equivalence. |
| Wetting Angle |
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.