(72 days)
UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.
UltraHealth™ Flat Cornea SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic, nondiseased eyes, with or without presbyopia. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.
The UltraHealth™ SiH Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea SiH Hybrid Contact Lenses are contact lenses that combine a gas permeable optic surrounded by a soft hydrophilic skirt that straddles the limbus of the eye:
- in the power range of -20.00 to +20.00 diopters for sphere,
- with center thickness from 0.16 mm to 0.39 mm
- with base curves of 5.5 mm to 9.00 mm
- with diameter of 14.50mm
When placed on the human cornea, the UltraHealth™ Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea act as a refracting medium to focus light rays onto the retina. The devices are available as lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in blue visibility tinted material.
The optics of the UltraHealth™ Hybrid Contact lens for Keratoconus and the UltraHealthI™ Flat Cornea lenses are a gas permeable polymer material (petrafocon A). The soft skirt is comprised of silicone hydrogel (hem-larafilcon A) with a 32% water content. The junction between the rigid material and soft material is bound by a proprietary method.
This document describes the premarket notification for UltraHealth™ SiH and UltraHealth™ Flat Cornea SiH Hybrid Contact Lenses. It details the device, its intended use, and its substantial equivalence to previously approved devices.
Here's a breakdown of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a tabulated format with numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices that have already been proven safe and effective. The "reported device performance" is essentially that the new lenses are equivalent in design and material to previously cleared safe and effective lenses. The table below summarizes the characteristics of the new lenses compared to predicate and reference lenses, implying that similarity to the predicate is the primary criterion for acceptance.
| Characteristic | UltraHealth™ SiH Hybrid Contact Lenses for Keratoconus (New Lens) | Synergeyes KC (Predicate) | Synergeyes SiH (Reference) |
|---|---|---|---|
| Material (RGP Center) | petrafocon A | paflufocon D | petrafocon A |
| Material (Soft Skirt) | hem-larafilcon A | hem-iberfilcon A | hem-larafilcon A |
| UV Blocking | Yes | No | Yes |
| Base Curves | 5.5 mm to 9.0 mm | 5.5 to 7.0 mm | 7.1 to 9.0 mm |
| Base Curve Chord | 6.0 mm to 6.5 mm | 6.0 mm | 6.0 mm to 6.5 mm |
| Design | Reverse geometry with anterior aspheric surface | Reverse geometry with anterior aspheric surface | Standard geometry with anterior aspheric surface |
| RGP Center | 8.40mm | 8.40mm | 8.40 mm |
| Diameters | 14.5mm | 14.5mm | 14.5 mm |
| Power Range | -20.00 to +20.00 | -20.00 to +20.00 | -20.00 to +20.00 |
| Add Powers (multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D | +1.00 D to +4.00 D |
| Refractive Index (RGP) | 1.442 | 1.442 | 1.442 |
| Refractive Index (S/H Skirt) | 1.435 | 1.448 | 1.435 |
| Specific Gravity (RGP) | 1.15 | 1.10 | 1.15 |
| Hardness (Shore D) RGP | 76 | 79 | 76 |
| Modulus (kgf/cm²) RGP Center | 14515.1 ±324 | 11137.9 ± 367 | 14515.1 ±324 |
| Tint | Visibility violet (D&C 2) | Visibility green (D&C Green #6) | Visibility violet (D&C 2) |
| Water Content (Soft Skirt) |
§ 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.