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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.

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