(34 days)
CIBASOFT® PROGRESSIVE TORIC (tefilcon) soft (hydrophilic) contact lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 0.75 to 2.75 diopters of refractive and/or corneal astigmatism that does not interfere with visual acuity.
CIBASCIFT® PROGRESSIVE TORIC soft contact lenses are hemispherical flexible shells maade of tefilcon, a hydrophilic polymer of hydroxyethylmethacrylate (HEMA), with a water content of 37,5% by weight in normal saline solution. The lens is available in 8.6mm and 8.9mm base curves, 14.5mm diameter with center thickness of 0.012mm at -3.00 dioxoters or 0.014mm at +3.00 diopters, and powers ranges from -25.00 to +25.00cicopters. CIBASOFT® PROGRESSIVE TORIC has a toric optic zone on its front surface with a centermost aspheric zone on its back surface. This aspheric zone has an add poweer range from 0.25 to 0.75 diopters for vision correction at near. For optimum stabilizatition of the lens on the cornea, there are two thin zones on the front surface at the 12 o'clock and 6 o'clock positions.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary for the CIBASOFT® PROGRESSIVE TORIC Soft (hydrophilic) Contact Lens, focusing on its substantial equivalence to a predicate device.
Specifically, the text states:
- "The addition of the multifocal or presbyopic feature to the centermost part of opptical zone of the base curve, does not raise new safety or efficacy issues, thus, CIBASQ5FT® PROGRESSIVE TORIC is substantially equivalent to the TORISOFT® lens."
This indicates that the manufacturer is relying on the established safety and efficacy of the predicate device (TORISOFT® Soft (hydrophilic) Contact Lens, PMA #810005), arguing that the modifications made to the CIBASOFT® PROGRESSIVE TORIC lens do not introduce new safety or effectiveness concerns that would require a new, independent study with specific acceptance criteria.
Therefore, I cannot provide the requested information as it is not present in the given document.
§ 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.