(175 days)
The SAUFLON CLARITI (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
The SAUFLON CLARITI TORIC (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes that may exhibit astigmatism up to 10.00 Diopters.
The SAUFLON CLARITI MULTIFOCAL (somofilcon A) Soft (hydrophilic) ontact Lens with UV blocker is indicated for monthly disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.
The SAUFLON CLARITI MULTIFOCAL TORIC (somofilcon A) Soft ydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and that may require a reading addition of +3.00 Diopters or less.
The lenses may be prescribed for daily wear with removal for cleaning and isinfection (chemical, not heat) prior to reinsertion as recommended by the eye care professional.
Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact lens with UV blocker help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Sauflon Clariti (somofilcon A) Soft (Silicone Hydrogel) Contact Lens with UV Blocker is available as a single vision, toric, multifocal and multifocal toric lens. The lens material (somofilcon A) is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate. When hydrated the lens consists of 44.0% somofilcon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used to block UV radiation.
The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380nm
The Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:
- Chord Diameter: 13.0mm to 15.5mm ● Centre Thickness: 0.03mm to 0.50mm . 7.5mm to 9.30mm Base Curve: . Powers: -20.00 DS to +20.00 DS . . Toric Cylinder options: -0.75, -1.25, -1.75 and -2.25
- Toric Axis options: .
- . Multifocal Add:
10° to 180° (10° steps).
Lens "LOW" = "low" for spectacle near ADD lens (Max +2.25 ADD) Lens "HIGH" = "high" for spectacle near ADD lens (+2.50 ADD or greater)
The physical/optical properties of the lenses are:
• Refractive Index: 1.4003
• %Transmittance @ 590nm: 98.13
• %Transmittance @ 280-315nm: 0.71
• %Transmittance @ 316-380nm: 20.62
• Surface Character: Hydrophilic
• Water Content: 56%
• Oxygen Permeability (DK): 60 x 10-11 (cm²/sec) (ml O2/ml x mmHg) at 35°C (Fatt Method for determination of oxygen permeability).
• Specific Gravity: 1.17
The provided document describes the K130342 510(k) summary for the Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker. It focuses on demonstrating substantial equivalence to predicate devices, primarily through physicochemical and toxicological studies, and a human clinical study.
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 doesn't explicitly state "acceptance criteria" for the clinical study in a quantifiable manner (e.g., "minimum visual acuity improvement of X"). Instead, it focuses on demonstrating safety, acceptability, and substantial equivalence. However, we can infer some performance metrics from the physicochemical properties table and the overall conclusion.
| Characteristic / Acceptance Criteria (Inferred from Predicate Equivalence) | Subject Device Performance (Sauflon Clariti) |
|---|---|
| Physicochemical Properties: | |
| Water Content | 56% |
| Refractive Index | 1.40 |
| Light Transmittance (Visible) | ≥96% (Reported as 98.13% @ 590nm) |
| Oxygen Permeability (DK @35°C) | 60 (polarographic method) |
| Modulus (MPa) | 0.55 |
| Tensile Strength (MPa) | 1.05 |
| Elongation at Break % | 163 |
| UV-B Transmittance (280-315nm) |
§ 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.