(29 days)
The CLARITI 1 DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuty.
The CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.
The CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical corrective ametropia (myopia and hyperopia) and/or presbyopia in phakic 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 CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical corrective ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +3.00 Diopters or less.
The Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is available as sphere lens, toric lens, multifocal lens, and multifocal toric lens.
In its hydrated state, Clariti 1 day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker when placed on the cornea acts as a refracting media to focus light rays on the retina.
Clariti 1 day (somofilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear Single Use are a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate and di-functional methacryloxypropyl-terminated poly(dimethylsiloxane).
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 in the contact lens to help protect against transmission of harmful UV radiation and Clariti 1 day (somofilcon A) Soft contact lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
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 lens has 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
• Base Curve: 7.5mm to 9.30mm
• Powers: -20.00 DS to +20.00 DS
• Toric Cylinder options: -0.75, -1.25, -1.75 and -2.25
• Toric Axis options: 10° to 180° (10° steps)
• Multifocal Add:
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 a 510(k) premarket notification for a contact lens, Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker. The submission asserts substantial equivalence to a predicate device and does not involve performance testing to support this claim, but rather a change from biological release to parametric release of the finished product. Therefore, the document does not describe a study testing the acceptance criteria of the device.
However, it does list several performance specifications/parameters for the device, which can be interpreted as acceptance criteria based on its equivalence to the predicate device.
Here's the information derived from the document, with explanations for aspects not explicitly stated:
1. A table of acceptance criteria and the reported device performance (based on the predicate device's performance properties):
| Acceptance Criteria (Performance Specifications/Parameters) | Reported Device Performance (Subject Device) | Comments |
|---|---|---|
| Water Content (%) | 56 | Same as predicate |
| Refractive Index | 1.401 | Same as predicate |
| Oxygen Permeability (Dk @ 35°C) | $60 x 10^{-11} [(cm^2/sec) x (ml O_2)/(ml x mm Hg)]$ | Same as predicate |
| Base Curve (mm) | 8.6 | Same as predicate |
| Diameter (mm) | 14.0 | Same as predicate |
| Light Transmittance (%) | >95 | Same as predicate |
| Modulus (MPa) | ≥0.3 | Same as predicate |
| Tensile Strength (MPa) | ≥0.4 | Same as predicate |
| Elongation to Break (%) | ≥100 | Same as predicate |
| Surface Treatment | No | Same as predicate |
| Center Thickness (mm) | Varies with power | Same as predicate |
| Power Range (D) | -20.00 to + 20.00 | Same as predicate |
| UV Blocker Transmittance (UVB range of 280 to 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.