(53 days)
Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 3.00 diopters or less, and are presbyopic. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Proclear UltraVue/D and Proclear UltraVue/N Multifocal (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be wom by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Proclear UltraVue Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 5.00 diopters or less. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient and should be decided by the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients eye and discarded after the recommended wearing period prescribed by the eve care practitioner. The lenses may be disinfected using a chemical disinfection system.
Proclear UltraVue Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are made of polymer of 2-hydroxy-ethylmethacrylate and 2-methacryloyloxyethyl phosphorylcholine crosslinked with ethylenedlycol dimethacrylate. The lenses are tinted edge for visibility purposes with the color additive C. I. Reactive Blue 4. Proclear UltraVue Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as astigmatic (toric) lenses.
Proclear UltraVue/D and Proclear UltraVue/N (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as a multifocal lens with an aspherical front surface and spherical back sufface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The Proclear UltraVue/D and Proclear UltraVue/N is designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength. The Proclear UltraVue/D has a spherical central zone for the correction of distance vision and an aspherical annular zone for the correction of intermediate and near vision. The Proclear UltraVue/N has a spherical central zone for the correction of near vision and an aspherical annular zone for the correction of intermediate and distance vision. The lenses are tinted edge for visibility purposes with the color additive C. I. Reactive Blue 4. The lens material, omafilcon A is a copolymer of 2-hydroxy-ethylmethacrylate and 2methacryloyloxyethyl phosphoryicholine crosslinked with ethyleneglycol dimethacrylate. The Proclear UltraVue/D and Proclear UltraVue/N (omafilcon A) Soft (Hydrophilic) Contact Lenses are flexible transparent hemispherical shells.
Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are made of polymer of 2-hydroxyethylmethacrylate and 2-methacryloyloxyethyl phosphorylcholine crosslinked with ethyleneglycol dimethacrylate. The lenses are tinted edge for visibility purposes with the color additive C. I. Reactive Blue 4. The front surface of the Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic. The Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric contact lenses are designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength. The Proclear UltraVue/D 2000T with a spherical central zone for the correction of distance vision and an aspherical annular zone for the correction of intermediate and near vision. The Proclear UltraVue/N 2000T with a spherical central zone for the correction of near vision and an aspherical annular zone for the correction of intermediate and distance vision. Both lenses are a flexible transparent hemispherical shell.
This is a 510(k) premarket notification for CooperVision contact lenses (Proclear UltraVue Toric, Proclear UltraVue Multifocal, and Proclear UltraVue 2000T Multifocal Toric). As such, it establishes substantial equivalence to predicate devices rather than conducting new clinical studies with acceptance criteria and statistical analyses as would be found in a PMA submission.
Therefore, the following information regarding acceptance criteria and a study proving a device meets them is not applicable to this document:
- A table of acceptance criteria and the reported device performance: Not present in a 510(k). The document provides physical properties of the lenses and compares them to predicate devices in a "Substantial Equivalence Table."
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set as described for a clinical study is detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable; this is not a study assessing diagnostic performance against ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable; this is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable; this is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
What the document does provide in lieu of a typical clinical study:
The document focuses on establishing substantial equivalence to already legally marketed predicate devices. This is achieved by demonstrating that the subject devices have:
- Same Material: Omafilcon A.
- Similar Physical Properties: Water Content (59%), Light Transmittance (>90%), Index of Refraction (1.40).
- Similar Design and Intended Use:
- Proclear UltraVue Toric (Subject Device) is compared to Proclear Tailor Made Toric (Predicate Device K952152) – both are Omafilcon A, Back Surface Toric, and for correction of visual acuity in patients with myopia or hyperopia and astigmatism.
- Proclear UltraVue Multifocal (Subject Device) is compared to Proclear UltraVue Multifocal (Predicate Device K043129) – both are Omafilcon A, Aspheric Multifocal, and for correction of visual acuity in patients with myopia or hyperopia and presbyopia.
- Proclear UltraVue 2000T Multifocal Toric (Subject Device) is compared to Proclear UltraVue 2000T Multifocal Toric (Predicate Device K0423129) – both are Omafilcon A, Aspheric Multifocal Toric, and for correction of visual acuity in patients with myopia or hyperopia, astigmatic, and presbyopic.
- Different Manufacturing Method: The subject devices use a "Finished Inside Polymerization System" compared to the "Lathe-Cut" method of the predicate devices. The submission implicitly argues that this manufacturing change does not raise new questions of safety or effectiveness, as evidenced by the similar physical properties and intended use.
- Oxygen Permeability: There is a slight difference mentioned (21.05 for Lathed Predicate vs. 25.0 for Finished Inside Polymerization System Subject Device, though the table for "Lathe-Cut Omafilcon A" shows 21.05 and the physical properties lists 21.05 x 10^-9 for the subject device - the table has a discrepancy here). This difference, if acknowledged and explained, is presumably not considered significant enough to negate substantial equivalence.
Conclusion stated in the document:
The conclusion emphasizes that the device will be manufactured according to specified process controls and an established quality assurance program, similar to devices already marketed by CooperVision. It states that "Being similar with respect to indications for use, the risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear basis." This statement serves as the basis for the declaration of substantial equivalence.
§ 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.