(132 days)
Proclear 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 nondiseased eyes that are myopic or hyperopic which, possess astigmatism to -5.75 diopters or less, and are presbyopic.
Proclear Multifocal XR (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 worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity.
Proclear Toric XR (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 which possess astigmatism corrections to -5.75 diopters.
Proclear Sphere and Asphere: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with nondiseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.
Proclear Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic or hyperopic The lens may be worn by persons who have astigmatism of 5.00D or less.
Proclear Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) and presbyopia in non-aphakic persons with non-diseased eyes. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.
Proclear (omafilcon A) Soft (hydrophilic) Contact 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 eyecare practitioners in consultation with their patients.
The Proclear lens is composed of polymer of 2-hydroxy-ethylmethacrylate and 2-metacryloloyoxyethyl phosphorylcholine cross linked with ethylene glycol dimethacrylate. The lenses are tinted blue from edge to edge for visibility purposes. The Proclear (omafilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. The physical properties and available dimensions are unchanged from predicate 510ks.
Proclear Toric and Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are back surface toric.
Proclear Multifocal and Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as a multifocal lens with an aspherical front surface and spherical back surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The multifocal lens has two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.
Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lens front surface is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eve that is astigmatic.
Proclear Sphere and Asphere: (omafilcon A) Soft (hydrophilic) Contact Lenses. The sphere lenses have spherical optical zone and asphere lens have an aspherical optical zone. This aspheric optical zone design (front surface) controls and limits the amount of longitudinal spherical aberration generated by the lens across the power range
The provided document describes a 510(k) premarket notification for CooperVision's Proclear (omafilcon A) Soft Contact Lenses. This submission aims to demonstrate substantial equivalence to previously cleared predicate devices based on modifications to the hydration and inspection processes.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Tested Characteristics Summary | Acceptance Criteria | Results |
|---|---|---|
| Total Extractables, Water content, Dk, Light Transmittance, refractive index tested per ISO 18369-4:2006 | Equivalent to predicate lens and meet tolerances in ISO 18369-2:2006 | Pass |
| Cytotoxicity Test ISO 10993-5:1999 | All 3 monolayers exposed to the test article show no grade greater than grade 2 (reactivity mild) | Pass |
| ISO Ocular Irritation ISO 10993-10:2002 | Test extract shows no significant irritation over the reagent control during the observation period. | Pass |
| Systemic Toxicity Study ISO 10993-11:1996 | During the observation period, none of the animals treated with the individual test extract exhibit a significantly greater reaction than the control animals. | Pass |
| ISO Contact Lens 22 Day Ocular Irritation Study ISO 9394 | Scores from macroscopic and microscopic ocular examinations equivalent between test and control eyes. | Pass |
Study to Prove Device Meets Acceptance Criteria:
The document clearly states that no clinical data is required because the "technical characteristics, formulation, manufacturing, and sterilization processes of this lens are not changing and are equivalent to omafilcon A soft contact lenses currently marketed by CooperVision."
Instead, the submission relies on non-clinical tests to demonstrate that the modifications to hydration and inspection processes do not alter the lens's safety and performance characteristics.
Here's a breakdown of the studies conducted:
-
Physicochemical Studies:
- Study Design: These studies tested properties such as Total Extractables, Water content, Dk (oxygen permeability), Light Transmittance, and Refractive Index according to ISO 18369-4:2006.
- Acceptance Criteria: The results needed to be equivalent to the predicate lens and meet tolerances specified in ISO 18369-2:2006.
- Results: The device "Pass"ed all these tests, indicating "no change to physicochemical properties of the lenses."
-
Toxicology Studies:
- Study Design: A series of in-vitro and in-vivo preclinical toxicology and biocompatibility tests were performed. These include:
- Cytotoxicity Test (ISO 10993-5:1999)
- ISO Ocular Irritation (ISO 10993-10:2002)
- Systemic Toxicity Study (ISO 10993-11:1996)
- ISO Contact Lens 22 Day Ocular Irritation Study (ISO 9394)
- Data Provenance: All tests were conducted in accordance with GLP regulation (21 CFR Part 56) or according to valid scientific protocols. The studies were performed by "Contract laboratories under Good Manufacturing Practice regulations" and "CooperVision" for chemistry, shelf-life, and leachability.
- Acceptance Criteria & Results: All tests "Pass"ed, confirming that the modified lens "remains non-toxic and biocompatible with the ocular environment."
- Study Design: A series of in-vitro and in-vivo preclinical toxicology and biocompatibility tests were performed. These include:
-
Material Comparison:
- A detailed table (Table 1) compares various material characteristics between the "Subject Device" and "Predicate Device." These characteristics include Product name, Material USAN Name, FDA Category, Manufacturing method, Curing, Sterilization, Packaging, Visibility tint, Package Saline buffers and surfactant, Water Content, Refractive Index, Oxygen Permeability, Light Transmission, Base Curve, Diameter, and Power.
- Acceptance Criteria: The conclusion drawn is that "all the material characteristics for the omafilcon A lens are equivalent between the predicate lens and the subject lens."
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of number of lenses or subjects. However, the studies mentioned are laboratory-based (physicochemical, in-vitro, in-vivo animal studies).
- Data Provenance: The studies were performed by "Contract laboratories under Good Manufacturing Practice regulations" and "CooperVision." They were conducted in accordance with GLP regulation (21 CFR Part 56) or valid scientific protocols. The country of origin for the data is not explicitly stated, but the submission is to the FDA (USA). These are prospective laboratory and animal studies, not retrospective human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission relies on non-clinical laboratory and animal studies, not expert consensus on medical images or clinical outcomes with human subjects. The "ground truth" (or acceptance criteria) for these tests are defined by international standards (e.g., ISO, GLP regulations) and direct measurement of physical/chemical properties.
4. Adjudication method for the test set
Not applicable. There was no human adjudication process involved as these were laboratory and animal studies with objective measurements against predefined standards.
5. 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 a 510(k) for contact lenses, not an AI/CADe device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a 510(k) for contact lenses, not an algorithm.
7. The type of ground truth used
The ground truth used for the non-clinical studies was based on:
- International Standards: ISO 18369-4:2006, ISO 18369-2:2006, ISO 10993-5:1999, ISO 10993-10:2002, ISO 10993-11:1996, ISO 9394.
- Predicate Device Equivalence: Direct comparison of material characteristics and performance to the previously cleared predicate lenses.
- Objective Measurements: Physicochemical properties (e.g., water content, Dk, refractive index) and biological responses (e.g., cytotoxicity grade, irritation scores) measured in laboratory settings using established protocols.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. The term "training set" doesn't apply here.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/machine learning device.
§ 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.