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 non-diseased eyes that are myopic or hyperopic in powers from -20.00, possess astigmatism to -5.75 diopters, 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 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 non-diseased eyes in powers from -20.00 to +20.00 that are myopic or hyperopic and are presbyonic. The lenses may be worn 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 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 and hyperopic in powers from -20.00 to +20.00 diopters and astigmatism corrections to -5.75 diopters. 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 eye care practitioner. The lenses may be disinfected using a chemical disinfection system.

Device Description

The Proclear Toric XR, Multifocal XR and Multifocal Toric (omafilcon A) Contact Lenses are made from a material containing 59% water and 41% omafilcon A, a polymer of 2-hydroxy-ethylmethacrylate and 2methacryloyloxyethyl phosphorylcholine crosslinked with ethyleneglycol dimethacrylate. The lenses are tinted edge for visibility purposes with Vat Blue 6.

Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lens is a back surface toric.

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 Proclear Multifocal XR is designed with 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 eye that is astigmatic.

AI/ML Overview

The provided document is a 510(k) summary for CooperVision's Proclear Toric XR, Multifocal, and Multifocal XR Daily Wear Soft Contact Lenses. It details non-clinical testing performed to assess the safety and effectiveness of the contact lenses.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Cytotoxicity Test ISO 10993 - 5: Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity	All 3 monolayers exposed to the test article show no grade greater than grade 2 (reactivity mild)	Pass
ISO Ocular Irritation ISO 10993 - 10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed Hypersensitivity	Test extract shows no significant irritation over the reagent control during the observation period.	Pass
Systemic Toxicity Study ISO 10993 - 11: Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity.	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 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products The determination of Biocompatibility by Ocular Study with Rabbit Eyes.	Scores from macroscopic and microscopic ocular examinations equivalent between test and control eyes.	Pass
Total Extractables, Water content, Dk, Light Transmittance, refractive index tested per ISO 18369-4:2006 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials: section 4.2	Equivalent to predicate lens	Pass

2. Sample size used for the test set and the data provenance

The document describes non-clinical laboratory tests using in-vitro and in-vivo methods. Specific sample sizes for each test are not explicitly stated. The in-vivo tests (Ocular Irritation Study, Systemic Toxicity Study) were conducted on animals (rabbits for ocular studies; the specific animal for systemic toxicity is implied but not named with a precise number).

The data provenance is from non-clinical laboratory studies conducted by "Contract laboratories under Good Manufacturing Practice regulations" and "CooperVision" itself for chemistry, shelf-life, and leachability studies. The country of origin for the data is not specified beyond "Contract laboratories" and CooperVision's internal studies. These are prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The tests described are laboratory-based, non-clinical evaluations (cytotoxicity, irritation, systemic toxicity, physicochemical properties). "Ground truth" in the context of expert consensus or clinical evaluation is not relevant here. The evaluation criteria are based on scientific standards (ISO norms) and controlled experimental results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical studies where experts review cases for a diagnosis or outcome. The tests conducted were laboratory tests with objective pass/fail criteria based on quantitative measurements and observations, not subjective expert adjudication of patient cases.

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

This section is not applicable. The device is a physical medical device (contact lens), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. As stated above, the device is a physical contact lens, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" is defined by:

Scientific Standards: Adherence to established ISO standards (ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 9394, ISO 18369-4).
Controlled Experimental Results: Objective measurements and observations from in-vitro assays and animal studies, interpreted against predefined acceptance criteria. For example, for cytotoxicity, the "ground truth" is no more than grade 2 reactivity; for ocular irritation, no significant irritation over control.
Predicate Device Equivalence: For physicochemical properties (Water content, Dk, Light Transmittance, refractive index), the "ground truth" is equivalence to the predicate lens.

8. The sample size for the training set

This section is not applicable. The document describes non-clinical testing for contact lenses, which does not involve a "training set" in the context of machine learning or AI models.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

Summary

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K110099

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6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588

T 925 621 2480
F 925 621 2487 www.coopervision.com JUN 2 9 2011

CooperVision"

CooperVision: 510(k) Summary (as required by section 807.92(c)). K110099

Submitted By:	CooperVision Inc.6150 Stoneridge Mall Road, Suite 370Pleasanton, CA 94588
Company Contact:	Sarah Harrington MS, MBARegulatory Affairs925 621-2458: Phone866 491-7424; FAXsharrington@coopervision.com
Date Prepared:	May 26 2011
Trade Name:	Proclear Toric XR (omafilcon A) Soft (hydrophilic) Contact LensProclear Multifocal XR (omafilcon A) Soft (hydrophilic) Contact LensProclear Multifocal Toric (omafilcon A) Soft (hydrophilic) Contact Lens
Common Name:	Soft Contact Lens
Classification:	Lenses, Soft Contact, Daily WearClass II: LPL, 21 CFR 886.5925

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510(k) Summary

Proclear Toric XR, Multifocal and Multifocal XR Daily Wear Soft Contact Lenses

Substantially Equivalent Devices:

Proclear Toric XR, Proclear Multifocal XR and Proclear Multifocal Toric (omafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear, K081865.

Proclear XC and Proclear 1 day (omafilcon A) Hydrophilic Contact Lenses for Daily Wear, K061948.

Device

Description:

Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lens is a back surface toric.

Indication for Use:

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 in powers from -20.00 to +20.00, possess astigmatism to -5.75 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 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 in powers from -20.00 to +20.00 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. 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).

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CooperVision K110099

--..

510(k) Summary

Proclear Toric XR, Multifocal and Multifocal XR Daily Wear Soft Contact Lenses

Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are Indication for Use indicated for daily wear for the correction of visual acuity in aphakic and (continued) not-aphakic persons with non-diseased eyes that are myopic or hyperopic in powers from -20.00 to +20.00 diopters and astigmatism corrections to -5.75 diopters. 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 to 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 eye care practitioner. The lenses may be disinfected using a chemical disinfection system.

Technological The technological characteristics of the subject lens and the predicate lenses Characteristics are compared in the following tables. The Subject device has the same technological characteristics (i.e., design, material, package, parameters) as the predicate devices.

Material Comparison
	Subject Device	PredicateDevice	PredicateDevice
Product name	Proclear Toric XRProclearMultifocal XRProclearMultifocal Toric	Proclear Toric XRProclearMultifocal XRProclearMultifocal Toric	Proclear XCProclear 1 day
Material USANName	Omafilcon A	Omafilcon A	Omafilcon A
510(k) number	This submission	K081865	K061948
FDA Category(Group)	Group II Non-lonicHigh Water	Group II Non-lonicHigh Water	Group II Non-IonicHigh Water
Manufacturingmethod	Finished InsidePolymerizationSystem II	Finished InsidePolymerizationSystem II	Cast molded
Curing	Thermal Cure	UV Cure	Thermal cure
Sterilization	Moist Heat (steam) invalidated Autoclave	Moist Heat (steam)in validatedAutoclave	Moist Heat (steam)in validatedAutoclave
Packaging	Blister Pack	Blister Pack	Blister Pack
Visibility tint	VAT Blue 6	VAT Blue 6	VAT Blue 6

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CooperVision K110099

510(k) Summary

Parameter Comparison
	Subject Device	PredicateDevice	PredicateDevice
Product name	Proclear Toric XR	Proclear Toric XR	Proclear XC
	ProclearMultifocal XR	ProclearMultifocal XR	Proclear 1 day
	ProclearMultifocal Toric	ProclearMultifocal Toric
Water Content	59% ± 2%	59% ± 2%	60% ± 2%
RefractiveIndex	1.395 ± 0.005	1.40	1.40
OxygenPermeability x10-11	21.05	21.05	21.00
LightTransmission	>90%	>90%	>90%
Base Curve	8.0 to .9.3 mm	8.0 to .9.3 mm	8.0 to .9.5 mm
Diameter	13.6 to 15.2 mm	13.6 to 15.2 mm	13.0 to 15.5 mm
Power	-20.00 to +20.00	-20.00 to +20.00	-20.00 to +20.00

Proclear Toric XR, Multifocal and Multifocal XR Daily Wear Soft Contact Lenses

Non-Clinical Testing

A series of in-vitro and in-vivo preclincal toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the contact lens. All tests were conducted in accordance with the GLP regulation (21 CFR Part 56) or according to valid scientific protocols.

Test	Acceptance Criteria	Result
Cytotoxicity Test ISO 10993 - 5:1999: Biological Evaluation ofMedical Devices - Part 5: Tests forIn Vitro Cytotoxicity	All 3 monolayers exposed tothe test article show no gradegreater than grade 2 (reactivitymild)	Pass
ISO Ocular IrritationISO 10993 - 10:2002: BiologicalEvaluation of Medical Devices - Part10: Tests for Irritation and DelayedHypersensitivity	Test extract shows nosignificant irritation over thereagent control during theobservation period.	Pass
Systemic Toxicity StudyISO 10993 - 11: 1996: BiologicalEvaluation of Medical Devices - Part11: Tests for Systemic Toxicity.	During the observation period,none of the animals treatedwith the individual test extractexhibit a significantly greaterreaction that the controlanimals.	Pass
(continued)	Test	Acceptance Criteria	Result
	ISO Contact Lens 22 Day OcularIrritation StudyISO 9394 Ophthalmic Optics - ContactLenses and Contact Lens Care ProductsThe determination of Biocompatibility	Scores from macroscopicand microscopic ocularexaminations equivalentbetween test and controleyes.	Pass
	by Ocular Study with Rabbit Eyes.Total Extractables , Water content, Dk,Light Transmittance, refractive indextested per ISO 18369-4:2006Ophthalmic optics - Contact lenses -Part 4: Physicochemical properties ofcontact lens materials:section 4.2	Equivalent to predicatelens	Pass
	The results for the non-clinical testing demonstrate:· The lens material and lens material extracts are non-toxic, non-irritatingunder the experimental conditions.· The lens physical and material properties are consistent with currentlymarketed soft contact lenses.· No evidence of unsafe amounts of residue in the extractables.· Physicochemical testing of the subject lenses demonstrated equivalency tothe predicate devices.
Clinical	· Lens remains sterile and stable in the package, for the established shelf life.The technical characteristics, manufacturing and sterilization process of the subjectlens are equivalent to omafilcon A soft contact lenses currently marketed byCooperVision, therefore no clinical data is required.
	Conclusion Drawn from Studies:
Validity ofScientificData	Contract laboratories under Good Manufacturing Practice regulations conductedtoxicological and microbiology studies.Chemistry, shelf-life and leachablility studies were conducted by CooperVisionand followed scientific protocols. The data were determined to be scientificallyvalid under 21 CFR 860.7
SubstantialEquivalence	Information presented in this Premarket Notification establishes that theCooper Vision (omafilcon A) Proclear Toric XR, Proclear Multifocal and ProclearMultifocal XR contact lens is as safe and effective as the predicate devices whenused in accordance with the labeled directions for use and for the requestedindications.
Risk and	The risks of the subject lens are the same as those normally attributed to thewearing of soft (hydrophilic) contact lenses on a daily wear basis. The benefits tothe patient are the same as those for other soft (hydrophilic) contact lenses.

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510(k) Summary

Proclear Toric XR, Multifocal and Multifocal XR

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

CooperVision Inc. c/o Ms. Lisa Hahn Global Regulatory Affairs Manager 6150 Stoneridge Mall Road, Suite 370 Pleasanton, CA 94588

JUN 2 9 2011

Re: K110099

Trade/Device Name:

Proclear Toric XR (Omafilcon A) Soft (hydrophilic) Contact Lens Proclear Multifocal XR (Omafilcon A) Soft (hydrophilic) Contact Lens Proclear Multifocal Toric (Omafilcon A) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: May 27, 2011 Received: May 31, 2011

Dear Ms. Hahn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Lisa Hahn

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersQffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

for

MR.
DR.
REV.
GEN.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Goper Visiona: SEE BEYOND THE ORDINAR

Traditional 510(k)

Proclear Toric XR, Multifocal and Multifocal XR Daily Wear Soft Contact Lenses

Indications for Use

510(k) Number (if known):

Device Name: Proclear Toric XR, Multifocal XR and Multifocal Toric (omafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear

Indications for Use:

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 non-diseased eves that are myopic or hyperopic in powers from -20.00, possess astigmatism to -5.75 diopters, 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),

Prescription Use: YES(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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Please Do Not Write Below this line-Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

Page 1 of 1

510(k) Number_K110099

Regulation Number and Section

§ 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.