Proclear Multifocal Toric (omaficon B) 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 to -5.75 diopters or less, and are presbyopic.

Proclear Multifocal XR (omafilcon B) 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 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 B) 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 corrections to -5.75 diopters.

Proclear Sphere and Asphere: (omafilcon B) 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 and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.

Proclear. Toric: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for-the-correction-of-visual-acuity-in-non-aphakic-persons-with-non-diseased-eves-thatare myopic or hyperopic .- The lens may be worn by persons who - have astigmatism of 5.00D or less.

Proclear Multifocal: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, 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 B) 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 eye care practitioners in consultation with their patients.

Device Description

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 B) Soft (hydrophilic) contact lenses are a hemispherical shell. The design and toxicological properties of the devices with the modified formula to increase the water content to 62% are unchanged from predicate 510ks.

Proclear Toric and Proclear Toric XR (omafilcon B) Soft (Hydrophilic) Contact Lenses are back surface toric.

Proclear Multifocal and Proclear Multifocal XR (omafilcon B) 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 B) 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.

Proclear Sphere and Asphere: (omofilcon B) 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CooperVision Proclear (omafilcon B) Soft (Hydrophilic) Contact Lenses, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Tested Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Total Extractables, Water Content, Dk, Light Transmission, Refractive Index (per ISO 18369-4:2006 Ophthalmic Optics – Contact Lenses)	Not explicitly stated	Pass
Cytotoxicity	No toxicity issues	No toxicity issues
Ocular Irritation	No toxicity issues	No toxicity issues
Systemic Toxicity	No toxicity issues	No toxicity issues

Note: The document states that the physicochemical properties were tested and "indicate no significant change" from predicate devices. The acceptance criteria for these tests are implicitly that they meet the standards for contact lens materials as per ISO 18369-4:2006, and that the results are comparable to the predicate devices. The "Pass" result signifies compliance with these implicit criteria.

2. Sample Size Used for the Test Set and Data Provenance

For Physicochemical Studies: Not explicitly stated. The studies were "conducted by CooperVision following scientific protocols."
For Biocompatibility Studies: Not explicitly stated. The studies were "conducted by contract laboratories under Good Manufacturing Practice regulations." Data provenance (country of origin) is not mentioned. These studies were retrospective in the sense that they were conducted on already manufactured materials.
No clinical studies were conducted. Therefore, there is no test set of human subjects or associated data provenance for clinical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable as no clinical studies were conducted involving human subjects to establish ground truth for clinical performance.
For physicochemical and biocompatibility tests, "ground truth" is established by the standardized methods themselves and the expertise of the laboratory personnel performing the tests, though their specific qualifications or numbers are not mentioned.

4. Adjudication Method for the Test Set

Not applicable as no clinical studies were conducted that would require an adjudication method for human reader/expert review.

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 device is a contact lens, not an AI-assisted diagnostic or therapeutic tool. No MRMC comparative effectiveness study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a contact lens. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

For Physicochemical Studies: The ground truth is established by standardized laboratory measurements and accepted scientific principles as defined in ISO 18369-4:2006, compared against pre-defined specifications and predicate device characteristics.
For Biocompatibility Studies: The ground truth is established by recognized toxicity endpoints and established scientific guidelines for cytotoxicity, ocular irritation, and systemic toxicity, which determine the safety of the material in biological systems.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device. The concept of a "training set" in this context is irrelevant. For the material properties, the "training" analogous to material science would involve R&D and historical data on similar materials, but no specific "training set" in the computational sense is mentioned.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/machine learning device and thus has no "training set" in that sense. The specifications for the material and its properties were likely established through R&D, industry standards, and regulatory requirements based on the predicate devices.

Summary

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510k Summary of Safety and Effectiveness - K123202

May 1, 2013

Applicant:

Applicant Contact:

CooperVision, Inc. 6150 Stoneridge Mall Road, Suite 370 Pleasanton, CA 94588 USA

Karin Gastineau Director, Global Regulatory Affairs 925-621-3732 (phone) 925-621-2488 (fax) Email: kgastineau@coopervision.com

Date Summary Prepared:

Device Trade Names:

Common/Usual Name:

Classification Name:

Predicate Devices:

Proclear Toric XR Proclear Multifocal XR Proclear Multifocal Toric Proclear Sphere and Asphere Proclear Toric Proclear Multifocal

omafilcon B Soft (Hydrophilic) Contact Lens

Daily Wear Soft (Hydrophilic) Contact Lens

Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere and Asphere, Proclear Toric, Proclear Multifocal (K110099, K112302)

Device Description:

Proclear Toric and Proclear Toric XR (omafilcon B) Soft (Hydrophilic) Contact Lenses are back surface toric.

MAY 3 0 2013

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multifocal lens has two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.

Indications for Use

Proclear Multifocal Toric (omafilcon B) 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 to -5.75 diopters or less, and are presbyopic.

Proclear Toric XR (omgfilcon B) 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 B) 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: (omofilcon B) 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 B) 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.

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Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.

FREQUENT PLANNED REPLACEMENT WEAR

When prescribed for frequent planned replacement wear 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.

DISPOSABLE WEAR

When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.

Physicochemical Studies

Results of physical, optical and chemical properties were performed and indicate no significant change to the physicochemical properties of the lenses.

Tested Characteristics	Results
Total Extractables, Water Content, Dk, LightTransmission, Refractive Index tested per ISO 18369-4:2006 Ophthalmic Optics – Contact Lenses – Part 4:Physicochemical Properties of Contact LensMaterials: Section 4.2	Pass

Biocompatibility

Cytotoxicity, Ocular Irritation, and Systemic Toxicity studies were performed in support of this modification. The results indicate there are no toxicity issues with the modified lens.

Clinical Studies

No clinical studies were conducted.

Conclusion Drawn from Studies

Validity of Scientific Data

All biocompatibility studies were conducted by contract laboratories under Good Manufacturing Practice regulations. Physiochemical studies were conducted by CooperVision following scientific protocols.

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Substantial Equivalence

Information presented in this Premarket Notification establishes that the CooperVision Proclear daily wear contact lenses are substantially equivalent to the predicate devices.

Substantial Equivalence Comparison
Characteristic	Subject Devices(38% omafilcon B, 62% water)	Predicate Devices(41% omafilcon A, 59% water)
Product Names	Proclear ToricProclear Toric XRProclear MultifocalProclear Multifocal XRProclear Multifocal ToricProclear SphereProclear Asphere	Proclear ToricProclear Toric XRProclear MultifocalProclear Multifocal XRProclear Multifocal ToricProclear SphereProclear Asphere
Indications for Use	Same	Same
Material USAN Name	omafilcon B	omafilcon A
FDA Category (Group)	Non-lonicHigh Water	Non-lonicHigh Water
Manufacturing Method	Finished InsidePolymerization System	Finished InsidePolymerization System
Curing	Thermal Cure	Thermal Cure
Sterilization	Moist Heat (steam)	Moist Heat (steam)
Packaging	Blister Pack	Blister Pack
Package Saline Buffers andSurfactant	Phosphate buffersPEG200 and Tween 80	Phosphate buffersPEG200 and Tween 80
Refractive Index	$1.390 \pm 0.005$	$1.395 \pm 0.005$
Oxygen Permeability x 10-11	27.00 ± 20%	21.05 ± 20%
Light Transmission	>90%	>90%
Base Curve	8.0 to .9.3 mm	8.0 to 9.3 mm
Diameter	13.6 to 15.2 mm	13.6 to 15.2 mm
Power	-20.00 to +20.00	-20.00 to +20.00
Water Content	62% ± 2%	59% ± 2%

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

May 30, 2013

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

Ms. Karin Gastineau Director. Global Regulatory Affairs CooperVision, Inc. 6150 Stoneridge Mall Road Pleasanton, CA 94588

Re: K123202

Trade/Device Name: Proclear (omafilcon B) Soft (Hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: April 30, 2013 Received: May 2, 2013

Dear Ms. Gastineau:

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.

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.

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Page 2 - Ms. Karin Gastineau

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Kesia Y. Alexander -S

for Malvina B. Eydelman, M.D.

-Director-Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K123202

Device Name: Proclear (omafilcon B) Soft (Hydrophilic) Contact Lens

Indications for Use:

Proclear Multifocal XR (omafilcon B) 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 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.

Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.

Page 1 of 2

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FREQUENT PLANNED REPLACEMENT WEAR

DISPOSABLE WEAR

When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE - ON - ANOTHER PAGE - OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/7/Picture/9 description: The image shows the text "Marc-Robboy" at the top. Below that, the date and time "2013:05:20 10:52:21" is displayed. The text "-04'00'" is at the bottom left.

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K123202

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.