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).

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

Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are made of polymer of 2hydroxy-ethylmethacrylate and 2-methacryloyloxyethyl phosphorylcholine crosslinked with ethyleneglycol dimethacrylate. The lenses are tinted edge to 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 and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are available in two versions. 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 of the following dimensions:

Chord Diameter: 14.5 mm
Center Thickness (minus): 0.15 mm to 0.20 mm
Center Thickness (plus): 0.20 mm to 0.96 mm
Base Curve: 8.3 mm to 8.9mm
Spherical Powers: -20.00 D to +20.00 D
Cylinder Powers: -0.75 to -2.75 D
Add Powers: +1.00 to +3.50
Central Zone Diameter: 2.3 mm to 2.6 mm (Proclear UltraVue/D 2000T), 1.7 mm to 2.0 mm (Proclear UltraVue/N 2000T)

AI/ML Overview

The provided text describes a 510(k) premarket notification for CooperVision's Proclear UltraVue Multifocal and Multifocal Toric Soft (hydrophilic) Contact Lenses. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

The document is a regulatory submission for substantial equivalence to a legally marketed predicate device, focusing on device description, intended use, and material/design comparisons, rather than a clinical performance study with acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study that proves the device meets them based on the provided text. The requested information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance is not present in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the CooperVision logo. The logo consists of the word "CooperVision" in a stylized font, with a square containing a spiral design to the right of the word. The logo is black and white.

643129

510(k) SUMMARY

1. Submitter:

Submitted on Behalf of:

트 Company Name:
트 Address:

Opti-Centre Laboratories, Inc. (Subsidiary of CooperVision, Inc.) 4375 Quimet Street Sherbrooke, Quebec Canada J1L 1X5

2. Official Correspondent:

트 Company Name:
트 Address:
미 Phone:
Fax:
1. Date Summary Prepared:

4. Device Identification:

트 Trade Name:
Sherbrooke, Quebec
Canada J1L 1X5

Bonnie Tsymbal

CooperVision, Inc. 711 North Road Scottsville, NY 14546 (585) 264-3210 (585) 889-5688

November 9th, 2004

Proclear UltraVue Multifocal Proclear UltraVue 2000T Multifocal Toric (omafilcon A) Soft (hydrophilic) Contact Lenses

프 Common Name:
1 Classification
트 Device Classification:

Hydrophilic Soft Contact Lens Lenses, Soft Contact, Daily Wear 86LPL Class II (21 CFR 886,5925)

5. Intended Use:

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 nondiseased 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).

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Image /page/1/Picture/1 description: The image shows the CooperVision logo, which includes the company name in a stylized font and a small, square graphic to the right. Below the logo, the words "Premarket Notification" are printed in a smaller, bold font. The logo is in black and white.

6. Device Description

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OgperVision D Premarket Notification

Both lenses are a flexible transparent hemispherical shell of the following dimensions:

Chord Diameter:
Center Thickness (minus): . Center Thickness (plus)
E Base Curve:
B Spherical Powers:
Cylinder Powers: .
Add Powers: 를
Central Zone Diameter: "

14.5 mm

0.15 mm to 0.20 mm 0.20 mm to 0.96 mm 8.3 mm to 8.9mm -20.00 D to +20.00 D -0.75 to -2.75 D +1.00 to +3.50 2.3 mm to 2.6 mm (Proclear UltraVue/D 2000T) 1.7 mm to 2.0 mm (Proclear UltraVue/N 2000T)

MATERIAL COMPARISON
	Proclear Tailor Made ToricPredicate Device (K952152)	Proclear UltraVueMultifocalSubject Device	Proclear UltraVue2000T (MultifocalToric) SubjectDevice
Material	Omafilcon A	Omafilcon A	Omafilcon A
Water Content	59%	59%	59%
Color Additive	Clear	C.I. ReactiveBlue #4	C.I. ReactiveBlue #4
Hardness	> 83 Shore D-Scale	> 83 Shore D-Scale	> 83 Shore D-Scale
DESIGN COMPARISON
	UltraVueMultifocalHioxifilcon BK974599	ProclearUltraVueMultifocalSubject DeviceOmafilcon A	UltraVue 2000T(Multifocal Toric)Hioxifilcon BK010256	Proclear UltraVue2000T(Multifocal Toric)Omafilcon ASubject Device
Lens Design	AsphericMultifocal	AsphericMultifocal	Aspheric MultifocalToric	Aspheric MultifocalToric
Intended Use	Correction ofvisual acuity inpatients withmyopia orhyperopia, andare presbyopic	Correction ofvisual acuity inpatients withmyopia orhyperopia, andare presbyopic	Correction of visualacuity in patientswith myopia orhyperopia, and areastigmatic andpresbyopic	Correction of visualacuity in patients withmyopia or hyperopia,and are astigmaticand presbyopic
ProductionMethod	Lathe-Cut	Lathe-Cut	Lathe-Cut	Lathe-Cut

7. Substantial Equivalence Table:

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8. CONCLUSION:

The device will be manufactured according to specified process controls and an established quality assurance program. The device will undergo the same manufacturing, packaging and sterilization procedures to devices currently marketed by Opti-Centre Laboratories Inc. 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.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

JAN 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Opti-Centre Laboratories c/o Ms. Bonnie Tsymbal Manager, Regulatory Affairs CooperVision, Inc. 711 North Road Scottsville, NY 14546

Re: K043129

Trade/Device Name: Proclear UltraVue Multifocal; Proclear UltraVue 2000T Mulifocal Toric (oafilcon A) Soft hydrophilic Contact Lenses Regulation Number: 21 CFR 886.1850 Regulation Name: Hydrophilic Soft Contact Lens Regulatory Class: Class II Product Code: LPL Dated: November 9, 2004 Received: November 15, 2004

Dear Ms Tsymbal:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); 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.

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Page 2 - Ms. Bonnie Tsymbal

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A halpi Rosenthal

A. Ralph Rosenthal, 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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Image /page/6/Picture/0 description: The image shows the logo for CooperVision. The logo consists of the word "CooperVision" in a stylized font. To the right of the word is a black square with a white circle inside.

Requiatory Affairs 711 North Road Scottsville, NY 14546 (585) 385-6810 Fax: (585) 889-5688

Indication for Use Statement

510(k) Number: 长 04 3 / 2 9

Device Name:

Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (hydrophilic) Contact Lens Proclear UltraVue/D and Proclear UltraVue/N Multifocal (omafilcon A) Soft (hydrophilic) Contact Lens

Indication for Use:

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 eves 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 persons with nondiseased eves 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-Siogren'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 patient's eve and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfection system.

PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises

ber R 043124

Prescription Use X (Per 21 CFR Subpart D) AND/OR

Over-The-Counter (Per 21 CFR Subpart C)

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.