PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC

K111966 · CooperVision, Inc. · LPL · Sep 15, 2011 · Ophthalmic

Device Facts

• Record ID: K111966
• Device Name: PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
• Applicant: CooperVision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Sep 15, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

Sphere and Aspheric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eves that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity. Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not 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. Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) and presbyopia in not 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. Multifocal Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic. Proclear XC and Proclear 1 Day (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. FREQUENT/PLANNED REPLACEMENT WEAR When prescribed for Frequent/Planned replacement the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens 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.

Device Story

Proclear (omafilcon A) soft contact lenses; hemispherical polymer shells; composed of 2-hydroxy-ethylmethacrylate and 2-methacryloyloxyethyl phosphorylcholine cross-linked with ethylmethacrylate. Designed for daily wear; correction of refractive errors including myopia, hyperopia, astigmatism, and presbyopia. Provides potential comfort benefits for patients with mild dryness/tear deficiency. Prescribed by eyecare practitioners; worn by patients. Available in frequent/planned replacement or daily disposable modalities. Lenses are tinted blue for visibility. Device modification involves updated shelf-life stability protocols, including alternate package integrity testing and storage temperature adjustments.

Clinical Evidence

No clinical data required. Technical characteristics, formulation, manufacturing, and sterilization processes remain unchanged from currently marketed omafilcon A lenses.

Technological Characteristics

Material: Omafilcon A (polymer of 2-hydroxy-ethylmethacrylate and 2-methacryloyloxyethyl phosphorylcholine cross-linked with ethylmethacrylate). FDA Group II Non-Ionic High Water Content. Form: Hemispherical shell, blue-tinted. Sterilization: Same as predicate processes.

Indications for Use

Indicated for daily wear in non-aphakic, non-diseased eyes for correction of myopia, hyperopia, astigmatism (up to 10.00D depending on lens type), and presbyopia. May provide comfort for patients with mild discomfort/dryness from Evaporative or Aqueous Tear Deficiency (non-Sjogren's).

Regulatory Classification

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.

Predicate Devices

• Proclear Daily Wear (Omafilcon A) Soft Contact Lenses (K952152)
• Proclear Compatibles Daily Wear (Omafilcon A) Soft Contact Lenses (K970095)
• Proclear and Proclear Compatibles (Omafilcon A) Soft Contact Lenses (K974408)
• Proclear Compatibles Multifocal (Omafilcon A) Soft Contact Lenses (K032873)
• Proclear Multifocal (Omafilcon A), Proclear Toric (Omafilcon A) and Proclear Multifocal Toric (Omafilcon A) Soft Contact Lenses (K050717)
• Proclear XC and Proclear 1 Day (Omafilcon A) Soft Contact Lenses (K061948)

Submission Summary (Full Text)

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## SEP 1 5 2011

#

## 510(k) Summary

| 1. Applicant Name and<br>Address | CooperVision, Inc.<br>6150 Stoneridge Mall Drive<br>Suite 370<br>Pleasanton CA 94588 | |
|----------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 2. Contact | Lisa Hahn<br>Global Regulatory Affairs<br>585-385-6810 ext 4221<br>[e-mail] | |
| 3. Date Prepared | Original July 1, 2011 | |
| 3. Device Identification | Trade Name: | Proclear 1 day<br>Proclear |
| | Common<br>Name: | Disposable Soft Contact Lenses,<br>or<br>Scheduled Replacement Soft<br>Contact Lenses |
| | Classification<br>Name: | Disposable, Daily Wear Soft Contact<br>lens<br>Daily Wear, Soft (hydrophilic)<br>Contact Lenses |
| | Device<br>Classification: | Class II (21 CFR 886.5925) |
| | FDA Material<br>Class: | FDA Group II Non-Ionic High Water<br>Content |
| | Product Code: | MVN, LPI |

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#### 4. Device Description

The Proclear lens is composed of polymer of 2-hydroxy-ethylmethacylate and 2-metacrylolovoxvethyl phosphorylcholine cross linked with ethylmethacrylate. 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.

The modifications to the stability - shelf life protocol include alternate test method for package integrity and adjusted storage temperatures for the packaged products that will be tested using alternate package integrity test method.

#### 5. Intended Use

#### Proclear and Proclear 1 day

Sphere and Aspheric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eves that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.

Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not 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.

Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) and presbyopia in not 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.

Multifocal Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic.

Proclear XC and Proclear 1 Day (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.

#### FREQUENT/PLANNED REPLACEMENT WEAR

When prescribed for Frequent/Planned replacement the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens 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.

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#### 6. Predicate Device(s)

Proclear Daily Wear (Omafilcon A) Soft Contact Lenses (K952152) Proclear Compatibles Daily Wear (Omafilcon A) Soft Contact Lenses (K970095) Proclear and Proclear Compatibles (Omafilcon A) Soft Contact Lenses (K974408) Proclear Compatibles Multifocal (Omafilcon A) Soft Contact Lenses (K032873) Proclear Multifocal (Omafilcon A), Proclear Toric (Omafilcon A) and Proclear Multifocal Toric (Omafilcon A) Soft Contact Lenses (K050717) Proclear XC and Proclear 1 Day (Omafilcon A) Soft Contact Lenses (K061948)

#### 7. Characteristics of Substantial Equivalence

The soft contact lenses have the following similarities to the predicate lenses which previously received 510(k) concurrence:

- have the same indicated use,
- . incorporate the same design,
- . incorporate the same materials,
- . have the same shelf life, and
- . are packaged and sterilized using the same materials and processes.

In summary, the omafilcon A soft contact lenses described in this submission are, substantially equivalent to the predicate devices.

#### 8. Physiochemical Studies

Results from physical, optical and chemical properties were not required as support for this modification to shelf life protocol. Change will not affect physicochemical properties of the lenses.

#### 9. Toxicology Studies

Results from in-vivo and in-vitro studies were not required as support for this modification to shelf life protocol. Change will not affect lenses ability to remain non-toxic and biocompatible with the ocular environment.

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#### 10. Conclusions of Non-Clinical Tests Performed:

- Physiochemical: 트
The physical, optical and chemical properties of this lens remain unchanged from the unmodified device, and are within established specifications for the lenses.

- 트 Toxicology:
Results from in-vivo and in-vitro studies originally conducted remain valid and verify that the lenses remain non-toxic and are biocompatible with the ocular environment.

#### 11. Clinical Studies

The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are not changing and therefore are equivalent to omafilcon A soft contact lenses currently marketed by CooperVision, therefore no clinical data is required.

#### 12. Conclusions

Based on no change to material, no change to manufacturing methods, no change to lens parameters and no change to indicated use, the omafilcon A soft contact lens described in this document is substantially equivalent with the predicate devices.

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Image /page/4/Picture/0 description: The image shows a logo with a stylized bird in flight on the right side. The bird is depicted with three curved lines suggesting its wings and body. To the left of the bird, there is a circular arrangement of text, though the specific words are not legible due to the image quality. The overall impression is that of a symbol or emblem, possibly representing an organization or brand.

I ood and chug Adminstration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

SEP 15 2011

Re: K111966

Trade/Device Name: Proclear (Omafilcon A) Soft (Hydrophilic) Contact Lenses: Proclear Daily Wear (Omafilcon A) Soft Contact Lenses Proclear Compatibles Daily Wear (Omafilcon A) Soft Contact Lenses Proclear and Proclear Compatibles (Omafileon A) Soft Contact Lenses Proclear Compatibles Multifocal (Omafilcon A) Soft Contact Lenses Proclear Multifocal (Omafilcon A). Proclear Toric (Omafilcon A). and Proclear Multifocal Toric (Omafilcon A) Soft Contact Lenses Proclear XC and Proclear 1 Day (Omafilcon A) Soft Contact Lenses Proclear Multifocal (Omafileon A), Proclear Toric (Omafilcon A) and Proclear Multifocal Toric (Omafilcon A) Soft Contact Lenses

Regulation Number: 21 CFR 886.5925

Regulation Name: Soft (hydrophilic) contact lenses

Regulatory Class: Class II Product Code: LPL and MVN Dated: August 31, 2011

Received: September 1, 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

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Page 2 - Ms. Lisa Hahn

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 not 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 (2) CFR Part 820); and if applicable, the records 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/CentersOffices/CDRH/CDRHOffices/ucm115809 lptm for l the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket noufication" (217)Part 807.97). For questions regarding the reporting of adverse events under the MDR regulting (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDeyices/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kesia Alexander

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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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### Indications for Use

510(k) Number (if known): حالها | الحكار | الكار | الكار | الكار | الكار

Device Name: Proclear (omafilcon A) Soft (hydrophilic) Contact Lenses

Indications for Use:

Sphere and Aspheric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not 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.

Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not 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.

Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in not 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.

Multifocal Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic.

Proclear and Proclear 1 Day (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.

#### FREQUENT/PLANNED REPLACEMENT WEAR

When prescribed for Frequent/Planned replacement the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens 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.

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|----------------------------------------------|---|
|----------------------------------------------|---|

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)

deuise Hanyh

(Division Sign-Off Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number K111966