PROCLEAR COMPATIBLES MULTIFOCAL

K032873 · CooperVision, Inc. · LPL · Nov 7, 2003 · Ophthalmic

Device Facts

• Record ID: K032873
• Device Name: PROCLEAR COMPATIBLES MULTIFOCAL
• Applicant: CooperVision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

Proclear Compatibles 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 aphakic and/or 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. These 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 eyecare practitioners in consultation with their patients. 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 eve care practitioner. The lens may be disinfected using a chemical disinfection system.

Device Story

Proclear Compatibles Multifocal is a soft, hydrophilic contact lens; hemispherical flexible shell covering cornea/sclera. Material: omafilcon A (copolymer of hydroxyethylmethacrylate and 2-methacryloyloxyethyl phosphorylcholine crosslinked with ethylene glycol dimethacrylate). Tinted with Reactive Blue No. 4. Used for daily wear correction of refractive errors and presbyopia; provides comfort for patients with tear deficiency. Prescribed by eyecare practitioners; patient-managed cleaning/disinfection via chemical systems. Lens geometry varies by power (-20.00 to +20.00 D; add powers +0.50 to +4.00 D). Benefits include vision correction and improved comfort for dry-eye symptomatic wearers.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing of physical and chemical properties, including oxygen permeability (27 x 10^-11 cm^2/sec), water content (62%), and refractive index (1.38).

Technological Characteristics

Material: omafilcon A (HEMA and 2-methacryloyloxyethyl phosphorylcholine copolymer crosslinked with EGDMA). Hydrophilic surface. Oxygen permeability: 27 x 10^-11 (cm^2/sec)(ml O2/ml x mmHg) at 35°C (modified ISO method). Water content: 62%. Refractive index: 1.38. Diameter: 14.2-15.0mm. Base curve: 8.0-9.5mm. Tinted with Reactive Blue No. 4. Chemical disinfection compatible.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, astigmatism (≤2.00D), and presbyopia in aphakic or non-aphakic persons with non-diseased eyes. Also indicated for patients experiencing mild discomfort or dryness symptoms associated with 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 Compatibles (omafilcon A) (K970095)
• Frequency 55 Multifocal (methafilcon A) (K002625)

Submission Summary (Full Text)

{0}------------------------------------------------

Premarket Notification Prodear Compatibles Multifocal - Omafficon A 510(k) Summar

NOV - 7 2003

K0328'73

510(k) Summary; Addresses requirements by the Safe Medical Devices Act of 1990 to summarize the safety and effectiveness information upon which the substantial equivalence for alternate lens design configuration determination is based.

#### 1. Submitter Information

CooperVision, Inc. 1215 Boissevain Ave Norfolk VA 23507

Contact person: Lisa Hahn Director of Quality and Regulatory Affairs Phone: [phone] Fax:

# 2. Identification of Device

Classification name: Daily Wear Soft Hydrophilic Contact Lenses

Proprietary name: Proclear Compatibles Multifocal (omafilcon A) Soft (Hydrophilic) Contact Lenses

Device classification: Class II (21 CFR 886.5925)

### 3. Predicate Devices

Proclear Compatibles (omafilcon A) Premarket Notification # K970095 Frequency 55 Multifocal (methafilcon A) Premarket Notification # K002625

# 4. Indications for Use

Proclear Compatibles 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 aphakic and/or 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.

These 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).

{1}------------------------------------------------

Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients. 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 eve care practitioner. The lens may be disinfected using a chemical disinfection system.

# 5. Device Description

The Proclear Compatibles Multifocal (omafilcon A soft (hydrophilic) contact lens is available as hemispherical flexible shell which covers the cornea and may cover a part of the adjacent sciera. Lens material, omafilcon A is a random copolymer of hydroxyethylmethacrylate and 2-methacryloyloxyethyl phosphorycholine crosslinked with ethylene glycol dimethacrylate. The lenses are tinted from edge to edge for visibility purposes with the color additive, Reactive Blue No. 4.

Proclear Compatibles Multifocal contact lens is hemispherical shell of the following dimensions:

| • Diameter: | 14.2mm to 15.0mm |
|---------------------|--------------------|
| • Base curve: | 8.0mm to 9.5mm |
| • Center Thickness: | 0.15mm to 0.96mm |
| | varies with power |
| • Powers: | -20.00 to +20.00 D |
| • Add powers: | +0.50 to +4.00 D |

1.38

62%

>ਰੇਟੋਅ

the power of

The physical properties of the lens are:

- . Refractive Index:
- Light Transmittance .
- Surface Character: Hydrophilic . ・
- Water Content ●
- Oxygen Permeability .

27 x 10-11 (cm2/sec){ml O2/ml x mmHq) at 35° C (modified ISO method for determination of oxygen permeability)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol of three human profiles merging into a single form, resembling a bird in flight. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2003

CooperVision, Inc. c/o Lisa Hahn Director of Quality and Regulatory Affairs 1215 Boissevain Ave. Norfolk, VA 23507

Re: K032873

Trade/Device Name: Proclear Compatibles Multifocal (omafilcon A) Soft Contact Lenses For Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Daily wear soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: LPL Dated: September 12, 2003 Received: September 15, 2003

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. Iisting 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.

{3}------------------------------------------------

#### Page 2 - Lisa Hahn

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FI)A 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A Károlyi Kórház

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

{4}------------------------------------------------

# 510(k) Number: K032873

Proclear Compatibles Multifocal Device name:

Indications for use:

Proclear Compatibles Multifocal (omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) and orestivonia in aphakic and/or 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.

These 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 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 sye care practitioner. The lens may be disinfected using a chemical disinfection system.

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANTOHER PAGE IF NEEDED

Concurrence of CDRH, office of Device Evaluation (ODE)

J. Savola

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

**510(k) Number** K032873

Prescription Use
(per 21 CFR 801.109)

OR

Over-The Counter