BIOFINITY (COMFILCON A) SOFT CONTACT LENS

K052560 · CooperVision, Inc. · LPL · Dec 6, 2005 · Ophthalmic

Device Facts

• Record ID: K052560
• Device Name: BIOFINITY (COMFILCON A) SOFT CONTACT LENS
• Applicant: CooperVision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Dec 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Indications for Use

BIOFINITY (comfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. BIOFINITY (comfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. BIOFINITY (comfilcon A) multifocal lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

Device Story

BIOFINITY (comfilcon A) is a daily wear, silicone hydrogel soft contact lens. Material consists of silicone macromers cross-linked with monomers and phthalocyanine blue handling tint. Manufactured via cast molding. Supplied sterile in blister packs with buffered saline. Available in spherical, aspherical, toric, and multifocal configurations. Used by patients for vision correction; prescribed by eye care professionals. Lens provides high oxygen permeability (Dk 128). Patients wear lenses daily; frequent/planned replacement schedule allows disinfection via chemical or hydrogen peroxide systems. Output is corrected refractive vision for the patient.

Clinical Evidence

Clinical study compared BIOFINITY to CIBA Vision Focus Night & Day. Evaluated daily wear performance and safety. Visual acuity showed no significant difference. Safety assessment via patient complaints and slit lamp observations showed no significant difference in clinical adverse events. No serious adverse events reported.

Technological Characteristics

Silicone hydrogel material (comfilcon A); Group I (low water, nonionic); 48% water content; Dk 128; cast molded; no surface treatment; phthalocyanine blue tint; spherical, aspherical, toric, multifocal designs; sterile blister pack; ISO 10993 biocompatibility.

Indications for Use

Indicated for correction of ametropia (myopia, hyperopia) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes. Includes correction for astigmatism up to 2.00D (sphere/asphere) or -0.25 to -10.00D (toric).

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

• CIBA Vision SEE3™ (lotrafilcon A) Soft Contact Lenses (K970746)
• CIBA Vision O2OPTIX™ (lotrafilcon B) Soft Contact Lenses (K033919)

Reference Devices

• CIBA Vision Focus Night & Day

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "DEC 6 2005" at the top. Below that is the text "K052560". The bottom of the image shows the word "CooperVision" with a registered trademark symbol.

# 510(k) SUMMARY

| 1. Applicant Name and Address | CooperVision, Inc.<br>5870 Stoneridge Dr.<br>Suite 1<br>Pleasanton, CA 94588<br>USA<br>[phone] | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact | Jack P. Douglas, Ph.D.<br>Dept. of Regulatory Affairs<br>[phone] | |
| 3. Manufacturer Information | CooperVision, Inc.<br>Hamble Ln.<br>Hamble<br>SO31 4NH<br>United Kingdom<br>Contact: Martin Newman<br>Telephone: [phone] | |
| 4. Device Identification | Common Name:<br>Trade Name:<br>Class. Name:<br>Classification:<br>Product Code: | Soft Contact Lens<br>BIOFINITY ( <i>comfilcon A</i> ) Soft<br>Contact Lens<br>Soft (hydrophilic) Contact Lens -<br>Daily Wear<br>Class II [21 CFR 886.5925]<br>LPL |

## 5. Device Description

The BIOFINITY (comfilcon A) soft contact lens is a Group I, daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high oxygen permeability (Dk). The lens material, comfilcon A, is composed of silicone macromers cross linked with other monomers, incorporating phthalocyanine blue as an integrated, handling tint. The lenses are made by cast molding. The lens will be manufactured in spherical, aspherical, toric and multifocal configurations with the following features and properties:

| • Chord Diameter | 13.5 mm to 15.0 mm |
|-------------------------------|---------------------------------------------------------------------|
| • Center Thickness | 0.05 mm to 0.50 mm |
| • Base Curve | 8.0 mm to 9.5 mm |
| • Power Range | -20.00D to +20.00D in 0.25 steps |
| • Cylinder Power (Toric) | -0.25 to -10.00 D |
| • Add Power (Multifocal) | +0.50 to +3.00D |
| • Refractive Index (hydrated) | 1.40 |
| • Water Content | 48% by weight in normal saline |
| • Oxygen permeability | 128 x 10-11 [(cm2/sec)(ml O2)/ml*mmHg],<br>34°C, Coulometric method |

The lens is supplied sterile in blister packs containing a buffered saline solution. Blister labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterifization process.

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Image /page/1/Picture/0 description: The image shows the logo for CooperVision. The logo consists of the company name in a stylized font. To the right of the name is a square containing a spiral shape.

# 6. Intended Use

# SPHFRICAL AND ASPHERICAL:

BIOFINITY (comfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

## TORIC:

BIOFINITY (comfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

## MULTIFOCAL:

BIOFINITY (comfilcon A) multifocal lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with nondiseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

(comfilcon A), BIOFINITY Toric (comfilcon A) and BIOFINITY Multifocal The BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

# 7. Predicate Device(s)

- + CIBA Vision SEE3™ (lotrafilcon A) Soft Contact Lenses [K970746]
- ♦ CIBA Vision O2OPTIX™ (lotrafilcon B) Soft Contact Lenses (K033919)

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Image /page/2/Picture/0 description: The image shows the CooperVision logo. The logo consists of the word "CooperVision" in a stylized font. To the right of the word is a square containing a stylized eye. There is a registered trademark symbol to the upper right of the square.

# 8. Characteristics of Substantial Equivalence

Characterisues of Substantial Equivalence
The BIOFINITY (comfilcon A) Soft Contact Lens is substantially equivalent to the ClBA Vision SEE3TM The DIOTH CF (confidentify Beto PTIX™ (lotrafilcon B) Soft Contact Lenses. All of these lenses are (corrapicon 7) and CIDT - Tionic 3,00 Linie) silicone hydrogel lenses. All of these lenses are Class II and have categorized as Ofoup I (10w water, nomone) Sheons Trategor relieve summarizes the primary features for this comparison, illustrating the similarities and differences.

| | CooperVision | CIBA Vision | CIBA Vision |
|----------------------------|-----------------------|--------------------------------------------------------------------------------------------|-----------------------------|
| | BIOFINITY | SEE3™ | O2 Optix™ |
| | [Current Submission] | [K970746] | [K033919] |
| Material | comfilcon A | lotrafilcon A | lotrafilcon B |
| | silicone hydrogel | silicone hydrogel | silicone hydrogel |
| Category (Group) | Group I | Group I | Group I |
| | (low water, nonionic) | (low water, nonionic) | (low water, nonionic) |
| Manufacturing Method | Cast Molded | Cast Molded | Cast Molded |
| Indication | Daily Wear | Daily Wear | Daily Wear |
| Replacement | Monthly | Monthly | Two weeks |
| Water Content (%) | 48 | 24 | 33 |
| Oxygen Permeability - Dk @ | 128 x 10-11 | 140 x 10-11 | 110 x 10-11 |
| 34°C [(cm2/sec) x (ml | | | |
| O2)/(ml x mm Hg)]* | | | |
| Refractive Index | 1.40 | 1.43 | 1.42 |
| Light Transmittance (%) | > 97 | > 99 | > 96 |
| Modulus (MPa) | 0.8 ± 0.1 | 1.4 ± 0.1 | 1.0 ± 0.1 |
| Tensile Strength (Mpa) | 0.50 ± 0.07 | 0.80 ± 0.08 | 0.73 ± 0.16 |
| Elongation to Break (%) | 130 ± 2 | 128 ± 22 | 186 ± 39 |
| Surface Treatment | No | Yes | Yes |
| Color Additive | Phthalocyanine Blue | None | Phthalocyanine Blue |
| Tint Process | IMT | N/A | IMT |
| Chord Diameter Range(mm) | 13.5 to 15.0 | 13.0 to 15.0 | 13.0 to 15.0 |
| Base Curve Range (mm) | 8.0 to 9.5 | 8.0 to 9.2 | 8.0 to 9.2 |
| Center Thickness (mm) | 0.08 @ -3.00D | 0.08 @ -3.00D | 0.08 @ -3.00D |
| Power Range | -20.00D to +20.00D | -20.00D to +20.00D | -20.00D to +20.00D |
| Chord Diameter (Nominal) | 14.0 | 13.8 | 14.2 |
| Base Curve | 8.6 | 8.4, 8.6 | 8.6 |
| Powers | -20.00D to +20.00D | +0.25 to +6.00, 0.25D steps<br>-0.25 to -8.00, 0.25D steps<br>-8.50 to -10.00, 0.50D steps | -1.00 to -6.00, 0.25D steps |
| | in 0.25 steps | | |

* coulometric method

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Image /page/3/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 square with a stylized eye inside of it. There is a registered trademark symbol next to the square.

### 9. Physicochemical Studies

The physical, optical and chemical properties of the lenses as assessed by various test methods show substantial I hi properal with the predicate devices as illustrated in the preceding table. Additional studies were conducted equired.org what leachable substances were either low or below measurable levels to assuage any concerns for its intended use.

#### 10. Toxicology Studies

Animal GLP studies were conducted and determined that BIOFINITY lenses were biocompatible for the intended use as assessed using ISO 10993 standards for cytotoxicity, maximization sensitization, ocular irritation, and systemic toxicity. All results passed with no evidence of adverse clinical effects caused by the BIOFINITY lens.

# 11. Human Clinical Studies

Clinical studies were conducted to demonstrate substantial equivalence of the BIOFINITY lens as compared with the CIBA Vision Focus Night & Day based on performance and safety. In a study of daily wear, assessment of visual acuity performance showed no significant difference between the two products. Safety as assessed by patient complaints or/and slit lamp observations showed no significant difference of clinical adverse events between the two products. There were no serious or significant adverse events attributable to the device during the study.

#### 12. Conclusions

Based on evaluations of material, manufacturing methods, lens parameters and indicated use, the BIOFINIT Y lens is substantially equivalent with the predicate, marketed lenses. Based on evaluation of chemical properties, biocompatibility and clinical studies, the BIOFINITY lens has been shown to be safe for its indicated use.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird, composed of three curved lines representing wings or feathers.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 6 2005

Cooper Vision, Inc. c/o Jack P. Douglas, Ph.D. 5870 Stoneridge Dr. Suite 1 Pleasanton, CA 94588

Re: K052560

Trade/Device Name: Biofinity (comfilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: September 15, 2005 Received: September 16, 2005

Dear Dr. Douglas:

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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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 [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/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting 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]: K052560

Device Name: BIOFINITY (comfilcon A) Soft Contact Lens

## Indications for Use:

## SPHERICAL AND ASPHERICAL:

BIOFINITY (comfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

TORIC:

BIOFINITY (comfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

#### MULTIFOCAL:

BIOFINITY (comfilcon A) multifocal lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-(tiropia and trypereply and worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

(comfilcon A), BIOFINITY Toric (comfilcon A) and BIOFINITY Multifocal The BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

### Additional Claims:

(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 Ear, Nose and Throat Devises | |
| 510(k) Number | K052560 |
| Prescription Use<br>(Per 21 CFR 801.109) | |