AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS

K071736 · CooperVision, Inc. · LPL · Jan 4, 2008 · Ophthalmic

Device Facts

• Record ID: K071736
• Device Name: AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
• Applicant: CooperVision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jan 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

AQUAIR (enfilcon 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. AQUAIR (enfilcon 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. AQUAIR (enfilcon 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 AQUAIR (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The lens may also be prescribed for single-use disposable daily wear.

Device Story

AQUAIR (enfilcon A) is a Group I, daily wear silicone hydrogel contact lens. Material consists of silicone macromers cross-linked with monomers; includes phthalocyanine blue handling tint and UV blocker. Manufactured in spherical, aspherical, toric, and multifocal configurations via cast molding. Supplied sterile in blister packs with buffered saline. Used by patients for vision correction; prescribed by eye care professionals. Lens provides high oxygen permeability to the cornea. Clinical benefit includes correction of refractive errors and presbyopia, improving visual acuity.

Clinical Evidence

Clinical study compared AQUAIR (enfilcon A) to historical data of COOPERVISION BIOFINITY. Evaluated visual acuity performance and safety via patient complaints and slit lamp observations. Results showed no significant difference in visual acuity or clinical adverse events between the two products. No serious adverse events reported.

Technological Characteristics

Material: enfilcon A (silicone hydrogel). Group I (low water, nonionic). Water content: 46%. Oxygen permeability (Dk): 100 x 10^-11. Refractive index: 1.40. Manufacturing: Cast molded. Configurations: Spherical, aspherical, toric, multifocal. UV blocker included. Sterilization: Sterile blister pack.

Indications for Use

Indicated for correction of ametropia (myopia, hyperopia) and presbyopia in aphakic/non-aphakic persons with non-diseased eyes. Includes toric correction for astigmatism. Contraindicated for diseased eyes.

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

• COOPERVISION BIOFINITY (comfilcon A) Soft Contact Lenses (K052560)
• CIBA Vision O2OPTIX (lotrafilcon B) Soft Contact Lenses (K033919)

Submission Summary (Full Text)

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K071736

# 510(k) SUMMARY

| 1. Applicant Name and Address | CooperVision, Inc.<br>6140 Stoneridge Mall Road<br>Suite 500<br>Pleasanton, CA 94588<br>USA<br>[phone] | JAN 4 - 2008 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 2. Contact | Jack P. Douglas, Ph.D.<br>Dept. of Regulatory Affairs<br>[phone] | |
| 3. Device Identification | Common Name: Soft Contact Lens<br>Trade Name: AQUAIR ( <i>enfilcon A</i> ) Soft Contact Lens<br>Class. Name: Soft (hydrophilic) Contact Lens - Daily Wear; Disposable<br>Classification: Class II [21 CFR 886.5925]<br>Product Code: LPL, MVN | |

# 4. Device Description

The AQUAIR (enfilcon A) soft contact lens is a Group I, daily wear silicone hydrogel contact lens that is not surface treated and is characterized by a high oxygen permeability (Dk). The lens material, enfilcon A, is composed of silicone macromers cross linked with other monomers, incorporating phthalocyanine blue as an integrated, handling tint. A UV blocker is added to reduce the amount of ultraviolet light transmitted into the eye. 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 0.60 mm |
| • Base Curve | 8.2 mm to 9.2 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 +4.00 D |
| • Refractive Index (hydrated) | 1.40 |
| • Water Content | 46% by weight in normal saline |
| • Oxygen permeability | 100 x 10-11 [(cm²/sec)(ml O₂)/ml*mmHg]], 34°C, Polarographic method (corrected) |

The lens is supplied sterile in blister packs containing a buffered saline solution. Labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating is established based on studies of product stability, package integrity, and sterility.

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Image /page/1/Picture/0 description: The image shows the word "CooperVision" in a stylized font. The "C" in Cooper is made up of two concentric circles, and the "o" in Vision is replaced by a black square with a white circle inside. There is an asterisk next to the black square. The text is black against a white background.

# 5. Intended Use

#### SPHERICAL AND ASPHERICAL:

AQUAIR (enfilcon 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:

AQUAIR (enfilcon 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:

AQUAIR (enfilcon 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 AQUAIR (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The lens may also be prescribed for single-use disposable daily wear.

# 6. Predicate Device(s)

- � COOPERVISION BIOFINITY (comfilcon A) Soft Contact Lenses [K052560]
- ♦ CIBA Vision O2OPTIX™ (lotrafilcon B) Soft Contact Lenses [K033919]

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# SoperVisiona®

# 7. Characteristics of Substantial Equivalence

The AQUAIR (enfilcon A) Soft Contact Lens is substantially equivalent to the COOPERVISION BIOFINITY (comfilcon A) and CIBA Vision OxOPTIX™ (lorrafileon B) Soft Contact Lenses. All of these lenses are Class II and have indications for daily wear per premarket notification. The following Table summarizes the primary features for this comparison, illustrating the similarities and differences.

| | CooperVision<br>AQUAIR<br>[Current Submission] | CooperVision<br>BIOFINITY<br>[K052560] | CIBA Vision<br>O2 Optix™<br>[K033919] |
|--------------------------------------------------------------------------|------------------------------------------------|----------------------------------------|---------------------------------------|
| Material | enfilcon A<br>silicone hydrogel | comfilcon A<br>silicone hydrogel | lotrafilcon B<br>silicone hydrogel |
| Category (Group) | Group I<br>(low water, nonionic) | Group I<br>(low water, nonionic) | Group I<br>(low water, nonionic) |
| Manufacturing Method | Cast Molded | Cast Molded | Cast Molded |
| Indication | Daily Wear | Daily Wear | Daily Wear |
| Water Content (%) | 46 | 48 | 33 |
| Oxygen Permeability - Dk<br>@ 35°C [(cm²/sec) x (ml<br>O2)/(ml x mm Hg)] | $100 \times 10^{11} \dagger$ | $128 \times 10^{11} \ddagger$ | $110 \times 10^{11} \ddagger$ |
| Refractive Index | 1.40 | 1.40 | 1.42 |
| Light Transmittance (%) | > 97 | > 97 | > 96 |
| Chord Diameter Range(mm) | 13.5 to 15.0 | 13.5 to 15.0 | 13.0 to 15.0 |
| Base Curve Range (mm) | 8.2 to 9.2 | 8.0 to 9.5 | 8.0 to 9.2 |
| Center Thickness (mm) | 0.08 @ -3.00D | 0.08 @ -3.00D | 0.08 @ -3.00D |
| Powers | -20.00D to +20.00D<br>in 0.25 steps | -20.00D to +20.00D<br>in 0.25 steps | -1.00 to -6.00, 0.25D steps |

† polarographic method (corrected) † coulometric method

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# 8. Physicochemical Studies

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

#### 9. Toxicology Studies

Animal GLP studies were conducted and determined that AQUAIR (enfilcon A) 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 AQUAIR lens.

# 10. Human Clinical Studies

Clinical studies were conducted to demonstrate substantial equivalence of the AQUAIR (enfilcon A) lens as compared with historical data of the COOPERVISION BIOFINTY lens 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.

#### 11. Conclusions

Based on evaluations of material, manufacturing methods, lens parameters and indicated use, the AQUAR (enfilcon A) lens is substantially equivalent with the predicate, marketed lenses. Based on evaluation of chemical properties, biocompatibility and clinical studies, the AQUAIR (enfilcon A) lens has been shown to be safe and effective for its indicated use.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized abstract symbol that resembles a human figure.

JAN - 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CooperVision Jack P. Douglas, Ph.D. 6140 Stoneridge Mall Road, Suite 500 Pleasanton CA 94588

Re: K071736

Trade/Device Name: Aquair (enfilcon A) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: December 13, 2007 Received: December 14, 2007

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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Page 2 - Jack P. Douglas, Ph.D.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

M.B. Eglekus, MD

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

Ko71736 510(k) Number [if known]:

# Device Name: AQUAIR (enfilcon A) Soft (Hydrophilic) Contact Lens

## Indications for Use:

#### SPHERICAL AND ASPHERICAL:

AQUAIR (enfilcon 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:

AQUAIR (enfilcon 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:

AQUAIR (enfilcon 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.

#### DAILY DISPOSABLE:

The AQUAIR (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for single-use disposable wear.

#### FREQUENT REPLACEMENT:

The AQUAIR (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for frequent replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.

# Additional Claims:

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

| Prescription Use | <div style="border: 1px solid black; padding: 10px;">X</div> | OR | Over-The-Counter Use __________ |
|------------------|--------------------------------------------------------------|----|---------------------------------|
|------------------|--------------------------------------------------------------|----|---------------------------------|

(Optional Format 1-2-96)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K071736 |
|---------------|---------|
|---------------|---------|