DEFINITIVE, FLEXLENS - SILICONE HYDROGEL

K100443 · X-Cel Contacts, Inc. · LPL · Oct 28, 2010 · Ophthalmic

Device Facts

• Record ID: K100443
• Device Name: DEFINITIVE, FLEXLENS - SILICONE HYDROGEL
• Applicant: X-Cel Contacts, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Oct 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Definitive, Flexlens, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The Definitive, Flexlens, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters. The Definitive, Flexlens, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding. 75 diopters and are presbyopic requiring add power of up to +4.00 diopters. The Definitive, Flexlens, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The Definitive, Flexlens, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Device Story

Definitive, Flexlens are daily wear, silicone hydrogel soft contact lenses fabricated from efrofilcon A; non-ionic, high water content (74%), non-surface treated. Lathe-cut for custom RX; supplied sterile in buffered saline vials. Function as refractive medium to focus light on retina. Prescribed by eyecare practitioners for daily wear; requires chemical or hydrogen peroxide disinfection. Benefits include vision correction for ametropia, astigmatism, presbyopia, and irregular corneal conditions.

Clinical Evidence

No clinical data. Bench testing only; includes in vitro and in vivo preclinical toxicology, biocompatibility, sterility, and physical property testing. Clinical performance of efrofilcon A material previously established.

Technological Characteristics

Material: efrofilcon A (26% polymer, 74% water). Lathe-cut manufacturing. Refractive index 1.38. Oxygen permeability 59.8 x 10^-11 (cm2/sec)(ml O2/ml x hPa). Non-ionic, non-surface treated. Sterile, vial-packaged.

Indications for Use

Indicated for aphakic and non-aphakic patients with non-diseased eyes requiring correction of myopia, hyperopia, and/or astigmatism (up to 12D). Includes presbyopic patients requiring add power up to +4.00D and patients with irregular corneal conditions (e.g., keratoconus, post-graft).

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

• IntelliWave, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) (K100221)
• Flexlens Multifocal (hioxifilcon B) (K070308)
• Biofinity (comfilcon A) (K052560)
• ActiFresh 400 (lidofilcon A) (K983637)

Submission Summary (Full Text)

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# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS 2 8 200

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

. .

| The assigned 510(k) number is: | K100443 |
|--------------------------------|--------------------------------------------------------------------------------------|
| Applicant information: | |
| Date Prepared: | September 24, 2010 |
| Name: | X-CEL CONTACTS, A Walman Optical Company |
| Address | 2775 Premiere Pkwy, Suite 600 Duluth, GA 30097 |
| Contact Person: | Robert Chambers Official Correspondent Director of Operations |
| Phone number: | [phone] |
| Consultant: | Martin Dalsing Medvice Consulting, Inc. 806 Kimball Avenue Grand Junction, CO 81501 |
| Phone number | [phone] |
| Device Information: | |
| Device Classification: | Class II |
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | Definitive, Flexlens - Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) |

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100443 AGE 2 OF

#### Equivalent Devices:

The Definitive, Flexlens Silicone Hydrogel Daily Wear Soft Contact Lenses (efrofilcon A) are substantially equivalent to the following predicate devices:

#### Predicate devices:

"IntelliWave', Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" by Art Optical Contact Lens, Inc. 510(k) number: K100221

"Flexlens Multifocal (hioxifilcon B)" by X-Cel Contacts. 510(k) number: K070308

"Biofinity (comfilcon A)" by Coopervision, Inc. 510(k) number; K052560

"ActiFresh 400 (lidofilcon A)" By Hydron Ltd. 510(k) number: K983637

#### Device Description:

The Definitive, Flexlens Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A. which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

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The Physical properties of the lens are:

| Refractive Index | 1.38 |
|---------------------|------------------------------------------------------------------------|
| Light Transmission | greater than 97% |
| Surface Character | hydrophilic |
| Water Content | 74 % |
| Specific Gravity | 1.048 (hydrated) |
| Oxygen Permeability | 59.8 x 10-11 (cm2/sec) (ml O₂/ml x hPa @ 35°C), (revised Fatt method). |

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, toric, multifocal, multifocal toric and irregular Cornea configurations with the following features and properties.

| • Chord Diameter | 12.0 mm to 16.00 mm |
|-------------------------------------|----------------------------------|
| • Center Thickness | 0.01 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) | -0.25D to -12.00D |
| • Cylinder Power (Multifocal Toric) | -0.25D to -4.00D |
| • Add Power (Multifocal) | +0.50D to +4.00D |

The lens is supplied sterile in vials containing a buffered saline solution. Vial 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 sterilization process.

# Intended Use:

The Definitive, Flexlens, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Definitive, Flexlens, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The Definitive, Flexlens, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding. 75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

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K100443
PAGE 4 OF 6

The Definitive, Flexlens, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Definitive, Flexlens, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning. disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

## Testing:

| Non-clinical Testing | A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were<br>performed to assess the safety and effectiveness of the Definitive, Flexlens, (efrofilcon<br>A) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. All non-clinical<br>toxicology tests were conducted in accordance with the GLP regulation. All other<br>testing was conducted according to valid scientific protocols. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Test results of the non-clinical testing on the Definitive, Flexlens, (efrofilcon A)<br>Silicone Hydrogel Soft Contact Lenses demonstrate that: |
| | Lenses supplied in glass vials are sterile for the indicated shelf-life,The packaging material and extracts are not toxic and not irritating, andLens physical and material properties are consistent with currently marketed lenses. |
| Clinical Data | The clinical performance of the (efrofilcon A) lens material has been previously<br>established, and therefore was not required for this 510(k). |
| | The Definitive, Flexlens, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact<br>Lens is identical to the cleared Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily<br>Wear Soft Contact Lens, cleared under K100221. |
| | The Definitive, Flexlens, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact<br>Lenses have the identical manufacturing process (lathe-cut versus lathe-cut) as the<br>marketed Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens,<br>cleared under K100221. |

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### Substantial Equivalence:

The following matrix illustrates the production method, lens function and material characteristics of the Definitive, Flexlens, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, as well as the predicate devices.

# Conclusions Drawn from Studies

### Validity of Scientific Data

Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, Microbiology, chemistry, shelf-life stability studies and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7

#### Substantial Equivalence

Information presented in this Premarket Notification establishes that the Definitive, Flexlens, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.

#### Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of Silicone Hydrogel, Daily Wear Soft Contact Lens. The benefits to the patient are the same as those for other Silicone Hydrogel contact lenses.

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| | Definitive - Flexlens Silicone Hydrogel (efrofilcon A) New Device | IntelliWave³, Silicone Hydrogel (efrofilcon A) predicate device | Flexlens Multifocal (hioxifilcon B) predicate device | CooperVision Biofinity (comfilcon A) predicate device | Hydron Ltd. ActiFresh 400 (lidofilcon A) predicate device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may also be prescribed for management of irregular corneal conditions such as keratoconus and post graft fitting | Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may also be prescribed for management of irregular corneal conditions such as keratoconus and post graft fitting. | Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, posses refractive astigmatism and/or are Presbyopic | Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. | Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia |
| Functionality | same as predicate device | The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina. | The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina | The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina. | The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina. |
| Indications | Daily wear, Silicone Hydrogel Soft (hydrophilic) contact lens | Daily wear, Silicone Hydrogel Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Silicone Hydrogel Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens |
| Production Method | Lathe-Cut, custom manufactured | Lathe-Cut, custom manufactured | Lathe-Cut, custom manufactured | Cast Molded, mass produced | Lathe-Cut, custom manufactured |
| USAN name | efrofilcon A | efrofilcon A | hioxifilcon B | comfilcon A | lidofilcon A |
| Water Content | 74% | 74% | 49% | 48.0% | 74.0% |
| Oxygen Permeability | $60 x 10^{-11} (cm^2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$ | $60 x 10^{-11} (cm^2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$ | $15 x 10^{-11} (cm^2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$ | $128 x 10^{-11} (cm^2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$ | $28 x 10^{-11} (cm^2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method)$ |
| Specific Gravity | 1.139 | 1.139 | 1.142 | 1.142 | 1.060 |

KI00443
PAGE 6 of 6

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct lines forming its body and wings. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

X-Cel Contacts c/o Medvice Consulting, Inc. Mr. Martin Dalsing Official Correspondent 806 Kimball Avenue Grand Junction, CO 81501

OCT 2 8 2010

Re: K100443

Trade/Device Name: Definitive Flexlens Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: September 24, 2010 Received: September 27, 2010

Dear Mr. Dalsing:

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 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.

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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); 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 (21 CFR Part 820); and if applicable, the electronic 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.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Debmal Falls

Malyina B. Evdelman, 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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#### Definitive, Flexlens Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) Device Name:

# INDICATIONS FOR USE:

The Definitive, FlexIens, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Definitive, Flexlens, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The Definitive, FlexIens, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding . 75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Definitive, Flextens, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Definitive, Flexlens, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting

Evecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✔ (Per 21 CFR 801.109)

Or

(Optional Format 1-2-96)

Over-The-Counter Use

Over-The-Counter Use
Marc Polloy

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

510(k) Number K100443