INTELLIWAVE3

K100221 · Art Optical Contact Lens, Inc. · LPL · Sep 14, 2010 · Ophthalmic

Device Facts

• Record ID: K100221
• Device Name: INTELLIWAVE3
• Applicant: Art Optical Contact Lens, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Sep 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The IntelliWave3, 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 IntelliWave3, 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 nondiseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters. The IntelliWave3, 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 IntelliWave3, 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 IntelliWave3, 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

IntelliWave3 silicone hydrogel contact lenses; fabricated from efrofilcon A; lathe-cut for custom RX. Lens acts as refractive medium focusing light on retina. Used by eyecare practitioners for daily wear; frequent/planned replacement. Patient cleans/disinfects via chemical or hydrogen peroxide systems. Benefits include vision correction for ametropia, presbyopia, and irregular corneal conditions. Device supplied sterile in vials.

Clinical Evidence

Bilateral, open-label, parallel group, randomized daily wear study; 63 patients; 3-month duration. Evaluated vision, health, comfort, and fit. Results demonstrated performance similar to predicate control.

Technological Characteristics

Material: efrofilcon A (silicone hydrogel); 74% water content; non-ionic. Oxygen permeability: 59.8 x 10^-11 (cm2/sec)(ml O2/ml x hPa @ 35°C). Refractive index: 1.38. Manufacturing: Lathe-cut. Form factor: Spherical, toric, multifocal, multifocal toric, irregular cornea. Sterilization: Sterile in vials with buffered saline.

Indications for Use

Indicated for daily wear correction of myopia/hyperopia in aphakic/non-aphakic persons with non-diseased eyes. Includes options for refractive astigmatism (up to 12D), presbyopia (add power up to +4.00D), and 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

• IntelliWave1 and Intelliwave2 (acofilcon B, hioxifilcon B) (K073621)
• Biofinity (comfilcon A) (K052560)
• ActiFresh 400 (lidofilcon A) (K983637)

Submission Summary (Full Text)

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# 510 (k) SUMMARY

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:

K100221

SEP 1 4 2010

#### Applicant information:

Device

| Date Prepared: | August 16, 2010 |
|------------------------|----------------------------------------------------------------------------------------------|
| Name:<br>Address | Art Optical Contact Lens, Inc.<br>3175 3 Mile Road NW<br>Walker, Michigan 49534 |
| Contact Person: | Mike Johnson, FCLSA<br>Director of Consultative Services |
| Phone number: | [phone] |
| Consultant: | Martin Dalsing<br>Medvice Consulting, Inc.<br>806 Kimball Avenue<br>Grand Junction, CO 81501 |
| Phone number | [phone] |
| Information: | |
| Device Classification: | Class II |
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact. Daily Wear |
| Trade Name: | IntelliWave³, Silicone Hydrogel Daily Wear Soft Contact<br>Lens (ofrofilcon A) |

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K100 221
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#### Equivalent Devices:

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

Predicate devices:

"IntelliWavel and Intelliwave2 (acofilcon B, hioxifilcon B)" by Art Optical Contact Lens. Inc.

510(k) number: K073621

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

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

#### Device Description:

The IntelliWave3 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 group 2, 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. 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 birghilic 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 and 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<br>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 step |
| • 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 IntelliWave3, 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 IntelliWave', toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated I he correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

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The IntelliWave , 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.

IGE 4 of 6

The IntelliWave", 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 IntelliWave , 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 vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the IntelliWave (efrofilcon A) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols.

> Test results of the non-clinical testing on the IntelliWave3 (efrofilcon A) 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, and .
- Lens physical and material properties are consistent with currently marketed . lenses.

#### A bilateral, open-label, parallel group, and randomized daily wear study was Clinical Testing A onlineral, open have, the safety and efficacy of the Intelli Wave³ (efrofilcon A) Silicone Hydrogel Soft Contact Lens. The study evaluated 63 patients over a three (3) months period. Clinical evaluation demonstrated similar overall performance to (2) months por readicate control in the clinically relevant areas of vision, health, and comfort and fit when worn for daily wear.

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K100221
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#### Substantial Equivalence:

The following matrix illustrates the production method, lens function and material characteristics of the IntelliWave", (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 IntelliWave 3, (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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| | IntelliWave3<br>New Device | Art Optical IntelliWave1 2<br>(acofilcon B)<br>(hioxifilcon B)<br>predicate device | CooperVision Biofinity<br>(comfilcon A)<br>predicate device | Hydron Ltd. ActiFresh 400<br>(lidofilcon A)<br>predicate device |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily wear for the<br>correction of visual acuity in aphakic<br>and not aphakic persons with non-<br>diseased eyes with myopia or<br>hyperopia. The lens may also be<br>prescribed for management of<br>irregular corneal conditions such as<br>keratoconus and post graft fitting. | Indicated for daily wear for the<br>correction of visual acuity in aphakic<br>and not aphakic persons with non-<br>diseased eyes with myopia or<br>hyperopia. | Indicated for daily wear for the<br>correction of visual acuity in aphakic<br>and not aphakic persons with non-<br>diseased eyes with myopia or<br>hyperopia. | Indicated for daily wear for the<br>correction of visual acuity in aphakic<br>and not aphakic persons with non-<br>diseased eyes with myopia or<br>hyperopia. |
| Functionality | same as<br>predicate device | The contact lenses act as a refractive<br>medium that focus light rays from near<br>and distant objects on the retina. | The contact lenses act as a refractive<br>medium that focus light rays from near<br>and distant objects on the retina. | The contact lenses act as a refractive<br>medium that focus light rays from near<br>and distant objects on the retina. |
| Indications | Daily wear, Silicone Hydrogel Soft<br>(hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact<br>lens | Daily wear, Silicone Hydrogel Soft<br>(hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact<br>lens |
| Production<br>Method | Lathe-Cut, custom manufactured | Lathe-Cut, custom manufactured | Cast Molded, mass produced | Lathe-Cut, custom manufactured |
| FDA Group # | Group # 11 (Silicone Hydrogel) > 50%<br>Water, Nonionic Polymers | Group # 1 < 50% Water, Nonionic<br>Polymers | Group # 1 (Silicone Hydrogel) < 50%<br>Water, Nonionic Polymers | Group # 11 > 50% Water, Nonionic<br>Polymers |
| USAN name | efrofilcon A | hioxifilcon B, acofilcon B | comfilcon A | lidofilcon A |
| Water Content | 74% | 48% | 48.0% | 74.0% |
| Oxygen<br>Permeability | 60 x 10-11 (cm2/sec)<br>(ml O2/ml x mm Hg @ 35 degrees C),<br>(revised Fatt method). | 15.89 x 10-11 (cm2/sec)<br>(ml O2/ml x mm Hg @ 35 degrees C),<br>(revised Fatt method). | 128 x 10-11 (cm2/sec)<br>(ml O2/ml x mm Hg @ 35 degrees C),<br>(revised Fatt method). | 28 x 10-11 (cm2/sec)<br>(ml O2/ml x mm Hg @ 35 degrees C),<br>(revised Fatt method). |
| Specific Gravity | 1.139 | 1.142 | 1.142 | 1.060 |

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Art Optical Contact Lens, Inc. c/o Medvice Consulting, Inc. Mr. Martin Dalsing Official Correspondent 806 Kimball Avenue Grand Junction, CO 81501

Re: K100221

Trade/Device Name: IntelliWave 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: August 16, 2010 "Received: August 19, 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. Iisting 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.

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

.

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Page 2 - Mr. Martin Dalsing

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 (OS) 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/ReportalProblem/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 yours,

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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## SEP 1 4 2010

### INDICATIONS FOR USE STATEMENT

#### IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) Device Name:

#### INDICATIONS FOR USE:

The IntelliWave', 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 IntelliWave", 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 nondiseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The IntelliWave", 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 IntelliWave ; 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 IntelliWave', 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.

(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) | <span style="text-decoration: overline;">✓</span> |
|---------------------------------------|---------------------------------------------------|
|---------------------------------------|---------------------------------------------------|

or
(Optional Format 1-2-96)

| Over-The-Counter Use | ____________________ |
|----------------------|----------------------|
|----------------------|----------------------|

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

510(k) Number K100221