AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER

K030748 · Clearlab Pte , Ltd. · LPL · May 14, 2003 · Ophthalmic

Device Facts

• Record ID: K030748
• Device Name: AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
• Applicant: Clearlab Pte , Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: May 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The AQUASOFT (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. 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 lens may be cleaned and disinfected using a chemical (not heat) lens care system. The AQUASOFT (ocufilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system. The AOUASOFT (ocufilcon D) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00D and have near add requirements up to 3.00D. The lens may be cleaned and disinfected using a chemical (not heat) lens care system. Eyecare practitioners may prescribe the lenses for daily wear for disposal after removal in a disposable lens program or for cleaning, disinfection and scheduled replacement in a frequent replacement program. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Story

AQUASOFT (ocufilcon D) soft contact lenses; hydrophilic copolymer of 2-HEMA and methacrylic acid; 55% water content; available as spherical, aspherical multifocal, or back surface toric lenses. Lenses function as refractive medium to focus light on retina. Prescribed by eyecare practitioners for daily wear; disposable or frequent replacement programs. Chemical disinfection required. UV-blocking monomer (benzophenone) included. Cast-molded production. Benefits include vision correction for myopia, hyperopia, astigmatism, and presbyopia.

Clinical Evidence

No clinical data required for this submission. Substantial equivalence supported by non-clinical performance data including toxicology, cytotoxicity, ocular irritation, systemic injection, leachability/residual monomer studies, and physiochemical property testing.

Technological Characteristics

Material: ocufilcon D (45% copolymer of 2-HEMA and methacrylic acid, 55% water). Refractive index: 1.408. Oxygen permeability: 19.7 x 10^-11 (cm²/sec)(ml O₂/ml x mm Hg @ 35°C). UV blocker: Benzophenone monomer. Tint: Reactive Blue 19. Production: Cast-molded. Form factor: Spherical, aspherical multifocal, and toric lenses.

Indications for Use

Indicated for daily wear correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes with myopia, hyperopia, or astigmatism (up to 7.00D for toric, 2.00D for multifocal). Multifocal indicated for presbyopic patients. 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

• BIOMEDICS 55 (K982947)
• Specialty D-UV (K011542)

Submission Summary (Full Text)

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# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

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: | K030748 |
|--------------------------------|---------|
|--------------------------------|---------|

Applicant information:

| Date Prepared: | March 3, 2003 |
|------------------------------------------|----------------------------------------------------------------------------------|
| Name: | ClearLab PTE, Ltd. |
| Address | 139, Joo Seng Raod #06-01<br>ATD Centre, Singapore 368362 |
| Contact Person: | Steve Newman |
| Phone number: | Country code 65+ 67491090 |
| Fax number: | Country code 65+ 62848534 |
| Parent Company: | 1800 CONTACTS, Inc.<br>66 E. Wadsworth Park Drive 3rd. Floor<br>Draper, UT 84020 |
| FDA US Agent/<br>Official Correspondent: | Medvice Consulting, Inc.<br>Martin Dalsing |
| Phone number | [phone] |
| Fax number | [phone] |

Device Information:

| Device Classification: | Class II |
|------------------------|-----------------------------------------------------------------------------------------------|
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | AQUASOFT (ocufilcon D) Daily Wear Contact Lens clear and<br>visibility tint, with UV blocker. |

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510(k) Premarket Notification

# Equivalent Devices:

The AOUASOFT (ocufilcon D) Spherical Soft Contact Lenses are substantially equivalent to the following predicate device

Predicate device:

"BIOMEDICS 55 " Manufactured/distributed by Ocular Sciences, Inc. 510(k) number; K982947

"Specialty D-UV" Manufactured/distributed by Specialty UltraVision, Inc. 510(k) number: K011542

## Device Description:

The AQUASOFT (ocufilcon D) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, aspherical multifocal lens and as a back surface astigmatic (toric) lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The ionic lens material. (ocufilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in normal buffered saline solution. The lens polymer contains a UV absorbing compound and is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.2121. The ocufilcon D name has been adopted by the United States Adopted Names Council (USAN).

In the AQUASOFT Contact Lens with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV blocking for AQUASOFT averages > 99% in the UVB range of 280nm -315nm and 83% in the UVA range of 316 - 380mm.

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 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 hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 55% water by weight. The physical properties of the lens are

| Refractive Index | 1.408 (hydrated) |
|-----------------------------|--------------------------------------------------|
| Light Transmission (clear) | greater than 95% |
| Light Transmission (tinted) | greater than 95% |
| Water Content | 55 % ± 2% |
| Specific Gravity | 1.062 |
| Oxygen Permeability | 19.7 X 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) |
| | (revised Fatt method). |

## Intended Use:

The AQUASOFT (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. 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 lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The AQUASOFT (ocufilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The AOUASOFT (ocufilcon D) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00D and have near add requirements up to 3.00D.

The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Eyecare practitioners may prescribe the lenses for disposal after removal in a disposable lens program or for cleaning, disinfection and scheduled replacement in a frequent replacement program. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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# Technological Characteristics:

The technological characteristics of the AQUASOFT contact lens as compared to the technological characteristics of the predicate device "BIOMEDICS 55" are illustrated in the following table.

| Pre-Clinical<br>equivalency /<br>Device | AQUASOFT (ocufilcon D)<br>new device | BIOMEDICS 55 (ocufilcon D)<br>predicate device |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission number | New Deivce | K982947 |
| 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 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 hyperopia. |
| Functionality | 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, Soft (hydrophilic) contact<br>lens | Daily wear, Soft (hydrophilic) contact<br>lens |
| Production Method | Cast-molded | Cast-molded |
| FDA Group # | Group # 4 >50% Water, Ionic Polymers | Group # 4 >50% Water, Ionic Polymers |
| USAN name | ocufilcon D | ocufilcon D |
| Water Uptake(%) | 55.0% | 55.0% |
| Oxygen<br>Permeability | 19.7 x 10-11 (cm2/sec)<br>(ml O2/ml x mm Hg @ 35 degrees C),<br>(revised Fatt method). | 19.7 x 10-11 (cm2/sec)<br>(ml O2/ml x mm Hg @ 35 degrees C),<br>(revised Fatt method). |
| Specific Gravity | 1.062 | 1.141 |

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510(k) Premarket Notification

#### Summary of Non-Clinical Performance Data:

The following non-clinical tests were conducted as recommended by the Premarket Notification 510(k) guidance document for Daily Wear Contact Lenses, revised May 1994.

Toxicology testing Cytotoxicity USP Ocular Irritation USP Systemic Injection Leachability / Residual monomer Studies Physiochemical property testing

#### Clinical Studies:

No clinical data is required for this submission.

#### Conclusions Drawn from the Studies:

The AQUASOFT Soft Contact Lens is substantially equivalent to the predicate device(s) and does not raise different questions of safety and effectiveness than that of the predicate devices.

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Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three wavy lines below them.

Public Health Service

MAY 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ClearLab Pte Ltd. c/o Martin Dalsing Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503

Re: K030748

Trade/Device Name: Aquasoft (ocufilcon D) Daily Wear Contact Lens clear and visibility tint, with UV blocker Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: March 3, 2003 Received: March 10, 2003

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.

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 - Martin Dalsing

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/dsma/dsmamain.html

Sincerely yours,

A. Levy Rosenthal

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

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# INDICATIONS FOR USE STATEMENT

AQUASOFT (ocufilcon D) Daily Wear Contact Lens clear and visibility tint, Device Name: with UV blocker.

# INDICATIONS FOR USE:

The AQUASOFT (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. 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 lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The AQUASOFT (ocufilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The AOUASOFT (ocufilcon D) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00D and have near add requirements up to 3.00D.

The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Eyecare practitioners may prescribe the lenses for daily wear for disposal after removal in a disposable lens program or for cleaning, disinfection and scheduled replacement in a frequent replacement program. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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

Concurrence of Division Sign-Office of Device Evaluation (ODE)
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K030748 |
|---------------|---------|
|---------------|---------|

| Prescription Use | X or Over-The-Counter Use |
|------------------|---------------------------|
|------------------|---------------------------|

(Per 21 CFR 801.109)
(Optional Format 1-2-96)