ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC

K013973 · Vistakon · LPL · Feb 26, 2002 · Ophthalmic

Device Facts

• Record ID: K013973
• Device Name: ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC
• Applicant: Vistakon
• Product Code: LPL · Ophthalmic
• Decision Date: Feb 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The ACUVUE® Brand Contact Lenses (spherical) are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism. The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism. The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC BIFOCAL Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less. ACUVUE® Brand (etafilcon A) Soft (hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. Eye Care Practitioners may prescribe the lens for either single-use disposable wear (See "Wearing Schedule").

Device Story

ACUVUE® Brand contact lenses (etafilcon A) are soft, hydrophilic lenses designed for daily wear; available in spherical, bifocal, and toric configurations; include UV-blocking properties; may feature cosmetic tints. Lenses are prescribed by eye care practitioners for refractive error correction or cosmetic use. This submission updates labeling to include a daily disposable wearing schedule, citing improved comfort for patients experiencing allergy-related itching and discomfort. Clinical research indicates 2 out of 3 patients report improved comfort when using the daily disposable schedule compared to longer replacement intervals. Lenses are worn directly on the eye; benefit includes vision correction, cosmetic enhancement, and potential reduction in allergy-associated discomfort.

Clinical Evidence

Clinical safety supported by data from previous submissions (K994324, K010114). Additional study conducted to support labeling modification for daily disposable wear. Results showed 2 out of 3 patients (approx. 67%) reported improved comfort regarding itching and mild discomfort associated with allergies during contact lens wear compared to replacement intervals greater than 2 weeks.

Technological Characteristics

Material: etafilcon A (hydrophilic polymer). Type: Soft contact lens. Features: UV blocker, spherical/bifocal/toric designs, optional cosmetic tint. Connectivity: None. Sterilization: Not specified in document.

Indications for Use

Indicated for daily wear in aphakic or non-aphakic persons with non-diseased eyes for correction of refractive ametropia (myopia, hyperopia, presbyopia) and astigmatism (up to 10.00 D), and for cosmetic color alteration. Prescribed by eye care practitioners.

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

• ACUVUE® Brand (etafilcon A) soft (hydrophilic) Contact Lenses (K994324)
• ACUVUE® 2 COLOURS Brand (etafilcon A) soft (hydrophilic) Contact Lens (K010114)

Reference Devices

• Focus® DAILIES® (nefilcon A) ONE-DAY CONTACT LENSES (K003586)

Submission Summary (Full Text)

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FEB 2 6 2002

| Name and<br>Address of<br>Submitter | VISTAKON®, Division of Johnson & Johnson Vision Care, Inc.<br>7500 Centurion Parkway, Suite 100<br>Jacksonville, Florida 32256<br>Contact: James W. Parziale<br>Phone: [phone]<br>Date Prepared: November 28, 2001 |
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| Identification of<br>Device | Trade Name: ACUVUE® Brand (etafilcon A) soft (hydrophilic) contact<br>lenses; clear and tinted (visibility and/or cosmetic) with UV blocker; for<br>daily wear Common or Usual Name: Soft (hydrophilic) Contact Lens (daily wear) Classification: Class II under 21 CFR 886.5925 |
| Predicate<br>Devices | The predicate devices are the:<br>ACUVUE® Brand (etafilcon A) soft (hydrophilic) Contact Lenses clear<br>and visibility tinted with UV blocker cleared most recently via K994324<br>on February 23, 2000, and ACUVUE® 2 <i>COLOURS</i> Brand (etafilcon A) soft (hydrophilic) Contact<br>Lens with UV blocker cleared most recently via K010114 on April 11,<br>2001. The additional indication is substantially equivalent to the labeling of:<br>CIBA Vision Corporation, Focus® DAILIES® (nefilcon A) ONE-DAY<br>CONTACT LENSES most recently cleared via K003586 on February 8,<br>2001. |
| Description of<br>Device | The device descriptions do not change from those cleared under K994324 and<br>K010114. |
| Intended Use | The ACUVUE® Brand Contact Lenses (spherical) are indicated for daily wear<br>to enhance or alter the apparent color of the eye for lenses with cosmetic tint<br>and/or for the correction of refractive ametropia (myopia and hyperopia) in<br>aphakic or not-aphakic persons with non-diseased eyes who may have 1.00 D<br>or less of astigmatism.<br>The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) BIFOCAL Contact<br>Lenses are indicated for daily wear to enhance or alter the apparent color of |
| Intended Use,<br>continued | the eye for lenses with cosmetic tint and for the correction of distance and<br>near vision in presbyopic, aphakic or not-aphakic persons with non-diseased<br>eyes who may have 0.75 D or less of astigmatism. |
| | The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC Contact<br>Lenses are indicated for daily wear to enhance or alter the apparent color of<br>the eye for lenses with cosmetic tint and for the correction of visual acuity in<br>aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or<br>myopic and may have 10.00 D or less of astigmatism. |
| | The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC BIFOCAL<br>Contact Lenses are indicated for daily wear to enhance or alter the apparent<br>color of the eye for lenses with cosmetic tint and for the correction of distance<br>and near vision in presbyopic aphakic or not-aphakic persons with non-<br>diseased eyes who may have 10.00 D of astigmatism or less. |
| | ACUVUE® Brand (etafilcon A) Soft (hydrophilic) UV Blocking Contact<br>Lenses help protect against transmission of harmful UV radiation to the<br>cornea and into the eye. |
| | Eye Care Practitioners may prescribe the lens for either single-use disposable<br>wear (See "Wearing Schedule"). |
| Reason For<br>510(k) | The reason for the 510(k) is to revise the "Wearing Schedule" section of<br>the Package Insert and the "Introduction" section of the Patient<br>Instruction Guide Disposable Daily Wear to include the following<br>statements: |
| | When worn on a daily disposable basis, ACUVUE® Brand (etafilcon A) Soft<br>(hydrophilic) Contact Lenses provide improved comfort for patients who<br>experience mild discomfort and itching associated with allergies during<br>contact lens wear compared to lenses replaced at intervals of greater than 2<br>weeks. |
| | Clinical research has shown that when worn on a daily disposable basis,<br>ACUVUE® Brand (etafilcon A) Soft (hydrophilic) Contact Lenses provided<br>improved comfort for 2 out of 3 patients who reported suffering from<br>itching and mild discomfort associated with allergies during contact lens<br>wear. |
| Technological<br>Characteristics | The technological characteristics do not change. They are the same as<br>previously submitted in K994324 and K010114. |
| Non-Clinical<br>Studies | Non-clinical studies (chemistry, toxicology, microbiology, shelf-life, and<br>leachability) on the lens material were not conducted since the lens material,<br>etafilcon A, does not change. |
| Clinical Studies | This 510(k) describes a labeling modification to the "Wearing Schedule"<br>section of the Package Insert and to the "Introduction" section of the<br>Patient Instruction Guide Disposable Daily Wear. There is no change in<br>lens material, the manufacturing process, nor the parameters and properties,<br>therefore, the clinical data previously submitted in K994324 and K010114<br>supports the clinical safety of the subject device. An additional study<br>supports the proposed labeling modification. |
| Conclusions | Additional safety studies were not conducted, therefore, the conclusions<br>drawn from studies previously submitted in K994324 and K010114 support<br>the non-clinical and clinical safety of the subject device. The additional<br>study supports the proposed labeling statement to be added to the<br>Package Insert and the Patient Instruction Guide Disposable Daily Wear. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular seal with the emblem of the U.S. Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The text around the seal reads "DEPARTMENT OF HEALTH & HUMAN SERVICES".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

Vistakon, Division of Johnson & Johnson Vision Care, Inc. c/o James W. Parziale 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256

Re: K013973

Trade/Device Name: ACUVUE® Band (etafilcon 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: November 30, 2001 Received: December 3, 2001

Dear Mr. Parziale:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the cherosare) to device Amendments, or to devices that have been reclassified in chaonnent unit of the Provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mander the Act include requirements for annual registration, listing of devices, confors provisions or use ice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 charkst Approval), it they of Sale, of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the Food and Drag reasult in regulatory action. In addition, FDA may publish comply with the GMT regarating your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your promations 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - James W. Parziale

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will and w you'll ought finding of substantial equivalence of your device to a legally prematics notification: "The slassification 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 and If you desire specific at 1100.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of 1 F F ac 6613. Additionally, for questions on the promotion and advertising of Compliance at [phone]. First of Compliance at [phone]. Also, please note the your dones, prease connecting by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general informational 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. Ralph 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

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#### Indications Statement

510(k) Number (if known):

ACUVUE® Brand (etafilcon A) soft (hydrophilic) contact lenses; clear Device Name: and with tint (visibility and/or cosmetic) with UV blocker; for daily wear

Indications for Use:

The ACUVUE® Brand Contact Lens (spherical) are indicated for daily wear to enhance or alter The ACO v OE - Brain over for lenses with cosmetic tint and/or for the correction of refractive ule apparent oolor of the vyeropia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lenses are indicated The ACO VOL - Brand (variater the apparent color of the eye for lenses with cosmetic tint and for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.

The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC Contact Lenses are indicated for THE TCO VOL "Brand (varent color of the eye for lenses with cosmetic tint and for durry wour of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.

The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC BIFOCAL Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic thatouted for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.

ACUVUE® Brand (etafilcon A) Soft (hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Eye Care Practitioners may prescribe the lens for single-use disposable wear (See "Wearing Schedule").

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

Prescription Use

OR Over the Counter

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K013973