VISTAKON (NARAFILCON) A SOFT CONTACT LENS

K073485 · Johnson & Johnson Vision Care, Inc. · LPL · Mar 3, 2008 · Ophthalmic

Device Facts

• Record ID: K073485
• Device Name: VISTAKON (NARAFILCON) A SOFT CONTACT LENS
• Applicant: Johnson & Johnson Vision Care, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Mar 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The VISTAKON® (narafilcon A) Soft Contact Lens (spherical) is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. The VISTAKON® (narafilcon A) Multifocal Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less. The VISTAKON® (narafilcon A) Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism. The VISTAKON® (narafilcon A) Multifocal-Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less. VISTAKON® (narafilcon A) Contact Lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye. The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.

Device Story

VISTAKON (narafilcon A) contact lens; silicone hydrogel material with internal wetting agent; spherical, toric, multifocal, and toric-multifocal designs. Includes Reactive Blue Dye #4 for visibility and benzotriazole UV-absorbing monomer for UV radiation protection. Supplied sterile in buffered saline with methyl ether cellulose. Prescribed by eye care professionals for daily wear, single-use; discarded after removal; no cleaning or disinfection required. Provides optical correction for refractive ametropia, presbyopia, and astigmatism in phakic or aphakic patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and material characterization.

Technological Characteristics

Silicone hydrogel (narafilcon A); 54% narafilcon A, 46% water content. Hemispherical or hemitoric shell. Includes internal wetting agent, Reactive Blue Dye #4, and benzotriazole UV-absorbing monomer. Transmittance <1% UVB (280-315nm), <10% UVA (316-380nm). Sterile, single-use.

Indications for Use

Indicated for daily wear, single-use optical correction of myopia, hyperopia, presbyopia, and astigmatism (up to 10.00D) in phakic or aphakic persons with non-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

• VISTAKON (galyfilcon A) Contact Lens (K032340)
• VISTAKON (etafilcon) Contact Lenses (K962804)

Submission Summary (Full Text)

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K073485

# 510(k) Summary

| Submitter<br>Information | Company:<br>Contact Person:<br>Email:<br>Telephone:<br>FAX:<br>Date Prepared: | VISTAKON®<br>Division of Johnson & Johnson Vision Care, Inc.<br>7500 Centurion Parkway<br>Suite 100<br>Jacksonville, FL 32256<br>Rosalind Baker Williams<br>[e-mail]<br>904-403-1504<br>904-403-1424<br>December 11, 2007 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of<br>the Device | Common Name:<br>Device Name:<br>Classification Name:<br>Device Classification: | Soft Contact Lens<br>VISTAKON® (narafilcon A) Contact Lens<br>Soft Hydrophilic Contact Lens, Daily Wear<br>Class II, 21 CFR 886.5925 (b) (1). |
| Predicate<br>Device(s) | Material<br>VISTAKON® (galyfilcon A) Contact Lens ">– K032340<br>(FDA Group I; low water, nonionic polymer)<br>Indication, Wear Schedule<br>VISTAKON® (etafilcon) Contact Lenses – K962804<br>(Daily wear, single use) | |

:

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## Executive Summary, Continued

| Description of<br>Device | • The VISTAKON® (narafilcon A) Contact Lens Clear and<br>Visibility Tinted with UV blocker is available as a spherical lens,<br>multifocal lens; toric lens, and toric-multifocal lens. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • The lenses are made of a silicone hydrogel material containing an<br>internal wetting agent. |
| | • The VISTAKON® (narafilcon A) Contact Lens may be tinted blue<br>using Reactive Blue Dye #4 to make the lens more visible for<br>handling |
| | • A benzotriazole UV absorbing monomer is used to block UV<br>radiation. The transmittance characteristics are less than 1% in the<br>UVB range of 280 – 315nm and less than 10% in the UVA range<br>of 316 – 380nm. |
| | • The VISTAKON® (narafilcon A) Contact Lens is a hemispherical<br>or hemitoric shell. |
| | • The lens is supplied in a sterile state, packaged in a buffered saline<br>solution with methyl ether cellulose. |
| | • The composition of the lens is 54% narafilcon A and 46% water<br>by weight when hydrated and stored in the buffered saline<br>solution. |

and the comments of the comments of the comments of the comments of the comments of the comments of

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### 510(k) Summary, Continued

#### Indications for Use

| Lens Design | Indication |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Spherical | The VISTAKON® (narafilcon A) Contact Lens is indicated<br>for daily wear single use only for the optical correction of<br>refractive ametropia (myopia and hyperopia) in phakic or<br>aphakic persons with non-diseased eyes who may have<br>1.00D or less of astigmatism. |
| Multifocal | The VISTAKON® (narafilcon A) Contact Lens is indicated<br>for daily wear single use only for the optical correction of<br>distance and near vision in presbyopic, phakic or aphakic<br>persons with non-diseased eyes who may have 0.75D of<br>astigmatism or less. |
| Toric | The VISTAKON® (narafilcon A) Contact Lens is indicated<br>for daily wear single use only for the optical correction of<br>visual acuity in phakic or aphakic persons with non-<br>diseased eyes that are hyperopic or myopic and may have<br>10.00D or less of astigmatism. |
| Multifocal<br>Toric | The VISTAKON® (narafilcon A) Contact Lens is indicated<br>for daily wear single use only for the optical correction of<br>distance and near vision in presbyopic phakic or aphakic<br>persons with non-diseased eyes who may have 10.00D of<br>astigmatism or less. |

- VISTAKON® (narafilcon A) Contact Lenses contain a UV Blocker to . help protect against transmission of harmful UV radiation to the cornea and into the eye.
- The Eye Care Professional should prescribe the lenses for daily wear . single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vistakon c/o Rosalind Baker Williams 7500 Centurion Parkway, Ste. 100 Jacksonville FL 32256

MAR - 3 2008

Re: K073485

Trade/Device Name: VISTAKON® (narafilcon A) Contact Lens for Daily Wear Single Use Only

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: December 11, 2007 Received: December 12, 2007

Dear Ms. Williams:

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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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 vours.

Malina Bepelaia, und

Malvina B. Eydelman, M. 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

510(k) Number:

Device Name:

VISTAKON® (narafilcon A) Contact Lens Clear and Visibility Tinted, with UV blocker

Indications for Use:

The VISTAKON® (narafilcon A) Soft Contact Lens (spherical) is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The VISTAKON® (narafilcon A) Multifocal Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less.

The VISTAKON® (narafilcon A) Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism.

The VISTAKON® (narafilcon A) Multifocal-Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.

VISTAKON® (narafilcon A) Contact Lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.

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

| Prescription Use | X |
|------------------|---------------------|
| | OR Over the Counter |

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

| 510(k) Number | K073485 |
|---------------|---------|
|---------------|---------|

CONFIDENTIAL