VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER

K994318 · Vistakon, Johnson & Johnson Vision Products, Inc. · LPL · Feb 23, 2000 · Ophthalmic

Device Facts

• Record ID: K994318
• Device Name: VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
• Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Feb 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. The VISTAKON BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism. The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism. The VISTAKON TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less. VISTAKON 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 or for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.

Device Story

Lenefilcon A soft (hydrophilic) contact lenses; clear or visibility tinted; includes UV blocker. Prescribed by eye care practitioners for daily wear; single-use disposable or frequent/planned replacement schedules. When used for frequent replacement, requires chemical disinfection. Labeling modification adds information regarding reduced risk of giant papillary conjunctivitis when replaced at intervals from 1 day to 2 weeks. Device provides refractive correction and UV protection.

Clinical Evidence

No new clinical studies conducted. Safety and efficacy supported by clinical data previously submitted in K991163 and literature published in the July 1999 CLAO Journal supporting the labeling modification.

Technological Characteristics

Material: lenefilcon A. Soft (hydrophilic) contact lens. Includes UV blocker. Daily wear modality. Chemical disinfection required for frequent replacement.

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia/hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. Spherical lenses for ≤1.00 D astigmatism; Bifocal for presbyopic patients with ≤0.75 D astigmatism; Toric for ≤10.00 D astigmatism; Toric Bifocal for presbyopic patients with ≤10.00 D astigmatism. Provides UV radiation protection.

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 (lenefilcon A) soft (hydrophilic) contact lenses (K991163)

Submission Summary (Full Text)

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# FEB 2 3 2000

K 9943/8

## Summary of 510(k) Submission

| Name and<br>address of<br>submitter | Vistakon, Johnson & Johnson Vision Products, Inc.<br>7500 Centurion Parkway<br>Jacksonville, Florida 32256<br>Contact: Sharon Briggs<br>Phone: [phone]<br>Date Prepared: December 21, 1999 | | | | | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|
| Identification of<br>device | • The trade name is VISTAKON (lenefilcon A) soft (hydrophilic) contact<br>lenses, clear and visibility Tinteded, with UV blocker, for daily wear<br>• The common or usual name is Soft (hydrophilic) Contact Lens (daily<br>wear).<br>• The FDA Classification is Class II. | | | | | |
| Predicate<br>devices | The predicate device is VISTAKON (lenefilcon A) soft (hydrophilic) contact<br>lenses, clear and visibility Tinteded, with UV blocker, for daily wear covered<br>under K991163. | | | | | |
| Description of<br>device | The device description does not change from that cleared under K991163. | | | | | |
| Continued on next page | | | | | | |

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## Summary of 510(k) Submission, Continued

| Indications for<br>Use | The VISTAKON Contact Lens (spherical) is indicated for daily wear<br>for the correction of refractive ametropia (myopia and hyperopia) in<br>aphakic or non-aphakic persons with non-diseased eyes who may have<br>1.00 D or less of astigmatism.<br><br>The VISTAKON BIFOCAL Contact Lens is indicated for daily wear<br>for the correction of distance and near vision in presbyopic, aphakic or<br>non-aphakic persons with non-diseased eyes who may have 0.75 D or<br>less of astigmatism.<br><br>The VISTAKON TORIC Contact Lens is indicated for daily wear for<br>the correction of visual acuity in aphakic or non-aphakic persons with<br>non-diseased eyes that are hyperopic or myopic and may have 10.00 D<br>or less of astigmatism.<br><br>The VISTAKON TORIC BIFOCAL Contact Lens is indicated for<br>daily wear for the correction of distance and near vision in presbyopic<br>aphakic or non-phakic persons with non-diseased eyes who may have<br>10.00 D of astigmatism or less.<br><br>VISTAKON Contact Lenses help protect against transmission of<br>harmful UV radiation to the cornea and into the eye.<br><br>Eye care practitioners may prescribe the lens for either single-use<br>disposable wear or for frequent/planned replacement wear, with<br>cleaning, disinfection and scheduled replacement. When prescribed<br>for frequent/planned replacement wear, the lens may be disinfected<br>using a chemical disinfection system only. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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Continued on next page

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### Summary of 510(k) Submission, Continued

:

| Reason for<br>510(k) | The reason for the 510(k) is to revise the “Wear Schedule” in the Draft<br>Package Insert, and the “Introduction” statements in the Draft Patient<br>Instruction Guides (Disposable and Frequent Replacement) for VISTAKON<br>(lenefilcon A) soft (hydrophilic) contact lenses, clear and visibility tinted,<br>with UV blocker, for daily wear to include the following statement:<br>When VISTAKON UV Blocking Contact Lenses are replaced at<br>intervals ranging from 1 day to 2 weeks, the risk of developing giant<br>papillary conjunctivitis may be reduced . |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | The characteristics do not change. They are the same as previously submitted<br>in K991163. |
| Non-clinical<br>studies | Non-clinical studies (chemistry, toxicology, microbiology, shelf-life, and<br>leachability) on the lens material were not conducted because the lens<br>material, lenefilcon A, does not change. |
| Clinical studies | This 510(k) describes a labeling modification which is supported by clinical<br>studies published in the July 1999 CLAO Journal (see Attachment A). There<br>is no change in lens material, the manufacturing process, nor the parameters<br>and properties, therefore, the clinical data previously submitted in K991163<br>supports the clinical safety of the subject device. |
| Conclusions<br>drawn from<br>studies | Additional studies were not conducted, therefore, the conclusions drawn from<br>studies previously submitted in K991163 support the non-clinical and clinical<br>safety of the subject device. The clinical studies published in the July 1999<br>CLAO Journal support the labeling modification that is the subject of this<br>510(k). |

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For the disposable patient guide, the statement is revised to: "When VISTAKON UV Blocking Contact Leases are replaced daily, the risk of developing giant papillary conjunctivitis may be reduced."

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### FEB 2 3 2000

Ms. Sharon A. Briggs Manager, Regulatory Submissions VISTAKONTM 7500 Centurion Parkway Jacksonville, FL 32256

Re: K994318

Trade Name: VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens Clear and Visibility Tinted with UV blocker

Regulatory Class: II Product Code: 86 LPL Dated: December 21, 1999 Received: December 22, 1999

Dear Ms. Briggs:

We have reviewed your Section 510(k) notification of intent to market the device referenced above 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 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). 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 (Premarket Approval), 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 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 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 - Ms. Sharon A. Briggs

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications Statement

510(k) Number (if known):

VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens Clear and Device Name: Visibility Tinted with UV blocker

Indication for Use:

The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eves who may have 1.00 D or less of astigmatism.

The VISTAKON BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with nondiseased eyes who may have 0.75 D or less of astigmatism.

The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.

The VISTAKON TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.

VISTAKON 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 or for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.

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 Devices

510(k) Number_K 99 43 | 4