VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR

K991163 · Vistakon, Johnson & Johnson Vision Products, Inc. · LPL · Jun 8, 1999 · Ophthalmic

Device Facts

• Record ID: K991163
• Device Name: VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR
• Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jun 8, 1999
• 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 10.00D of astigmatism or less. VISTAKON 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 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

VISTAKON (lenefilcon A) soft (hydrophilic) contact lenses; daily wear; clear or visibility tint; UV blocker. Corrects refractive ametropia, presbyopia, and astigmatism. Prescribed by eye care practitioners for single-use disposable or frequent/planned replacement. Requires chemical disinfection for planned replacement. UV blocker provides protection against transmission of UV radiation to cornea/eye. Device is identical to predicate K983912; no changes to material, manufacturing, or physical properties.

Clinical Evidence

No new clinical studies were conducted. Clinical safety is supported by data previously submitted in K983912, as the lens material, manufacturing process, and device parameters remain unchanged.

Technological Characteristics

Material: lenefilcon A. Form factor: soft (hydrophilic) contact lens. Features: UV blocker (95% UVA, 99.9% UVB). Sterilization: chemical disinfection system (for planned 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: ≤1.00 D astigmatism. Bifocal: presbyopic, ≤0.75 D astigmatism. Toric: hyperopic or myopic, ≤10.00 D astigmatism. Toric Bifocal: presbyopic, ≤10.00 D astigmatism.

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 (K983912)

Submission Summary (Full Text)

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# K991163

## Summary of 510(k) Submission

| Name and<br>address of<br>submitter | Vistakon, Johnson & Johnson Vision Products, Inc.<br>4500 Salisbury Road, Suite 300<br>Jacksonville, Florida 32216<br>Contact: Martine D. Martino<br>Phone: [phone]<br>Date of Original: April 22, 1999<br>Date Modified: May 26, 1999 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of<br>device | The trade name is VISTAKON (lenefilcon A) soft (hydrophilic) contact<br>lenses, clear and visibility tint, with UV blocker, for daily wear The common or usual name is Soft (hydrophilic) Contact Lens (daily<br>wear). The FDA Classification is Class II. |
| Predicate<br>devices | The predicate device is VISTAKON (lenefilcon A) soft (hydrophilic) contact<br>lenses, clear and visibility tint, with UV blocker, for daily wear covered under<br>K983912. |
| Description of<br>device | The device description does not change from that cleared under K983912. |

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

The reason for the 510(k) is to add the following Indications Statement (see Intended use bold text) for VISTAKON (lenefilcon A) soft (hydrophilic) contact lenses, clear and visibility tint, with UV blocker, for daily wear. The revised Indications Statement is included with this 510(k): 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 10.00D of astigmatism or less. VISTAKON 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 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.

Continued on next page

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## Summary of 510(k) Submission, Continued

| Characteristics | The characteristics do not change. They are the same as previously submitted<br>in K983912. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical<br>studies | Non-clinical studies (microbiology, toxicology, chemistry, shelf-life, and<br>leachability) on the lens material were not conducted because the lens<br>material, lenefilcon A, does not change. Non-clinical studies were conducted to support the following modified<br>Actions in the labeling. The average UV blocking for VISTAKON (lenefilcon A) Contact<br>Lenses with UV Blocker for UVA is 95% and for UVB is 99.9%. |
| Clinical studies | This 510(k) describes a labeling modification: an additional Indications<br>Statement. There is no change in lens material, the manufacturing process,<br>nor the parameters and properties, therefore, the clinical data previously<br>submitted in K983912 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 K983912 support the non-clinical and clinical<br>safety of the subject device. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 8 1699

Ms. Martin D. Martino Regulatory Affairs Specialist Vistakon Johnson & Johnson Vision Products, Inc. 4500 Salisbury Road Suite 300 Jacksonville, FL 32216

Re: K991163

Trade Name: VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tint, with UV Blocker, for daily Wear

Regulatory Class: II Product Code: 86 LPL Dated: April 6, 1999 Received: April 7, 1999

Dear Ms. Martino:

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

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Page 2 - Ms. Martin D. Martino

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

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

K991163 510(k) Number:

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

The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or nonaphakic 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 10.00D of astigmatism or less.

VISTAKON 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 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)
(Division Sign-Off)
Division of Ophthalmic Devices

| 510(k) Number | K991163 |
|------------------|----------------------------------------------|
| Prescription Use | <img alt="check mark" src="check_mark.png"/> |
| | OR Over the Counter |