VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT

K964612 · Vistakon, Johnson & Johnson Vision Products, Inc. · LPL · Jan 30, 1997 · Ophthalmic

Device Facts

• Record ID: K964612
• Device Name: VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT
• Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jan 30, 1997
• 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, hyperopia and presbyopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less. The VISTAKON MULTIFOCAL 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 of astigmatism or less. 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 of astigmatism or less. Eye care practitioners may prescribe the lens for single-use disposable wear or for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement (see WEARING SCHEDULE). When prescribed for frequent/planned replacement, the lens may be disinfected using a chemical disinfection system only.

Device Story

VISTAKON (genfilcon A) is a soft, hydrophilic contact lens available in spherical, multifocal, and toric designs. Composed of a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with tetraethylene glycol dimethacrylate and ethylene glycol dimethacrylate. Hemispherical shell shape; includes blue visibility tint (Reactive Blue Dye #4). Prescribed by eye care practitioners for daily wear; single-use disposable or frequent/planned replacement. Patients clean and disinfect lenses using chemical systems. Provides vision correction for refractive ametropia; benefits include improved visual acuity and convenience of daily wear modality.

Clinical Evidence

Clinical trial evaluated at least 50 patients over 3 months with a 2:1 ratio of subject to predicate device. Measured adverse reactions, symptoms, slit lamp evaluations, visual acuity, lens wear time, fit assessment, and discontinuations. Results indicated the lens is safe, effective, and substantially clinically equivalent to the predicate.

Technological Characteristics

Material: genfilcon A (copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with tetraethylene glycol dimethacrylate and ethylene glycol dimethacrylate). FDA Group I material. Hemispherical shell form factor. Sterilization: moist heat (SAL 10^-6).

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia, hyperopia, presbyopia) in aphakic or non-aphakic persons with non-diseased eyes. Spherical: up to 1.00 D astigmatism. Multifocal: presbyopic, up to 0.75 D astigmatism. Toric: hyperopic or myopic, up to 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

• Optima FW (polymacon) Visibility Tinted Contact Lens

Submission Summary (Full Text)

{0}

Summary of 510(k) Submission K964612 JAN 30 1997

Summary
The 510(k) submission summary consists of these sections
- Name and address of submitter
- Identification of device
- Predicate device
- Description of device
- Intended use
- Characteristics
- Non clinical studies
- Clinical studies
- Conclusions drawn from studies
- Flow Chart for 510(k) Daily Wear Contact Lens Materials

Name and address of submitter
Vistakon, Johnson & Johnson Vision Products, Inc.
4500 Salisbury Road, Suite 300
Jacksonville, Florida 32216
Contact: Susan L. Walton
Phone: [phone]
Date Prepared: November 14, 1996

Identification of Device
- Trade name: VISTAKON (genfilcon A) Contact Lens, clear and with visibility tint.
- Common or usual name: Soft (hydrophilic) Contact Lens (daily wear)
- FDA Classification: Class II

Predicate Device
Optima FW (polymacon) Visibility Tinted Contact Lens

Continued on next page

{1}

Summary of 510(k) Submission, Continued

## Description of Device

The VISTAKON (genfilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, a spherical multifocal lens and an astigmatic (toric) lens. The lens material (genfilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with tetraethylene glycol dimethacrylate and ethylene glycol dimethacrylate. The VISTAKON Contact Lens with visibility tint is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. The VISTAKON Contact Lens is a hemispherical shell.

## Intended Use

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

The VISTAKON MULTIFOCAL 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 of astigmatism or less.

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 of astigmatism or less.

Eye care practitioners may prescribe the lens for single-use disposable wear or for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement (see WEARING SCHEDULE). When prescribed for frequent/planned replacement, the lens may be disinfected using a chemical disinfection system only.

## Characteristics

The VISTAKON (genfilcon A) Contact Lens is classified into FDA Group I for contact lens materials. The predicate device was chosen from FDA Group I. The VISTAKON (genfilcon A) Contact Lens is compared to the predicate device in the following table.

Continued on next page

{2}

Summary of 510(k) Submission, Continued

| | VISTAKON (genfilcon A)
Contact Lens with visibility tint | | Optima FW Visibility Tinted
Contact Lens | |
| --- | --- | --- | --- | --- |
| | Measured | Label | Measured | Label |
| Water Content, % | 47.5 | 48 | 41.2 | 38.6 |
| Refractive Index @ 20°C | 1.43 | 1.43 | 1.44 | 1.43 |
| Dk, non-edge corrected | 14.1 | 13.0 | 7.5 | 8.5* |
| Color (if tinted) | light blue | light blue | light blue | light blue |
| Base Curve, mm | 8.6 | 8.6 | 8.4 | 8.7 |
| Diameter, mm | 14.0 | 14.0 | 14.0 | 14.0 |
| Power, D | -0.99 | -1.00 | -0.98 | -1.00 |

Dk units = x 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg)
*edge correction method not identified in Bausch & Lomb labeling

## Non clinical Studies

Included as non clinical studies are
- chemistry,
- toxicology, lenses and package,
- microbiology

## Chemistry

Material property data were generated on the subject device and the predicate device. The data for both devices reflect properties of Group I lenses. The lens care product manufacturers have previously shown compatibility of Group I lenses with their products.

The shelf-life stability for VISTAKON (genfilcon A) Contact Lenses is based upon approved stability protocols from N18-033. The initial shelf-life of the lens will be declared based on the data generated under one of these protocols. Shelf-life will not be claimed until a minimum of six months of real time data have been collected and found to be acceptable.

Studies were conducted to determine the leachable materials from the subject and predicate devices. The results indicate that, at the levels of detection reported, there are no significant differences between the subject device and the predicate device.

Continued on next page

{3}

Summary of 510(k) Submission, Continued

Toxicology, genfilcon A lens material
In accordance with the May 1994 Guidance Document for Daily Wear contact lenses, toxicology studies have been conducted on the VISTAKON (genfilcon A) soft (hydrophilic) contact lenses, clear and with visibility tint.
1. The Ocular Irritation study indicates the extracts would not be considered ocular irritants under the conditions of the study.
2. The USP Systemic Toxicity study indicates the extracts would not be considered systemically toxic under the conditions of the study.
3. The Cytotoxicity study indicates that the lens is not cytotoxic under the conditions of the study.

Toxicology, package materials
No additional toxicology studies have been conducted on the plastic primary packaging materials, as the materials are the same as those previously tested and reported under N18-033.

Microbiology
The lens sterilization process, moist heat sterilization, has been validated to deliver a minimum SAL of 10⁻⁶. The lens care product manufacturers have established a reasonable assurance of disinfection efficacy of their care products with the lens groups for which they are approved. The lens will be presented in the same primary package currently used for other products approved under N18-033. There are shelf-life stability data which support lens sterility throughout the shelf-life claimed for the product.

Clinical studies
The safety of the lens material in the spherical design has been confirmed through a clinical trial for daily wear contact lens materials with a new USAN name according to the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses (May 1994). The study evaluated at least 50 patients with a 2:1 ratio of subject device to predicate device for three (3) months. Parameters measured included adverse reactions, symptoms, problems and complaints, slit lamp evaluations, visual acuity, lens wear time, fit assessment and discontinuations. The VISTAKON (genfilcon A) trial contact lens was found to be safe and effective for its intended use and at least substantially clinically equivalent to the predicate device.

Continued on next page

{4}

Summary of 510(k) Submission, Continued

## Conclusions drawn from studies

1. Validity of Scientific Data
Toxicology studies were conducted by a contract laboratory under Good Laboratory Practice Regulations. Microbiology, chemistry, shelf-life stability, and leachables studies were conducted by in-house laboratories and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

2. Safety and Effectiveness
The data presented in this Premarket Notification support the safety and effectiveness of the subject device when used in accordance with the labeled directions for use and for the requested indication. The subject device has been shown to be substantially equivalent to the predicate device.

3. Risk and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear basis. The benefits to the patient are the same as those for other soft (hydrophilic) contact lenses.