PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS

K994335 · Wesley Jessen Corp. · LPL · Mar 20, 2000 · Ophthalmic

Device Facts

• Record ID: K994335
• Device Name: PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS
• Applicant: Wesley Jessen Corp.
• Product Code: LPL · Ophthalmic
• Decision Date: Mar 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

ProSoft™ Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.00 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear. ProSoft™ Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear. The Spherical and Toric lenses may be prescribed for daily wear in not-aphakic or aphakic persons. The eye care practitioner may prescribe the lens with routine cleaning, rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only. ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Story

ProSoft contact lenses are hemispherical shells composed of phemfilcon A (hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate); tinted with Vat Green #1 dye via custom tinting process to enhance perception of colored objects. Lenses are lathed from cured rods to spherical or toric configurations. Used by patients for daily wear to correct refractive errors and provide UV protection; prescribed by eye care practitioners. Output is visual acuity correction and enhanced contrast perception. Lenses require chemical (non-heat) disinfection.

Clinical Evidence

Bench testing only. Studies included cytotoxicity (USP requirements), systemic injection (USP requirements), and ocular irritation (rabbit model). Residual analysis confirmed no dye extractables. Lens compatibility and light transmittance were evaluated over 30 cycles of chemical disinfection, showing no adverse effects on lens parameters or UV transmittance.

Technological Characteristics

Material: phemfilcon A (hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate). Configuration: Spherical or Toric. Tinting: Vat Green #1 dye. Manufacturing: Lathed from cured rods. UV protection: Integrated. Disinfection: Chemical (non-heat) systems only.

Indications for Use

Indicated for correction of visual acuity in non-diseased eyes of myopic or hyperopic patients (aphakic or non-aphakic). Spherical lenses for astigmatism up to 2.00D; Toric lenses for astigmatism up to 6.00D. Power range -20.00 to +20.00D. Daily wear only.

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

• DuraSoft 3 UV (K965052)
• CustomEyes (bufilcon A) (PMA P850057)

Submission Summary (Full Text)

{0}------------------------------------------------

MAR 200 zuuu

Image /page/0/Picture/1 description: The image shows a sequence of characters, which appear to be handwritten. The sequence is "K994335". The characters are bold and dark, contrasting with the white background. The style of the characters suggests a casual or informal writing style.

# SECTION VI

# Summary of Safety and Effectiveness

# A. General Information

| 1. Name and Address of Applicant: | Wesley Jessen Corporation<br>333 East Howard Avenue<br>Des Plaines, IL 60018 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph F. Foos<br>Vice President, Scientific Affairs<br>Phone: [phone]<br>Fax: [phone] |
| 2. Name of the Device: | |
| Common Name: | Daily wear soft (hydrophilic) contact lens |
| Trade Name: | ProSoft (phemfilcon A) |
| Device Classification: | As per 21 CFR Section 886.5925. S<br>(hydrophilic) daily wear contact lenses<br>classified as a Class II device. |
| Classification Number: | LPL; Ophthalmic Devices Panel |

## B. Indications for use:

## Spherical

ProSoft™ Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.00 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear.

## Toric

ProSoft™ Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.

The Spherical and Toric lenses may be prescribed for daily wear in not-aphakic or aphakic persons. The eye care practitioner may prescribe the lens with routine cleaning, rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only.

Soft are

{1}------------------------------------------------

ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eve.

#### C. Description of device:

ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are hemispherical shells of the lens material (phemfilcon A), which is a hydrophilic copolymer of 2hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate.

Once cured the rods are cut to buttons and then lathed to the proper spherical or toric configuration. The ProSoft contact lenses are made by adding Vat Green #1 dye to the finished lens using the CTL (custom tinting) process.

Prosoft lenses enhance perception of colored objects relative to other background colors. This enables the wearer to see a ball or selected objects with greater clarity than with the naked eye, on the tennis court, golf course or other background.

### Physical and Mechanical Properties

The ProSoft contact lenses were compared to the current lathed DuraSoft 3 UV lenses for physical and mechanical properties. The measured properties show that the lathed lenses are equivalent to predicate lenses.

### Toxicology

The safety of phemfilcon A is well established (PMA P830037). The preclinical studies on ProSoft with the CTL tinting process using Vat Green #1 were conducted to assure that the safety of this material, phemfilcon A, has not been altered by these changes. The studies are summarized below:

#### a. Cytotoxicity:

The negative controls and positive controls performed as anticipated. Under the condition of this study, the test article showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the USP.

#### b. Systemic Injection:

Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the extracts. Each test article extract met the USP requirements.

#### C. Ocular irritation:

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

Under the conditions of this study, the SC (sodium chloride) and CSO (cottonseed oil) test article extracts would not be considered irritants to the ocular tissue of the rabbit.

{2}------------------------------------------------

## Residual Analysis:

Samples of lenses were extracted in saline and the extracts analyzed to determine if dye extractables from the material would be detected. There were no dye extractables detected.

### Lens Compatibility with the Recommended Lens Care Regimen

Any changes in parameters through 30 cycles were within manufacturing tolerances. Cycling in the ReNu Multipurpose System® did not adversely affect measured lens parameters relative to the uncycled control lenses. Tint color was still evident after 30 cycles.

### Light Transmittance:

The ultraviolet spectra of cycled lenses was individually measured before and after cvcling. All variances were within the experimental tolerance. It can be considered that there was no significant difference between the light transmittance before and after cycling.

### Microbiology:

Lens manufacturing, packaging and sterilization are identical to the sterilization described for the predicate device, DuraSoft 3 UV, therefore sterilization validation is not required.

## D. Conclusion:

ProSoft (phemfilcon A) contact lenses are substantially equivalent to marketed DuraSoft® 3UV lenses of the same material as approved under 510(k) premarket notification, K965052, and the tinting process is substantially equivalent to the approved process for CustomEyes (bufilcon A) contact lenses under PMA P850057.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2000

Wesley Jessen Corporation Mr. Joseph F. Foos Vice President, Scientific Affairs 333 East Howard Avenue Des Plaines, Illinois 60018-5903

Re: K994335

Trade Name: ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: December 21, 1999

Received: December 23, 1999

Dear Mr. Foos:

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 .

{4}------------------------------------------------

Page 2 - Mr. Joseph F. Foos

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

{5}------------------------------------------------

# INDICATIONS STATEMENT

K994335 510(k) Number (if known)

ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Device Name: Contact Lenses for Daily Wear

### Indications for Use:

### Spherical

ProSoft™ Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.00 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear.

### Toric

ProSoft™ Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.

The Spherical and Toric lenses may be prescribed for daily wear in not-aphakic or aphakic persons. The eye care practitioner may prescribe the lens with routine cleaning, rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only.

ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________

X

Counter

(Division Sign-Off)
Division of Ophthalmic Devices

00011