FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS

K991550 · Wesley Jessen Corp. · LPL · May 14, 1999 · Ophthalmic

Device Facts

• Record ID: K991550
• Device Name: FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS
• Applicant: Wesley Jessen Corp.
• Product Code: LPL · Ophthalmic
• Decision Date: May 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fresh Look Bifocal UV-absorbing Spherical (phemfilcon A) Soft (Hydrophille) Contact Lenses are indicated for the correction of visual aculty and prosbyopia in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does net interfere with visual acuity. The lons ranges in power from -20.00 to +20.00 not their ore tor daily war. The letters may be prescribed for Daily Wear to agraduic or not appartic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning, disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disingles chemical disinfection system. FreshLook Lenses with UV-absorbing monomer help protect against transmission of hannful UV radiation to the comes and into the eye.

Device Story

FreshLook Bifocal UV-absorbing contact lenses are hemispherical hydrophilic shells (phemfilcon A) designed for daily wear to correct presbyopia and visual acuity. Lenses are immersed in 0.9% sodium chloride solution. Device incorporates a UV-absorbing monomer into the polymer matrix to reduce UV radiation transmission to the cornea. Prescribed by eye care practitioners for daily disposable or frequent replacement programs. Patients use lenses to improve near and distance vision; clinical benefit includes vision correction and UV protection.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical material composition and physical properties to the predicate device.

Technological Characteristics

Material: phemfilcon A (copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate). Water content: 55%. Oxygen permeability (Dk): 16.1 x 10^-11. Refractive index: 1.411 @ 25°C. Specific gravity: 1.152. Includes UV-absorbing monomer. Form: Hemispherical shell, 12.0-15.0 mm diameter, 7.80-9.00 mm base curve. Power range: -20.00 D to +20.00 D; Add powers: +0.50 D to +3.00 D.

Indications for Use

Indicated for correction of visual acuity and presbyopia in non-diseased myopic or hyperopic eyes with refractive astigmatism up to 0.75 diopters. Suitable for aphakic or non-aphakic patients for daily wear.

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

• FreshLook® UV (phemfilcon A) Molded Spherical Handling Tint and Colors Soft (Hydrophilic) Contact Lenses

Reference Devices

• PMA Supplement P830037/S042

Submission Summary (Full Text)

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K991550

# SECTION III

# 510(k) Summary

# FreshLook® Bifocal UV-absorbing Contact Lenses

### A. Product Summary

#### 1. Name and Address of Applicant:

Wesley Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018

#### Contact Person:

Joseph Foos Vice President Scientific Affairs Phone: [phone] [phone] Fax:

#### 2. Name of the Device:

Classification Name:

Trade Name:

FreshLook® Bifocal UV-absorbing (phemfilcon A) Molded Spherical Handling Tint and Colors Soft (Hydrophilic) Contact Lenses for Daily Wear

Soft (Hydrophilic) Contact Lenses for Daily Wear.

FreshLook® Bifocal UV-absorbing (phemfilcon A)

Spherical Soft (Hydrophilic) Contact Lenses.

FreshLook® Bifocal Common Name:

Proprietary Name:

Facility Registration Number:

1422160

- 3. Identification of predicate device:
FreshLook® UV (phemfilcon A) Molded Spherical Handling Tint and Colors Soft (Hydrophilic) Contact Lenses. FreshLook® Bifocal is an alternate design to the currently marketed FreshLook® UV (phemfilcon A) Contact Lenses.

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# 4. Description of device:

The FreshLook® Bifocal UV-absorbing (phemfilcon A) Spherical Soft (Hydrophilic) contact lenses in Handling Tint and Colors are hemispherical shells indicated for the correction of visual acuity in presbyopic patients for daily wear. The generic name (USAN) is phemfilcon A. The form in which the device is to be delivered is a contact lens immersed in 0.9% sodium chloride solution. Exclusive of the saline solution, the lens is a hydrophilic polymer swollen with water, in the polymer/water weight ratio of 45/55 respectively.

The components of the FreshLook® Bifocal UV-absorbing lenses are identical to the currently manufactured FreshLook® UV. The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate and a proprietary UV absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light.

The FreshLook® Bifocal lenses are available in the following parameter range:

| Chord Diameter: | 12.0 to 15.0 mm |
|-------------------------|--------------------------------------------------|
| Base Curve: | 7.80 to 9.00 mm |
| Distance Power Zone: | 5 mm (colors) |
| Distance Power Zone: | 5 mm to 9 mm (Handling Tint - varies with power) |
| Increments: | 0.25 D |
| Center Thickness: | 0.08 to 0.56 mm (Varies with power) |
| Distance Powers: | -20.00 D to +20.00 D |
| Bifocal Add Powers: | +0.50 D to +3.00 D |
| Near Power Zone: | 1.00 to 3.80 mm |
| Progressive Power Zone: | 1.40 to 4.80 mm |

The physical properties of the FreshLook® Bifocal UV-absorbing lens are identical to the FreshLook® UV lens and are as follows:

| Physical Property | FreshLook® Bifocal UV |
|---------------------------------|-------------------------------------------|
| Specific Gravity | 1.152 |
| Refractive Index | 1.411 @ 25°C |
| Light Transmittance | 95% (minimum) |
| Surface Character | Hydrophilic |
| Water Content | 55% |
| Oxygen Permeability (Dk) | $16.1 x 10^{-11}$ ml O2 cm2 / sec ml mmHg |
| Oxygen Transmissibility* (Dk/L) | $20 x 10^{-9}$ ml O2 cm / sec ml mmHg |

10° ml O₂ cm / sec ml mmHg at 35°C (Dr. Irving Fatt Method)

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Reference PMA Supplement P830037/S042 Exhibit IV-1, Exhibit IV-2 and subsequent Amendment #1 for a detailed physical description, drawing and canter thickness table of the FreshLook Bifocal UV-absorbing Sphencal (phemfilcon A) Soft (Hydrophilic) Contact Lonses submitted to the agency for Real Time Review,

# 8. Statement of Intended Use

Fresh Look Bifocal UV-absorbing Spherical (phemfilcon A) Soft (Hydrophille) Contact Lenses are indicated for the correction of visual aculty and prosbyopia in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does net interfere with visual acuity. The lons ranges in power from -20.00 to +20.00 not their ore tor daily war.
display for daily war.
display for daily war.
The for daily war.

The letters may be prescribed for Daily Wear to agraduic or not appartic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning. disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disingles chemical disinfection system.

FreshLook Lenses with UV-absorbing monomer help protect against transmission of hannful UV radiation to the comes and into the eye.

# C. Technological Characteristics of the Device and Comparison

Reference PMA Supplement P830037/S042 for technological device characteriatios. of the FreshLook® Bifocal UV-absorbing Spherical (phemfijcon A) Soft (Hydrophille) Contact Lenses submitted to the agency for Real Time Review.

# D. Device Manufacturing Section

Reference PMA Supplement P830037/S042 for the manufacturing of the Freah Look® Bifocal UV-absorbing Spherical (phermflicon A) Soft (Hydrophillic) Contact Lenses. All device manufacturing information submitted to the FDA In the PMA Supplement P830037/S042 Real Time Review is applicable to this submission.

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 1999

Mr. Joseph Foos Vice President, Scientific Affairs Wesley Jessen 333 E. Howard Avenue Des Plaines, IL 60018

Re: K991550

> Trade Name: FreshLook® Bifocal UV-absorbing (phemfilcon A) Molded Spherical Handling Tint and Colors Soft (Hydrophilic) Contact Lenses for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: May 3, 1999 Received: May 4, 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.

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Page 2 - Mr. Joseph 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

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# INDICATIONS STATEMENT

510(k) Number (if known)

# Device Name:

# FreshLook® Bifocal UV-absorbing (phomfilcon A) Molded Spherical Handling Tint and Colors Soft (Hvdrophille) Contact Lenses for nondiseased presbyopic eves Dally Wear

### Indication for Use:

### Spherical

FreshLook® Sphencal (phemfilcon A) Soft (Hydrophilic) Contact Lenses are Indicated for the correction of visual acuity in persons with non-diseased eves that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity.

### Toric

Fresh Look Toric (chemfilcon A) Soft (Hydrophille) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eves that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 dioptors.

# Bifocal

:

Pres

FrashLook® Bifocal UV-absorbing Sphenical (phemfilcon A) Soft (Hydrophille) Contact Lenses are Indicated for the correction of visual aculty and presbyoble in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does not interfers with visual acuity. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The lenses may be prescribed for Daily Wear in aphakic or not applantic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning, disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disinfected using a chemical disinfection system. · - - ·· · . .. .. -- · - ----

FreshLock Lenses with UV-absorbing money help protect against transmission of harmful UV rediation to the comes and Into the eye.

(PLEASE DO NOT WRITTERE (OWLTHIS I INE CONTINUE ON ANOTHER PAGE IF NEEDED) Conference of CORH, Office of Device Eveluation (ODE)

| cription Use | OR | Over-The Counter |
|--------------|----|------------------|
|--------------|----|------------------|

(Division Sign-Off)

Division of Ophthalmic Devices

| 510(k) Number | K991550 |
|---------------|---------|
|---------------|---------|

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