BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS

K984046 · Ocular Sciences Puerto Rico, Inc. · LPL · Jan 21, 1999 · Ophthalmic

Device Facts

• Record ID: K984046
• Device Name: BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS
• Applicant: Ocular Sciences Puerto Rico, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jan 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The BIOMEDICS 55 (ocufilcon D) UV Blocking soft (hydrophilic) contact lens is indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or frequent replacement scheduled program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Frequent Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.

Device Story

Soft, hydrophilic contact lens; hemispherical shell design; fits over corneal surface. Manufactured from polymerized HEMA and monomeric ingredients; includes proprietary UV absorber; crosslinked with EGDMA. Corrects refractive errors (myopia, hyperopia, astigmatism) by providing corrective power corresponding to eye's refractive needs. Features base curves, optical zone (>6mm), secondary/tertiary curves, and beveled edges for centration and comfort. Used by eyecare practitioners to prescribe for daily wear; patient performs daily disposal or cleaning/disinfection via chemical regimen. Provides UV protection; benefits patient by correcting vision and reducing ocular UV exposure.

Clinical Evidence

Bench testing only. Evidence consists of physical, optical, and chemical property comparisons and ultraviolet transmittance profiles (UVA/UVB) compared to human cornea and crystalline lens.

Technological Characteristics

Material: Ocufilcon D (HEMA, monomeric ingredients, UV absorber, EGDMA crosslinker). Form: Hemispherical soft contact lens. Dimensions: Base curves 6.5-10.8mm, diameter 12.5-18.0mm, center thickness 0.025-0.27mm. Power: -20.00 to +20.00 D. Tint: Blue visibility. Sterilization: Chemical disinfection regimen.

Indications for Use

Indicated for daily wear in non-aphakic, normal eyes with myopia, hyperopia, or astigmatism (-20.00 to +20.00 D; astigmatic correction -0.25 to -10.00 D). Spherical lenses may mask up to 2.00 D of 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

• BIOMEDICS 55 (ocufilcon D) In Monomer Tint (K972303)
• BIOMEDICS 55 (ocufilcon D) (K942214)
• P890023/S26
• P890023/S4

Submission Summary (Full Text)

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JAN 2 1 1999

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K984046

# 510(k) Summary

SUBMITTER:

# Submitted on behalf of:

Company Name: Address: Phone: Fax:

Ocular Sciences, Inc. 475 Eccles Av. South San Francisco, CA 95014 [phone] [phone]

CONTACT PERSON:

Richard E. Lippman, O.D., F.A.A.O. Official Representative and Correspondent C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway Suite 625 Rockville, MD 20852

# DATE SUMMARY PREPARED: October 1, 1998

TRADE NAME:

BIOMEDICS® 55 (ocufilcon D) UV Blocking Daily Wear soft (Hydrophilic) Contact Lens

## COMMON NAME: contact lens

## SUBSTANTIALLY EQUIVALENT TO:

The BIOMEDICS 55 (ocufilcon D) UV Blocking Daily Wear Contact Lens with In-Monomer Tint is equivalent to the daily wear lens of the same material as cleared in K942214, P890023/S26, P890023/S4,and K972303 in-monomer visibility tint cast molded ocufilcon D for daily wear currently marketed by Ocular Sciences, Inc.

The BIOMEDICS 55 (ocufilcon D) UV Blocking Daily Wear contact lens is substantially equivalent to the indication for use of the BIOMEDICS 55 (ocufilcon D) In Monomer Tint ocufilcon D cast molded contact lens marketed for use in the U.S. by Ocular Sciences, Inc. cleared under K972303. Additionally, the subject contact lens is equivalent and has the same characteristics and properties as the clear BIOMEDICS® 55 (ocufilcon D) cast molded contact lens, cleared under K942214, and P890023/S26. The cast molding process was approved under P890023/S4. This lens is in the Lens Group IV high water ionic group as established by the FDA and located in the Guidance

# 000032

**Corporate Offices:**
475 Eccles Avenue
South San Francisco.
California 94080
800-628-5367
Ph: 650-583-1400

Canada:
110 Cochrane Drive
Markham, Ontario
L3R 9S1
Canada
Ph: 905-940-1998

England:
Reliant Close
Chandlers Ford
Eastleigh
Hampshire S053 4ND
England

Hungary:
Hársmajor u.8
1118 Budapest
Hungary
Ph: 36-1-319-6241
Fax: [phone]

RICO:
P.O. Box 2801
Highway 538 km. 0.7
Santa Isabel Industrial Park
Santa Isabel,
Puerto Rico 00757

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Document for Daily Wear Contact Lenses, Revised Edition May 1994. The physical, optical, and chemical properties of the BIOMEDICS® 55 (ocufilcon D) UV visibility tint cast molded Ocular Sciences, Inc.contact lens are substantially equivalent to both the clear and tinted versions of the BIOMEDICS 55 (ocufilcon D) ocufilcon D cast molded contact lenses.

#### DESCRIPTION of the DEVICE:

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients including a proprietary ultraviolet absorber, crosslinked with EGDMA and other components which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

#### INDICATIONS FOR USE:

The BIOMEDICS® 55 (ocufilcon D) soft (hydrophilic) contact lens is indicated for daily wear in normal eyes whose eyes are either myopic, hyperopic, or astigmatic in powers from -20.00 to +20.00 Diopters and astigmatic corrections from -0.25 to -10.00 Diopters. Spherical lenses may mask astigmatism of up to 2.00 Diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or frequent replacement scheduled program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Frequent Replacement Program, as recommended by the evecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.

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# PARAMETERS AVAILABLE:

| Base Curves: | 6.50 mm to 10.8 mm |
|-------------------|----------------------------------------|
| Diameters: | 12.5 mm to 18.0 mm |
| Powers: | -20.00 to +20.00 Diopters sphere |
| Cylinder Power: | -00.25 to -10.00 Diopters |
| Center Thickness: | 0.025 mm to 0.27 mm depending on power |
| Tint: | Blue Visibility tint |

# ULTRAVIOLET TRANSMITTANCE CURVES

The following graph represents the transmittance of ultraviolet light in the UVA and UVB range as well as light transmittance through the visual spectrum, as compared to the human cornea and crystalline lens:

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#### Typical Transmittance Profile of Ocufilcon D Hydrophilic Contact Lens with UV versus a Human Cornea and a Human Lens

Image /page/3/Figure/1 description: The image is a graph comparing the percentage of light transmission through different types of lenses at different wavelengths. The x-axis represents the wavelength in nanometers, ranging from 200 to 750. The y-axis represents the percentage of transmission, ranging from 0 to 100. The graph shows the transmission of light through an Ocufilcon D contact lens with UV protection, a human cornea from a 24-year-old person, and a human crystalline lens from a 25-year-old person.

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# Typical Transmittance Profile of -2.50 D Ocufilcon D Hydrophilic Contact Lens with UVC versus a Human Cornea and a Human Lens

Image /page/4/Figure/1 description: The image is a graph that shows the percentage of transmission of light through different materials as a function of wavelength. The x-axis represents the wavelength of light in nanometers, ranging from 200 to 750 nm. The y-axis represents the percentage of transmission, ranging from 0 to 100%. There are three lines on the graph, representing the transmission of light through Ocufilcon D contact lens, the human cornea of a 24-year-old person, and the human crystalline lens of a 25-year-old person.

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# Typical Transmittance Profile of Ocufilcon D Hydrophilic Contact Lens with UVAM versus a Human Cornea and a Human Lens

Image /page/5/Figure/1 description: The image is a graph comparing the percentage of light transmission through different parts of the human eye and a contact lens. The x-axis represents the wavelength of light in nanometers, ranging from 200 to 750. The y-axis represents the percentage of light transmission, ranging from 0 to 100. The graph shows the transmission of light through the Ocufilcon D contact lens, the human cornea of a 24-year-old, and the human crystalline lens of a 25-year-old.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1999

Ocular Sciences, American Hydron, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway Rockville, Maryland 20852

Re: K984046 Trade Name: Biomedics ® 55 (ocufilcon D) UV Blocking Soft Contact Lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: November 6, 1998 Received: November 13, 1998

Dear Dr. Lippman:

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 - Richard E. Lippman, O.D., F.A.A.O.

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) K984046

Device Name; Biomedics 55 (ocufilcon D) UV Blocking Daily Wear Contact Lens

#### Indications for Use:

Additional Claims:

The BIOMEDICS 55 (ocufilcon D) UV Blocking soft (hydrophilic) contact lens is indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or frequent replacement scheduled program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Frequent Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Presription Use | X |
|----------------------|---|
| Over-The-Counter Use | |

(Division Sign-Off)

Division of Ophthalmic Devices

(Oprtional Format 1-2-96)

510(k) Number_K984046

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