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

K982947 · Ocular Sciences Puerto Rico, Inc. · LPL · Jan 29, 1999 · Ophthalmic

Device Facts

• Record ID: K982947
• Device Name: BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS
• Applicant: Ocular Sciences Puerto Rico, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jan 29, 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 scheduled replacement 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 Scheduled Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.

Device Story

Soft contact lens; hemispherical shell; manufactured from polymerized HEMA, other monomers, and UVAM (ultraviolet absorber); crosslinked with EGDMA. Designed to fit over corneal surface; provides corrective refraction for myopia, hyperopia, and astigmatism. Features varying base curves, optical zone, secondary/tertiary curves, and beveled edges for centration and comfort. Prescribed by eyecare practitioners for daily wear; patient-operated. Lens provides UV blocking; intended for daily disposable or scheduled replacement programs; requires chemical disinfection.

Clinical Evidence

No clinical data provided. Substantial equivalence based on physical, optical, and chemical property comparisons to predicate devices and bench testing of UV transmittance profiles.

Technological Characteristics

Material: ocufilcon D (HEMA, UVAM, EGDMA). High water ionic group (Group IV). Form factor: hemispherical shell, 12.5-18.0 mm diameter, 6.50-10.8 mm base curve. UV-blocking via UVAM monomer. Chemical disinfection required.

Indications for Use

Indicated for daily wear in non-aphakic, normal eyes with myopia, hyperopia, or astigmatism. Powers: -20.00 to +20.00D; astigmatic corrections: -0.25 to -10.00D. Spherical lenses may mask up to 2.00D 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) clear contact lens (K942214)
• BIOMEDICS 55 (ocufilcon D) clear contact lens (P890023/S26)

Submission Summary (Full Text)

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JAN 29 1999

Image /page/0/Picture/1 description: The image shows a logo for Ocular Sciences American Hydron. Below the logo is the number K982947 in a handwritten style. The logo is black and white and features a target symbol.

# 510(k) Summary

SUBMITTER:

Submitted on behalf of:

Company Name: Address:

Phone: Fax:

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

CONTACT PERSON:

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

## DATE SUMMARY PREPARED: January 1999

TRADE NAME:

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

COMMON NAME: contact lens

# SUBSTANTIALLY EQUIVALENT TO:

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

COCCCO

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

110 Cochrane Drive
Markham, Ontario
L3A 9S1
Canada
Ph: 905-940-1998
Fax: [phone]

England:
Reliant Close
Chandlers Ford
Eastleigh
Hampshire S053 4ND
England
Ph: 01703-268268
Fax: [phone]

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

Al Industrial Park

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The BIOMEDICS 55 (ocufilcon D) UV Blocking 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. approved under K972303. Additionally, the subject contact lens is identical and has the same characteristics and properties as the clear BIOMEDICS 55 (ocufilcon D) cast molded contact lens, cleared under K942214, and P890023/S26. This lens is in the Lens Group IV high water ionic group as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition May 1994. The physical, optical, and chemical properties of the BIOMEDICS 55 (ocufileon 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 UVAM, an 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) 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 scheduled replacement program. The lenses may be prescribed

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for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Scheduled Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.

# 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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Image /page/3/Figure/0 description: The image shows the title of a graph. The title reads, "Typical Transmittance Profile of Ocufilcon D Hydrophilic Contact Lens with UVAM versus a Human Cornea and a Human Lens." The title is centered on the page and is written in a clear, easy-to-read font. The text is black and the background is white.

Image /page/3/Figure/1 description: The figure shows the percentage transmission as a function of wavelength. The x-axis shows the wavelength in nanometers, ranging from 200 to 750. The y-axis shows the percentage transmission, ranging from 0 to 100. There are three curves in the figure, representing Ocufilcon D contact lens with UVAM, Human Cornea (24 year old person), and Human crystalline lens (25 year old person).

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird-like figure with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird. The text is in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 29 1999

Ocular Science, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway Suite 625 Rockville, Maryland 20852

Re: K982947 Trade Name: BIOMEDICS 55 (ocufilcon D) UV Blocking Soft (hydrophilic) Contact Lens for Daily Wear Regulatory Class: II Product Code: LPL Dated: December 31, 1998 Received: January 5, 1999

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 Roerl lorentthal

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) K982947

Device Name: ___ Biomedics 55_(ocufilcon D) UV_Blocking Daily_Wear_Contact Lens

#### Indications for 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 scheduled replacement 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 Scheduled Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.

Additional Claims:

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

Presription Use

Division of Ophthalmic Devices K982947 510(k) Number _

(Oprtional Format 1-2-96)