OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS

K992264 · Ocular Sciences Puerto Rico, Inc. · LPL · Nov 24, 1999 · Ophthalmic

Device Facts

• Record ID: K992264
• Device Name: OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
• Applicant: Ocular Sciences Puerto Rico, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

Spherical: Biomedics® 60 (ocufilcon F) UV Blocking 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 up to 2.00 diopters that does not interfere with visual acuity. Toric: Biomedics® 60 (ocufilcon F) UV Blocking 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 10.00 diopters. The lenses may be prescribed for Daily Wear in not-aphakic persons. The eye care practitioner may prescribe the contact lens for either single use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement (SEE WEARING SCHEDULE). When prescribing for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system. Biomedics 60 (ocufilcon F) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Story

Biomedics 60 (ocufilcon F) is a soft, hydrophilic contact lens; hemispherical shell design; fits over corneal surface. Corrects refractive errors: myopia, hyperopia, astigmatism. Manufactured via cast molding; material consists of HEMA, proprietary UV absorber, and EDGMA crosslinker. Lens features varying base curves, optical zone >6mm, and beveled edges for centration/comfort. Prescribed by eye care practitioners for daily wear; patient performs cleaning/disinfection (chemical only, no heat) for frequent replacement models. Provides refractive correction and UV radiation protection. No clinical investigation performed; equivalence established via physical, chemical, and optical property comparison to predicate lenses.

Clinical Evidence

Bench testing only. No clinical investigation conducted. Preclinical data included toxicological analyses (ocular irritation, cytotoxicity, systemic toxicity) in animals, confirming non-toxicity. Physical/optical parameters (oxygen permeability 25.3 x 10^-11, 60% water content, 1.4041 refractive index) and UV transmittance curves were compared to predicate devices to establish equivalence.

Technological Characteristics

Material: ocufilcon F (HEMA, UV absorber, EDGMA crosslinker). Type: Group IV (high water, ionic). Oxygen permeability: 25.3 x 10^-11 (cm³/sec)(mL x mm Hg). Water content: 60%. Refractive index: 1.4041. Light transmittance: 97.7%. Form factor: Hemispherical shell, 6.50-10.8mm base curves, 12.5-18.0mm diameters. Power range: -6.00 to +10.00D sphere, -0.25 to -10.00D cylinder. Manufacturing: Cast molded.

Indications for Use

Indicated for non-aphakic persons with non-diseased eyes requiring correction of myopia, hyperopia, and refractive astigmatism (up to 2.00D for spherical, up to 10.00D for toric). Prescribed for daily wear, single-use disposable, or frequent replacement.

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) (K984046, K942214, K972303, P890023/S26, P890023/S4, P890023/S7)

Submission Summary (Full Text)

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NOV 2 4 1999

Image /page/0/Picture/1 description: The image shows a logo with the words "OCULAR SCIENCES" in bold, uppercase letters on a black rectangle. Below the rectangle is a circle with a crosshair inside of it, next to the words "AMERICAN HYDRON" in bold, uppercase letters. The logo is black and white and appears to be for a company in the ocular science or eye care industry.

K 992264

### 510(k) Summary

### SUBMITTER:

### Submitted on behalf of:

Company Name: Address:

Phone: Fax:

CONTACT PERSON:

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

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:

November 1, 1999

BIOMEDICS 60 (ocufilcon "F") UV Blocking In TRADE NAME: Monomer Tint Visibility Daily Wear soft (Hydrophilic) Contact Lens

COMMON NAME: contact lens

## SUBSTANTIALLY EQUIVALENT TO:

The BIOMEDICS 60 (ocufilcon "F") UV Blocking Daily Wear Contact Lens with In-Monomer Tint is equivalent to the daily wear lens of the same material but of a modified water content, as cleared in K984046, K942214 and K972303 for daily wear, and P890023/S26, P890023/S4 P890023/S7 for extended wear, currently marketed by Ocular Sciences, Inc.

The BIOMEDICS® 60 (ocufilcon "F") 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.

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cleared under K984046 and K972303. Additionally, the subject contact lens is equivalent and has similar and equivalent 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 Document for Daily Wear Contact Lenses. Revised Edition May 1994. The physical, and chemical properties of the BIOMEDICS 60 (ocufilcon "F") 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) 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 EDGMA and other components which vield 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:

#### Spherical:

Biomedics 60 (ocufilcon F) UV Blocking 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 up to 2.00 diopters that does not interfere with visual acuity.

#### Toric:

Biomedics 60 (ocufilcon F) UV Blocking 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 10.00 diopters.

The lenses may be prescribed for Daily Wear in not-aphakic persons. The eve care practitioner may prescribe the contact lens for either single use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement (SEE WEARING SCHEDULE). When prescribing for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system.

Biomedics 60 (ocufilcon F) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye

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### PARAMETERS AVAILABLE:

6.50 mm to 10.8 mm Base Curves: 12.5 mm to 18.0 mm Diameters: -6.00 to +10.00 Diopters sphere Powers: -00.25 to -10.00 Diopters Cylinder Power: 0.025 mm to 0.27 mm depending on power Center Thickness: 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:

> Figure L Transmittance Curves

Image /page/2/Figure/5 description: The image is a graph that shows the percentage of transmission of light through different types of lenses. The x-axis represents the wavelength of light in nanometers, ranging from 200 to 750. The y-axis represents the percentage of transmission, ranging from 0 to 100. There are three lines on the graph, representing the Oculicon 60% water contact lens, the human cornea (24 year old person), and the human crystalline lens (25 year old person).

at . 2,50 0 Ocurilcon 50% Water Concent Hydropoulle Canta

The average ultraviolet transmittance in terms of percent for the thinnest lenses (0.07mm includes lenses from -2.25D to -6.00D) are UV-A (23.4%) and UV-B (5.8%).

#### PRECLINICAL INFORMATION

A battery of preclinical tests including toxicological analyses of Ocular Irritation, Cytotoxicity, and Systemic Toxicity were conducted on the material in animals. The results of these tests indicated that the finished materials or extracts of the finished materials were non-toxic to the tissues of the animals which were tested. Residuals of chemical monomers and the UV additive

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were evaluated and found to be of extremely low levels for the product monomers, and undetectable for the UV additive, to the sensitivity of the instrumentation used to calculate such residuals.

The physical, optical and chemical properties of the lens indicate that the device is substantially equivalent to the parent device of the marketed lens (ocufilcon D) material. The oxygen permeability of the material is 25.3 X 10-11 (cm³/sec)(mL x mm Hg); a water content of 60%, a refractive index of 1.4041; light transmittance of 97.7%.

Other physical characteristics of the device were equivalent to the company's prior marketed lenses to which this lens is compared.

The lens characteristics place it in Category IV (high water, ionic) and the device is compatible with all soft contact lens solutions available on the market for cleaning, rinsing and disinfection.

There was no clinical investigation of this lens as the characteristics of the device are substantially equivalent to the device from which the lens was modified. The safety information provided and physical, optical and chemical parameters of the lens are substantially equivalent to lenses already having had clinical evaluation.

### LABELING

The Biometrics 60 (ocufilcon "F") UV Blocking IMT Visibility Tint Contact Lens for Daily Wear is provided to the user with a Package Insert, Patient Instruction Booklet for either Daily Disposable or Scheduled Replacement, and a Practitioner Fitting Guide. These materials are also available from the company. The address is as follows:

> Ocular Sciences, Inc. 475 Eccles Ave. South San Francisco, CA 94080 [phone]

> > 4

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Image /page/4/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 with three lines extending from its head, representing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 2 4 1999

Ocular Science, Inc. c/o Richard E. Lippman, O.D. Senior Consultant CL MCINTOSH 12300 Twinbrook Parkway Suite 625 Rockville, MD 20852

Re: K992264

Trade Name: Biomedics® 60 (ocufilcon F) UV Blocking Contact Lens for Daily Wear (Spherical and Toric, Visibility Tint with or without UV Blocker, cast molded) Regulatory Class: II Product Code: 86 LPL, MVN Dated: November 15, 1999 Received: November 15, 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

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Page 2 - Dr. Richard E. Lippman, O.D.

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) K992264

Device Name:_ Biomedics® 60 (ocufilcon "F") UV Blocking Daily Wear Contact Lens

#### Indications for Use:

Spherical:

Biomedics® 60 (ocufilcon F) UV Blocking 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 up to 2.00 diopters that does not interfere with visual acuity.

Toric:

Biomedics® 60 (ocufilcon F) UV Blocking 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 10.00 diopters.

The lenses may be prescribed for Daily Wear in not-aphakic persons. The eye care practitioner may prescribe the contact lens for either single use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement (SEE WEARING SCHEDULE). When prescribing for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system.

Biomedics 60 (ocufilcon F) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

### Additional Claims:

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

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| | Division of Ophthalmic Devices |
| 510(k) Number | K 992264 |

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