(LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI

K972807 · Benz Research and Development Corp. · LPL · Oct 15, 1997 · Ophthalmic

Device Facts

• Record ID: K972807
• Device Name: (LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI
• Applicant: Benz Research and Development Corp.
• Product Code: LPL · Ophthalmic
• Decision Date: Oct 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The BENZ hefilcon A SPHERICAL Soft (Hydrophilic) Contact Lenses in clear or with a light blue or light green visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The spherical lenses are available from +20.00 to -20.00 Diopters and may be worn by patients who can accomodate up to 1.5 Diopters of astigmatism. The BENZ hefilcon A TORIC Soft (Hydrophilic) Contact Lenses in clear or with a light blue or light green visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The Toric lenses are available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction where it does not interefere with visual acuity. The BENZ hefilcon A Spherical and Toric Contact lenses may be disinfected using either the heat (thermal) or the chemical (nonheat) disinfection system.

Device Story

BENZ Hefilcon A Soft (Hydrophilic) Contact Lenses are lathe-cut, daily wear lenses available in spherical and toric designs. Lenses are clear or feature light blue/light-green visibility tints. Intended for vision correction in aphakic and non-aphakic patients. Lenses are compatible with both heat (thermal) and chemical (non-heat) disinfection systems. Device is prescribed by eye care professionals for patient daily wear.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device characteristics and intended use.

Technological Characteristics

Material: Hefilcon A (hydrophilic polymer). Design: Lathe-cut spherical and toric contact lenses. Power range: +20.00 to -20.00 Diopters. Astigmatic correction: up to 4.50 Diopters. Tint: Clear, light blue, or light green. Disinfection compatibility: Heat (thermal) or chemical (non-heat) systems.

Indications for Use

Indicated for daily wear correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. Spherical lenses: +20.00 to -20.00 Diopters, up to 1.5 Diopters astigmatism. Toric lenses: +20.00 to -20.00 Diopters, up to 4.50 Diopters astigmatic correction.

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.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1997

Benz Research and Development Corporation, Inc. c/o Wally Sterling South East Regulatory Associates, Inc. 235 North Talbot Court Roswell, GA 30076-2480

Re: K972807

> Trade Name: BENZ Hefilcon A Soft (Hydrophilic) Daily Wear Contact Lenses (Clear, and Blue or Light-Green Visibility Tinted, Lathe-Cut) Regulatory Class: II Product Code: 86 LPL Dated: July 25, 1997 Received: July 28, 1997

Dear Mr. Sterling:

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.

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

Page 2 - Mr. Wally Sterling

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

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

510(k) Number:

BENZ hefilcon A Spherical and Toric Contact Device Name: Lenses in clear and with light blue or light green visibility tint for Daily Wear

SECTION 7 INDICATIONS for USE

The BENZ hefilcon A SPHERICAL Soft (Hydrophilic) Contact Lenses in clear or with a light blue or light green visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The spherical lenses are available from +20.00 to -20.00 Diopters and may be worn by patients who can accomodate up to 1.5 Diopters of astigmatism.

The BENZ hefilcon A TORIC Soft (Hydrophilic) Contact Lenses in clear or with a light blue or light green visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The Toric lenses are available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction where it does not interefere with visual acuity.

The BENZ hefilcon A Spherical and Toric Contact lenses may be disinfected using either the heat (thermal) or the chemical (nonheat) disinfection system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Myra Smith

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K972807

OR

Over-The-Counter Use (Optional Format 1-2-96