BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WER

K980418 · Benz Research and Development Corp. · LPL · Feb 27, 1998 · Ophthalmic

Device Facts

• Record ID: K980418
• Device Name: BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WER
• Applicant: Benz Research and Development Corp.
• Product Code: LPL · Ophthalmic
• Decision Date: Feb 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens. The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity. The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction. The BENZ methafilcon A optical blanks are lathed into a soft (hydrophilic) spherical or toric hemispherical shell. The spherical lenses have a spherical base curve and the toric lenses have a non-spherical base curve. The lenses may be disinfected using chemical disinfection systems.

Device Story

BENZ methafilcon A contact lenses; clear, lathe-cut, soft (hydrophilic) spherical or toric hemispherical shells. Input: optical blanks lathed into final lens geometry. Principle: hydrated co-polymer (45% methafilcon A, 55% water) acts as refracting medium to focus light on retina. Used by patients for daily wear; prescribed by eye care professionals. Output: visual acuity correction. Benefits: vision correction for aphakic/non-aphakic patients. Device manufactured from non-ionic co-polymer of 2-HEMA and methacrylic acid crosslinked with ethylene glycol dimethacrylate.

Clinical Evidence

No clinical data. Evidence consists of bench testing including primary ocular irritation, systemic injection, agar diffusion, burst testing, and lens parameter testing. Microbiology, solutions compatibility, shelf life, and preservative uptake data were leveraged from predicate K950294.

Technological Characteristics

Material: non-ionic co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid crosslinked with Ethylene Glycole Dimethacrylate. Hydration: 55% water by weight. Form: lathe-cut spherical or toric hemispherical shells. Power range: +20.00 to -20.00 diopters. Sterilization: chemical disinfection systems.

Indications for Use

Indicated for correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes for daily wear. Spherical lenses correct +20.00 to -20.00 diopters and mask up to 1.50 diopters of astigmatism. Toric lenses correct +20.00 to -20.00 diopters with up to 4.50 diopters of 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.

Predicate Devices

• Flexlens 55 (methafilcon A) Soft Contact Lenses (K950294)

Submission Summary (Full Text)

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# 980418

## 510(k) Notification BENZ Methafilcon A

January 30, 1998

#### SUMMARY STATEMENT OF SAFETY & EFFECTIVENESS FEB 2 7 1998

Soft (hydrophilic) contact lenses for Daily Wear manufactured from methafilcon A material are generally recognized as safe and effective. Such lenses have been successfully marketed in the U.S. since the early 1980's by several manufacturers of both optical blanks and finished lenses. To date, there are more than twelve approved methafilcon A products (PMA's & 510(k)'s) on the U.S. market.

To demonstrate the methafilcon A material manufactured by BENZ R&D and the finished lenses manufactured from BENZ methafilcon A is safe and effective for its intended use, we offer the following statements :

# 1. PURPOSE OF THIS NOTIFICATION

BENZ's primary interest is in the distribution of optical blanks. They will manufacture and test a limited number of finished lenses for Quality Assurance and customer support purposes. The methafilcon A blanks will only be sold to finishing laboratories with the appropriate regulatory approvals for the distribution of methafilcon A contact lenses.

# 2. DEVICE DESCRIPTION

The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens.

The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity.

The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction.

The BENZ methafilcon A optical blanks are lathed into a soft (hydrophilic) spherical or toric hemispherical shell. The spherical lenses have a spherical base curve and the toric lenses have a non-spherical base curve.

This non-ionic material is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid crosslinked with Ethylene Glycole Dimethacrylate, plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in normal buffered saline solution.

When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light rays on the retina.

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510(k) Notification BENZ Methafilcon A

January 30, 1998

SUMMARY STATEMENT OF SAFETY & EFFECTIVENESS (continued)

# 3. ALTERNATIVE PRACTICES AND PROCEDURES

Alternative practices and procedures for the same indications are in use and generally consist of other prescription products such In use and generally Combines made from other materials, or spectacles.

# 4. TECHNICAL SUMMARY

## A. PRE-CLINICAL TESTING

The following pre-clinical tests were run by a recognized independent testing facility:

i. Primary Ocular Irritation ii. Systemic Injection iii. Agar Diffusion

All results obtained were within normal limits hence this material All results obtainsd were within his for Class II contact lenses.

B. PHYSICAL TESTING

The following tests were run to demonstrate the physical properties of the lens material are within normal limits:

i. Burst Test

This test was performed by an independent laboratory and inis test was performed by an entires of the material is within normal limits.

- ii. 12 Lens Parameter Test 2 Lens Farameter 200lenses made from BENZ methafilcon A optical blanks. The fenses made from being accidentes when measured were within normal limits.
### C. FINISHED LENS TESTING

All lenses to be produced form BENZ methafilcon A will be manufactured in accordance with the methods, equipments, and mandlactard in anted in the referenced 510(k) Notification K950294 Flexlens 55 (methafilcon A) Soft Contact Lenses.

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January 30, 1998 510(k) Notification BENZ Methafilcon A

SUMMARY STATEMENT OF SAFETY & EFFECTIVENESS (continued)

Please refer to K950294 for the following information for all BENZ methafilcon A lenses:

i. Microbiology ii. Solutions Compatibility iii. Shelf Life/Stability iv. Preservative Uptake/Release

12000

A letter of authorization to reference this 510(k) is included with this Notification.

Flexlens last FDA inspection was March 7, 1996 and there are no outstanding GMP deficiencies.

5. CONCLUDING STATEMENTS

Any adverse effects to the patient would not be any more likely or any more severe with lenses made from BENZ methafilcon A than with lenses made from any other methafilcon A or any other soft contact lens material.

From the above referenced test data, it can be deduced that the BENZ methafilcon A material is safe and effective for its intended purpose as a daily wear contact lens.

t

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael A. Clark Consultant to BENZ c/o South East Regulatory Associates, Inc. 1070 Thornwood Lane Dacula, GA 30019

FEB 2 7 1998

K980418 Re:

Trade Name: BENZ methafilcon A Spherical and Toric Soft (hydrophilic) contact lenses (clear, lathe cut) for Daily Wear

Regulatory Class: II Product Code: 86 LPL Dated: January 30, 1998 Received: February 3, 1998

Dear Mr. Clark:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices 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.

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The symbol is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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Page 2 - Mr. Michael A. Clark

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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 FOR USE

The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens.

The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity.

The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction.

The BENZ methafilcon A optical blanks are lathed into a soft (hydrophilic) spherical or toric hemispherical shell. The spherical lenses have a spherical base curve and the toric lenses have a non-spherical base curve.

The lenses may be disinfected using chemical disinfection systems.

****************************************************************************************************************************************************************************** (Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W.C. Brown, Ph.D.
Division Sign-Off

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K980418

OR

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)