BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT

K961103 · Benz Research and Development Corp. · LPL · Aug 23, 1996 · Ophthalmic

Device Facts

• Record ID: K961103
• Device Name: BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT
• Applicant: Benz Research and Development Corp.
• Product Code: LPL · Ophthalmic
• Decision Date: Aug 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

BENZ 38 (polymacon) Spherical soft (hydrophilic) contact lenses in clear or with blue visibility tint form are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters and masking up to 1.50' Diopters of astigmatism where it does not interfere with visual acuity. BENZ 38 (polymacon) Toric soft (hydrophilic) contact lenses in clear or with blue visibility tint form are also indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters up to 4.50 Diopters of astigmatism where it does not interfere with visual acuity.

Device Story

BENZ 38 is a soft (hydrophilic) contact lens material (polymacon) used to manufacture spherical and toric lenses. The lens acts as a refracting medium when placed on the cornea to focus light on the retina. It is intended for daily wear to correct visual acuity in non-aphakic patients. The device is provided as optical buttons or finished lenses. The material is a non-ionic, ultra-high molecular weight homo-polymer of 2-hydroxyethyl methacrylate (2-HEMA). It is hydrated in saline solution. The device is used by patients under the guidance of an eye care professional. The visibility tint version uses a pigment identical to previously cleared devices. The device benefits patients by providing vision correction through a biocompatible, hydrophilic polymer.

Clinical Evidence

Clinical study data for the original BENZ 38 clear material was previously submitted and approved under P830012/S04. Non-clinical toxicology, microbiology, and lens compatibility studies for the clear and tinted versions were performed and results were within normal limits.

Technological Characteristics

Material: Polymacon (hioxifilcon A), a homo-polymer of 2-hydroxyethyl methacrylate (2-HEMA). Composition: 62% polymer, 38% water when hydrated in saline. Form: Spherical and toric soft contact lenses or optical buttons. Sterilization: Autoclave. Connectivity: None.

Indications for Use

Indicated for daily wear correction of visual acuity in non-aphakic patients with non-diseased eyes. Spherical lenses correct +12.00 to -20.00 Diopters and up to 1.50D astigmatism. Toric lenses correct +12.00 to -20.00 Diopters and up to 4.50D 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

• PMA P830012/S04
• BENZ-G 55 (hioxifilcon A) (K952620)

Submission Summary (Full Text)

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KG61163

510(k) NOTIFICATION FOR BENZ 38 (polymacon) MAR 19, 1996

AUG 23 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

## I. General Information:

A. Generic (USAN) Name: polymacon

B. Device Trade Name: BENZ 38 Clear and Visibility Tinted optical buttons and BENZ 38 Lenses Clear and Visibility Tinted

C. Sponsor's Name and Address: Benz Research and Development, Inc.
6447 Parkland Drive
Sarasota, FL 34243
[phone]

D. 510(k) Number: TO BE ASSIGNED

E. Date Notice of approval sent to Sponsor:

G. Additional Lens manufacturers who will be asking for FDA approval to manufacture and distribute soft (hydrophilic) contact lenses made from BENZ 38 will file a separate 510(k) notification. The first will be:

UNILENS CORP., USA
10431 - 72nd Street North
Largo, Florida 34543
[phone]

## II. Indications

BENZ 38 (polymacon) Spherical soft (hydrophilic) contact lenses in clear or with blue visibility tint form are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters and masking up to 1.50' Diopters of astigmatism where it does not interfere with visual acuity.

BENZ 38 (polymacon) Toric soft (hydrophilic) contact lenses in clear or with blue visibility tint form are also indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters up to 4.50 Diopters of astigmatism where it does not interfere with visual acuity.

## III. Device Description

BENZ 38 (polymacon) lens can be lathed into a spherical soft (hydrophilic) contact lens which becomes a hemispherical shell. The non-ionic material, hioxifilcon A is an ultra high molecular weight homo-polymer of 2-hydroxyethyl methacrylate (2-HEMA). This material is made from extremely

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510(k) NOTIFICATION FOR BENZ 38 (polymacon) MAR. 19, 1996

high purity monomer using state of the art polymer synthesis technique. It consists of 62% hioxifilcon A and 38% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.

The lens made from BENZ 38 (polymacon) when hydrated and placed on the cornea acts as a refracting medium to focus light rays on the retina. BENZ 38 with the visibility tint was subjected to leeching tests and showed no identifiable evidence of leeching.

The clear BENZ 38 (polymacon) optical buttons are identical to the polymacon optical buttons made by Benz Research and development in PMA P830012/S04 approved June 5, 1990. The pigment used in the BENZ-38 Blue Visibility tinted buttons and in BENZ-38 blue visibility tinted lenses is identical to the pigment used in K952620 BENZ-G 55 (hioxifilcon A) Class II Soft(hydrophilic) contact lenses Class 86-LPL, approved DEC. 1, 1995.

## IV. Alternative Practices or Procedures

Alternative practices or procedures are in the use of available prescription products with the same indication.

## V. Technical Summaries

### A. Nonclinical

1. Toxicology

BENZ RESEARCH AND DEVELOPMENT, INC. ran all pre-clinical studies for the clear lenses in 1990 and for the blue visibility tinted product in 1995 (submitted with this notification.

Conclusion: Clear Approved 1990. Test results on Blue Visibility tinted product are within the same acceptable limits.

2. Microbiology

We are submitting all microbiology work done by Unilens Corp..USA. in 1995 using a validated process.

Conclusion: Clear approved in 1990

3. Lens compatibility studies run by BENZ Research and Development included with this Notification in "Lens Compatibility Studies"

Conclusion: Within Normal Limits

4. Lens Stability The Shelf life will be run by each lens manufacturing unit. Our lenses were sterilized at Unilens Corp. USA and we are asking for the same expiration date as they will. The results are listed under Shelf Life.

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510(k) NOTIFICATION FOR BENZ 38 (polymacon) MAR. 19, 1996

have to make it's own protocol for this study and apply for an individual shelf life.

5. Preservative Uptake Tests were run by on the original BENZ 38 material for P830012/S04 approved June 5, 1990.

Results are within normal limits.

## B. Clinical

Clinical Study was done on the original BENZ 38 Clear material for P830012/S04 which was approved June 5, 1990.

Study results fell within normal limits.

BENZ RESEARCH AND DEVELOPMENT, INC. will own the polymer BENZ 38 (polymacon) in clear and visibility tint and is applying to the FDA for permission to have this basic optical polymer approved.

In a separate notification UNILENS, Corp., USA will apply to the FDA to approve their facilities for the manufacture and distribution of soft (hydrophilic) contact lenses made from this polymer BENZ 38 (polymacon).

The equipment manufacturers of lathes, autoclaves, laminar flow units, polishing equipment may be different between those at BENZ Research and Development and the alternate site companies however the end contact lens products are for all intents equivalent.

The manufacturing materials, manufacturing methods, and quality control methods employed by both companies are equivalent.

Benz Research and Development intends to add additional finishing laboratories in the future. These will be the subject of separate 510(k) notifications.

BENZ R&D was last FDA inspected on March 20, 1990

## VI. RECOMMENDATION

This Notification is based on the previous FDA approval of P830012/S04 on June 5, 1990 and the approval of a similar polymer with the identical pigment for visibility tint in K952620 on Dec. 1, 1995.

A favorable recommendation from the FDA is anticipated for the manufacture and distribution of optical button of BENZ 38 (polymacon) clear and blue visibility tinted as well as the manufacture and distribution of soft (hydrophilic) lenses made from this polymer. Any additional information will be supplied by the individuals who's name and address first appear in this notification.

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