BENZ-G 4X HIOXIFILCON D

K062854 · Benz Research and Development Corp. · LPL · Aug 6, 2007 · Ophthalmic

Device Facts

• Record ID: K062854
• Device Name: BENZ-G 4X HIOXIFILCON D
• Applicant: Benz Research and Development Corp.
• Product Code: LPL · Ophthalmic
• Decision Date: Aug 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Benz G 4X (Hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters. Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribe for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Device Story

Benz-G 4X is a soft contact lens (spherical or toric) fabricated from hioxifilcon D (copolymer of 2-HEMA and GMA, cross-linked with EGDMA). Lens is a hemispherical shell, 54% water content, blue visibility tint. Used by patients for daily wear; prescribed by eye care practitioners for frequent/planned replacement. Lens conforms to corneal curvature to provide optical correction. Requires maintenance in hydrated state using compatible solutions; chemical disinfection system used for cleaning. Benefits include visual acuity correction for myopic, hyperopic, and astigmatic patients.

Clinical Evidence

No clinical data. Safety and effectiveness established via bench testing and comparison of physical, chemical, and toxicological properties to the predicate device.

Technological Characteristics

Material: Hioxifilcon D (non-ionic copolymer of 2-HEMA and GMA, cross-linked with EGDMA). Water content: 54%. Refractive index: 1.408 (hydrated). Oxygen permeability (Dk): 18. Light transmission: >95%. Tint: Blue phthalocyanato (2) - (copper). Manufacturing: Lathe-cut. FDA Group 2.

Indications for Use

Indicated for daily wear correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes (myopic or hyperopic). Spherical lens for astigmatism ≤ 0.75D; toric lens for astigmatism up to 10.00D.

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

• Extreme H2O® 54% (hioxifilcon D) molded soft contact lens (K051430)

Reference Devices

• Benz-G 5X (hioxifilcon A) (K952620)
• Benz-G 3X (hioxifilcon B) (K964528)

Submission Summary (Full Text)

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# BENZ RESEARCH & DEVELOPMENT

510(k) Premarket Notification

AUG -6 2007

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### Kob2854 The assigned 510(k) number is:

#### Applicant Information:

| Date Prepared: | 8/03/2007 |
|------------------------|--------------------------------------------------------------------------|
| Name: | Benz Research & Development<br>6447 Parkland Drive<br>Sarasota, FL 34243 |
| Contact Person: | Arthur Ward<br>Regulatory Consultant<br>Benz Research & Development |
| Phone number: | 941-758-8256 |
| Fax number: | 941-758-1191 |
| Device Information: | |
| Device Classification: | Class II |
| Classification number: | LPL |
| Classification Name: | Lens, Soft Contact, Daily Wear |
| Trade Name: | Benz-G 4X (hioxifilcon D) Lathed Sphere and<br>Toric Lenses |

#### Purpose of the 510(k) Submission:

Benz Research & Development is requesting clearance from the FDA to manufacture and market Benz-G 4X (hioxifilcon D) Lathed Lenses.

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#### Predicate Devices:

The Benz-G 4X 54% (hioxifilcon D) lathed soft contact lens is substantially equivalent to the Extreme H2O® 54% (hioxifilcon D) molded soft contact lens already cleared under 510(k) K051430.

In addition, Benz-G 4X (hioxifilcon D) lathed lens is manufactured at Benz Research & Development according to the same manufacturing processes as the following previously cleared hydrophilic contact lenses:

| Benz-G 5X (hioxifilcon A) | K952620 | (MAF-700) |
|---------------------------|---------|-----------|
| Benz-G 3X (hioxifilcon B) | K964528 | (MAF-816) |

#### Device Description:

Benz-G 4X 54% (hioxifilcon D) lathed soft contact lenses are hemispherical shells and are available as spherical or toric lens designs. The Benz-G 4X 54% (hioxifilcon D) lathed soft contact lens is fabricated from hioxifilcon D, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifileon D and 54% water by weight when immersed in normal buffered saline solution buffered. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped. However, it will return to its proper configuration when completely rehydrated in the proper storage solution.

#### Intended Use (Indications):

The Benz-G 4X 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters.

Eve care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for

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frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

#### Comparison to Predicate Device:

Side by side comparison testing was conducted on the molded lenses Extreme H2O® 54% (hioxifilcon D) cleared under 510(k) K051430 and lathed lenses manufactured by Benz Research & Development from hioxifilcon D material.

| | Predicate Device | New Device |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Extreme H₂O® 54% Molded Lens | Benz-G 4X Lathed Lens |
| Intended Use: | Intended for daily wear for the<br>correction of visual acuity in aphakic<br>and non aphakic persons with non-<br>diseased eyes that are myopic or<br>hyperopic. The spherical lens may be<br>worn by persons who exhibit<br>astigmatism of 0.75 Diopters or less<br>that does not interfere with visual<br>acuity. The toric lens may be worn<br>by persons who exhibit astigmatism<br>of up to 10.00 Diopters.<br>Lenses are intended for frequent and<br>/ or planned replacement wear as<br>prescribed by the eye care<br>practitioner. | Intended for daily wear for the<br>correction of visual acuity in aphakic<br>and non aphakic persons with non-<br>diseased eyes that are myopic or<br>hyperopic. The spherical lens may be<br>worn by persons who exhibit<br>astigmatism of 0.75 Diopters or less<br>that does not interfere with visual<br>acuity. The toric lens may be worn<br>by persons who exhibit astigmatism<br>of up to 10.00 Diopters.<br>Lenses are intended for frequent and<br>/ or planned replacement wear as<br>prescribed by the eye care<br>practitioner. |
| Lens Material: | Hioxifilcon D | Hioxifilcon D |
| Material Classification: | FDA Group 2<br>(> 50% H₂O, non-ionic polymer) | FDA Group 2<br>(> 50% H₂O, non-ionic polymer) |
| Production Method: | Cast-Molded | Lathe-Cut |
| Water content: | 54% +/- 2 | 54% +/- 2 |
| Refractive Index: | 1.414 hydrated | 1.408 hydrated |
| Light Transmission: | Greater than 95% T | Greater than 95% T |
| Tint | Blue Phthalocyanato (2) - (copper) | Blue Phthalocyanato (2) - (copper) |
| Oxygen Permeability<br>(ANSI Z80:2004 upgraded<br>polarographic method) in Fatt<br>Dk units | 21 | 18 |

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#### Non-clinical Testing:

The following toxicological testing was performed in accordance with the regulations set forth in 21 CFR, Part 58

- a) Agar Diffusion Test ISO The test article is considered non-cytotoxic
- b) Systemic Injection Test ISO The test article did not induce a significantly greater biological reaction than their control articles.
- c) Primary Ocular Irritation ISO The test article is considered to be a non-irritant

#### Clinical Data:

It was determined that clinical studies were not necessary to establish the safety and effectiveness of the Benz-G 4X (hioxifilcon D) lathed lens. The Benz-G 4X (hioxifilcon D) lathed lens is formulated from the same components as the previously cleared Extreme H2O® 54% (hioxifilcon D) molded contact lens. The physical / chemical / toxicological results of the Benz-G 4X (hioxifilcon D) lathed lens also show that it is substantially equivalent to the Extreme H2O® 54% (hioxifilcon D) molded contact lens.

#### Conclusion:

The information provided in this premarket submission establishes that the Benz-G 4X (hioxifilcon D) lathed lens is substantially equivalent in terms of intended use, materials, toxicological and physiochemical properties to the predicate device, Extreme H2O® 54% (hioxifilcon D) molded contact lens. In addition, The Benz-G 4X (hioxifilcon D) lathed lens is manufactured at Benz Research & Development according to the same manufacturing processes as the following previously cleared hydrophilic contact lenses: Benz-G 5X (hioxifilcon A) K952620 Benz-G 3X (hioxifilcon B) K964528 (MAF-816)

The Benz-G 4X (hioxifilcon D) material is formulated from the same components as the previously cleared Benz-G 5X (hioxifilcon A) and Benz-G 3X (hioxifilcon B), but with a different ratio of components that bracket the new material between these two cleared materials.

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Benz-G 4X (hioxifilcon D) lathed lens therefore meets the requirements of substantial equivalence and is as safe and effective as the predicate device.

・

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, with flowing lines suggesting movement or progress.

AUG -6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Benz Research & Development c/o Arthur J. Ward, Ph.D. AJW Technologies Consultants, Inc. 962 Allegro Lanc Apollo Beach, FL 33572

Re: K062854

Trade/Device Name: Benz-G 4X (hioxifilcon D) Lathed Sphere and Toric Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Lens, Soft Contact, Daily Wear Regulatory Class: Class II Product Code: LPL Dated: July 25, 2007 Received: July 30, 2007

Dear Dr. Ward:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Isting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

M.B. Egelhus, MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

Device Name: Benz G 4X (Hioxifilcon D) soft contact lens

#### INDICATIONS FOR USE:

The Benz G 4X (Hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribe for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | Ming-chuen Shl |
|-----------------------------|----------------|
| Division of Ophthalmic Ear, | |
| Nose and Throat Devises | |
| 510(k) Number | K062854 |

| Prescription Use (Per 21 CRF 801.109) | X | or | Over-The-Counter Use |
|---------------------------------------|---|----|----------------------|
|---------------------------------------|---|----|----------------------|

(Optional Format 1-2-96)