AQUAFLEX 2 (TEFILCON) CONTACT LENS

K050743 · Unilens Corp., USA · LPL · Apr 13, 2005 · Ophthalmic

Device Facts

• Record ID: K050743
• Device Name: AQUAFLEX 2 (TEFILCON) CONTACT LENS
• Applicant: Unilens Corp., USA
• Product Code: LPL · Ophthalmic
• Decision Date: Apr 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Aquaflex 2 Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism up to 1.50 diopters or less in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.

Device Story

Aquaflex 2 is a spherical, soft (hydrophilic) contact lens made of tefilcon (polymer of 2-hydroxyethyl methacrylate crosslinked with ethylene glycol dimethacrylate). Device functions as a corrective lens for refractive ametropia and astigmatism. Used by patients for daily wear; prescribed by eye care professionals. Lens is a hemispherical shell available in various base curves, diameters, and powers (-20.00 to +20.00D). Disinfection via heat or chemical systems. Provides vision correction by altering light refraction before entering the eye.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on material composition, physical construction, and established safety profile of predicate devices.

Technological Characteristics

Material: tefilcon (hydrophilic polymer of 2-hydroxyethyl methacrylate crosslinked with ethylene glycol dimethacrylate). Water content: 37.5%. Oxygen permeability: 8.9 x 10-11 (cm/sec)(ml O2/ml x mm Hg) at 21°C. Refractive index: 1.43. Specific gravity: 1.18. Light transmittance: 98%. Dimensions: 12.5-17.0mm diameter, 7.0-10.5mm base curve, 0.05-0.56mm center thickness.

Indications for Use

Indicated for daily wear for correction of refractive ametropia (myopia/hyperopia) and astigmatism ≤ 1.50D in aphakic and non-aphakic persons with non-diseased eyes.

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

• BayVue (polymacon) Soft (hydrophilic) Contact Lens

Reference Devices

• LL-Bifocal (tefilcon) Contact Lens (K971647)

Submission Summary (Full Text)

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

# APR 1 3 2005

# 510(k) Summary

# K 050743

### Applicant Information

| Date prepared: | March 21, 2005 |
|-----------------|---------------------------------------------|
| Name: | Unilens Corp., USA |
| Address: | 10431 72nd Street, North<br>Largo, FL 33777 |
| Contact person: | Josepha Bruno, Director Quality Assurance |
| Phone number: | [phone] x306 |
| Fax number: | [phone] |

# Device Information

| Device classification: | Class II |
|------------------------|-------------------------------------------------------|
| Classification number: | LPL |
| Classification name: | Lenses, Soft Contact, Daily Wear |
| Trade name: | Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens |

## Equivalent device

The Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device identified below in terms of intended use and design.

Predicate device: BayVue (polymacon) Soft (hydrophilic) Contact Lens

#### Device description

The Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens is available as a spherical lens. The lens material, tefilcon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate crosslinked with ethylene glycol dimethacrylate.

The Aquaflex 2 Contact Lens is a hemispherical shell of the following dimensions:

| Chord diameters | 12.5 to 17.0mm |
|------------------------|--------------------------------------------------------------------------------------------------|
| Center thickness | varies with power; Standard design 0.10 mm to 0.56 mm<br>and Superthin design 0.05 mm to 0.39 mm |
| Base curves | 7.0 to 10.5mm |
| Powers | -20.00 to +20.00D |
| Optical zone diameters | 5.0 to 10.0mm |

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

The physical/optical properties of the lens are:

| specific gravity | 1.18 |
|------------------------|------------------------------------------------------------------------|
| refractive index (wet) | 1.43 |
| light transmittance | 98% |
| water content | 37.5% |
| oxygen permeability | 8.9 x 10-11 (cm/sec)(ml O2/ml x mm Hg), measured at 21°C (Fatt Method) |

#### Intended use

The Aquaflex 2 Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism up to 1.50 diopters or less in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.

#### Substantial equivalence

The new device will be manufactured according to specified process controls and a quality management system currently in place. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Unilens Corp., USA. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the LL-Bifocal (tefilcon) Contact Lens, 510(k) K971647. Being similar with respect to indications for use, materials, physical construction and safety and effectiveness to the predicate device, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above.

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

Image /page/2/Picture/12 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

APR 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Unilens Corp., USA c/o Josepha Bruno Director, Quality Assurance 10431 72nd Street North Largo, FL 33777

Re: K050743

Trade/Device Name: Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 21, 2005 Received: March 21, 2005

Dear Ms. Bruno:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978) in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic Act (110c) that do noves, subject to the general controls provisions of the Act. The I ou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is onashined (600 a00 rols. Existing major regulations affecting your device can may be subject to back acceral Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous or ements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Drivedants of your device complies with other requirements of the Act that I DA has made a acternmentations administered by other Federal agencies. You must of ally I colch statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Act 31equirements, as a manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty by sions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

#### Page 2 - Josepha Bruno

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

David M. Whipple

Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): _k050743____________________________________________________________________________________________________________________________________________

Device Name: Aquaflex 2 (tefilcon) Soft (Hydrophilic) Contact Lens

Indications for Use:

The Aquaflex 2 Contact Lens is indicated for daily wear for the correction of refractive I he Aquariex 2 Conact Lons is no astigmatism up to 1.50 diopters or less in aphakic and/or anteropia (inyopia and ifyperopla) and antigation way be disinfected using either a heat or chemical disinfection system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | | |
|-------------------------------------------------|--------|-----------------------------------------------------|--|
| | AND/OR | Over-The-Counter-Use<br>(Part 21 CFR 807 Subpart C) | |

(Division Sign-Off)

Division of Ophthalmic Ear,

Nose and Throat Devises

| 510(k) Number | K050743 |
|---------------|---------|
|---------------|---------|

24