CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K023732 · Ciba Vision Corporation · LPL · Dec 10, 2002 · Ophthalmic

Device Facts

• Record ID: K023732
• Device Name: CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
• Applicant: Ciba Vision Corporation
• Product Code: LPL · Ophthalmic
• Decision Date: Dec 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

CIBASOFT® PROGRESSIVE TORIC (tefilcon) soft (hydrophilic) contact lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 0.75 to 2.75 diopters of refractive and/or corneal astigmatism that does not interfere with visual acuity.

Device Story

CIBASOFT® PROGRESSIVE TORIC is a soft (hydrophilic) contact lens made of tefilcon; designed for daily wear. Lens features a toric optic zone on the front surface for astigmatism correction and a centermost aspheric zone on the back surface for presbyopia correction (add power 0.25 to 0.75 diopters). Stabilization achieved via two thin zones at 12 and 6 o'clock positions. Device provides vision correction for patients with refractive ametropia. Prescribed by eye care professionals.

Clinical Evidence

No clinical data provided; substantial equivalence based on material and manufacturing process similarity to predicate.

Technological Characteristics

Material: tefilcon (HEMA-based hydrophilic polymer); Water content: 37.5% by weight; Base curves: 8.6mm, 8.9mm; Diameter: 14.5mm; Power range: -25.00 to +25.00 diopters; Manufacturing: back curve molded/front curve lathed process.

Indications for Use

Indicated for daily wear for correction of myopia, hyperopia, astigmatism, and presbyopia in aphakic or non-aphakic persons with non-diseased eyes; patients with 0.75 to 2.75 diopters of refractive/corneal 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

• TORISOFT® Soft (hydrophilic) Contact Lens (PMA #810005)

Submission Summary (Full Text)

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# DEC 1 0 2002

## PART VIII.

In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.

## SUMMARY OF SAFETY AND EFFECTIVENESS FOR CIBASOFT® PROGRESSIVE TORIC Soft (hydrophille) Contact Lenses

#### 1. Submitter Information

CIBA Vission Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person:Terrina Wilder Telephone No. 678-415-3809

### 2. Device Name

Classification Name: Proprietary Name:

Soft (hydrophilic) Contact Lens CIBASOFT® PROGRESSIVE TORIC Soft (hydrophilic) Contact Lens

#### 3. Predicate Device

TORISC)FT® Soft (hydrophilic) Contact Lens (PMA #810005)

#### 4. Description of the Device

CIBASCIFT® PROGRESSIVE TORIC soft contact lenses are hemispherical flexible shells maade of tefilcon, a hydrophilic polymer of hydroxyethylmethacrylate (HEMA), with a water content of 37,5% by weight in normal saline solution. The lens is available in 8.6mm and 8.9mm base curves, 14.5mm diameter with center thickness of 0.012mm at -3.00 dioxoters or 0.014mm at +3.00 diopters, and powers ranges from -25.00 to +25.00cicopters. CIBASOFT® PROGRESSIVE TORIC has a toric optic zone on its front surface with a centermost aspheric zone on its back surface. This aspheric zone has an add poweer range from 0.25 to 0.75 diopters for vision correction at near. For optimum stabilizatition of the lens on the cornea, there are two thin zones on the front surface at the 12 o'clock and 6 o'clock positions.

### 5. Indicatisons for Use

CIBASOITT® PROGRESSIVE TORIC (tefilcon) soft (hydrophilic) contact lenses are indicated: for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not aphakic persons with non-diseased eyes. The lensees may be worn by persons who have 0.75 to 2.75 diopters of refractive and/or corneal aastigmatism that does not interfere with visual acuity.

#### 6. Desoripation of Safety and Substantial Equivalence

CIBASOFT® PROGRESSIVE TORIC lenses represent a modification to CIBA Visions TORISOFT® lenses. Both lenses are made of the same tefilcon material and manufacctured by a back curve molded/front curve lathed process (commonly known as the B0011 process). The addition of the multifocal or presbyopic feature to the centermost part of opptical zone of the base curve, does not raise new safety or efficacy issues, thus, CIBASQ5FT® PROGRESSIVE TORIC is substantially equivalent to the TORISOFT® lens.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CIBA Vision Corporation C/O Terrina Wilder 11460 Johns Creek Parkway Duluth, GA 30097-1556

K023732 · Re:

Trade/Device Name: CIBASOFT ® PROGRESSIVE TORIC (tefilcon) Hydropilic Contact Lens for Daily Wear

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: November 4, 2002 Received: November 6, 2002

Dear Ms. Wilder:

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, 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 (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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Page 2 - Ms. Terrina Wilder

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATIONS FOR USE STATEMENT

510(k)

Devloe Name:

## CIBASOFT® PROGRESSIVE TORIC (teflioon) So (hydrophillo) Contact Lens

## Indloations for Use:

CIBASOFT® PROGRESSIVE TORIC (tefilcon) soft (hydrophilic) contact lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 0.75 to 2.75 diopters of refractive and/or corneal astigmatism that does not interfere with visual acuity.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Over-the-Counter: ■

Laura Warburton 12/6/02

or

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

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510(k) Number K023732