CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS

K033919 · Ciba Vision Corporation · LPL · Mar 12, 2004 · Ophthalmic

Device Facts

• Record ID: K033919
• Device Name: CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS
• Applicant: Ciba Vision Corporation
• Product Code: LPL · Ophthalmic
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The CIBA Vision® (lotrafilcon B) spherical soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. The CIBA Vision® Toric (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 10.00 diopters (D) or less of astigmatism. The CIBA Vision® Progressives (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism. The CIBA Vision® Progressive Toric (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 10.00 diopters (D) or less of refractive and/or corneal astigmatism. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

Device Story

Fluoro-silicone hydrogel soft contact lenses; 33% water content; surface-treated. Available in spherical, toric, multifocal, and toric multifocal designs. Contains copper phthalocyanine handling tint. Supplied sterile in blister packs with isotonic phosphate buffered saline. Prescribed by eye care professionals for daily wear; patient removes for chemical cleaning/disinfection. Provides refractive correction for ametropia and presbyopia. Benefits include improved visual acuity and comfort.

Clinical Evidence

Two-month prospective daily wear clinical study compared the modified lotrafilcon B lens to an FDA-approved control lens. Evaluated performance in vision, ocular health, comfort, and fit. Results demonstrated similar overall performance to the control lens.

Technological Characteristics

Material: 33% water, 67% lotrafilcon B (fluoro-silicone hydrogel). Surface-treated. Oxygen permeability: 110 x 10^-11 (cm²/sec)(ml O2/ml*mmHg) at 35°C. Refractive index: 1.42 (hydrated). Light transmittance: >96%. Sterilization: Steam sterilization. Packaging: Blister packs with isotonic phosphate buffered saline.

Indications for Use

Indicated for optical correction of myopia, hyperopia, astigmatism, and presbyopia in phakic or aphakic persons with non-diseased eyes. Specific astigmatism limits apply based on lens type (up to 1.50D or 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

• CIBA Vision Excelens (lotrafilcon B) soft contact lens (K020139)

Submission Summary (Full Text)

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CIBA Vision® Corporation 4-Mar-04, v02 11460 Johns Creek Parkway Duluth, Georgia USA 30097 Page 1 of 4 Lotrafilcon B Soft Contact Lenses 510(k) Summary of Safety and Substantial Equivalence

## 510(k) Summary: K033919

### 1. Submitter Information:

| Company: | CIBA Vision Corporation<br>11460 Johns Creek Parkway<br>Duluth, Georgia USA 30097 |
|--------------------------------------|-----------------------------------------------------------------------------------|
| Contact Person: | Alicia M. Plesnarski, RAC<br>Director, Global Regulatory Affairs |
| Telephone:<br>FAX:<br>Date Prepared: | 678-415-3924<br>678-415-3454<br>4 March 2004 |

#### Device Name: 2.

- Soft Contact Lens Common Name: .
- CIBA Vision® (lotrafilcon B) Trade/Proprietary Name: .
- Daily Wear Soft Contact Lens Classification Name: .
- Class || [21 CFR 886.5925 (b) (1)] Device Classification: .

### 3. Predicate Device:

The CIBA Vision® (lotrafilcon B) lens is a modification in surface treatment of the The CIDA Vision's Excelens™ (lotrafilcon B) soft contact lens. Both are in Predicate Group 1 (low water, nonic polymer). CIBA Vision obtained FDA 510(k) r DA Group 1 (low water, nomonio posythe for daily wear on April 9, 2002 (K020139).

### 4. Description of Device:

The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated.

Lotrafilcon B lens designs include spherical, toric, multifocal and toric multifocal lenses in the following parameter ranges:

- 13.0 to 15.0 mm Diameter Range: .
- 8.0 to 9.2 mm Base Curve Range: �
- -20.00D to +20.00D Power Range: .
- varies with power (0.080 mm for -3.00D spherical) Center Thickness: .

Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling.

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| CIBA Vision.<br>A Novartis Company | CIBA Vision® Corporation<br>11460 Johns Creek Parkway<br>Duluth, Georgia USA 30097 |
|------------------------------------|------------------------------------------------------------------------------------|
| | 4-Mar-04, v02<br>Page 2 of 4 |

Lotrafilcon B Soft Contact Lenses

510(k) Summary of Safety and Substantial Equivalence

Lenses have the following properties:

- 1.42 (hydrated) Refractive index: ◆
- > 96 % Light transmittance: .
- 33% by weight in normal saline Water content : .
- 110 x 10 -11 Oxygen permeability .

[(cm² /sec)(ml O2 /ml●mmHg)]

measured at 35°C (intrinsic Dk-Coulometric method)

Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed packaging System has been domenation are effectively steam sterilized in a validated lens products, and packagou forloos are labeled with the lens parameters, lot number and autoclave. Dilster pack ochtainers article date has been established through stability product capiration action the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.

### 5. Indications for Use:

The CIBA Vision® (lotrafilcon B) spherical soft contact lens is indicated for the optical The GIDA Vision (ibramoon b) Sphropia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

The CIBA Vision® Toric (lotrafilcon B) soft contact lens is indicated for the optical The OlDA Vision - Pho (lottails (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 10.00 diopters (D) or less of astigmatism.

The CIBA Vision® Progressives (Iotrafilcon B) soft contact lens is indicated for the optical The CIDA Vision - Progression (myopia and hyperopia) and/or presbyopia in phakic or conection of rendority and opes who may require a reading addition of +3.00 aphake persons who may have up to approximately 1.50 diopters of astigmatism.

The CIBA Vision® Progressive Toric (Iotrafilcon B) soft contact lens is indicated for the The of creetion of refractive ametropia (myopia, astigmatism and opitical Correction - en Tenaotro "anstropia" (1)-pisseased eyes. The lenses may be presbyopla) in phalks of aprilance persons (D) or less of refractive and/or corneal astigmatism.

The lenses may be prescribed for daily wear with removal for cleaning and disinfection The lefises may be presonbod for daily woul while one one professional.

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| CIBA<br>Vision. | CIBA Vision® Corporation<br>11460 Johns Creek Parkway<br>Duluth, Georgia USA 30097 |
|--------------------|------------------------------------------------------------------------------------|
| A Novartis Company | 4-Mar-04, v02<br>Page 3 of 4 |

Lotrafilcon B Soft Contact Lenses

# 510(k) Summary of Safety and Substantial Equivalence

# 6. Description of Safety and Substantial Equivalence:

A series of non-clinical tests and clinical studies were performed to demonstrate the substantial equivalence of the device modification and establish substantial equivalence Substantial oqurralerice. All testing was conducted in accordance with the May 1994 FDA to the premier. All tooling was 510(k) Guidance Document for Class II Contact guidenne three i romornot not applicable device regulations. Results verify that the modified lens remains non-toxic and biocompatible, and has material characteristics mounted lens Temains Than other currently marketed soft contact lenses. Clinically, the Comparable to of bettler than other samonily wear investigation. Results from all tests lens has performed satisfacterily in a atin't results of the substant of the substante (control) lenses.

### Nonclinical Testing:

A series of pre-clinical testing was performed to verify equivalence of the modified A Senes of the predicate device. Non-clinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58).

The results of all non-clinical testing on the modified (lotrafilcon B) contact lens demonstrate:

- The lens material and extracts of the modified device are equivalent to the predicate . and remain not toxic and non-irritating.
- Lens physical and material properties of the modified device are consistent with . industry marketed lenses, and equivalent to the predicate lens.
- The lens material is compatible with commonly available lens care products. .

### Clinical Testing:

The (lotrafilcon B) contact lens was investigated in daily wear clinical study. The twomonth clinical evaluation was conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, and 812). The study I raction and publication regulation of the modified lens as compared to an FDA approved and commercially available contact lens.

Clinical evaluation of the (lotrafilcon B) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit as compared to the control lens when used under daily wear conditions.

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| | CIBA Vision A Novartis Company |
|--|------------------------------------------------------|
| | CIBA Vision® Corporation |
| | 11460 Johns Creek Parkway |
| | Duluth, Georgia USA 30097 |
| | 4-Mar-04, v02 |
| | Page 4 of 4 |
| | <b>Lotrafilcon B Soft Contact Lenses</b> |
| | 510(k) Summary of Safety and Substantial Equivalence |

# Substantial Equivalence:

The modified (lotrafilcon B) contact lens is equivalent to the predicate lens and similar to The modified (iotramoon D) offically to mater content (33% water) and ionic other daily weal son contact lenses in torno of water water water and indications Characteristics (i DA Choup in the nemonth hemoney, not chemical, not heat, disinfection regimen.

Any differences which may exist between the (lotrafilcon B) soft contact lens and other Any differences which may oxlet betwoon the (retrailed) affect the safety and effectiveness of the device.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2004

CIBA VISION c/o Ms. Alicia M. Plesnarski, RAC Director, Global Regulatory Affaire 11460 Johns Creek Parkway Duluth, GA 30097-1556

Re: K033919

Trade/Device Name: CIBA Vision® (lotrafilcon B) Soft Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: December 16, 2003 Received: December 18, 2003

Dear Ms. Plesnarski:

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. Alicia M. Plesnarski, RAC

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/dsma/dsmamain.html

Sincerely yours.

A helyl 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

Enclosure

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Indications for Use Statement, v03, 8-Mar-04, Page 1 of 1 Premarket Notification 510(k) Ki)33919: (lotrafilcon B) Soft Contact Lens for Daily Wear

### INDICATIONS FOR USE STATEMENT

510(k) Number:

K033919

Device Name:

CIBA Vision® (lotrafilcon B) Soft Contact Lenses

: 广

Indications For Use:

The CIBA Vision® (lotrafilcon B) spherical soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

The CIBA Vision® Toric (Iotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 10.00 diopters (D) or less of astigmatism.

The CIBA Vision® Progressives (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.

The CIBA Vision® Progressive Toric (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eves. The lenses may be worn by persons who have 10.00 diopters (D) or less of refractive and/or comeal astigmatism.

The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

Prescription Use:
(21 CFR Part 801 Subpart D)

510(k) Number_

AND/OR

Over the Counter Use 0 (21 CFR Part 801 Subpart C)

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

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| Division of Ophthalmic Ear, |
| Nose and Throat Devises |