CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS

K062262 · Ciba Vision Corporation · LPL · Nov 14, 2006 · Ophthalmic

Device Facts

• Record ID: K062262
• Device Name: CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS
• Applicant: Ciba Vision Corporation
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

CIBA Vision® (sifilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 1.50 diopters or less of astigmatism. CIBA Vision® Toric (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 10.00 diopters (D) or less of astigmatism. CIBA Vision® Multifocal (sifilcon A) soft contact lenses are 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 +4.00 diopters (D) or less and who have 1.50 diopters or less of astigmatism. CIBA Vision® Multifocal Toric (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +4.00 diopters (D) or less and have 4.00 diopters (D) or less of 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

Sifilcon A soft contact lenses; fluoro-silicone hydrogel material; 32% water content; surface treated. Available in spherical, toric, multifocal, and multifocal toric designs. Includes Phthalocyanine Green handling tint. Supplied sterile in blister-packs with isotonic phosphate buffered saline. Intended for daily wear; requires removal for chemical disinfection. Prescribed by eye care professionals to correct refractive errors. Benefits include vision correction for phakic/aphakic patients.

Clinical Evidence

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

Technological Characteristics

Material: 32% water, 68% sifilcon A (fluoro-silicone hydrogel). Surface treated. Refractive index: 1.43 (hydrated). Oxygen permeability (Dk): 82 x 10^-11. Diameter: 12.0-15.0 mm. Base curve: 7.0-9.2 mm. Power: -20.00D to +20.00D. Sterilization: Steam autoclave.

Indications for Use

Indicated for optical correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in phakic or aphakic persons with non-diseased eyes. Contraindicated for 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

• CIBA Vision (lotrafilcon B) soft contact lenses (K033919)

Submission Summary (Full Text)

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K062262

Image /page/0/Picture/24 description: The image shows the logo for CIBA Vision, a Novartis company. The logo is black and white and features the words "CIBA Vision" in a bold, sans-serif font. Below the company name is the text "A Novartis Company" in a smaller font. The logo is simple and modern, and it is likely used on the company's products and marketing materials.

CIBA Vision® Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097

3-Aug-2006 Page 1 of 4 V01

Sifilcon A Soft Contact Lenses for Daily Wear 510(k) Summary of Safety and Substantial Equivalence

### 510(k) Summary

# 1. Submitter Information:

NOV 1 4 2006

| Company: | CIBA Vision Corporation<br>11460 Johns Creek Parkway<br>Duluth, Georgia USA 30097 | |
|-----------------|-----------------------------------------------------------------------------------|--|
| Contact Person: | Alicia M. Plesnarski, RAC<br>Director Global Regulatory Aff | |

lobal Regulatory Affairs [e-mail]

| Telephone: | 678-415-3924 |
|----------------|---------------|
| FAX: | 678-415-3454 |
| Date Prepared: | 3 August 2006 |

#### Device Name: 2.

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

#### Predicate Device: 3.

CIBA Vision's (lotrafilcon B) soft contact lenses. Both lotrafilcon B (predicate) and sifilcon A are in FDA Group 1 (low water, nonionic polymer). CIBA Vision obtained FDA 510(k) clearance for (lotrafilcon B) lenses for daily wear on March 12, 2004 (K033919).

### 4. Description of Device:

The lens material is 32% water and 68% sifilcon A a fluoro-silicone containing hydrogel which is surface treated.

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

| Diameter Range: | 12.0 to 15.0 mm |
|-------------------|---------------------------------------------------|
| Base Curve Range: | 7.0 to 9.2 mm |
| Power Range: | -20.00D to +20.00D |
| Center Thickness: | 0.070 mm for -3.00D spherical (varies with power) |

Lenses contain the color additive Phthalocyanine Green (PCN Green), a light green handling tint, which makes them easier to see when handling.

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| ROHOTI.<br>A Novariis Company | CIBA Vision® Corporation<br>11460 Johns Creek Parkway<br>Duluth, Georgia USA 30097 | 3-Aug-2006<br>Page 2 of 4<br>v01 | |
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| Sifilcon A Soft Contact Lenses for Daily Wear<br>510(k) Summary of Safety and Substantial Equivalence | | | |

Lenses have the following properties:

| • | Refractive index: | 1.43 (hydrated) |
|---|-------------------|-----------------|
|---|-------------------|-----------------|

- approximately 92 % Light transmittance:
- . 32% by weight in normal saline Water content : .
- 82 x 10 -11 Oxygen permeability
- [(cm2 /sec)(ml O2 /ml=mmHg)]

measured at 35°C (intrinsic Dk-Polarographic 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 CIBA Vision marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister-pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of he lens and package integrity (ability to Shelf-life studies are ongoing to establish and extend the labeled maintain sterility). expiration date.

# 5. Indications for Use:

.

CIBA Vision® (sifilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 1.50 diopters or less of astigmatism.

CIBA Vision® Toric (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who have 10.00 diopters (D) or less of astigmatism.

CIBA Vision® Multifocal (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +4.00 diopters (D) or less and who have 1.50 diopters or less of astigmatism.

CIBA Vision® Multifocal Toric (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +4.00 diopters (D) or less and have 10.00 diopters (D) or less of 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.

### 6. Description of Safety and Substantial Equivalence:

A series of non-clinical tests and a clinical study were performed to demonstrate the substantial equivalence of the device to the predicate device. All testing was conducted in

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Image /page/2/Picture/0 description: The image shows the logo for CIBA Vision, a Novartis company. The logo is in black and white, with the word "CIBA" in large, bold letters above the word "Vision." The word "Vision" has a stylized "i" with a circle in the center. Below the word "Vision" is the text "A Novartis Company" in smaller letters.

CIBA Vision® Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097

3-Aug-2006 Page 3 of 4 V01

# Sifilcon A Soft Contact Lenses for Daily Wear 510(k) Summary of Safety and Substantial Equivalence

accordance with the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and in conformance to applicable device regulations. Results verify that sifilcon Alenses have material characteristics comparable to or better than other currently marketed soft contact lenses, are compatible with commonly available lens care products and are non-toxic and biocompatible. Clinically, the lens performed satisfactorily in a daily wear investigation. Results from all tests demonstrate the substantial equivalence to a previously FDA approved predicate (control) lenses.

Non-clinical Testing:

A series of non-clinical testing was performed to verify equivalence of the device to 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 (sifilcon A) contact lens demonstrate:

- Lens physical and material properties of the device are consistent with or better than . industry marketed lenses, and substantially equivalent to the predicate lens.
- The lens material is compatible with commonly available lens care products. .
- The lens material and extracts of the device are substantially equivalent to the . predicate device and are non toxic and non-irritating.

### Clinical Testing:

The sifilcon A contact lens was investigated in daily wear clinical study. The three-month clinical evaluation was conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, and 812). The study assessed the clinical performance of the lenses as compared to an FDA approved and commercially available contact lens.

Clinical evaluation of the sifilcon Alens 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<br>A Novartis Company | CIBA Vision® Corporation<br>11460 Johns Creek Parkway<br>Duluth, Georgia USA 30097 | 3-Aug-2006<br>Page 4 of 4<br>v01 |
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Sifilcon A Soft Contact Lenses for Daily Wear

510(k) Summary of Safety and Substantial Equivalence

Substantial Equivalence:

The CIBA Vision (sifilcon A) contact lens is substantially equivalent to the predicate lens and similar to other daily wear soft contact lenses in terms of water content (32% water) and ionic characteristics (FDA Group I: low water, nonionic), clinical performance, and indications for use. In addition, the lenses may be disinfected using a chemical, not heat, disinfection regimen.

Any differences which may exist between the sifilcon A soft contact lens and other Group I soft hydrophilic contact lenses do not adversely 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 Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV I 4 2006

Ciba Vision Corporation c/o Alicia M. Plesnarski, RAC 11460 Johns Creek Parkway Duluth, GA 30097

Re: K062262

> Trade/Device Name: Ciba Vision® (sifilcon A) Soft Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: LPL Dated: October 19, 2006 Received: October 20, 2006

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 – 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/industry/support/index.html.

Sincerely yours,

M.B. Eychlemi S.M.D

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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Part II. Indications for Use Statement, v01, 3-Aug-2006, Page 1 of 1 Premarket Notification 510(k): (sifilcon A) Soft Contact Lens for Daily Wear

#### PART II. INDICATIONS FOR USE STATEMENT

KO62262 510(k) Number:

CIBA Vision® (sifilcon A) Soft Contact Lenses Device Name:

Indications For Use:

CIBA Vision® (sifilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 1.50 diopters or less of astigmatism.

CIBA Vision® Toric (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 10.00 diopters (D) or less of astigmatism.

CIBA Vision® Multifocal (sifilcon A) soft contact lenses are 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 +4.00 diopters (D) or less and who have 1.50 diopters or less of astigmatism.

CIBA Vision® Multifocal Toric (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +4.00 diopters (D) or less and have 4.00 diopters (D) or less of 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 eve care professional.

Concurrence of CDRH, Office of Device Evaluation (ODE)
*Division Sign-Off)*
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K062262 |
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|---------------|---------|

| Prescription Use: | <div><span style="text-decoration: overline;">X</span> or Over the Counter Use <input type="checkbox"/></div> |
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