FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES

K033701 · Ciba Vision Corporation · MVN · Dec 15, 2003 · Ophthalmic

Device Facts

• Record ID: K033701
• Device Name: FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES
• Applicant: Ciba Vision Corporation
• Product Code: MVN · Ophthalmic
• Decision Date: Dec 15, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

Focus® DAILIES® and Focus® DAILIES® Toric (neifilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of presbyopia in not aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity. The lenses are to be prescribed for single-use daily disposable wear. DAILIES lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Device Story

Soft contact lenses (nelfilcon A) for daily disposable wear; spherical, toric (double thin zone), and progressive aspheric simultaneous vision designs. Lens material: 69% water, 31% nelfilcon A polymer. Supplied sterile in blister packs with phosphate-acetate buffered saline. Prescribed by eye care professionals for patients with refractive errors or presbyopia. Lenses provide optical correction; discarded after single use; no cleaning or disinfection required. Benefits include convenience of daily replacement and visual correction for distance, intermediate, and near ranges.

Clinical Evidence

One-month clinical study comparing subject lenses to concurrent predicate control. Evaluated performance in vision, ocular health, comfort, and fit. Results demonstrated similar overall performance to the predicate.

Technological Characteristics

Material: 69% water, 31% nelfilcon A (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). FDA Group 2 (nonionic). Oxygen permeability (Dk): 26 x 10^-11. Refractive index: 1.38. Manufacturing: Full Mold Cast Lightstream Technology. Sterilization: Steam/autoclave. Packaging: Blister pack with phosphate-acetate buffered saline containing up to 0.02% Poloxamer 108.

Indications for Use

Indicated for daily wear optical correction of refractive ametropia (myopia, hyperopia, astigmatism) or presbyopia in non-aphakic persons with non-diseased eyes. Presbyopic patients require reading addition ≤ +3.00D and astigmatism ≤ 2.00D. Single-use daily disposable wear.

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

• Focus® DAILIES® (nelfilcon A) One-Day Contact Lens (K943487)
• VISITINT® lenses (K984273)
• Manufacturing Change-Surfactant Additive (K010636)
• Focus® DAILIES® Progressives (nelfilcon A) One-Day Visitint lenses (K003826)

Submission Summary (Full Text)

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DEC 1 5 2003

| CIBA Vision® Corporation | | | | Page 1 of 4 |
|------------------------------------------------------------|--|--|--|-------------|
| 11460 Johns Creek Parkway | | | | |
| Duluth, GA USA 30097 | | | | |
| Focus® DAILIES®, Focus® DAILIES® Toric and Focus® DAILIES® | | | | |
| Progressives | | | | |
| (nelfilcon A) ONE-DAY Soft Contact Lenses | | | | |
| 510(k) Summary of Safety and Effectiveness | | | | |

510(k) Summary , K

O33701

| <b>1. Submitter Information:</b> | | |
|----------------------------------|-------------------------------------------------------------------------------------|---------|
| Company: | CIBA Vision Corporation | |
| | 11460 Johns Creek Parkway | |
| | Duluth, Georgia USA 30097 | |
| Contact Person: | Alicia M. Plesnarski, RAC | |
| | Director, Global Regulatory Affairs | |
| Telephone: | 678-415-3924 | |
| FAX: | 678-415-3454 | |
| Date Prepared: | 24 November 2003 | |
| <b>2. Device Name:</b> | | |
| Common Name: | Soft Contact Lens | |
| Trade/Proprietary Name: | Focus® DAILIES®, Focus® DAILIES® Toric and | |
| | Focus® DAILIES® Progressives | |
| | (nelfilcon A) ONE-DAY CONTACT LENS | |
| Classification Name: | Daily Wear | |
| | Soft (hydrophilic) Contact Lens | |
| Device Classification: | Class II [21 CFR 886.5925 (b) (1)] | |
| <b>3. Predicate Device(s):</b> | | |
| | Lens Material: CIBA Vision's Focus® DAILIES® (nelfilcon A) One-Day Contact Lens | |
| | Clear lenses (spherical & toric): | K943487 |
| | VISITINT® lenses: | K984273 |
| | Manufacturing Change-Surfactant Additive: | K010636 |
| | Multifocal Design: CIBA Vision's Focus® DAILIES® Progressives (nelfilcon A) One-Day | |
| | Visitint lenses: | K003826 |

### 4. Description of Device:

The Focus® DAILIES®, Focus® DAILIES® Toric and Focus® DAILIES® Progressives (nelfilcon A) ONE-DAY CONTACT LENS are daily wear soft contact lenses intended for single use daily disposable wear. The Dailies lens is a spherical soft contact, Dailies toric lenses have a double thin zone design, and the Dailies Progressives iens is a progressive aspheric simultaneous vision soft contact lens. A constant near power profile is incorporated into each Progressive lens across the full range of distance powers. The near and intermediate powers are concentrated primarily in the central portion of the optical zone while the surrounding portion is weighted toward distance. The continuous changes in power across the surface of the lens allow patients

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| CIBA Vision.<br>A Novartis Company | CIBA Vision® Corporation<br>11460 Johns Creek Parkway<br>Duluth, GA USA 30097 | Page 2 of 4 |
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Focus® DAILIES®, Focus® DAILIES® Toric and Focus® DAILIES®
Progressives
(nelfilcon A) ONE-DAY Soft Contact Lenses

510(k) Summary of Safety and Effectiveness

requiring a reading addition of up to +3.00 diopters to see clearly at far, intermediate and near distances.

The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are clear or tinted from edge to edge for visibility purposes with the color additive copper phthalocyanine (CuP).

Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphateacetate buffered saline solution. The package storage saline may contain up to 0.02% Poloxamer 108.

The physical properties of the lens are:

| Refractive Index: | 1.38 (hydrated) |
|------------------------------------------------------|----------------------------------------------------|
| Center Thickness: | 0.09 to0.17 mm<br>(0.10 at -3.00D; 0.15 at +3.00D) |
| Light Transmittance: | 96% (approx) |
| Oxygen Permeability (Dk):<br>[35° C, Fatt corrected] | 26 x 10-11 (cm²/sec) (ml O2/ml x mm Hg) |
| Water Content: | 69% by weight in normal saline |

#### 5. Indications for Use:

Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not aphakic persons with non-diseased eyes.

Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of presbyopia in not aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

The lenses are to be prescribed for single use daily disposable wear. DAILIES® lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

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Image /page/2/Picture/0 description: This image shows a product information label for CIBA Vision Corporation, located at 11460 Johns Creek Parkway in Duluth, GA 30097. The label indicates that it is page 3 of 4. The product is Focus DAILIES, Focus DAILIES Toric, and Focus DAILIES Progressives, which are (nelfilcon A) ONE-DAY Soft Contact Lenses, and the label is a 510(k) Summary of Safety and Effectiveness.

# 6. Description of Safety and Substantial Equivalence

## 6.1 Comparison to Predicate Device (s):

- Lens Material [Predicate Lens current Focus DAILIES (nelfilcon A)]: . Lens material, chemical composition, formulation (except for addition of the manufacturing additive), manufacturing process, packaging and the sterilization method and cycle remain unchanged from the descriptions previously provided in motion and order remarket Notifications 510(k) K963487, K992446, K003826, K010636.
- Lens Design: . No change to established spherical, toric or multi-focal lens designs.

| | Comparison to CIBA Vision's Predicate Device | |
|-------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Table 1: | Predicate Device<br>Focus DAILIES (nelfilcon A) made without additive nelfilcon A | Focus DAILIES (nelfilcon A) made with additive nelfilcon A |
| Lens Material: | | |
| Material<br>Classification: | FDA Group 2<br>(> 50% H2O, nonionic polymer) | FDA Group 2<br>(> 50% H2O, nonionic polymer) |
| Water Content: | 69.4% | 68.4% |
| Light Transmittance<br>(clear lenses): | 100% | 100% |
| Oxygen Permeability<br>(Dk, Coulometric): | ~ 25 barrer | 25.86 barrer |
| Power Range: | +20.00 to -20.00D | +20.00 to -20.00D |
| Visibility Tint: | With or without Copper Phthalocyanine | With or without Copper<br>Phthalocyanine |
| Manufacturing<br>Method: | Full Mold Cast<br>Lightstream Technology | Full Mold Cast<br>Lightstream Technology |
| Lens Design: | Spherical and/or Multi-focal | Spherical and/or Multi-focal |
| Sterilization: | Steam sterilization, Validated<br>autoclave | Steam sterilization, Validated<br>autoclave |
| Packaging: | Blister Pack | Blister Pack |
| Package Storage<br>saline solution | Phosphate-acetate buffered saline with<br>up to 0.02% Poloxamer 108 | Phosphate-acetate buffered saline<br>with up to 0.02% Poloxamer 108 |

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Image /page/3/Picture/0 description: This image shows a document from CIBA Vision Corporation located in Duluth, GA. The document is labeled as "Page 4 of 4". The document discusses Focus DAILIES Toric and Focus DAILIES Progressives (nelfilcon A) ONE-DAY Soft Contact Lenses and is a 510(k) Summary of Safety and Effectiveness.

### 6.2 Non-clinical Testing

Results from a series of physical/chemical tests confirm that DAILIES lenses made r with or without the manufacturing additive were equivalent and within established specifications for the lenses. Successful results from in-vivo and in-vitro toxicology tests confirm the lenses remain non-toxic and biocompatible with the ocular environment.

### 6.3 Clinical Testing:

A one-month clinical study demonstrated similar overall performance to the concurrent predicate control in the clinically relevant areas of vision, health, and comfort and fit when worn for daily wear.

#### 7. Substantial Equivalence

DAILIES lenses made with or without the manufacturing additive are equivalent and within established specifications for the lens. The lenses maintain clinical performance expectations, established physical/chemical characteristics, and are stable and biocompatible with the ocular environment.

Any differences which may exist between lenses made with or without the additive do not adverselv affect the established performance characteristics and safety and effectiveness profile of the device.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

DEC 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alicia M. Plesnarski Director, Global Regulatory Affairs CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097-1556

Re: K033701

Trade Name: Focus® DAILIES®, Focus® DAILIES® Toric and Focus® DAILIES® Progressives (nelfilcon A) One-Day Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL; MVN Dated: November 24, 2003 Received: November 28, 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 - Alicia M. Plesnarski

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. Palgi 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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Part III. Indications for Use Statement v01, 24-Nov-03, Page 1 of 1 Premarket Notification 510(k): (nelfilcon A) Soft Contact Lens

#### INDICATIONS FOR USE STATEMENT PART III.

#### 510(k) Number:

Device Name(s):

Focus® DAILIES®, Focus® Toric, Focus® DAILIES® Progressives (nelfilcon A) One-Day Contact Lens

#### Indications For Use:

Focus® DAILIES® and Focus® DAILIES® Toric (neifilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.

Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of presbyopia in not aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

The lenses are to be prescribed for single-use daily disposable wear. DAILIES lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

| Prescription Use | |
|-----------------------------|--|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use ((21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,

**Nose and Throat Devices**

510(k) Number K 033701