FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES

K050065 · Ciba Vision Corporation · MVN · May 27, 2005 · Ophthalmic

Device Facts

• Record ID: K050065
• Device Name: FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
• Applicant: Ciba Vision Corporation
• Product Code: MVN · Ophthalmic
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon 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 eves. 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 sinqle use.

Device Story

Focus DAILIES are daily-wear, single-use soft contact lenses made of nelfilcon A polymer. Available in spherical, toric (double thin zone), and progressive aspheric simultaneous vision designs. Progressives feature constant near power profile in central optical zone for far, intermediate, and near vision. Lenses are 69% water, tinted with copper phthalocyanine for visibility, and supplied in sterile saline blister packs. Prescribed by eye care professionals for patients with refractive errors or presbyopia. Patients wear lenses for one day and discard; no cleaning or disinfection required. Benefits include convenience of daily disposal and correction of vision without maintenance.

Clinical Evidence

Clinical studies demonstrated performance equivalent to concurrent predicate control in vision, ocular health, comfort, and fit for daily wear. Bench testing included physical/chemical characterization and in-vitro toxicology confirming non-toxicity and biocompatibility.

Technological Characteristics

Material: 69% water, 31% nelfilcon A (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). FDA Group 2 (>50% H2O, nonionic). Manufacturing: Full Mold Cast, Lightstream Technology. Sterilization: Steam/autoclave. Connectivity: None. Form factor: Spherical, toric, or progressive aspheric soft lens.

Indications for Use

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

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)
• Manufacturing Change-Processing Additive (K033701)
• Focus® DAILIES® Progressives (nelfilcon A) One-Day Visitint lenses (K003826)

Submission Summary (Full Text)

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

K050065

Image /page/0/Picture/2 description: The image shows the logo for CIBA Vision, a Novartis company. The logo is in black and white and features the word "CIBA" stacked on top of the word "Vision". The "i" in "Vision" is replaced with an eye symbol. Below the logo, it says "A Novartis Company".

CIBA Vision Corporation 11460 Johns Creek Parkway

Duluth, Georgia 30097-1556

# 510(k) Summary

#### 1. Submitter Information:

| Company: | CIBA Vision Corporation<br>11460 Johns Creek Parkway<br>Duluth, Georgia USA 30097 |
|-----------------|-----------------------------------------------------------------------------------|
| Contact Person: | Penny Northcutt, RAC |
| | Director, Global Regulatory Affairs |
| Telephone: | 678-415-3214 |
| FAX: | 678-415-4024 |

Date Prepared: 10 January 2005

## 2. Device Name:

- Common Name:
Soft Contact Lens

| • | Trade/Proprietary Name: Focus® DAILIES®, Focus® DAILIES® Toric and<br>Focus® DAILIES® Progressives<br>(nelfilcon A) ONE-DAY CONTACT LENS |
|---|------------------------------------------------------------------------------------------------------------------------------------------|
| • | Classification Name: Daily Wear<br>Soft (hydrophilic) Contact Lens |
| • | Device Classification: Class II [21 CFR 886.5925 (b) (1)] |

# 3. Predicate Device(s):

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 Manufacturing Change-Processing Additive: K033701

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 lens 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 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 tinted from edge to edge for visibility purposes with the color additive copper phthalocyanine (CuP).

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

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 nondiseased eves 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.

# 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 cleared Premarket Notifications 510(k) K963487, K984273, K992446, K003826, K010636, K033701.
- . Lens Design:

No change to established spherical, toric or multi-focal lens designs.

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

| Table 1: | Predicate Device | Modified Device |
|------------------|---------------------------------------------|---------------------------------------------------------|
| | Focus DAILIES (nelfilcon A) | Focus DAILIES (nelfilcon A) made<br>with additional PVA |
| Lens Material: | nelfilcon A | nelfilcon A |
| Material | FDA Group 2 | FDA Group 2 |
| Classification: | (> 50% H2O, nonionic polymer) | (> 50% H2O, nonionic polymer) |
| Water Content: | 69.4% | 68.4% |
| Power Range: | +20.00 to -20.00D | +20.00 to -20.00D |
| Visibility Tint: | With or without Copper Phthalocyanine | With Copper Phthalocyanine |
| Manufacturing | Full Mold Cast | Full Mold Cast |
| Method: | Lightstream Technology | 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 | Phosphate-acetate buffered saline with | Phosphate-acetate buffered saline |
| saline solution | up to 0.02% Poloxamer 108 | with up to 0.02% Poloxamer 108 |

## Comparison to CIBA Vision's Predicate Device

### 6.2 Non-clinical Testing:

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

### 6.3 Clinical Testing:

Clinical studies 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 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 adversely affect the established performance characteristics and safety and effectiveness profile of the device.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 2005

CIBA Vision Corporation c/o Ms. Penny M. Northcutt, RAC Director, Global Regulatory Affairs 11460 Johns Creek Parkway Duluth, GA 30097-1556

Re: K050065

Trade/Device Name: Focus® Dailies® (nelfilcon A) One-Day Contact Lens for Daily Wear (Spherical, Toric and Progressives) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: MVN Dated: May 23, 2005 Received: May 24, 2005

Dear Ms. Northcutt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed 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 encreate) is tegains actment date of the Medical Device Amendments, or to conniner of the ritar to May 20, 1978, in occordance with the provisions of the Federal Food, Drug, devices that have been received in quire approval of a premarket approval application (PMA). and Costnetter rest (110) that be device, subject to the general controls provisions of the Act. The I ou may, morelore, mainer of the Act include requirements for annual registration, listing of goleral controls pro resuring 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 to such additional controls. Existing major regulations affecting your device can may or subject to such adala 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 r lease of advisou that I Driver and in that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I catalog and the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Not 8 requirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of K Fart 677, Mooning (21 CFR Part 820); and if applicable, the electronic form in alle qualis (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

{5}------------------------------------------------

Part III. Indications for Use Statement v01, 07 January 2005, Page 1 of 1 Special 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 (nelfilcon 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 eves.

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 sinqle use.

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|-------------------|------------------------------------------------------------------------------------------|
| | <i>(Division Sign-Off)</i> |
| | Division of Ophthalmic Ear, Nose and Throat Devises |
| 510(k) Number | K050065 |
| Prescription Use: | <span style="text-decoration: overline;">X</span> or Over the Counter Use <span>☐</span> |