FRESHLOOK ONE-DAY COLOR CONTACT LENS

{0}------------------------------------------------ ### MAR 2 8 2005 Image /page/0/Picture/1 description: The image shows the logo for CIBA Vision, a Novartis company, along with their corporate address. The address is listed as 11460 Johns Creek Parkway, Duluth, GA USA 30097. The image also mentions FreshLook sphere, FreshLook Toric, and FreshLook products. Page 1 of 2 FreshLook® sphere, FreshLook® Toric and FreshLook® Progressives (neifilcon A) One Day Color Soft Contact Lenses 510(k) Summary of Safety and Effectiveness 510(k) Summary K050213 1. Submitter Information: | Company: | CIBA Vision Corporation<br>11460 Johns Creek Parkway<br>Duluth, Georgia USA 30097 | |-----------------|---------------------------------------------------------------------------------------------------| | Contact Person: | Angela L. Bunn, RAC<br>Senior Regulatory Affairs Specialist,<br>Fashion Wear and Specialty Lenses | | Telephone: | Global Regulatory Affairs<br>678-415-3784 | 678-415-3454 FAX: 10, February 2005 Date Prepared: ### 2. Device Name: Soft Contact Lens - Common Name: . Trade/Proprietary Name: FreshLook®, FreshLook® Toric and ● FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses Classification Name: Daily Wear . - Soft (hydrophilic) Contact Lens - Class II [21 CFR 886.5925 (b) (1)] Device Classification: . ### 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 | Multifocal Design: CIBA Vision's Focus® DAILIES® Progressives (nelfilcon A) One Day K003826 Visitint lenses: # Print Process/Use of Color Additives: contact lenses P830037 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the CIBA Vision logo and address. The address is 11460 Johns Creek Parkway, Duluth, GA USA 30097. The image also mentions Freshlook sphere, Freshlook Toric, and FreshLook Progressives. FreshLook® sphere, FreshLook® Toric and FreshLook® Progressives (nelfilcon A) One Day Color Soft Contact Lenses 510(k) Summary of Safety and Effectiveness ### 4. Description of Device: FreshLook® (nelfilcon A) Soft (hydrophilic) One Day Color Contact Lenses are available in a spherical lens design, FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses are available in a multifocal lens design and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses are available in a toric design. The lenses are to be prescribed for single use daily disposable wear. The FreshLook®, FreshLook® Toric and FreshLook® Progressives (nelfilcon A) One-Day Colors Contact Lens are daily wear soft contact lenses intended for single use daily disposable wear. The FreshLook One-Day Colors contact lens is a spherical soft contact, FreshLook One-Day Colors Toric lenses have a double thin zone design, and the FreshLook One-Day Colors 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. IThe 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 (polyvinyl 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). FreshLook® (nelfilcon A) One Day Color Contact Lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, [phthalocyaninato (2-)] copper, chromium oxide and carbazole violet. Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphate-acetate buffered saline solution. The package storage saline may contain up to 0.02% Poloxamer 108. The physical properties of the lenses are: | - | Refractive Index: | 1.38 (hydrated) | |---|---------------------------|-----------------------------------------| | - | Center Thickness: | 0.09 to0.17 mm | | | | (0.10 at -3.00D; 0.15 at +3.00D) | | | | (varies with power) | | - | Light Transmittance: | Clear ≥ 97% | | | | Visitint 96% (approx) | | - | Oxygen Permeability (Dk): | 26 x 10-11 (cm2/sec) (ml O2/ml x mm Hg) | | | | at 35° C (Fatt corrected) | | - | Water Content: | 69% by weight in normal saline | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "Page 3 of" in a simple, sans-serif font. The text is positioned at the top left corner of the image. The number 3 is clearly visible, indicating that it is the third page of a document. The overall impression is that it is a header or footer element from a multi-page document. Image /page/2/Picture/1 description: The image shows the logo for CIBA Vision, a Novartis company, along with their corporate address at 11460 Johns Creek Parkway, Duluth, GA USA 30097. The image also contains the product names FreshLook sphere, FreshLook Toric, and FreshLook Progressives. These are identified as (nelfilcon A) One Day Color Soft Contact Lenses. The page number 'Page 3 of' is also visible in the upper right corner. 510(k) Summary of Safety and Effectiveness ### 5. Indications for Use: FreshLook® spherical and FreshLook® Toric (nelfilcon A) One Day Color Contact I Younesone indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased (myopla; nypoplaat and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye. FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or 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 FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye. The FreshLook® (nelfilcon A) One Day Color Contact Lenses are to be prescribed for single-use Daily Disposable Wear. The 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 DAILIES® (nelfilcon A)]: � Lens material, chemical composition, formulation, 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. - Lens Design: . No change to established spherical, toric or multi-focal lens designs. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for CIBA Vision, a Novartis company. The logo is black and white and features the word "CIBA" in large, bold letters above the word "Vision." The "i" in Vision is replaced with an eye symbol. Below the logo, the text "A Novartis Company" is written in a smaller font. CIBA Vision® Corporation 11460 Johns Creek Parkway Duluth, GA USA 30097 ## FreshLook® sphere, FreshLook® Toric and FreshLook® Progressives (nelfilcon A) One Day Color Soft Contact Lenses 510(k) Summary of Safety and Effectiveness | Comparison to CIBA Vision's Predicate Device | | | |----------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------| | Table 1: | Predicate Device | | | | DAILIES® (nelfilcon A) One Day Contact Lens<br>nelfilcon A | FreshLook® (nelfilcon A) One Day Color Contact Lens<br>nelfilcon A | | Lens Material: | nelfilcon A | nelfilcon A | | Material<br>Classification: | FDA Group 2<br>(> 50% H2O, nonionic polymer) | FDA Group 2<br>(> 50% H2O, nonionic polymer) | | Water Content: | 69% | 69% | | Light Transmittance<br>(clear lenses): | 99% | 97% | | Oxygen Permeability<br>(Dk, Coulometric): | ~25 barrers | ~25 barrers | | Power Range: | +20.00 to -20.00D | +20.00 to -20.00D | | Visibility Tint: | With or without Copper<br>Phthalocyanine | With or without Copper<br>Phthalocyanine | | Manufacturing<br>Method: | Full Mold Cast<br>Lightstream Technology | Full Mold Cast<br>Lightstream Technology<br>3-in-1 Print 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 | Phosphate-acetate buffered saline | ### rison to CIRA Vision's Predicate Device ### 6.2 Non-clinical Testing: - Results from a series of physical/chemical tests confirm that FreshLook® (nelfilcon A) One-Day Colors contact lenses were equivalent and within established specifications for the lenses. Preliminary shelf-life studies confirm the lenses are stable and compatible with the container packaging system, and have established a product shelf-life that will be extended over time following successful completion of testing intervals. Successful results from in-vivo and in-vitro toxicology tests confirm the lenses remain non-toxic and biocompatible with the ocular environment. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for CIBA Vision, a Novartis company, along with their corporate address at 11460 Johns Creek Parkway, Duluth, GA USA 30097. The image also mentions FreshLook sphere, FreshLook Toric, and FreshLook Progressives contact lenses. These are (nelfilcon A) One Day Color Soft Contact Lenses. The image also indicates that it is page 5 of 5. 510(k) Summary of Safety and Effectiveness ### 6.3 Clinical Testing: It was determined that Clinical Studies were not necessary to establish the safety it was dotemined the FreshLook® One Day Color (nelfilcon A) Soft Contact Lenses. This determination was based on the following: - The FreshLook® One Day Color (nelfilcon A) Soft Contact Lenses were . The FreshEdon® One Coaly equivalent to the predicate Dailies Consideration A) demonstrated to be substantially equivalent to the predicate Dailiers on Microsoft Soft Contact Lenses (K963487, K984273, K992446, K003826, and K010636). - The FreshLook® One Day Color (nelfilcon A) Soft Contact Lenses were . demonstrated to be substantially equivalent to the predicate FreshLook® Color, FreshLook ColorBlends®, FreshLook Dimensions™ and FreshLook Radiance™ (phemfilcon A) and the print technology and use of approved color additives under P830037. ### 7. Substantial Equivalence FreshLook® One Day Color contact lenses made with currently approved contact lens color additives utilizing the current 3-in-1 print technology used in FreshLook® (phemfilcon A) products is 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 difference which may exist between lenses made with or without the color additives does not adversely effect the established performance characteristics and safety and effectiveness profile of the device. The information provided in this submission established that the FreshLook ® One Day Color (nelfilcon A) Soft Contact Lenses in multiple designs and multiple colors and effects is equivalent in optical, chemical and physical properties of the predicate devices and does not rise any questions of safety and effectiveness. Therefore, the device is substantially equivalent to the predicate devices of Dailies® and FreshLook® Colors, FreshLook ColorBlends®, FreshLook Dimensions™ and FreshLook Radiance™. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human figures or abstract shapes. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 8 2005 CIBA Vision Corporation c/o Paul G. Oris Head, Global Regulatory Affairs 11460 Johns Creek Parkway Duluth, GA 30097-1556 Re: K050213 K030213 Trade/Device Name: FreshLook® (nelfilcon A) One Day Color Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: MVN Dated: December 29, 2004 Received: January 31, 2005 Dear Mr. Oris: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaller of 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 encreativent of the enactment date of the Medical Device Amendments, or to conninered proc to may 20, 1970) in accordance with the provisions of the Federal Food, Drug, de vices that have occh recuire approval of a premarket approval application (PMA). and Cosmette Act (110) that to neview subject to the general controls provisions of the Act. The I ou may, dicrorer, mains of the Act include requirements for annual registration, listing of general controls provision 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 is elassified (600 a007 of ols. Existing major regulations affecting your device can may or sate, or sater as a sateral Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found inther announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advisod that I Dr Firstean.that your device complies with other requirements of the Act that I Dr Has made a assnd regulations administered by other Federal agencies. You must or uny I oderal other 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 OFF 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. {6}------------------------------------------------ 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 (301) 827-8910. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, David M. Whipple 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 {7}------------------------------------------------ ### 510(k) Number: Device Name(s): FreshLook® Sphere, FreshLook® Toric and FreshLook® Toric and FreshLook® Progressives (nelfilcon A) One Day Color Contact Lens #### Indications For Use: FreshLook® spherical and FreshLook® Toric (nelfilcon A) One Day Color Contact FreshE00KW sphencarand PreshE0SC Toris (no the conection of refractive ametropia Lenses are indication for astigmatism) in not-aphakic persons with non-diseased (myopia, hyperopia and actiginal and FreshLook® Toric (nelfilcon A) One Day eyes. "The Presiness also act to enhance or alter the apparent color of the eye. FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses are i resnLooke i rogroson of (nomicolical correction of refractive ametropia (myopia or indicated for daily would on the open and opersons with non-diseased eyes who nyperopia) androi proubyopla in 100 diopters (D) or less and who may have 2.00 require a leading addition of - 5.00 the motinterfere with visual acuity. The diopters (D) on 1000 or designelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye. The FreshLook® (nelfilcon A) One Day Color Contact Lenses are to be prescribed The FreshEvoke (nollioon A) One ar. The lenses are not intended to be cleaned or disinfected and should be discarded after a single-use. Concurrence of CDRH, Office of Device Evaluation (ODE)  (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises | 510(k) Number | K050213 | |---------------|---------| |---------------|---------| | Prescription Use: | <img alt="prescription checkmark" src="prescription_checkmark.jpg"/> or Over the Counter Use <input type="checkbox" value="0"/> | |-------------------|---------------------------------------------------------------------------------------------------------------------------------| |-------------------|---------------------------------------------------------------------------------------------------------------------------------|