SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER

{0}------------------------------------------------ #### SAUFLON CLARITI 1 DAY CONTACT LENS 510(k) #### 510(K) SUMMARY AS REQUIRED BY SECTION 807.92(c) # JUL 2 6 2013 ## 1 .- SUBMITTER INFORMATION: Company Name: Sauflon Pharmaceuticals Ltd. Address: 49 - 53 York Street Twickenham Middlesex TWI 3LP Phone: 020 8322 4200 Fax: 020 8891 2833 Contact Person: Dr Christopher Smejkal DATE SUMMARY PREPARED: 16th January 2013 #### DEVICE NAME: | Trade Name: | Sauflon Clariti 1 Day (somofilcon A) Soft<br>(hydrophilic) Daily Disposable Contact Lens with UV<br>Blocker | |-----------------|-------------------------------------------------------------------------------------------------------------| | Common Name: | Soft Contact Lens | | Classification: | CLASS II (21 CFR 886.5925) CODE -LPL, MVN<br>SOFT (HYDROPHILIC) CONTACT LENS | ## 2 .- SUBSTANTIAL EQUIVALENCE: The sponsor considers the Sauflon Clariti 1 Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker to be substantially equivalent to the Acuvue Trueye (Narafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear single use which has been approved pursuant to K073485, and Air Optix (Lotrafilcon B) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear which has been approved pursuant to K033919/K073459. ## 3 .- DESCRIPTION of the DEVICE: The Sauflon Clariti I Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is available as a single vision, toric and multifocal The lens material (somofileon A) is a hydrophilic co-polymer of silicone lens. containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate. When hydrated the lens consists of 44.0% {1}------------------------------------------------ ## SAUFLON CLARITI I DAY CONTACT LENS 510(k) somofilcon A and 56,0%, water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used to block UV radiation: The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 30% in the UVA range of 316-380nm The Sauffon Clariti 1 Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sciera, with the following dimensions; | • Chord Diameter: | 13.0mm to 15.5mm | |---------------------------|-------------------------------| | • Centre Thickness: | 0.03mm to 0.50mm | | • Base Curve: | 7.5mm to 9.30mm | | • Powers: | -20.00 DS to +20.00 DS | | • Toric Cylinder options: | -0.75, -1.25, -1.75 and -2.25 | | • Toric Axis options: | 10° to 180° (10° steps). | - Multifocal Add: . Lens "LOW" = "low" for spectacle near ADD lens (Max +2.25 ADD) Lens "HIGH" = "high" for spectacle near ADD lens (+2.50 ADD or greater) The physical/optical properties of the lenses are: | Refractive Index: | 1.4003 | |-----------------------------|-------------------------------------------------------------------------------------------------------| | %Transmittance @ 590nm: | 98.13 | | %Transmittance @ 280-315nm: | 0.71 | | %Transmittance @ 316-380nm: | 20.62 | | Surface Character: | Hydrophilic | | Water Content: | 56% | | Oxygen Permeability (DK): | 60 x 10-11 (cm2/sec) (ml O2/ml x mmHg at 35°C (Fatt Method for determination of oxygen permeability). | | Specific Gravity: | 1.17 | ## 4.- INDICATIONS FOR USE Sauflon Clariti 1 Day (somofilcon A) Soft:(hydrophilic) Duily Disposable Contact Lens with UV blocker is indicated for: The SAUFLON CLARITI 1 DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2:00 Diopters that does not interfere with visual acuity. The SAUFLON CLARITI 1 DAY TORIC (somofilcon: A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or {2}------------------------------------------------ #### SAUFLON CLARITI 1 DAY CONTACT LENS 510(k) aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopiers. The SAUFLON CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-discused eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less. The SAUFLON CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eves that may exhibit astigmatism up to 10:00 Diopters and require a reading addition of +3.00 Diopters or less. The eye care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal: therefore no cleaning or disinfecting is required. Sauflon Clariti I Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Icns with UV blocker help protect against transmission of harmful UV radiation to the cornea and into the eve. #### 5 .- PREDICATE DEVICES The sponsor considers the SAUFLON CLARITI IDAY (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker to be substantially equivalent to the Acuvue Trueye (Narafilcon A) Soft (hydrophilic) Visibility Tinted Contact Lens for Daily Wear single use which has been approved pursuant to K073485, and Air Optix (Lotrafilcon B) Soft (hydrophilic) Visibility Tinted Contact Lens for Daily Wear which has been approved pursuant to K033919/K073459. The following table summarises the primary features for this comparison, illustrating the similarities and differences. {3}------------------------------------------------ | | | | omparison of Physical / Optical Properties for the SAUFLON CLARITI / Day (frydrophilit Contact Lenser Lenser Lenses for Daily Wear | TINT | CI Reactive Blue Dye 4 | Copper phthalocyanine | | |-------------------------------|----------------------------------------------------------|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | | ACUVUE<br>REDICATE DEVICE – SUEYE – SUEYE (RUEYE (RUEYE) | REDICATE DEVICE – AIR OPTIX 033919/K073459) | SUBJECT DEVICE - SAUFLON CLA | UV BLOCKER | Benzotriazole | None | Benzophenone | | ns matizria | larafilcon | otrafikon | Somofilcon . | MODULUS (MPa) | 0.66 | 0.92 | 0.55 | | SIDICATIONS<br>usi- | FOR Daily wear single | Daily wear monthly replacem | ally wear single us | TENSILE STRENGTH (MPa) | 0.72 | 0.9 | 1.05 | | MANUFAGTUR PROCESS | ist Mouldin | Cast Moulding | Cast Moulding | ELONGATION AT BREAK % | 170 | 205 | 163 | | | 47% | | | PACKAGING MATERIALS | Injected molded polypropylene blisters covered by aluminium foil laminate and blister strips are packed into printed cartons | Injected molded polypropylene blisters covered by aluminium foil laminate and blister strips are packed into printed cartons | Injected molded polypropylene blisters covered by aluminium foil laminate and blister strips are packed into printed cartons | | WATER CONTIEN REFRACTIVE NDEX | :41 | র হার। পর্যা | ୍ତା । ୨୦୦୯ | PACKAGING SOLUTION | Buffered saline solution containing up to 0.01% methyl ether cellulose | Phosphate buffered saline solution | Borate buffered saline solution containing 0.05% poloxamer | | ាត់ | 5% minimi | -96.9% | 296% | PACKAGING METHOD | Hermetically sealed blister pack | Hermetically sealed blister pack | Hermetically sealed blister pack | | | polurographic method | 0 ( Coulometric metho | (polarographic metho | | | | | | | 0.00 to +20.00 ID Tuc Visibility Tim | 0.00 to +20.00 | 00 to +20.00 | | | | | | | | Blue Visibility Tin | No Visibility Tin | | | | | . . . AUFLON CLARITI I DAY CONTACT LENS 510(K) . {4}------------------------------------------------ SAUFLON CLARITI I DAY CONTACT LENS 510(k : 上 . 1 -- {5}------------------------------------------------ ## SAUFLON CLARITI 1 DAY CONTACT LENS 510(k) ## 6 .- PHYSICOCHEMICAL STUDIES The physical, optical and chemical properties of the lenses as assessed by various test methods show substantial equivalency with the predicate devices as illustrated in the preceding table. Studies were also conducted to verify that leachable substances were either low or below measurable levels to assuage any concerns for its intended use, ## 7.- TOXICOLOGY STUDIES Sauflon Clariti (somofileon A) Soft (hydrophilie) Contact Lenses were assessed using ISO 10993 standards for cytotoxicity, maximization sensitisation, ocular irritation and systemic toxicity. All results passed with no evidence of adverse clinical effects caused by the lens. ## 8.- HUMAN CLINICAL STUDIES A clinical study was conducted to evaluate the safety and efficacy of SAUIFLON CLARITI (somofilcon.A) Soft (hydrophilic) Contact Lens with UV Blocker by comparison with Air Optix Aqua hydrophilic contact lenses (Ciba Vision Inc.). Subjects used OptiFree Replenish solution (Alcon'Laboratories Inc.) for daily lens maintenance, care and storage. The results of this study showed the safety. acceptability and substantial equivalence of the Sauflon CLARITI (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker to the predicate device for its intended use. ### 9 .- CONCLUSIONS Based on the above evaluations the SAUFLON CLARITI I DAY (somofileon Ay Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is substantially equivalent to the predicate, marketed lenses. Based on these evaluations the SAUFLON CLARITI I DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker has been shown to be safe and effective for its intended use. {6}------------------------------------------------ Public Health Service Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 26, 2013 Christopher Smejkal, M.D. Sauflon Pharmaceuticals, Ltd. Strategic Technical Projects Manager 49 - 53 York St. Twickenham, Middlesex United Kingdom TW1-3LP Re: K130331/S002 Trade Name: Sauflon Clariti 1-Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: II Product Code: MVN, LPL Dated: July 1, 2013 Received: July 8, 2013 Dear Dr. Smejkal: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {7}------------------------------------------------ Page 2 - Dr. Christopher Smejkal 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, ## Kesia Y. Alexander -S for 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 {8}------------------------------------------------ ## Indications for Use 510(k) Number (if known): ## Device Name: Sauflon Clarit 1-Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker Indications For Use: The SAUFLON CLARITI 1-DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The SAUFLON CLARITI 1-DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters. The SAUFLON CLARITI 1-DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less. The SAUFLON CLARITI 1-DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +3.00 Diopters or less. The eve care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required. Sauflon Clariti 1-Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lenses with UV Blocker help protect against transmission of harmful UV radiation to the cornea and into the eye. Page 1 of 2 {9}------------------------------------------------ ______________________________________________________________________________________________________________________________________________________________________________ Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Joseph C. Hutter -S 2013.07.22 15:45:02 -04'00' (Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number_ K130331 Page 2 of __2____