SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER

{0}------------------------------------------------ #### K130342 # 510(K) SUMMARY AS REQUIRED BY SECTION 807.92(c) # 1.- SUBMITTER INFORMATION: | Company Name: | Sauflon Pharmaceuticals Ltd. | |------------------------|-----------------------------------------------------------------------------------| | Address: | 49 - 53 York Street<br>Twickenham<br>Middlesex<br>TW1 3LP | | Phone: | 020 8322 4200 | | Fax: | 020 8891 2833 | | Contact Person: | Dr Christopher Smejkal | | DATE SUMMARY PREPARED: | 12th March 2013 | | | AUG 0 5 2013 | | DEVICE NAME: | | | Trade Name: | Sauflon Clariti (somofilcon A) Soft (hydrophilic)<br>Contact Lens with UV 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 (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker to be substantially equivalent to the Acuvue Advance (Galyfilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear single use which has been approved pursuant to K032340, 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 (somofilcon A) Soft (Silicone Hydrogel) Contact Lens with UV Blocker is available as a single vision, toric, multifocal and multifocal toric lens. The lens material (somofilcon A) is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate. When hydrated the lens consists of 44.0% 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. {1}------------------------------------------------ The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380nm The Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions: - Chord Diameter: 13.0mm to 15.5mm ● Centre Thickness: 0.03mm to 0.50mm . 7.5mm to 9.30mm Base Curve: . Powers: -20.00 DS to +20.00 DS . . Toric Cylinder options: -0.75, -1.25, -1.75 and -2.25 - Toric Axis options: . - . Multifocal Add: 10° to 180° (10° steps). 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)<br>at 35°C (Fatt Method for determination<br>of oxygen permeability). | | • Specific Gravity: | 1.17 | #### 4 .- INDICATIONS FOR USE Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker is indicated for: The SAUFLON CLARITI (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear 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 TORIC (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes that may exhibit astigmatism up to 10.00 Diopters. {2}------------------------------------------------ The SAUFLON CLARITI MULTIFOCAL (somofilcon A) Soft (hydrophilic) ontact Lens with UV blocker is indicated for monthly disposable wear 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 MULTIFOCAL TORIC (somofilcon A) Soft ydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear 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 that may require a reading addition of +3.00 Diopters or less. The lenses may be prescribed for daily wear with removal for cleaning and isinfection (chemical, not heat) prior to reinsertion as recommended by the eye care professional. Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact lens with UV blocker help protect against transmission of harmful UV radiation to the cornea and into the eye. # 5 .- PREDICATE DEVICES The sponsor considers the SAUFLON CLARITI (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker to be substantially equivalent to the Acuvue Advance (Galyfilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear which has been approved pursuant to K032340, and Air Optix (Lotrafilcon B) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear which has been approved pursuant to K033919/K073459. he following table summarises the primary features for this comparison, illustrating the similarities and differences. {3}------------------------------------------------ AUFLON CLARITI CONTACT LENS 510 K130342 omparison of Physical / Optical Properties for the SAUFLON A) hydrophilic Contact Lenser Lens with UV Blocker vs Acuvu dvance (Galyfilcon A) and Air Optix (Lorafilcon B) Soft | Advance (Galyfilcon A) and Air Optix (Lotrafilcon B) Soft (Hydrophilic) Visibility Tinted Contact Lenses for Daily Wear | | | | |-------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------------------------------------|----------------------------------| | | PREDICATE DEVICE – ACUVUE<br>(K032340) | PREDICATE DEVICE – AIR OPTIX<br>(K033919/K073459) | SUBJECT DEVICE - SAUFLON CLARITI | | LENS MATERIAL | Galyfilcon A | Lotrafilcon B | Somofilcon A | | INDICATIONS FOR USE | Daily wear bi-weekly replacement | Daily wear monthly replacement | Daily wear monthly replacement | | MANUFACTURING PROCESS | Cast Moulding | Cast Moulding | Cast Moulding | | WATER CONTENT | 47% | 33% | 56% | | REFRACTIVE INDEX | 1.41 | 1.42 | 1.40 | | LIGHT<br>TRANSMITTANCE | No data | ≥96% | ≥96% | | DK @35°C (EDGE<br>CORRECTED) | 60 (polarographic method) | 110 (Coulometric method) | 60 (polarographic method) | | POWERS | -20.00 to +20.00 D | -20.00 to +20.00 D | -20.00 to +20.00 D | | COLOUR | Aquamarine Visibility Tint | Blue Visibility Tint | No Visibility Tint | 9 Page 4 of {4}------------------------------------------------ K130342 | TINT | CI Reactive Blue Dye 4 | Copper phthalocyanine | | |------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | UV BLOCKER | Benzotriazole | None | Benzophenone | | MODULUS (MPa) | 0.39 | 0.92 | 0.55 | | TENSILE STRENGTH (MPa) | 0.68 | 0.9 | 1.05 | | ELONGATION AT BREAK % | 216 | 205 | 163 | | 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 | | 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 407. | | PACKAGING METHOD | Hermetically sealed blister pack | Hermetically sealed blister pack | Hermetically sealed blister pack | Page 5 of 6 {5}------------------------------------------------ # 6 .- PHYSICOCHEMICAL STUDIES The physical, optical and chemical properties of the lenses as assessed by various test methods show substantial equivalence 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 (somofilcon A) Soft (hydrophilic) 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 effects caused by the lens. #### 8.- HUMAN CLINICAL STUDIES A clinical study was conducted to evaluate the safety and efficacy of SAUFLON 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 (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is substantially equivalent to the predicate, marketed lenses. Based on these evaluations the SAUFLON CLARITI (somofilcon A) Soft (hydrophilic) 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 or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 5, 2013 Sauflon Pharmaceuticals Ltd c/o Dr. Christopher Smejkal Strategic Technical Projects Manager 49-53 York Street Twickenham, Middlesex TWI 3LP England Re: K130342 Trade/Device Name: Sauflon Clariti (somofileon A) Soft (hydrophilic) Contact Lens with UV blocker Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: July 2, 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}------------------------------------------------ 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm. Sincerely yours, # Deborah L. Falls -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: Sautlon Clariti (somofileon A) Soft (hydrophilie) Contact Lens with I'V blocker Indication for use: Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV hlocker is indicated for: The SAUFLON CLARITI (somofileon A) Soft (hydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-discased eyes that may exhibit astigmatism up to 2.00 Dioplers that does not interfere with visual acuity. The SAUFLON CLARITI TORK' (somofileon A) Soft (hydrophilic) Contact Lens with I V blocker is indivated for monthly disposable wear for the optical correction of refractive ancetopia (myopia and hyperopia) in phakic or aphakic persons with non-diseased cycs that may exhibit astigmatism up to 10.00 Diopters. The SAUFLON CLARITI MULTIFOCAL (somotileon A) Soft (hydrophilie) Contact Lens with IV blocker is indicated for monthly disposable wear for the optical correction of refractive anietronia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eves 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 MULTIFOCAL TORIC (somofilicon A) Soft (hydrophilic) Contact Lens with UV blocker is indicuted for monthly disposable wear for the optical correction of relractive ametropia (myopia and hyperopia) and/or preshyopia in phakic or aphakic persons with non-diseased eyes that may exhibit ustigmatism up to 10.00 Diopters and that may require a reading addition of +3.00 Diopters or less. The lenses may be prescribed for daily wear with removal for cleaning und disintection (chemical, not heat) prior to reinsertion as recommended by the eye care professional. Sauflon Clariti (somofileon A) Soft (hydrophilic) Contact lens with UV blocker help protect against transmission of harmful UV radiation to the cornea and into the eye. Over-The-Counter Use . . AND·OR Prescription I lse . (Part 21 CFR 801 Subpan 1)) (2) ('FR 80) Subpun C) (PLEASF DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of the CDRH. Office of Device Evaluation (ODE) J Angelo Green 2013.08.01 16:53:00 -04'00' (Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number: K130342