SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS

{0}------------------------------------------------ K121201 OCT 2 6 2012 # 05 Summary of 510(k) Submission # Submitter Information: Address: St. Shine Optical Co., Ltd. 4,5F No. 276-2, Sec. 1, Ta Tung Rd. Hsi Chih Dist., 221, New Taipei City Taiwan R.O.C. Registration No .: 9617499 | Contact Person: | Thomas Kuo, | | |-----------------|-------------------|--| | | Manager, R&D Div. | | | Telephone: | 886-2-2647-9356 | | | Fax: | 886-2-8691-6776 | | | Date Prepared: | 11. Oct., 2012 | | ## Device: | Common Name: | Soft (Hydrophilic) Contact Lens | | | |-------------------------|---------------------------------------------------------------------------------------------------|--|--| | Trade/Proprietary Name: | Saview-Aqua 55 UV (methafilcon A) Visibility Tinted<br>Soft (Hydrophilic) Contact Lens | | | | | Saview-Aqua 55 UV Toric (methafilcon A) Visibility<br>Tinted Soft (Hydrophilic) Contact Lens | | | | | Saview-Aqua 55 UV Multifocal (methafilcon A)<br>Visibility Tinted Soft (Hydrophilic) Contact Lens | | | | Classification Name: | Soft (Hydrophilic) Contact Lens (daily wear) | | | | Device Classification: | Class II (21 CFR 886.5925) | | | | Product Code: | LPL | | | | Panel: | Ophthalmic | | | ## Predicate Devices: The predicate devices are Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens, Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Lens, and Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens covered under 510(k) K090806 and 55 UV (mcthafilcon A) Soft (hydrophilic) Contact Lens, 55 UV Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens and 55 UV Toric (methafilcon A) Soft (hydrophilic) Contact Lens covered under 510(k) K051095. {1}------------------------------------------------ #### Description of Devices: The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate, and using azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The UV blocker for Saview-Aqua 55 UV (methafilcon A) Visibility tinted Soft (Hydrophilic) Contact Lens averages 87.630 in the UVA range of 316 nm to 380 nm and 98.975 % in the UVB range of 315 % nm to 280 nm. The lens contains 55% water by weight and each lens is supplied sterile in a blister container containing 0.2 % hyaluronic acid polymer in saline solution. The lens is visibility tinted using Pigment Blue 15(Copper phthalocyanine) to make the lens more visible for handling. The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as a single vision lens. The Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable. The Savicw-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens. {2}------------------------------------------------ # K121201 # Table 1 Comparison Chart · · : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : | | Saview-Aqua 55 UV,<br>Saview-Aqua 55 UV Toric, and<br>Saview-Aqua 55 UV Multifocal Soft<br>(Hydrophilic) Contact Lens | 55 UV, 55UV<br>Multifocal, and 55 UV<br>Toric Soft<br>(Hydrophilic) Contact<br>Lens - K051095 | Safi-gel, Safi-gel Toric<br>and Safi-gel Multifocal<br>Soft (Hydrophilic)<br>Contact Lens - K090806 | |--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <b>Device</b> | | | | | <b>Material<br/>(Classification)</b> | methafilcon A<br>(Group 4) | methafilcon A<br>(Group 4) | methafilcon A<br>(Group 4) | | <b>Indication for use</b> | myopia, hyperopia,<br>presbyopia and<br>astigmatism | myopia, hyperopia,<br>presbyopia and<br>astigmatism | myopia, hyperopia,<br>presbyopia and<br>astigmatism | | <b>Water content</b> | 55 % | 55% | 55 % | | <b>Visible light<br/>transmittance<br/>(381 nm ~ 780 nm)</b> | 96.78 % | 90.3% | 90.30 % | | <b>UV Transmittance</b> | 6.7% | 9.1 % | 9.3 % | | <b>UVA(316 nm ~ 380 nm)</b> | 12.370 % | 15.816 % | | | <b>UVB(280 nm ~ 315 nm)</b> | 1.025 % | 2.435 % | | | <b>Dk (35° C)</b> | $21.4x10^{-11}$ | $18.9 x 10^{-11}$ | $18.9 x 10^{-11}$ | | <b>Powers</b> | +12.00D to -20.00D;<br>Cylinder powers -0.50D<br>to -2.50D (Saview-Aqua<br>55 UV Toric only);<br>Continuous add power to<br>+3.25 (Saview-Aqua<br>55 Multifocal only) | +4.00 D to -20.00 D;<br>Cylinder powers 0.50 D<br>to -2.50 D (55 UV Toric<br>only);<br>Continuous add power<br>to +3.25 (55UV<br>Multifocal only) | +4.00D to -20.00D;<br>Cylinder powers -0.50D<br>to -2.50D (Safi-gel Toric<br>only);<br>+12.00 D to -20.00 D<br>Continuous add power to<br>+3.25 (Safi-gel<br>Multifocal only) | | <b>Color</b> | Pigment blue 15 | Pigment blue 15 | Pigment blue 15 | | <b>Refractive index</b> | 1.404 (wet) | 1.410 (wet) | 1.410 (wet) | | <b>Method of manufacture</b> | Moulded | Moulded | Moulded | | <b>Package Storage saline<br/>solution</b> | Saline solution<br>containing hyaluronic<br>acid polymer | Saline solution | Saline solution with<br>hyaluropolymer | 05-3 ・ {3}------------------------------------------------ # Indication for Use: The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric and Saview-Aqua 55 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric and Saview-Aqua 55 UV Multifocal 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. # Description of Safety and Substantial Equivalence: A scries of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric, and Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, and to establish substantial equivalence to the predicate devices. Results of Acute Systemic Injection, Ocular Irritation and In Vitro Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. The Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric, and Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens were extracted and evaluated for presence of residue. Results showed no evidence of unsafe amounts of residue in the {4}------------------------------------------------ extracts. Moreover, results of Oral Toxicity, Acute Ocular Irritation and In Vitro Cytotoxicity Tests show the packaging or the storage solution to be non-toxic and non-irritating as well. Physicochemical testing of the Saview-Aqua 55 UV Lenses demonstrated equivalency to the predicate devices. #### Conclusion: · Information submitted in the 510(k) establishes that the Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric, and Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown our products remain sterile and the properties do not change before the expiration date. Therefore, the devices are substantially equivalent to the predicate devices. {5}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 St. Shine Optical Co., Ltd. Mr. Thomas Kuo Manager, R&D Division 4,5F No. 276-2, Sec. 1, Ta Tung Rd. Hsi Chih Dist., 221 New Taipei City Taiwan R.O.C. OCT.26 2002 Re: K121201 Trade/Device Name: Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Codes: LPL, MVN Dated: September 24, 2012 Received: October 1, 2012 Dear Mr. Kuo: 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, de needs mat hat (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 I ou may, arones 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. {6}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Drivised by a levice complies with other requirements of the Act that I Dri has intact a are regulations administered by other Federal agencies. You must or any I cutar statues and registents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI'N I all 607), labeling (21 OFR 803); good manufacturing practice requirements as set de rice-related daverse overals) (21 CER Part 820); and if applicable, the electronic form in the quant on 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 11 you desire specific ad 170 bout FDA/Centers Offices/CDRHOffices/ucm115809.htm for go to mtp.//www.idai.gov.il Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation onations 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 I ou may of amel generational 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, Dubral Falls Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ KI2I20I # 04 Indications for Use Statement ## 510(k) Number (if known):___K121201 #### Device Name: Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens #### Indications for Use: The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wcar for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive am etropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) the correction of refractive ametropia Contact Lens is indicated for daily wear for (myopia and hyperopia) and presbyopia in aphakic or or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric and Saview-Aqua 55 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are to be prescribed for single-use daily disposable wear and 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 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Marc Robley (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K121201