SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS

{0}------------------------------------------------ # K123484 Page 1 of 5 Page 1 of 3 # MAR 2 9 2013 ## 510(k) Summary ### 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: | Ella Lee | | | Project Manager, R&D Div. | | Telephone: | 886-2-2647-9356 | | Fax: | 886-2-8691-6776 | | Date Prepared: | Mar. 12, 2013 | #### Device: | Common Name: | Soft (Hydrophilic) Contact Lens | |-------------------------|-----------------------------------------------------------------------------| | Trade/Proprietary Name: | Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens | | | Saview-Colors 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens | | | Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens | | Classification Name: | Soft (Hydrophilic) Contact Lens (daily wear) | | Device Classification: | Class II (21 CFR 886.5925) | | Product Code: | LPL, MVN | | Panel: | Ophthalmic | ### Predicate Devices: The predicate devices are S 42 UV Single Vision (hefilcon A) Soft (hydrophilic) Lens, T 42 UV Toric (hefilcon A) Soft (hydrophilic) Lens and M 42 UV Multifocal (hefilcon A) Soft (hydrophilic) Lens covered under 510(k) K040900 and FreshLook ", Freshlook® Toric and FreshLook® Progressive (nelfilcon A) One Day Color Contact Lens covered under 510(k) K050213. #### Description of Devices: {1}------------------------------------------------ The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA), and using azobisisobutyronitrile (AIBN) as the initiator. A compound 22-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl] UV absorbing ethvl methacrylate is incorporated into the lens polymer. The lens contains 42% water by weight and each lens is supplied sterile in a blister container in saline solution. The lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, phthalocyanine green and carbazole violet listed in 21 CFR Part 73 and [phthalocyaninato (2-)] copper list in 21 CFR Part 74. The Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is available as a single vision lens. The Saview-Colors 42 UV Toric (hefilcon A) 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 Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens. #### Indication for Use: The Saview-Colors 42 UV (hefilcon A) 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-Colors 42 UV also acts to enhance or alter the apparent color of the eye. The Saview-Colors 42 UV Toric (hefilcon A) 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-Colors 42 UV Toric lens also acts to enhance or alter the apparent color of the eye. The Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and {2}------------------------------------------------ hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal 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-Colors 42 UV lens also acts to enhance or alter the apparent color of the eye. Eve care practitioners may prescribe the lenses for single use disposable wear or frequent replacement. When prescribed for a Disposable Wearing Schedule, the lenses are not intended to be cleaned or disinfected and should be discarded after a single use. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. The Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. #### Non-Clinical Testing: The following tests were conducted as recommended by the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994. - Stability Testing - . Toxicology Testing - Cytotoxicity i - Ocular Irritation 8 - Acute Systemic Injection - Physical/Chemical Testing C #### Clinical Testing: Clinical data is not required for this submission. #### Description of Safety and Substantial Equivalence: Information submitted in the 510(k) cstablishes that the Savicw-Colors 42 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Results of Results of acute systemic injection, ocular irritation and in vitro cvrotoxicity tests showed the Saview-Colors 42 UV lenses are substantially equivalent to the predicate device in safety and biocompatibility. Therefore, the Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices. {3}------------------------------------------------ and the comments of the country of the country of : . : 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上一篇: 上 . . | | | S 42 UV Single Vision,<br>T 42 UV Toric and M<br>42 UV Multifocal<br>(hefilcon A) Soft<br>(hydrophilic) Lens -<br>K040900 | FreshLook®<br>(nelfilcon A) One<br>Day Color Contact<br>Lens - K050213 | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Device | Saview-Colors 42 UV,<br>Saview-Colors 42 UV Toric,<br>and Saview-Colors 42 UV<br>Multifocal (hefilcon A) Soft<br>(Hydrophilic) Contact Lens | | | | Material<br>(Classification) | hefilcon A<br>(Group 1) | hefilcon A<br>(Group 1) | nelfilcon A<br>(Group 2) | | Indication for use | myopia, hyperopia, presbyopia<br>and astigmatism | myopia, hyperopia,<br>presbyopia and<br>astigmatism | myopia, hyperopia,<br>presbyopia and<br>astigmatism | | Water content | 42 % | 42 % | 69 % | | Visible light<br>transmittance | 97.06 % | 90.3 % | Clear≥97 %<br>Vistint 96 % | | UV Transmittance | UVA : 0.49 %<br>UVB : 9.22 % | <10 % | N/A | | Dk (35° C) | $10.89x10^{-11}$ | $13.375x10^{-11}$ | $26x10^{-11}$ | | Powers | +12.00D to -20.00D; | +20.00D to -20.00D; | +20.00D to -20.00D | | Refractive index | 1.4347 (wet) | 1.416 (wet) | 1.38 (wet) | | Method of<br>manufacture | Moulded | Moulded | Moulded | | Packaging | PP Blister Pack | PP Blister Pack | Blister Pack | | Package Storage<br>saline solution | Saline solution | Saline solution | Phosphate-acetate<br>buffered saline | | Colorants | Iron oxides<br>Titanium dioxide<br>[Phthalocyaninato (2-)] copper<br>Phthalocyanine green | N/A | Iron oxides<br>Titanium dioxide<br>[Phthalocyaninato<br>(2-)] copper<br>Chromium oxide | ## Table 1 Comparison Chart : : : . 05-4 : . . {4}------------------------------------------------ #### Conclusion: A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens and to establish substantial equivalence to the predicate devices. Information submitted in the 510(k) also establishes that the Savicw-Colors 42 UV lenses do not raise questions of safety and effectiveness. Therefore, the Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices. ------ {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bodies, representing service to the individual and the family. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement. #### DEPARTMENT OF HEALTH & HUMAN SERVICES March 29, 2013 Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 St. Shine Optical Co., Ltd. Ms. Ella Lee Product Manager, R&D Division 4,5 F/L No. 276-2, Sec. 1, Ta Tung Rd. Hsi Chih Dist., 221, New Taipei City Taiwan R.O.C. Re: K123484 Trade/Device Name: Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL. MVN Dated: March 5, 2013 Received: March 7, 2013 Dear Ms. Lee: 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. {6}------------------------------------------------ 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. 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Kesia YAlexander -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 {7}------------------------------------------------ #### Indications for Use Statement 510(k) Number (if known): K123484 Device Name: Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens Saview-Colors 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens #### Indications for Use: The Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia) 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-Colors 42 UV also acts to enhance or alter the apparent color of the eye. The Saview-Colors 42 UV Toric (hefilcon A) 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-Colors 42 UV Toric lens also acts to enhance or alter the apparent color of the eye. The Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the corrective ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal 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-Colors 42 UV lens also acts to enhance or alter the apparent color of the eye. Eve care practitioners may prescribe the lenses for single use disposable wear or frequent replacement. When prescribed for a Disposable Wearing Schedule, the lenses are not intended to be cleaned or disinfected and should be discarded after a single use. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. The Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. Prescription Use X (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) Marc Robboy 2013.03.21 08:33:09 -04'00' (Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K123484