EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D)

{0}------------------------------------------------ Image /page/0/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 of three human profiles facing right, arranged in a cascading manner. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 15, 2015 EyeReg Consulting, Inc. I-SEE VISION TECHNOLOGY Inc. Mr. Bret Andre Official Correspondent 474 NE 61st PL Hillsboro, OR 97124 Re: K150293 Trade/Device Name: Ezvue Uv, Soft Daily Wear Contact Lenses (ocufilcon D), Ezvue Colors, Soft Daily Wear Contact Lenses (oculfilcon D) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: February 3, 2015 Received: February 6, 2015 Dear Mr. Andre: 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. {1}------------------------------------------------ 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 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 Y. Alexander -A 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 {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K150293 #### Device Name EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D) EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D) Indications for Use (Describe) The EZvue UV (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The EZvue Colors (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients. Frequent/Planned Replacement Wear: Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for single use Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lens is to be discarded after each removal. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | The assigned 510(k) number is: | <b>K150293</b> | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------| | Applicant information: | | | Date Prepared: | 03/30/2015 | | Name: | I-SEE VISION TECHNOLOGY INC.<br>1F, No.45, Lane 2, Sec. 2,<br>Kuang-Fu Road, Hsinchu 30071,<br>Taiwan, R.O.C. | | Contact Person: | Isaac Huang<br>Special Assistant to President | | Phone number: | +886-3-5752822 | | Consultant: | Bret J Andre<br>EyeReg Consulting, Inc.<br>474 NE 61st Pl<br>Hillsboro, OR 97124<br>United States | | Phone number: | (503) 372-5226 | | Device Information: | | | Device Classification: | Class II | | Product Code: | LPL; MVN | | Classification Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) | | Trade Name: | EZvue UV, Soft Daily Wear Contact Lenses<br>(ocufilcon D)<br>EZvue Colors, Soft Daily Wear Contact Lenses<br>(ocufilcon D) | {5}------------------------------------------------ ## Equivalent Devices: The EZvue UV (ocufilcon D) and EZvue Colors (ocufilcon D), Soft Daily Wear Contact Lenses are substantially equivalent to the following predicate devices: Predicate devices: - "EZyue (ocufilcon D)" . By I-See Vision Technology Inc. 510(k) number: K082879 Primary Predicate - "42 UV (hefilcon A)" . By Optical Connection, Inc. 510(k) number: K040900 Reference Predicate - "Frequency Colors (methafilcon A)" . By Coopervision, Inc. 510(k) number: K001090 Reference Predicate ## EZvue UV(ocufilcon D) Device Description: The EZvue UV soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The nonionic lens material (ocufilcon D) is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution. The (ocufilcon D) name has been adopted by the United States Adopted Names Council (USAN). A UV absorbing monomer-2-(Benzoyl-3-hydroxyphenoxy)ethyl acrylate-is incorporated in the contact lens material to block UV radiation. The UV blocking for EZvue UV averages >95% in the UVB range of 280nm - 315nm and >50% in the UVA range of 316nm - 380mm. EZvue UV lenses are available clear and visibility tinted (for handling) using C.I. Reactive Blue Dye #19. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (ocufilcon D) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution. {6}------------------------------------------------ ## EZvue Colors (ocufilcon D) Device Description: The EZvue Colors soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The nonionic lens material (ocufilcon D) is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution. The (ocufilcon D) name has been adopted by the United States Adopted Names Council (USAN). EZvue Colors lenses are tinted to enhance or alter the apparent color of the eye. Lenses are tinted with a combination of one or more of the following 'listed' color additives: | Name of Colorant | Listing | |-------------------------|------------------| | C.I. Reactive Blue 19 | 21 CFR § 73.3127 | | C.I. Pigment Green 7 | 21 CFR § 73.3124 | | Iron oxides | 21 CFR § 73.3125 | | C.I. Reactive Yellow 86 | 21 CFR § 73.3121 | | C.I. Reactive Black 5 | 21 CFR § 73.3127 | | C.I. Pigment Violet 23 | 21 CFR § 73.3107 | | Titanium dioxide | 21 CFR § 73.3126 | Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by imprinting a listed color additive(s) on the non-optical zone area of the lens, which corresponds to the location of the iris. The imprinted color pattern is surrounded on both sides by layers of contact lens material (ocufilcon D). As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove any excess color additives. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens in the location that corresponds to the iris, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a Clear Pupil diameter of 5.5 to 9.0 mm. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (ocufilcon D) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution. {7}------------------------------------------------ The physical properties of the EZvue UV (ocufilcon D) and EZvue Colors (ocufilcon D). Soft Daily Wear Contact Lenses are: | Refractive Index | 1.410 | |-------------------------------|----------------------------------------------------------------------| | Light Transmission (clear/UV) | greater than 93% | | Light Transmission (color) | greater than 93% (clear region corresponding to pupil) | | Surface Character | hydrophilic | | Water Content | 55±2% | | Specific Gravity | 1.05 (hydrated) | | Oxygen Permeability | 16 x 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revised Fatt method) | The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 55% water by weight. The lenses will be manufactured in the spherical design configuration with the following features and properties: | Chord Diameter: | 13.60 mm to 15.00 mm | |-------------------|----------------------------------| | Center Thickness: | 0.060 mm to 0.200 mm | | Base Curve: | 8.40 mm to 9.10 mm | | Power Range | | | - Sphere Power: | -12.00D to +8.00D in 0.25D steps | ## Intended Use: The EZvue UV (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The EZvue Colors (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients. Frequent/Planned Replacement Wear: Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. {8}------------------------------------------------ #### K150293 ## Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for single use Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lens is to be discarded after each removal. ## Testing: - Non-clinical Testing A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the EZvue UV (ocufilcon D) and EZvue Colors (ocufilcon D), Soft Daily Wear Contact Lenses packaged in blister packages. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols. Test results of the non-clinical testing on the EZvue UV (ocufilcon D) and EZvue Colors (ocufilcon D), Soft Daily Wear Contact Lenses demonstrate that: - . Lenses supplied in blister packages are sterile for the indicated shelf-life, - . The packaging material and extracts are not toxic and not irritating, - Clinical Data The clinical performance of the (polymacon) lens material has been previously established, and therefore was not required for this 510(k). ## Conclusions Drawn from Studies #### Validity of Scientific Data Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, microbiology, chemistry, shelf-life stability studies and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7 ## Substantial Equivalence Information presented in this Premarket Notification establishes that the EZvue UV (ocufilcon D) and EZvue Colors (ocufilcon D), Soft Daily Wear Contact Lenses is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication. ## Risks and Benefits The risks of the subject device are the same as those normally attributed to the wearing of daily wear soft contact lenses. The benefits to the patient are the same as those for other daily wear soft contact lenses. {9}------------------------------------------------ ## Substantial Equivalence: The EZvue UV/ EZvue Colors Soft Contact Lens will be manufactured according to specified process controls and a cGMP quality assurance program currently in place. The final packaging and sterilization of the lenses will be carried out in accordance with the currently established procedures for EZvue (K082879), the predicate device. The established safety profile of the EZvue UV/ EZvue Colors contact lens material is equivalent to the predicate devices identified previously. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above. The following matrix illustrates the equivalencies of the EZvue UV(ocufilcon D) / EZvue Colors (ocufilcon D) Soft Contact Lenses for Daily Wear, as well as the substantial equivalent predicate devices. {10}------------------------------------------------ ## Substantial Equivalence Matrix | | I-See Vision<br>Technology Inc.<br>EZvue UV<br>(Subject Device) | I-See Vision<br>Technology Inc.<br>EZvue Colors<br>(Subject Device) | I-See Vision<br>Technology Inc.<br>EZvue<br>(Primary Predicate<br>Device) | Optical<br>Connection, Inc.<br>42 UV<br>(Reference<br>Predicate Device) | Coopervision,<br>Inc.<br>Frequency<br>Colors<br>(Reference Predicate<br>Device) | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Soft Contact Lenses for<br>daily wear are indicated<br>for the correction of<br>refractive error in<br>aphakic and not aphakic<br>persons with non-<br>diseased eyes with<br>myopia or hyperopia<br>and/or possesses<br>refractive astigmatism<br>not exceeding 2.00<br>Diopters, and/or are<br>presbyopic. | Soft Contact Lenses for<br>daily wear are indicated<br>for the correction of<br>refractive error in<br>aphakic and not aphakic<br>persons with non-<br>diseased eyes with<br>myopia or hyperopia<br>and/or possesses<br>refractive astigmatism<br>not exceeding 2.00<br>Diopters, and/or are<br>presbyopic. The lens<br>may be used to enhance<br>or alter the apparent<br>color of the eye. | Soft Contact Lenses<br>for daily wear are<br>indicated for the<br>correction of<br>refractive error in<br>aphakic and not<br>aphakic persons with<br>non-diseased eyes<br>with myopia or<br>hyperopia and/or<br>possesses refractive<br>astigmatism not<br>exceeding 2.00<br>Diopters, and/or are<br>presbyopic. | Soft Contact Lenses<br>for daily wear are<br>indicated for the<br>correction of<br>refractive error in<br>aphakic and not<br>aphakic persons with<br>non-diseased eyes<br>with myopia or<br>hyperopia and/or<br>possesses refractive<br>astigmatism not<br>exceeding 2.00<br>Diopters, and/or are<br>presbyopic. | Soft Contact Lenses<br>for daily wear to<br>enhance or alter the<br>apparent color of<br>the eye, including<br>ocular masking, in<br>either sighted or<br>non-sighted eyes<br>that require<br>prosthetic contact<br>lens for the<br>management of<br>conditions such as<br>corneal, iris, or lens<br>abnormalities. | | Functionality | Same as predicate<br>device | Same as predicate<br>device | The contact<br>lenses act as a<br>refractive<br>medium that<br>focus light rays<br>from near and<br>distant objects<br>on the retina | The contact<br>lenses act as a<br>refractive<br>medium that<br>focus light rays<br>from near and<br>distant objects on<br>the retina | The contact<br>lenses act as a<br>refractive<br>medium that<br>focus light rays<br>from near and<br>distant objects<br>on the retina | | Indications | Daily Wear, Soft<br>(hydrophilic)<br>Contact Lens | Daily Wear, Soft<br>(hydrophilic)<br>Contact Lens | Daily Wear, Soft<br>(hydrophilic)<br>Contact Lens | Daily Wear, Soft<br>(hydrophilic)<br>Contact Lens | Daily Wear, Soft<br>(hydrophilic)<br>Contact Lens | | Production<br>Method | Fully-molded | Fully-molded | Fully-molded | Fully-molded | Fully-molded | | USAN name | ocufilcon D | ocufilcon D | ocufilcon D | hefilcon A | methafilcon A | | Water Content<br>(%) | 55±2% | 55±2% | 55±2% | 42±2% | 55±2% | | Oxygen<br>Permeability | $16 x 10^{-11}$<br>(cm²/sec)(mlO₂)/(ml x<br>mmHg @ 35°C))<br>(revised Fatt method) | $16 x 10^{-11}$<br>(cm²/sec)(mlO₂)/(ml x<br>mmHg @ 35°C))<br>(revised Fatt method) | $16 x 10^{-11}$<br>(cm²/sec)(mlO₂)/(ml<br>x mmHg @ 35°C))<br>(revised Fatt method) | | $15.04 x 10^{-11}$<br>(cm²/sec)(mlO₂)/(ml<br>x mmHg @ 35°C)) | | UV<br>Transmittance | <5% UVB<br>(280nm - 315nm)<br><50% UVA<br>(316nm - 380nm) | | | < 10% UVB | | | Specific Gravity | 1.05 (hydrated) | 1.05 (hydrated) | 1.05 (hydrated) | 1.039 (hydrated) | |