Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 9, 2019 VizionFocus, Inc. Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068 Re: K192225 Trade/Device Name: Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: November 1, 2019 Received: November 4, 2019 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192225 ### Device Name Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses Indications for Use (Describe) The Legacy (ocufilcon D) Performance-Tinted SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The Legacy (ocufilcon D) Performance-Tinted TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not-aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The Legacy ( ocufilcon D) Performance-Tinted MUL TIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with nondiseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients. Eye care 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. Eye care 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) | <span style="font-family: Arial, sans-serif;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |-----------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ # 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: K192225 #### SUBMITTER I. | Date Prepared: | December 6th, 2019 | |-----------------|---------------------------------------------------------------------------------| | Name: | VIZIONFOCUS INC. | | Address: | No.66, Youyi Rd., Zhunan Township<br>Miaoli County 350,<br>Taiwan (R.O.C.) | | Contact Person: | Angus Shih<br>General Manager | | Phone number: | 037-582900 | | Consultant: | Bret Andre<br>EyeReg Consulting, Inc.<br>6119 Canter Ln.<br>West Linn, OR 97068 | | Phone number: | (503) 372-5226 | #### II. DEVICE | Trade Name: | Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear<br>Contact Lenses | |-------------------------|-----------------------------------------------------------------------------------------| | Common<br>Name: | Contact Lens, Daily Wear | | Classification<br>Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) | | Regulatory<br>Class: | Class II | | Product Code: | LPL; MVN | ## Purpose of 510(k) Submission: ~ New Device ~ {4}------------------------------------------------ #### III. PREDICATE DEVICE The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are substantially equivalent to the following predicate device(s): - ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)" . By Vizionfocus, Inc. 510(k) number; K182247 Primary predicate . MAXSIGHT (polymacon) Sport-Tinted Contact Lens - By Bausch & Lomb, Inc. 510(k) number: K050157 Reference predicate ### IV. DEVICE DESCRIPTION The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufiocon D and 55% water by weight when immersed in saline solution. The (ocufiocon D) name has been adopted by the United States Adopted Names Council (USAN). The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are subsequently tinted to achieve different colors using permanently listed color additives that conform to 21 CFR Part 73.3121. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: | Color Additive | CAS Reg. No | Listing | |--------------------|-------------|------------------| | Reactive Black 5 | 17095-24-8 | 21 CFR § 73.3121 | | Reactive yellow 15 | 60958-41-0 | 21 CFR § 73.3121 | | Reactive orange 78 | 68189-39-9 | 21 CFR § 73.3121 | | Reactive red 180 | 98114-32-0 | 21 CFR § 73.3121 | The Legacy (ocufilcon D) Performance-Tinted Contact Lenses are designed to aid visual performance in athletic settings. Legacy (ocufilcon D) Performance Tinted Contact Lenses enhance contrast in a wide range of outdoor light conditions. This enables the wearer to see a ball or selected objects with greater clarity than with the naked eye. {5}------------------------------------------------ The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280mm - 315nm), and >50% in the UVA range (316nm - 380nm). The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are manufactured in the sphere, toric, and multifocal design configurations. The material properties and available parameters of the finished lenses are as follows: | Parameter | Range | Tolerance* | |----------------------------------------------------------------|----------------------------------------|---------------------------------------------------------------------------------| | Chord Diameter | 11.00 mm to 15.00 mm | ±0.20 mm | | Center Thickness | 0.05 mm to 0.15 mm | When ≤ 0.10 mm → ±0.010 mm + 10%<br>When > 0.10 mm → ±0.015 mm + 5% | | Base Curve | 7.00 mm to 10.0 mm | ±0.20 mm | | Back Vertex Power (F'v) | +20.00D to -20.00D<br>(in 0.25D steps) | When 0.00 < F'v ≤ 10.00 D → ±0.25 D<br>When 10.00 < F'v ≤ 20.00 D → ±0.50 D | | Cylinder Power (F'c) | -0.25D to -4.00D<br>(in 0.25D steps) | When 0.00 < F'c ≤ 2.00 D → ±0.25 D<br>When 2.00 < F'c ≤ 4.00 D → ±0.37 D | | Cylinder Axis | 10° to 180°<br>(in 10° steps) | When 0.00 < F'c ≤ 1.50 D → ± 8°<br>When F'c > 1.50 D → ± 5° | | Multifocal Add Power | +0.25D to +4.00D (0.50D steps) | ±0.37 D | | Surface Appearance | - | Lenses should be clear with no surface defect | | Oxygen Permeability<br>(x 10-11(cm²/sec)(mlO2)/(ml<br>x mmHg)) | 19.6 | ±20% | | Light Transmission - Tinted<br>(@ 380-780nm) | > 38% | ±5% | | Ultraviolet Radiation<br>Transmittance | < 5 % TUVB<br>< 50 %TUVA | TUVB (280 to 315 nm) < 0.05Tv<br>TUVA (316 to 380 nm) < 0.50Tv | | Water Content | 55% | ±2% | | Refractive Index | 1.410 (hydrated) | ±0.005 | *ANSI Z80.20, Ophthalmics – Contact Lenses – Standard Terminology, Tolerances, Measurements And Physicochemical Properties (2010) {6}------------------------------------------------ ### V. INDICATIONS FOR USE The Legacy (ocufilcon D) Performance-Tinted SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or notaphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The Legacy (ocufilcon D) Performance-Tinted TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The Legacy (ocufilcon D) Performance-Tinted MULTIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients. Eye care 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. Eye care 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. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE VI. DEVICE The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are substantially equivalent to the predicate devices identified (K182247 and K050157) in terms of the following: - USAN contact lens material (ocufilcon D) . - 트 FDA Group 4 (>50% H2O, ionic polymer) - FDA classification Soft (hydrophilic) Contact Lens (21 CFR 886.5925) . - . Intended use - daily wear contact lenses - " Actions - 트 Indications for use - Design configurations available (spherical, toric, multifocal) 트 - . UV absorber - I Cast molded production method {7}------------------------------------------------ The following matrix illustrates the production method, lens function and material characteristics of the Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses, as well as the predicate devices. | | Vizionfocus<br>Legacy Performance-<br>Tinted<br>(Subject Device) | Vizionfocus<br>ILICON 55 UV<br>(Predicate Device)<br>(K182247) | Bausch & Lomb,<br>Maxsight sport-tinted<br>(Predicate Device)<br>(K050157) | |------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Indicated for daily wear<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 presbyopia. | Indicated for daily wear<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. | For the correction of visual<br>acuity in not aphakic<br>persons with non-diseased<br>eyes with myopia or<br>hyperopia and may<br>exhibited refractive<br>astigmatism up to 2.00<br>diopters that does not<br>interfere with visual acuity. | | Actions | The contact lenses act as<br>a refractive medium that<br>focus light rays from<br>near and distant objects<br>on the retina | The contact lenses act as<br>a refractive medium that<br>focus light rays from<br>near and distant objects<br>on the retina | The contact lenses act as a<br>refractive medium that<br>focus light rays from near<br>and distant objects on the<br>retina | | FDA Classification | Soft (hydrophilic)<br>Contact Lens (21 CFR<br>886.5925) | Soft (hydrophilic)<br>Contact Lens (21 CFR<br>886.5925) | Soft (hydrophilic) Contact<br>Lens (21 CFR 886.5925) | | FDA Group | FDA Group 4<br>(>50% H2O, ionic<br>polymer) | FDA Group 4<br>(>50% H2O, ionic<br>polymer) | FDA Group 1<br>(<50% H2O, non-ionic<br>polymer) | | Production Method | Fully molded | Fully molded | Fully molded | | USAN name | ocufilcon D | ocufilcon D | polymacon | | Water Content (%) | 55±2% | 55±2% | 38.6±2% | | Oxygen Permeability<br>x 10-11 (cm²/sec)(mlO2)/(ml x<br>mmHg @ 35°C)) (revised Fatt<br>method) | 19.6 | 19.6 | 8.4 | | Refractive Index<br>(hydrated) | 1.410 | 1.410 | 1.43 | | Modulus (MPa) | 0.49 | 0.49 | - | | UV Blocker | Yes | Yes | No | ## Substantial Equivalence Matrix {8}------------------------------------------------ #### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ## Non-clinical Testing A series of preclinical testing was performed to demonstrate the safety and effectiveness of the finished contact lenses. The results support the claim that the Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are substantially equivalent to the currently marketed predicate devices. A summary of the results from the preclinical studies is presented below. ## Toxicology: All non-clinical toxicology tests were conducted in accordance with the GLP regulation. - · In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the finished lenses and packaging materials are non-toxic. - · Systemic Toxicity: The finished lenses and packaging materials meet the requirements of the systemic injection test in accordance with ISO 10993-11 and are considered non-toxic. - Acute Ocular Irritation: Acute ocular irritation test was performed in accordance with ISO 10993-10 and produced no ocular irritation for the finished lenses and packaging materials. ## Solution Compatibility: The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are manufactured from ocufilcon D (USAN), which is compatible with chemical disinfection systems currently marketed in the US for use with soft (hydrophilic) contact lenses. ## Shelf Life: Testing was performed to evaluate the stability, sterility, and package integrity of the Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses over the duration of the labeled expiration date. The data presented supports substantial equivalence of the contact lenses to the already marketed predicate devices. ## Physicochemical & Mechanical Properties: The following tests were completed to verify substantial equivalence with the primary predicate device: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals. {9}------------------------------------------------ Results of physicochemical and mechanical property testing demonstrate consistent material properties between the Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses and the predicate devices. ## Clinical Testing Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from ocufilcon D materials has been demonstrated previously. ## VIII. CONCLUSIONS ## Validity of Scientific Data Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability studies following 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 Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication. ## Risks and Benefits The risks of the subject device are the same as those normally attributed to the wearing of tinted soft (hydrophilic) daily wear contact lenses. In addition to the benefits from other tinted soft (hydrophilic) daily wear contact lenses, Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses aid visual performance in athletic settings.