TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

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August 5, 2022 DK Medivision Co., Ltd. % Bret Andre Principal Consultant EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068 ### Re: K220045 Trade/Device Name: TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: June 28, 2022 Received: July 1, 2022 ### Dear Bret 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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 Quality 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) K220045 #### Device Name TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) #### Indications for Use (Describe) The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit 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 eve, The eye care professionals may prescribe the lens for single use daily wear in a frequent replacement program. As prescribed for planned replacement, the lens should be dising a chemical or hydrogen peroxide disinfecting system. 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) #### 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 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: K220045 #### I. SUBMITTER | Date Prepared: | June 25th, 2022 | |-------------------|--------------------------------------------------------------------------------------------------------------| | Name:<br>Address: | DK Medivision Co., Ltd.<br>23 Busong 1-gil, jiksan-eup,<br>Seobuk-gu Cheonan-si, Chungcheongnam-do,<br>KOREA | | Contact Person: | Henry Hong<br>Q.A manager | | Phone number: | (82)415810100 | | 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: | TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted Color) | |----------------------|----------------------------------------------------------------------| | Common Name: | Contact Lens, Daily Wear | | Classification Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) | | Regulatory Class: | Class II | | Product Code: | LPL; MVN | ## Purpose of 510(k) Submission: ~ New Device ~ {4}------------------------------------------------ #### III. PREDICATE DEVICE The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are substantially equivalent to the following predicate device(s): - "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens" By YUNG SHENG OPTICAL 510(k) number; K132854 Primary Predicate - "ChicView (Polymacon) Daily Wear Soft (Hydrophilic) Contact Lenses (Tinted/Color)" By JOOWON INNOVATION CO., LTD. 510(k) number: K161098 Reference Predicate #### IV. DEVICE DESCRIPTION The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN). The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are available clear, tinted for visibility, or tinted to enhance or alter the apparent color of the eye. 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 | Listing | |-------------------------|------------------| | Iron Oxide | 21 CFR § 73.3125 | | C.I. Reactive Blue No.4 | 21 CFR § 73.3121 | | Reactive Black 5 | 21 CFR § 73.3127 | | Titanium Dioxide | 21 CFR § 73.3126 | When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm. The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315mm), and >50% in the UVA range (316nm - 380nm). {5}------------------------------------------------ ### The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are manufactured in an aspheric design configuration. 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)<br>(in 0.25D steps) | -0.50 D to -12.00D | When 0.00 < F'v ≤ 10.00 D → ±0.25 D<br>When 10.00 < F'v ≤ 20.00 D → ±0.50 D | | Surface Appearance | - | Lenses should be clear with no surface defect | | Oxygen Permeability<br>(x 10-11(cm²/sec)(mlO2)/(ml<br>x mmHg)) | 11.12 | ±20% | | Light Transmission - Tinted<br>(@ 380-780nm) | 95% | ±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 | 38% | ±2% | | Refractive Index | 1.440 (hydrated) | ±0.005 | * ISO 18369-2:2017 Ophthalmic optics - Contact lenses - Part 2: Tolerances #### V. INDICATIONS FOR USE The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who exhibit 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. The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a frequent replacement program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system. {6}------------------------------------------------ #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are substantially equivalent to the predicate devices identified (K132854 and K161098) in terms of the following: - USAN contact lens material (polymacon) - FDA Group 1 (<50% H2O, non-ionic polymer) - FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925) - 트 Intended use - daily wear contact lenses - Actions - Indications for use - 트 UV absorber - Cast molded production method - Pad-printing contact lens tinting method (reference predicate K161098) The following matrix illustrates the production method, lens function and material characteristics of the TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color), as well as the predicate devices. | | DK Medivision<br>TREVUES<br>(Subject Device) | Yung Sheng Optical<br>Eyesecret 38 UV<br>(K132854) | Joowon Innovation<br>ChicView<br>(K161098) | |----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | Actions | The contact lenses act as a<br>refractive medium that focus<br>light rays from near and distant<br>objects on the retina | The contact lenses act as a<br>refractive medium that focus<br>light rays from near and<br>distant objects on the retina | The contact lenses act as a<br>refractive medium that focus<br>light rays from near and<br>distant objects on the retina | | FDA Classification | Soft (hydrophilic) Contact<br>Lens (21 CFR 886.5925) | Soft (hydrophilic) Contact<br>Lens (21 CFR 886.5925) | Soft (hydrophilic) Contact<br>Lens (21 CFR 886.5925) | | FDA Group | FDA Group 1<br>(<50% H2O, non-ionic<br>polymer) | FDA Group 1<br>(<50% H2O, non-ionic<br>polymer) | FDA Group 1<br>(<50% H2O, non-ionic<br>polymer) | | Production Method | Fully molded | Fully molded | Fully molded | | USAN name | polymacon | polymacon | polymacon | | Water Content (%) | 38±2% | 38±2% | 38±2% | | Oxygen Permeability<br>x 10-11 (cm2/sec)(mlO2)/(ml x mmHg<br>(@ 35°C)) (revised Fatt method) | 11.12 | 13.35 | 11.15 | | Refractive Index<br>(hydrated) | 1.440 | 1.440 | 1.435 | | UV Blocker | Yes | Yes | No | | Pad-Printed Tinting | Yes | No | Yes | | Sterilization Process | Steam sterilization | Steam sterilization | Steam sterilization | | Packaging | Blister | Blister | Blister | {7}------------------------------------------------ | | Indications for Use | |----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | DK Medivision<br>TREVUES<br>(Subject<br>Device) | The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for the<br>correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased<br>eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters where the<br>astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used<br>to enhance or alter the apparent color of the eye.<br>The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a<br>Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected<br>using a chemical or hydrogen peroxide disinfecting system. | | Yung Sheng<br>Optical<br>Eyesecret 38<br>UV<br>(K132854) | The Eye Secret 38 UV Apsheric (polymacon) Soft (hydrophilic) Contact Lenses for Daily Wear<br>Wear are indicated for the correction of ametropia (myopia) in aphakic and not-aphakic<br>persons with non-diseased eyes. The lenses may be worn by persons who exhibit<br>astigmatism of 2.00 diopters or less that does not interfere with visual acuity. | | Joowon<br>Innovation<br>ChicView<br>(K161098) | The ChicView (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the<br>correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or<br>hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or<br>less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted<br>and may be used to enhance or alter the apparent color of the eye.<br>Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare<br>practitioners in consultation with their patients.<br>Frequent/Planned Replacement Wear: Eyecare practitioners may prescribe any of the above lenses for<br>frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When<br>prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical<br>disinfecting system.<br>Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear.<br>When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting<br>systems as they are to be discarded after a single use. | {8}------------------------------------------------ #### PERFORMANCE DATA VII. 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 TREVUES (polymacon) finished contact lenses. The results support the claim that the TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) 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. ### Shelf Life: Testing was performed to evaluate the stability, sterility, and package integrity of the TREVUES (polymacon) finished 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 to predicate devices: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistency of the material properties between the TREVUES (polymacon) contact lenses and the predicate devices. {9}------------------------------------------------ ### Clinical Testing Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from polymacon materials has been demonstrated previously. ## VIII. CONCLUSIONS ### Validity of Scientific Data Laboratories conducted biocompatiblity, 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 TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are as safe and effective as the predicate device when used in accordance with the labeled directions for the proposed indication. #### Risks and Benefits The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft (hydrophilic) daily wear contact lenses.