Optixon 1-Day

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 18, 2020 Optixon Inc. % Eunbae Cho General Manager IGC Co., Ltd. Rm. 501, Daeryung techno town 7th, #638, Seobusaet-gil, Geumcheon-gu Seoul, Republic of Korea 08504 Re: K201013 Trade/Device Name: Optixon 1-Day Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 13, 2020 Received: August 17, 2020 Dear Eunbae Cho: 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. 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 {1}------------------------------------------------ 801); medical device 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-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-device-safety/medical-device-reportingmdr-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/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) K201013 Device Name OPTIXON 1- DAY Indications for Use (Describe) OPTIXON I- DAY are indicated for single-use, disposable daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity. Type of Use (Select one or both, as applicable) | <div style="display:flex; align-items:center;"> <input checked="true" type="checkbox"/> <span>Depository Use (Part 21 CFR 601 Subpart D)</span> </div> | |--------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"> <input type="checkbox"/> <span>Own-Use Sample (21 CFR 601 Subpart D)</span> </div> | > 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 #### Preparation Date: Sep 10, 2020 #### A.510k Number: K201013 #### B. Applicant: Company name: OPTIXON Inc Address: 105/106 ho, 164, Obonq-ro, Buk-Gu, Daequ, Rep. of Korea C. Proprietary and Established Names: OPTIXON Inc Address: 105/106 ho, 164, Obong-ro, Buk-Gu, Daegu, Rep. of Korea #### D. Regulatory Information - Classification Name: lenses, soft contact, daily wear - Common / Usual Name: Soft (hydrophilic) contact lens - Proprietary Name: OPTIXON 1- DAY - Classification / Product Code: Class 2 / LPL (21 CFR 886.5925) #### E. Indications for Use OPT IXON 1- DAY are indicated for single-use, disposable daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity. #### F. Description OPTIXON 1- DAY (omafilcon A)is daily disposable soft contact lenses(single use) produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine) The contact lenses contain 59% water by weight and is sold in the blister package immersed in packaging saline. RB 246 pigment conforms to 21 CFR Part 73.3106 is used to provide the handling blue tint for the lens. The device is a corneal contact lens having a total diameter more than the visible iris diameter and is designed to be worn in its entirety on the cornea. The device has an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve). The contact lenses are hydrophilic, soft and it is supplied in sterile state. {4}------------------------------------------------ ## G. Substantial Equivalence Information -Predicate Device-1 SE Number: K162223 Product name: Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses Company: Supervision Optimax Sdn Bhd -Predicate Device-2 SE Number: K 112302 Product name: Proclear lens Company: CooperVision, Inc. | Manufacturer | OPTIXON Inc | Supervision Optimax<br>Sdn Bhd | CooperVision, Inc | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | OPTIXON 1-DAY | Aveo (omafilcon A)<br>1-DAY Aspheric Soft<br>(Hydrophilic) Contact<br>Lens | Proclear (omafilcon A)<br>Soft Contact Lenses | | 510(k) No. | - | K162223 | K 112302 | | Intended Use | OPTIXON 1- DAY are<br>indicated for single-use,<br>disposable daily wear for<br>the correction of visual<br>acuity in non-aphakic<br>persons with<br>non-diseased eyes that<br>are myopic and exhibit<br>astigmatism of 1.00D or<br>less that does not<br>interfere with visual<br>acuity. | Aveo (omafilcon A) 1-Day<br>Aspheric Soft<br>(Hydrophilic) Contact<br>Lenses are indicated for<br>daily wear for the<br>correction of visual acuity<br>in not aphakic persons<br>with nondiseased eyes<br>that are myopic or<br>hyperopic and exhibit<br>astigmatism of 1.00D or<br>less that does not<br>interfere with visual<br>acuity. The contact lenses<br>are intended for daily<br>wear, single use and are<br>to be discarded at the end<br>of the day. | Proclear Asphere<br>omafilcon A) Soft<br>Contact lenses are<br>indicated for daily wear<br>for the correction of<br>visual acuity in<br>nonaphakic persons<br>with non-diseased eyes<br>that are myopic or<br>hyperopic and exhibit<br>astigmatism of 2.00D or<br>less that does not<br>interfere with visual<br>acuity. | | Modality | Daily Wear | Daily Wear | Daily Wear | | Material<br>USAN Name | omafilcon A | omafilcon A | omafilcon A | | FDA Category | Group II | Group II | Group II | | (Group) | Non-ionic, High water | Non-ionic, High water | Non-ionic, High water | | Manufacturing<br>Method | Cast Molded | Cast Molded | Finished Inside<br>Polymerization System<br>II | | Curing | Thermal Cure | Thermal Cure | Thermal Cure | {5}------------------------------------------------ | Sterilization | Moist heat sterilization | Moist heat sterilization | Moist heat sterilization | |---------------------------------------|--------------------------|--------------------------|------------------------------------------| | Visibility Tint | Reactive Blue Dye 246 | Reactive Blue Dye 246 | VAT Blue 6 | | Water<br>Content | 59% ± 2% | 59% ± 2% | 59% ± 2% | | Package<br>Saline | Phosphate<br>Saline | Phosphate<br>Saline | Phosphate Buffers<br>PEG200 and Tween 80 | | Oxygen<br>Permeability<br>(Dk) x10-11 | 25.68 | 25.68 | 21.05 | | Light<br>transmission | 98% | 98% | >90% | | Base Curve | 8.4mm to 8.8mm | 8.4mm to 8.8mm | 8.0mm to 9.3mm | | Diameter Øт | 14.0 to 14.4mm | 14.0mm to 14.4mm | 13.6mm to 15.2mm | | Power | -0.50D to - 10.0D | -10.00 to +6.00 | -20.00 to +20.00 | #### H. Substantial Equivalent Based on Assessment of Non-Clinical Performance Data ### Physiochemical Studies The physiochemical studies were conducted according to ISO 18369-4:2006 Ophthalmic Optics-Contact Lenses-Part 4: Physiochemical properties of contact lens materials and ISO 18369-3:2006 Ophthalmic Optic-Contact Lenses-Part 3: Measurement methods. The physical, optical and chemical properties of the lens are within established specifications for the lenses. #### Toxicology Studies Toxicology (in-vivo and in-vitro) studies reports show that the lenses are non-toxic and biocompatible with the ocular environment. | Cytotoxicity test | According to EN ISO 10993- 5 :2009 | Passed | |-------------------------|------------------------------------|--------| | Skin sensitization test | According to EN ISO 10993-10 :2010 | Passed | | Ocular irritation test | According to EN ISO 10993-10 :2010 | Passed | | Acute Systemic Toxicity | According to ISO 10993-11 : 2017 | Passed | ## I. Clinical Test The technological characteristics, formulation, manufacturing and sterilization processes are the same as the predicate device Aveo (omafilcon A) 1-DAY Aspheric Soft (Hydrophilic) Contact Lens K162223 and Proclear (omafilcon A) Soft Contact Lenses K 112302. Therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device. ## J. Conclusion OPTIXON 1-DAY is substantially equivalent to the predicate device. Aveo (omafilcon A) 1-DAY Aspheric Soft (Hydrophilic) Contact Lens K162223 and Proclear (omafilcon A) Soft Contact Lenses K 112302 in term of optical property, Physiochemical and pre-clinical toxicology. They {6}------------------------------------------------ are produced from the same material (omafilcon A), have the same functional and scientific technology, lens characteristics and the intended use is identical. It is concluded that the lenses are as safe, as effective and perform as well as the predicate devices.