Miru 1day UpSide (midafilcon A)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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. June 17, 2020 Menicon Co., Ltd. Li Haosheng, Ph.D. International Regulatory Affairs 3-21-19. Aoi. Naka-ku Nagoya, 460-0006 Japan Re: K193399 Trade/Device Name: Miru 1day UpSide (midafilcon A) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: May 15, 2020 Received: May 18, 2020 Dear Li Haosheng, 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 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 {1}------------------------------------------------ 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 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K193399 Device Name Miru 1day UpSide (midafilcon A) #### Indications for Use (Describe) The Miru 1day UpSide (midafilcon A) SPHERICAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myperopia) in aphakic and non-aphakic people with disease free eyes who may have 1.50 diopter (D) or less of astigmatism. The Miru 1day UpSide (midafilcon A) TORIC Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic people with disease free eyes with 3.00 diopter (D) or less of refractive astigmatism. The Miru 1day UpSide (midafilcon A) MULTIFOCAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia) and emmetropia with presbyopia in aphakic and non-aphakic people with disease free eyes who may require a reading addition of 3.00 diopter (D) or less and who may have 1.50 diopter (D) or less of astigmatism. The Miru 1day UpSide (midafilcon A) should only be worn once and then discarded at the end of each wearing period on a daily basis. The patient should start the next wearing period with fresh lenses should not be cleaned or disinfected and should be discarded after a single use. | Type of Use (Select one or both, as applicable) | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:inline-block;">☒ Prescription Use (Part 21 CFR 801 Subpart D)</div> <div style="display:inline-block;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text "Menicon Co., Ltd." The text is written in a simple, sans-serif font. The text is centered in the image and is the only element present. # 510(k) Summary # Miru 1day UpSide (midafilcon A) #### 1. Applicant Information Menicon Co., Ltd. 21-19, Aoi 3, Naka-ku, Nagoya, 460-0006 JAPAN | Contact Person: | Li Haosheng, Ph.D. | |-----------------|---------------------------| | Telephone No.: | +81-52-935-1676 | | Fax No.: | +81-52-935-1633 | | E-mail: | haosheng-li@menicon.co.jp | | Date Prepared: | June 16, 2020 | #### 2. Device Information | Classification name: | Soft (hydrophilic) Contact Lens | |------------------------|---------------------------------| | Device classification: | Class II | | Regulation number: | 21 CFR 886.5925 | | Product code: | LPL, MVN | | Proprietary name: | Miru 1day UpSide (midafilcon A) | #### 3. Predicate Device Menicon claims substantial equivalence to K160344 Visco Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lens and K131378 CooperVision MyDay (stenfilcon A) Soft Contact Lens. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the alphanumeric string "K193399". The string is written in a simple, sans-serif font. The characters are all the same size and are evenly spaced. #### 4. Description of Device Menicon Co., Ltd. The Miru 1day UpSide (midafilcon A) is a hydrophilic contact lens which is available as a spherical, toric and multifocal lens. The lens is indicated for daily wear disposable single use. The non-ionic lens material (midafilcon A) is a random co-polymer containing polydimethyl siloxane macromonomer. It consists of 46% midafilcon A and 54% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibility handling tint. The lens contains a benzotriazole UV absorbing monomer which is used to block UV radiation. The transmittance characteristics for the lens (-3.00D) are less than 5% of UVB radiation and less than 50% of UVA radiation. #### 5. Indications for Use The Miru 1day UpSide (midafilcon A) SPHERICAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic people with disease free eyes who may have 1.50 diopter (D) or less of astigmatism. The Miru 1day UpSide (midafilcon A) TORIC Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic people with disease free eyes with 3.00 diopter (D) or less of refractive astigmatism. The Miru 1day UpSide (midafilcon A) MULTIFOCAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic people with disease free eyes who may require a reading addition of 3.00 diopter (D) or less and who may have 1.50 diopter (D) or less of astigmatism. The Miru 1day UpSide (midafilcon A) should only be worn once and then discarded at the end of each wearing period on a daily basis. The patient should start the next wearing period with fresh lenses. The lenses should not be cleaned or disinfected and should be discarded after a single use. {5}------------------------------------------------ ## 6. Performance Data #### Non-Clinical Data A series of in-vitro and in-vivo preclinical tests were performed to assess the safety and effectiveness of the Miru 1day UpSide (midafilcon A). All tests were conducted in accordance with the GLP regulation (21 CFR Part 58) or according to valid scientific protocols. The results of the non-clinical testing and evaluation demonstrate that the lens material/extracts are non-toxic, non-irritating and non-sensitizing under the experimental conditions, and the material properties are consistent with the predicate lens. #### Clinical Data A three-month randomized controlled clinical study was completed to evaluate the safety and efficacy of the Miru 1day UpSide (midafilcon A) contact lenses for daily wear, single use. The study evaluated 148 male and female subjects who were randomized and dispensed lenses in a 1:1 ratio into the test and control groups. The efficacy outcome measures were lens visual acuity comparisons between the test and the control contact lenses. The safety outcome measures included adverse event rates, biomicroscopy and subjective acceptance. The test contact lens was found to be substantially equivalent to the control contact lens for safety and efficacy. #### Conclusion Based upon the data presented, the Miru 1day UpSide (midafilcon A) is as safe, as effective and performs as well as the predicate devices. {6}------------------------------------------------ ## 7. Substantial equivalence Menicon Co., Ltd. The claim of substantial equivalence to the previously cleared devices is supported by the following tables of Comparison of Characteristics. | | Miru 1day UpSide | Visco Si-Hy | MyDay | |-----------------------------------------------------|---------------------------------------------|-----------------------------------------------|-------------------------------------------------------| | 510(k) | K193399 | K160344 | K131378 | | USAN | midafilcon A | olifilcon B | stenfilcon A | | Product Code | LPL, MVN | LPL, MVN | LPL, MVN | | Modality | Daily wear,<br>Single Use | Daily wear,<br>Single Use | Daily wear,<br>Single Use | | FDA Lens Group | SiHy class 5 | SiHy class 5 | SiHy class 5 | | Device Classification | II | II | II | | Manufacturing Method | Cast Molded | Cast Molded | Cast Molded | | Sterilization | Moist Heat | Moist Heat | Moist Heat | | Packaging | Blister Pack | Blister Pack | Blister Pack | | Visibility Tint | Reactive Blue #246<br>Reactive Blue #247 | Reactive Blue #19 | Reactive Blue #246 | | Light Transmittance | > 92 % | 94% | 96% | | Water Content | 54% (USAN specification) | 47% | 54% | | Refractive Index | 1.403 | 1.410 | 1.401 | | Dk<br>× 10-11 [(cm²/sec) × (mL O₂)/(mL × mm Hg)] | 64 | 120 | 80 | | Powers | - 20.00 to +20.00 D | - 20.00 to +20.00 D | - 20.00 to +20.00 D | | Diameter | 13.0 to 18.0 mm | 13.0 to 15.0 mm | 13.0 to 15.5 mm | | Base Curve | 8.0 to 9.0 mm | 8.0 to 9.2 mm | 8.4 and 8.7 mm | | Optical Design | Spherical, Toric,<br>Multifocal | Spherical, Toric,<br>Multifocal | Aspherical, Toric,<br>Multifocal,<br>Multifocal Toric | | Comparison of Characteristics (Indications for Use) | | | | | Miru 1day UpSide | Visco Si-Hy | MyDay | | | The Miru 1day UpSide (midafilcon A) | The Si-Hy Spherical Silicone Hydrogel Soft | MyDay ASPHERE Soft Contact lenses are | | | SPHERICAL Lens is indicated for daily | Contact Lenses are indicated as daily wear | indicated for the correctionof ametropia | | | wear single use only for the optical | single use soft contact lens for the | (myopia and hyperopia) in aphakic and | | | correction of refractive ametropia (myopia | correction of refractive ametropia (myopia | non-aphakic persons with non-diseased | | | and hyperopia) in aphakic and non-aphakic | and hyperopia) in phakic or aphakic | eyes in powers from -20.00D to +20.00D | | | people with disease free eyes who may | persons with non-diseased eyes who exhibit | diopters. The lenses may be worn by | | | have 1.50 diopter (D) or less of | refractive astigmatism of 1.00D or less | persons who exhibit astigmatism of -2.00 | | | astigmatism. | where the astigmatism does not interfere | diopters or less that does not interfere with | | | The Miru 1day UpSide (midafilcon A) | with visual acuity. | visual acuity. | | | TORIC Lens is indicated for daily wear | The Si-Hy Toric Silicone Hydrogel Soft | Toric: MyDay (stenfilcon A) Toric Soft | | | single use only for the optical correction of | Contact Lenses are indicated as daily wear | Contact lenses are indicated for the | | | refractive ametropia (myopia or hyperopia | for the correction of ametropia (myopia and | correction of ametropia (myopia or | | | with astigmatism) in aphakic and non- | hyperopia) with astigmatism in aphakic and | hyperopia with astigmatism) in aphakic and | | | aphakic people with disease free eyes with | non-aphakic persons with non-diseased | non-aphakic persons with non-diseased | | | 3.00 diopter (D) or less of refractive | eyes and whose powers are from -20.00 to | eyes in powers from -20.00 to +20.00 | | | astigmatism. | +20.00 diopters and astigmatic corrections | diopters and astigmatic corrections from - | | | The Miru 1day UpSide (midafilcon A) | are from -0.75 to -2.25 diopters. | 0.25 to -10.00 diopters. | | | MULTIFOCAL Lens is indicated for daily | The Si-Hy Multifocal Silicone Hydrogel | Multifocal: MyDay (stenfilcon A) | | | wear single use only for the optical | Soft Contact lenses are indicated as daily | MULTIFOCAL Soft Contact lenses are | | | correction of refractive ametropia (myopia | wear for the correction of ametropia | indicated for the correction of refractive | | | and hyperopia) and emmetropia with | (myopia and hyperopia) and emmetropia | ametropia (myopia and hyperopia) and | | | presbyopia in aphakic and non-aphakic | with presbyopia in aphakic and non-aphakic | emmetropia with presbyopia in aphakic and | | | people with disease free eyes who may | persons with non-diseased eyes and whose | non-aphakic persons with non-diseased | | | require a reading addition of 3.00 diopter | powers are from -20.00 to +20.00 diopters | eyes. The lenses may be worn by persons | | | (D) or less and who may have 1.50 diopter | with add powers from +0.75 to +2.75 | who exhibit astigmatism of -2.00 diopters | | | (D) or less of astigmatism. | diopters. The lenses may be worn by | or less that does not interfere with visual | | | The Miru 1day UpSide (midafilcon A) | persons who exhibit astigmatism of 1.00 | acuity. | | | should only be worn once and then | diopters or less where the astigmatism does | Multifocal Toric: MyDay (stenfilcon A) | | | discarded at the end of each wearing period | not interfere with visual acuity. | MULTIFOCAL TORIC Soft Contact lenses | | | on a daily basis. The patient should start the | Eye care practitioners may prescribe the | are indicated for the optical correction of | | | next wearing period with fresh lenses. The | lens for daily wear (disposable use) single | distance and near vision in presbyopic | | | lenses should not be cleaned or disinfected | use. The lenses are to be discarded upon | phakic or aphakic persons with non- | | | and should be discarded after a single use. | removal. Therefore, no cleaning or | diseased eyes who may have -10.00 | | | | disinfecting is required. | diopters of astigmatism or less. | | ### Comparison of Characteristics (General Information) Image /page/6/Picture/7 description: The image shows a logo that is divided into two halves. The top half is red, and the bottom half is green. A white line runs through the middle of the logo, creating a stylized letter 'f' shape. The logo is simple and uses contrasting colors to create a visually appealing design. {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the logo for Menicon Co., Ltd. The logo consists of a red and green circular design with a white stylized "M" in the center. To the right of the logo is the text "Menicon Co., Ltd." in a simple, sans-serif font. #### C 10 10