Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION". March 13, 2023 Innova Vision Inc. Kari Huang Engineer 2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park Hsinchu. 300091 TWN Re: K222954 Trade/Device Name: Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: January 6, 2023 Received: February 3, 2023 ## Dear Kari Huang: 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 {1}------------------------------------------------ (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/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). Sincerelv. J Angelo Green -S Image /page/1/Picture/6 description: The image shows the logo for the Food and Drug Administration (FDA). The logo is in a light blue color and is displayed on a white background. The letters "FDA" are large and bold. 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) K222954 ### Device Name Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens ### Indications for Use (Describe) ### Sphere/Asphere Innova Vision Sphere and Asphere (Etafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuty. ### Toric Innova Vision Toric (Etafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. ### Multifocal Innova Vision Multifocal (Etafilcon A) Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. ### Multifocal Toric Innova Vision Multifocal Toric (Etafilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eves in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters. Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear. When prescribed for frequent/planned replacement, the Innova Vision Hydrogel (Etafficon A) Soft (Hydrophilic) Contact Lens is to be cleaned. rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only. When prescribed for single-use disposable wear, Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {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 #### 5.1 Type of Submission: Traditional #### 5.2 Date of Summary: 03/03/2023 5.3 Submitter: Innova Vision Inc. Address: 2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park 300091, Taiwan Phone: +886-3-5927299 Contact: Kari Huang (karihuang@innovavision.com.tw) ### 5.4 Identification of the Device: | Proprietary/Trade name: | Innova Vision Hydrogel (Etafilcon A) Soft | |------------------------------|-------------------------------------------| | | (Hydrophilic) Contact Lens | | Classification Product Code: | LPL | | Subsequent Product Code: | MVN | | Regulation Number: | 886.5925 | | Regulation Description: | Soft (hydrophilic) contact lens | | Review Panel: | Ophthalmic | | Device Class: | II | | Basis for the Submissions | New Device | #### 5.5 Identification of the Predicate Device: | Predicate Device Name: | Discon Plus (Etafilcon A) Contact Lens<br>visibility tint with UV blocker | |------------------------------|---------------------------------------------------------------------------| | Applicant: | Innova Vision Inc. | | Classification Product Code: | LPL, MVN | | Regulation number: | 886.5925 | | Device Class: | II | | 510(k) Number: | K083288 | {5}------------------------------------------------ #### 5.6 Identification of the Reference Device: | Reference Device Name: | Innova Vision Hydrogel (Hioxifilcon A)<br>Soft (Hydrophilic) Contact Lens | |------------------------------|---------------------------------------------------------------------------| | Applicant: | Innova Vision Inc. | | Classification Product Code: | LPL, MVN | | Regulation number: | 886.5925 | | Device Class: | II | | 510(k) Number: | K213119 | #### 5.7 Indications for Use / Intended Use of the Device ## Sphere/Asphere Innova Vision Sphere and Asphere (Etafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. ## Toric Innova Vision Toric (Etafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. ## Multifocal Innova Vision Multifocal (Etafilcon A) Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. {6}------------------------------------------------ ## Multifocal Toric Innova Vision Multifocal Toric (Etafilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters. Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear. When prescribed for frequent/planned replacement, the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only. When prescribed for single-use disposable wear, Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal. #### 5.8 Description of the Device Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (58% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) a via UV photo-polymerization. Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for for handling and contains 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxyl-phenyl]ethyl as an {7}------------------------------------------------ additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 30% in the UVA region. The properties of the lens are: | ● | Chord Diameter: | 13.00 mm to 15.00 mm | |---|--------------------------------|-----------------------------------------------| | ● | Center Thickness | 0.080 mm to 0.580 mm | | ● | Base Curve: | 8.0 mm to 9.8 mm | | ● | Power Range | | | | Sphere Power: | -20.00 D to +20.00 D in 0.25 D steps | | | Cylinder Power (Toric): | -0.25 D to -2.25 D in 0.25 D steps | | | Cylinder Axis (Toric): | 10° to 180° in 10° steps | | | Multifocal Power: | +0.25 D to +4.00 D in 0.25 D steps | | ● | Specific Gravity: | 0.98 to 1.12 | | ● | Refractive Index: | 1.400 ± 0.005 | | ● | Visible Light Transmittance: | > 95% | | ● | UVA (315 nm~380 nm) Absorbance | < 30% | | ● | UVB (285 nm~315 nm) Absorbance | < 5% | | ● | Surface Character: | Hydrophilic | | ● | Water Content: | 58% ± 2% | | ● | Oxygen Permeability: | 24 × 10-11 (cm²•ml O2)/(sec•ml•mmHg)<br>+ 20% | #### Non-clinical Testing 5.9 A series of non-clinical safety and performance studies were conducted on the subject device. The following tests and studies were according to the FDA guidance "Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses, Issued May 1994" and related recognized consensus standards. All the test results met the requirements of products specification. - . Sterilization validation and Shelf life Test results demonstrated that subject device complies with ISO 11138-1, {8}------------------------------------------------ ISO 11138-3, ISO 11137-1, ISO 11137-2, ISO 17665-1, ASTM F1929-15, ISO 18369-3, ISO 11987, ISO 11737-2 and ASTM F2338-09 requirements. - . Biocompatibility Test results demonstrated that subject device complies with ISO 10993-1, ISO 10993-5, ISO 10993-12, ISO 10993-23, ISO 10993-10, ISO 10993-11 and ASTM F750-87 requirements. - . Performance - Geometric Parameters - Luminous Transmittance - Refractive Index । - Water Content । - । Oxygen Permeability - Extractables । - Tensile Strength । - pH Value Determination - - Osmolality Determination । - Specific Gravity - - Lens Compatibility with Multi-Purpose Solution Test results demonstrated that subject device complies with ISO 18369-4, ISO 18369-3, ASTM D882-18 and ASTM D1708-18 requirements. ## 5.10 Clinical Testing No clinical test data was used to support the decision of substantial equivalence. The safety and effectiveness of finished contact lenses have been established through previous non-clinical performance testing. ## 5.11 Substantial Equivalence Determination The Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens submitted in this 510(k) file is substantially equivalent in intended use, main {9}------------------------------------------------ materials, and safety and performance claims to the cleared device, Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker (K083288) and Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K213119). Differences between the devices cited in this section do not raise any new issue of substantial equivalence. {10}------------------------------------------------ | Item | Subject Device | Predicate Device | Reference Device | Substantial Equivalence Discussion | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Manufacturer | Innova Vision Inc. | Innova Vision Inc. | Innova Vision Inc. | | | Trade Name | Innova Vision Hydrogel<br>(Etafilcon A) Soft (Hydrophilic)<br>Contact Lens | Discon Plus (Etafilcon A)<br>Contact Lens visibility tint<br>with UV blocker | Innova Vision Hydrogel<br>(Hioxifilcon A) Soft<br>(Hydrophilic) Contact Lens | Substantial Equivalence Discussion | | 510(k) No. | (to be assigned) | K083288 | K213119 | | | Indications For Use | Sphere/Asphere<br>Innova Vision Sphere and<br>Asphere (Etafilcon A) Soft<br>Contact lenses are indicated for<br>the correction of ametropia<br>(myopia and hyperopia) in<br>aphakic and non-aphakic persons<br>with non-diseased eyes in<br>powers from -20.00 to +20.00<br>diopters. The lenses may be<br>worn by persons who exhibit<br>astigmatism of 2.00 diopters or<br>less that does not interfere with<br>visual acuity.<br>Toric<br>Innova Vision Toric (Etafilcon | Sphere/Asphere<br>Discon Plus (Etafilcon A)<br>Contact Lens visibility tint with<br>UV blocker is indicated for daily<br>wear for the correction of<br>refractive ametropia in<br>not-aphakic persons with<br>non-diseased eyes that are<br>myopic or hyperopic and may<br>exhibit refractive astigmatism up<br>to 2.00 diopters that does not<br>interfere with visual acuity.<br>Eye care practitioners may<br>prescribe the lenses for either<br>single-use daily disposable wear<br>or frequent/planned replacement<br>wear with cleaning, rinsing, | Sphere/Asphere<br>Innova Vision Sphere and<br>Asphere (Hioxifilcon A) Soft<br>Contact lenses are indicated for<br>the correction of ametropia<br>(myopia and hyperopia) in<br>aphakic and non-aphakic persons<br>with non-diseased eyes in<br>powers from -20.00 to +20.00<br>diopters. The lenses may be<br>worn by persons who exhibit<br>astigmatism of 2.00 diopters or<br>less that does not interfere with<br>visual acuity.<br>Toric<br>Innova Vision Toric (Hioxifilcon | Equivalent<br>The main indication is the<br>same, and the few different<br>wordings do not affect the<br>equivalence. | {11}------------------------------------------------ | A) Soft Contact lenses are<br>indicated for the correction of<br>ametropia (myopia or hyperopia<br>with astigmatism) in aphakic and<br>non-aphakic persons with<br>non-diseased eyes in powers<br>from -20.00 to +20.00 diopters<br>and astigmatic corrections from<br>-0.25 to -10.00 diopters.<br>Multifocal<br>Innova Vision Multifocal<br>(Etafilcon A) Soft Contact lenses<br>are indicated for the correction<br>of refractive ametropia (myopia<br>and hyperopia) and emmetropia<br>with presbyopia in aphakic and<br>non-aphakic persons with<br>non-diseased eyes in powers<br>from -20.00 to +20.00 diopters<br>and with add powers from +0.25<br>to +4.00 diopters. The lenses<br>may be worn by persons who<br>exhibit astigmatism of 2.00 | disinfection and scheduled<br>replacement as prescribed by the<br>eyecare professional. When<br>prescribed for frequent/planned<br>replacement wear, the lens may<br>be disinfected using a chemical<br>(not heat) disinfection system.<br>Disposable Wear:<br>Eyecare practitioners may<br>prescribe any of the above lenses<br>for single use daily disposable<br>wear. When Prescribed for daily<br>disposable wear the lens is to be<br>discarded after each removal. | A) Soft Contact lenses are<br>indicated for the correction of<br>ametropia (myopia or hyperopia<br>with astigmatism) in aphakic and<br>non-aphakic persons with<br>non-diseased eyes in powers<br>from -20.00 to +20.00 diopters<br>and astigmatic corrections from<br>-0.25 to -10.00 diopters.<br>Multifocal<br>Innova Vision Multifocal<br>(Hioxifilcon A) Soft Contact<br>lenses are indicated for the<br>correction of refractive<br>ametropia (myopia and<br>hyperopia) and emmetropia with<br>presbyopia in aphakic and<br>non-aphakic persons with<br>non-diseased eyes in powers<br>from -20.00 to +20.00 diopters<br>and with add powers from +0.25<br>to +4.00 diopters. The lenses<br>may be worn by persons who | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | diopters or less that does not<br>interfere with visual acuity.<br><br><b>Multifocal Toric</b><br>Innova Vision Multifocal Toric<br>(Etafilcon A) Soft Contact lenses<br>are indicated for the optic<br>correction of distance and near<br>vision in presbyopic phakic or<br>aphakic persons with<br>non-diseased eyes in powers of<br>-20.00 to +20.00 diopters with<br>add powers from +0.25 to +4.00<br>diopters and astigmatism<br>corrections from -0.25 to -10.00<br>diopters.<br><br>Eye Care Practitioners may<br>prescribe the Innova Vision<br>(Etafilcon A) Soft (Hydrophilic)<br>Contact Lenses for<br>frequent/planned replacement<br>wear, with cleaning, disinfection<br>and scheduled replacement or for<br>single-use disposable wear. | exhibit astigmatism of 2.00<br>diopters or less that does not<br>interfere with visual acuity.<br><br><b>Multifocal Toric</b><br>Innova Vision Multifocal Toric<br>(Hioxifilcon A) Soft Contact<br>lenses are indicated for the optic<br>correction of distance and near<br>vision in presbyopic phakic or<br>aphakic persons with<br>non-diseased eyes in powers of<br>-20.00 to +20.00 diopters with<br>add powers from +0.25 to +4.00<br>diopters and astigmatism<br>corrections from -0.25 to -10.00<br>diopters.<br><br>Eye Care Practitioners may<br>prescribe the Innova Vision<br>Hydrogel (Hioxifilcon A) Soft<br>(Hydrophilic) Contact lenses for<br>frequent/planned replacement<br>wear, with cleaning, disinfection<br>and scheduled replacement or for | | | When prescribed for<br>frequent/planned replacement,<br>the Innova Vision (Etafilcon A)<br>Soft (Hydrophilic) Contact Lens<br>is to be cleaned, rinsed and<br>disinfected each time the lens is<br>removed. The contact lens is to<br>be discarded after the<br>recommended wearing period as<br>prescribed by the Eye Care<br>Professional. When prescribed<br>for frequent/planned replacement<br>wear, the lenses may be<br>disinfected using a chemical<br>disinfection only.<br>When prescribed for single-use<br>disposable wear, Innova Vision<br>(Etafilcon A) Soft (Hydrophilic)<br>Contact Lens is to be discarded<br>after each removal. | single-use disposable wear.<br>When prescribed for<br>frequent/planned replacement,<br>the Innova Vision Hydrogel<br>(Hioxifilcon A) Soft<br>(Hydrophilic) Contact Lens is to<br>be cleaned, rinsed and<br>disinfected each time the lens is<br>removed. The contact lens is to<br>be discarded after the<br>recommended wearing period as<br>prescribed by the Eye Care<br>Professional. When prescribed<br>for frequent/planned replacement<br>wear, the lenses may be<br>disinfected using a chemical<br>disinfection only.<br>When prescribed for single-use<br>disposable wear, Innova Vision<br>Hydrogel (Hioxifilcon A) Soft<br>(Hydrophilic) Contact Lens is to<br>be discarded after each removal. | | {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ | Item | Subject device | Predicate device | Reference device | Substantial Equivalence<br>Discussion | |------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Innova Vision Inc. | Innova Vision Inc. | Innova Vision Inc. | | | Trade Name | Innova Vision Hydrogel<br>(Etafilcon A) Soft (Hydrophilic)<br>Contact Lens | Discon Plus (Etafilcon A)<br>Contact Lens visibility tint<br>with UV blocker | Innova Vision Hydrogel<br>(Hioxifilcon A) Soft<br>(Hydrophilic) Contact Lens | | | 510(k) No. | (to be assigned) | K083288 | K213119 | | | Type of Use | Prescription Use | Prescription Use | Prescription Use | Same | | UV blocking | Yes | Yes | Yes | Same | | Production<br>Method | Cast-molded | Spin-casting | Cast-molded | Equivalent<br>Different but the<br>performance of the device<br>are not affected and meet<br>the requirements. Therefore<br>it would not affect the<br>equivalence. | | USAN Name | Etafilcon A | Etafilcon A | Hioxifilcon A | Same<br>The material USAN name<br>Etafilcon A, is the same as<br>the predicate device<br>K083288. | | Water Content | $58 \pm 2\%$ | 58% | $59 \pm 2\%$ | Equivalent<br>Not significantly different<br>and meets the requirements | | | | | | therefore it would not affect<br>the equivalence. | | Oxygen<br>Permeability | $24 × 10^{-11}(cm^2•ml O_2)/(sec•ml•mmHg) ± 20%$ | $24 × 10^{-11}(cm^2/sec) (mlO_2/ml-mmHg)$ | $25 × 10^{-11}(cm^2/s) (mlO_2/[ml*mmHg]) ± 20%$ | <b>Equivalent</b><br>Not significantly different<br>and meets the requirement;<br>therefore it would not affect<br>the equivalence. | | Refractive<br>Index | 1.400 ± 0.005 | 1.40 | 1.400 ± 0.005 | <b>Equivalent</b><br>Not significantly different<br>and meets the requirement;<br>therefore it would not affect<br>the equivalence. | {15}------------------------------------------------ {16}------------------------------------------------ ## 5.12 Similarity and Difference The Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is compared with Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker and Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens. The subject device has same intended use and technology/mechanism of action, and similar safety and performance as the predicate device and reference device. No specifications are significantly different between these three devices. Furthermore, the subject device has undergone other safety and performance tests, and the results complied with the testing guidance. Therefore, any differences between the subject device, the predicate device and reference device are insignificant and do not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device and reference device in intended use, design and performance claims. ## 5.13 Conclusion After analyzing non-clinical laboratory studies, safety and performance testing data, it can be concluded that the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is substantially equivalent to the predicate device and reference device.