Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)

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June 13, 2018 Qualimed SRL % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068 Re: K181050 Trade/Device Name: Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: April 16, 2018 Received: April 20, 2018 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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation 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) K181050 #### Device Name Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) #### Indications for Use (Describe) The Desio (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 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 Desio (hioxifileon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. 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> <span style="font-size: 10px;"> </span> <span style="text-decoration: overline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> | <span> <span style="font-size: 10px;"> </span> 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 comblete 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." **Page 1 of 1** {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: K181050 #### I. SUBMITTER - April 16, 2018 Date Prepared: - Qualimed SRL Name: Address: Corso Sempione 176 Busto Arsizio Varese, Italy 21052 | Contact Person: | Ms. Tereza Uhrova<br>Legal Representative | |-----------------|--------------------------------------------------------------------------------| | Phone number: | +39 0331 1629910 | | 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: | Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses<br>(Clear and Tinted) | |-------------------------|------------------------------------------------------------------------------------------| | 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 | {4}------------------------------------------------ ### Purpose of 510(k) Submission: ~ New Device ~ #### III. PREDICATE DEVICE The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lens is substantially equivalent to the following predicate device: - . "Extreme H2O 54% (hioxifilcon D) Soft Contact Lens" Hydrogel Vision Corporation 510(k) number: K051430 Primary Predicate #### IV. DEVICE DESCRIPTION The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from hioxifilcon D, which is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA), and cross-linked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in saline solution. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN). The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses are available clear or tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: | Color Additive | Listing | |-----------------------|------------------| | Titanium Dioxide | 21 CFR § 73.3126 | | Phthalocyanine Green | 21 CFR § 73.3124 | | Carbazole Violet | 21 CFR § 73.3107 | | Reactive Blue 19 | 21 CFR § 73.3127 | | C.I. Reactive black 5 | 21 CFR § 73.3127 | Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the pad-printing manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. The color additives 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 standard Clear Pupil diameter of 6.0 mm. {5}------------------------------------------------ The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315nm), and >67% in the UVA range (316nm - 380nm). The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses will be manufactured in the sphere and toric design configurations. The material properties and available parameters of the finished lenses are as follows: | Parameter | Range | Tolerance* | |----------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Chord Diameter | 12.80 mm to 15.00 mm | ±0.20 mm | | Center Thickness | 0.05 mm to 0.210 mm | When ≤ 0.10 mm → ±0.010 mm + 10%<br>When > 0.10 mm → ±0.015 mm + 5% | | Base Curve | 7.85 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° | | Surface Appearance | | Lenses should be clear with no surface defect | | Oxygen Permeability<br>(x 10-11(cm²/sec)(mlO2)/(ml<br>x mmHg)) | 21.50 | ±20% | | Light Transmission - Clear<br>(@ 380-780nm) | >98% | ±5% | | Light Transmission - Tinted<br>(@ 380-780nm) | >96% (at region corresponding to<br>pupil); Opaque or 0-10% (at<br>region corresponding to iris) | ±5% | | Ultraviolet Radiation<br>Transmittance | <5% TUVB<br><33% TUVA | TUVB (280 to 315 nm) < 0.05TV<br>TUVA (316 to 380 nm) < 0.50TV | | Water Content | 54% | ±2% | | Refractive Index | 1.400 (hydrated) | ±0.005 | * ANSI Z80.20, Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements And Physicochemical Properties (2010) {6}------------------------------------------------ #### V. INDICATIONS FOR USE The Desio (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 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 Desio (hioxifilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. 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. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses are substantially equivalent to Extreme H2O 54% (hioxifilcon D) Soft Contact Lenses (cleared under K051430) in terms of the following: - 트 USAN contact lens material (hioxifilcon D) - 트 Intended use - daily wear contact lenses - 트 Indications for use - I Cast molded production method {7}------------------------------------------------ The following matrix illustrates the production method, lens function and material characteristics of the Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses, as well as the predicate device. | | Qualimed SRL<br>Desio<br>(Subject Device) | Hydrogel Vision Corp.<br>Extreme H2O 54% (Predicate) | |---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Indicated for daily wear for the correction<br>of refractive error in aphakic and not<br>aphakic persons with non-diseased eyes<br>with myopia or hyperopia. | Indicated for daily wear for the correction<br>of refractive error in aphakic and not<br>aphakic persons with non-diseased eyes<br>with myopia or hyperopia. | | Functionality | The contact lenses act as a refractive<br>medium that focus light rays from near<br>and distant objects on the retina | The contact lenses act as a refractive<br>medium that focus light rays from near<br>and distant objects on the retina | | FDA Classification | Soft (hydrophilic) Contact Lens (21 CFR<br>886.5925) | Soft (hydrophilic) Contact Lens (21 CFR<br>886.5925) | | FDA Group | FDA Group 2<br>(>50% H2O, non-ionic polymer) | FDA Group 2<br>(>50% H2O, non-ionic polymer) | | Production Method | Fully molded | Fully molded | | USAN name | hioxifilcon D | hioxifilcon D | | Water Content (%) | 54±2% | 54±2% | | Oxygen Permeability<br>x 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @<br>35°C)) (revised Fatt method) | 21.50 | 21 | | Refractive Index<br>(hydrated) | 1.40 | 1.41 | | UV Blocker | Yes | No | | Pad-Printed Tinting | 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 Desio (hioxifilcon D) finished contact lenses. The results support the claim that the Desio (hioxifilcon D) Soft 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 test article is non-toxic. - · Systemic Toxicity: The lens material meets the requirements of the systemic injection test in accordance with ISO 10993-11 and is considered non-toxic. - Acute Ocular Irritation: Acute ocular irritation test was performed in accordance with ISO 10993-10 and produced no ocular irritation. ### Shelf Life: The data presented supports substantial equivalence of the Desio (hioxifilcon D) finished contact lenses to the already marketed predicate devices. ### Physicochemical & Mechanical Properties: The following tests were completed to verify substantial equivalence: 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 consistent material properties between the Desio (hioxifilcon D) contact lenses and the predicate devices. ### Clinical Testing Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from hioxifilcon D materials has been demonstrated previously. {9}------------------------------------------------ ### 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 Desio (hioxiffileon D) Daily Wear Soft (hydrophilic) 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 soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft (hydrophilic) daily wear contact lenses.