Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 18, 2017 Tangible Science LLC % Bret Andre Consultant/Official Correspondent EyeReg Consulting, Inc. 6119 Canter Ln West Linn. OR 97068 Re: K171125 Trade/Device Name: Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: September 5. 2017 Received: September 8, 2017 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. 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. {1}------------------------------------------------ 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. # Denise L. Hampton -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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K171125 #### Device Name Etafilcon with Tangible Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses #### Indications for Use (Describe) The Etafilcon with Tangible Coating (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. The Etafilcon with Tangible Coating (etafilcon A) TORIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes who may have 5.00 D or less of astigmatism. The Etafilcon with Tangible Coating (etafilcon A) MULTIFOCAL Soft (Hydrophilic) Daily Wear Contact Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 2.50 D of ADD power and may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. The contact lenses should be discarded upon removal. Type of Use (Select one or both, as applicable) | <span style="text-decoration: overline;">X</span> 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 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: | <b>K171125</b> | |--------------------------------|-------------------------------------------------------------------------------| | Applicant information: | | | Date Prepared: | October 10th, 2017 | | Name: | Tangible Science LLC | | Address | 173 Jefferson Drive<br>Menlo Park CA 94025 | | Contact Person: | Vic McCray, MD<br>President & CEO | | Phone number: | 1-650-241-1045 | | Consultant: | Bret Andre<br>EyeReg Consulting, Inc<br>6119 Canter Ln<br>West Linn, OR 97068 | | Phone number | (503) 372-5226 | # Device Information: | Device Classification: | Class II | |------------------------|-----------------------------------------------------------------------------------------------| | Product Code: | LPL; MVN | | Classification Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) | | Trade Name: | Etafilcon with TangibleTM Coating (etafilcon A) Soft<br>(Hydrophilic) Daily Wear Contact Lens | {4}------------------------------------------------ ## Predicate Devices: Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are substantially equivalent to the following predicate devices: - "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear" . By UNICON Optical Co., LTD. 510(k) number: K141917 Primary Predicate - "IntelliWave4 with HPT (safrofilcon A) Silicone Hydrogel Contact Lens" . by Art Optical Contact Lens, Inc. 510(k) number: K152046 Reference Predicate ## Device Description: The Etafilcon with Tangible """ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is available in an aspheric design and manufactured using the cast-molding process. The lenses consist of 58% water and 42% etafilcon A. The lens material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which are crosslinked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The Etafilcon with Tangible™ Coating (etafficon A) Soft (Hydrophilic) Daily Wear Contact Lenses are available in a light blue tint ([Phthalocyaninato(2-)]copper) for visibility and handling. The lenses also contain a Benzotriazole ultraviolet (UV) absorbing monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range (280 to 315 mm), and less than 30% in the UVA range (316 to 380nm). The Etafilcon with Tangible "M Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is treated to incorporate Tangible TM Coating Technology-which is a thin biocompatible polymer that is covalently bonded to the surface of the contact lens. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (etafilcon A) soft hydrophilic contact lens has an aspheric back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; it will return to its proper configuration when completely rehydrated in the proper storage solution. The lenses are supplied sterile in blister packages containing a buffered saline solution. Package labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process. {5}------------------------------------------------ The Physical properties of the lens are: | Refractive Index (wet) | 1.404 | |----------------------------|----------------------------------------| | Visible Light Transmission | >90% | | Surface Character | hydrophilic | | Water Content | 58 ±2% | | Specific Gravity | 1.14 (hydrated) | | Oxygen Permeability | 24.1 x 10-11 (cm²/sec) (ml O2/ml-mmHg) | The lenses will be manufactured in the aspheric, toric, and multifocal design configurations with the following properties: | • Chord Diameter | 12.0 mm to 15.00 mm | |--------------------|------------------------------------| | • Center Thickness | 0.01 mm to 0.50 mm | | • Base Curve | 7.85 mm to 10.0 mm | | • Power Range | +6.00D to -10.00D (in 0.25D steps) | | - Cylinder | -0.75D to -2.50D (in 0.25D steps) | | - Axis | 10° to 180° (in 10° steps) | | - Add | +1.00D to +2.50D (in 0.50D steps) | ## Indication for Use: The Etafilcon with Tangible "1" Coating (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. The Etafilcon with Tangible™ Coating (etafilcon A) TORIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 5.00 D or less of astigmatism. The Etafilcon with Tangible 101 Coating (etafilcon A) MULTIFOCAL Soft (Hydrophilic) Daily Wear Contact Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 2.50 D of ADD power and may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. The contact lenses should be discarded upon removal. ## Testing: - Non-clinical Testing A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the Etafilcon with Tangible " 1 Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses packaged in blister packaging. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols. {6}------------------------------------------------ Test results of the non-clinical testing on the Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses demonstrate that: - Lenses supplied in blister packages are sterile for the indicated shelf-life, ● - The finished lenses, packaging material and extracts are non-toxic and non-irritating, and - Lens physical and material properties are consistent with currently ● marketed lenses. #### Clinical Testing The safety and effectiveness of finished contact lenses manufactured from the (etafilcon A) material has been established previously through clinical performance testing. ## Conclusions Drawn from Studies #### Validity of Scientific Data Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, Microbiology, chemistry, shelf-life stability studies and followed 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 Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication. #### Risks and Benefits The risks of the subject device are the same as those normally attributed to the wearing of daily wear soft contact lenses. The benefits to the patient are the same as those for other soft contact lenses. {7}------------------------------------------------ ### Substantial Equivalence: The following matrix illustrates the production and material characteristics of the Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens, as well as the predicate devices. # Substantial Equivalence Matrix | | Etafilcon with TangibleTM<br>Coating (etafilcon A) Soft<br>(Hydrophilic) Contact Lens<br>for Daily Wear<br>New Device | UNICON (etafilcon A) Soft<br>(Hydrophilic) Contact Lens<br>for Daily Wear<br>Predicate Device<br>510(k) K141917 | Art Optical<br>IntelliWave4 with HPT,<br>Silicone Hydrogel<br>(safrofilcon A)<br>Predicate Device<br>510(k) K152046 | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Indicated for the correction of<br>ametropia (myopia and hyperopia)<br>and/or are presbyopic in aphakic or<br>non-aphakic persons with non-<br>diseased eye who may have 5.00 D or<br>less astigmatism. | Indicated for the correction of<br>ametropia (myopia and hyperopia) in<br>aphakic or non-aphakic persons with<br>non-diseased eye who may have 1.00<br>D or less astigmatism. | Indicated for daily wear for the<br>correction of visual acuity in aphakic<br>and not apjakic persons with non-<br>diseased eyes with myopia or<br>hyperopia. The lens may also be<br>prescribed for management of<br>irregular corneal conditions such as<br>keratoconus and post graft fitting. | | Functionality | 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 | The contact lenses act as a<br>refractive medium that focus<br>light rays from near and distant<br>objects on the retina | | Indications | Daily wear. Soft (hydrophilic)<br>Contact Lens | Daily wear. Soft (hydrophilic)<br>Contact Lens | Daily wear. Silicone Hydrogel<br>Soft (hydrophilic) Contact<br>Lens | | Production Method | Cast-Molded | Cast-Molded | Lathe-Cut | | USAN name | etafilcon A | etafilcon A | safrofilcon A | | Water Content (%) | 58% | 58% | 65% | | Oxygen Permeability | 24.1 x 1011 (cm2/sec) (ml<br>02/ml-mmHg) | 30.8 x 1011 (cm2/sec) (ml<br>02/ml-mmHg) | 46.46 x 10-11 (cm2/sec) (ml O2/ml<br>x hPa ) | | Specific Gravity | 1.140 | 1.140 | 1.102 |