HEXA100 (hexafocon A) Daily Wear Contact Lenses

{0}------------------------------------------------ ## 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. #### 510(k) number: K171077 #### Applicant information: | Date Prepared: | June 27th, 2017 | |------------------------|---------------------------------------------------------------------------------| | Name: | Contamac Ltd. | | Address | Carlton House<br>Shire Hill<br>Saffron Walden<br>Essex CB11 3AU | | Contact Person: | Robert McGregor<br>Managing Director | | Phone number: | 44-1799 542 000 | | 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: | HQD; MUW | Classification Name: Daily Wear Rigid Gas Permeable Contact Lens (21 CFR 886.5916) Trade Name: HEXA100 (hexafocon A) Daily Wear Contact Lens #### Purpose of 510(k) Submission: ~ New Device ~ #### Predicate Devices: The HEXA100 (hexafocon A) Daily Wear Contact Lenses are substantially equivalent to the following predicate devices: "Boston XO (hexafocon A) Daily Wear Contact Lens" -primary predicate By Bausch & Lomb, Inc. {1}------------------------------------------------ 510(k) number: K071043 "OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens (roflufocon D & E)" by Contamac Ltd. 510(k) number; K160859 "Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses" by Contamac Ltd. 510(k) number; K161100 ### Device Description: The HEXA100 (hexafocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. In the HEXA100 (hexafocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV blocking for HEXA100 averages > 98% in the UVB range of 280nm - 315nm and >84% in the UVA range of 316 - 380nm. The HEXA100 (hexafocon A) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17. The HEXA100 (hexafocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes. The HEXA100 (hexafocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible "10 Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible 10 Hydra-PEG, the underlying material (hexafocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness. The following table depicts the contact angle of the coated HEXA100 (hexafocon A) Daily Wear Contact Lenses: | | HEXA 100 - Hexafocon A | | |------------------------------------------------------|------------------------|--------------------------------| | | Uncoated* | Tangible™ Hydra-PEG<br>Coated* | | Average Sessile Drop Contact Angle<br>(degrees) n=30 | 96.4° | 49.1° | | Standard Deviation | 2.79 | 5.81 | | % Standard Deviation | 2.90 | 11.82 | *lenses were manufactured and soaked in borate buffered saline for 24 hours prior to contact angle measurement The HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or {2}------------------------------------------------ "wet" in a polypropylene contact lens case. The primary container for shipping the HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%. The physical properties of the HEXA100 (hexafocon A) Daily Wear Contact Lenses are as follows: | | HEXA100 (hexafocon A) | HEXA100 (hexafocon A) with<br>Tangible™ Hydra-PEG | |--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Refractive Index (dry) | 1.4136 | 1.4134 | | Light Transmission (@380-780nm) | >91% | >94% | | UVA Transmission (@316-380nm) | <16% | <16% | | UVB Transmission (@280-315nm) | <2% | <2% | | Specific Gravity (g/cm³) | 1.266 | 1.266 | | Oxygen Permeability<br>(Dk)<br>ISO/FATT Method | 113 x 10-11 11<br>(cm /sec) (ml O /ml x mm Hg @<br>35°C) | 118 x 10-11 "<br>(cm /sec) (ml O /ml x mm Hg @<br>35°C) | | Visitint lenses contain one or more of the<br>following color additives conforming to:<br>21 CFR Part 73 & 74, Subpart D | D&C Green No. 6, C.I. Solvent<br>Yellow No. 18, D&C Violet No. 2 and<br>D&C Red No. 17 | D&C Green No. 6, C.I. Solvent<br>Yellow No. 18, D&C Violet No. 2<br>and D&C Red No. 17 | The HEXA100 (hexafocon A) Daily Wear Contact Lens is available in the Spherical. Toric. Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters: | • Chord Diameter: | 7.0mm to 22.0mm | |-------------------|-----------------| |-------------------|-----------------| - Center Thickness: - Base Curve: ● ● - Spherical Powers: - Toric Powers: - Add Powers: - Varies 5.0mm to 8.0mm - -20.00 Diopters to +20.00 Diopters - up to -10.00 Diopters - up to +4.00 Diopters The HEXA100 (hexafocon A) Daily Wear Contact Lens for daily wear orthokeratology is available in following lens parameters: - 6.5 to 11.5 mm ● Chord Diameter: - Center Thickness: 0.10 to 0.70 mm ● - Base Curve (BC): 6.5 to 11.0 mm - 0.10 to 2.0 mm (flatter or steeper than BC) ● Secondary Curves: - 0.10 to 2.0 mm (flatter or steeper than BC) Peripheral Curves: ● - Spherical Powers: -10.00 to +3.00 D {3}------------------------------------------------ #### Intended Use: The HEXA100 (hexafocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia. The HEXA100 (hexafocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear 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 10.00 diopters. The HEXA100 (hexafocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear 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 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The HEXA100 (hexafocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The HEXA100 (hexafocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system. #### 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 HEXA100 (hexafocon A) Daily Wear Contact Lens. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols. Test results of the non-clinical testing on the HEXA100 (hexafocon A) Daily Wear Contact Lens demonstrate that: - The finished lenses (uncoated and coated with Tangible " Hydra-PEG) are ● not toxic and not irritating, - The physicochemical, mechanical, and optical properties of the Tangible™ . Hydra-PEG coated and uncoated lenses are substantially equivalent to the predicate device. - Bioburden levels are below the acceptance criteria (<100 cfu/lens) initially ● (dry) and following 30 days of storage in Unique pH at ambient temperatures, {4}------------------------------------------------ - Physical parameters are stable following 30 days of storage in Menicon ● Unique pH at ambient temperatures, and - The Tangible "10 HydraPEG coated Hexafocon A lenses are physically ● compatible with currently marketed care solutions. Clinical Testing The clinical safety and effectiveness has been previously established for contact lenses manufactured from (hexafocon A) and contact lenses coated with Tangible™ Hydra-PEG. #### Conclusions Drawn from Studies #### 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 HEXA100 (hexafocon A) 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 proposed indication. #### Risks and Benefits The risks of the subject device are the same as those normally attributed to the wearing of rigid gas permeable (RGP) daily wear contact lenses. The benefits to the patient are the same as those for other RGP contact lenses. #### Substantial Equivalence: The HEXA100 (hexafocon A) Daily Wear Contact Lens is substantially equivalent to the Boston XO (hexafocon A) Daily Wear Contact Lens (cleared under K071043) in terms of the following: - contact lens material (hexafocon A) - production method: lathe cut manufacturing process ● - functionality - indications for use (sphere, toric, multifocal, irregular cornea) The HEXA100 (hexafocon A) Daily Wear Contact Lens is substantially equivalent to the OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens (roflufocon D & E) (cleared under K160859) in terms of the following: - indications for use (daily wear orthokeratology) - orthokeratology lens design ● The HEXA100 (hexafocon A) Daily Wear Contact Lens is substantially equivalent to the Optimum {5}------------------------------------------------ GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens (cleared under K161100) in terms of the following: - may incorporate the Tangible™ Hydra-PEG surface coating . The following matrix illustrates the production method, lens function and material characteristics of the HEXA100 (hexafocon A) Daily Wear Contact Lens as well as the predicate devices. #### Substantial Equivalence Matrix | HEXA100 (hexafocon A)<br>New Device | Boston XO<br>(hexafocon A)<br>Predicate Device | Optimum GP with<br>HPT<br>(roflufocon C, D, E)<br>Predicate Device | OPTIMUM GP OK<br>(Orthokeratology)<br>(roflufocon D & E)<br>Predicate Device | | |------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Indicated for daily wear for the<br>correction of visual acuity in<br>aphakic and not aphakic persons<br>with non-diseased eyes with<br>myopia or hyperopia and/or<br>presbyopia. The lens may also be<br>prescribed for management of<br>irregular corneal conditions such as<br>keratoconus and post graft fitting.<br>Indicated for daily wear in an<br>orthokeratology fitting program for<br>the temporary reduction of myopia<br>of up to 5.00 diopters in non-<br>diseased eyes. To maintain the<br>orthokeratology effect of myopia<br>reduction, lens wear must be<br>continued on a prescribed wearing<br>schedule. | Indicated for daily<br>wear for the correction<br>of visual acuity in<br>aphakic and not<br>aphakic persons with<br>non-diseased eyes with<br>myopia or hyperopia<br>and/or presbyopia.<br>The lens may also be<br>prescribed for<br>management of<br>irregular corneal<br>conditions such as<br>keratoconus and post<br>graft fitting. | Indicated for daily wear for<br>the correction of visual<br>acuity in aphakic and not<br>aphakic persons with non-<br>diseased eyes with myopia<br>or hyperopia and/or<br>presbyopia. The lens may<br>also be prescribed for<br>management of irregular<br>corneal conditions such as<br>keratoconus and post graft<br>fitting. | Indicated for daily wear in<br>an orthokeratology fitting<br>program for the temporary<br>reduction of myopia of up<br>to 5.00 diopters in non-<br>diseased eyes. To maintain<br>the orthokeratology effect<br>of myopia reduction, lens<br>wear must be continued on<br>a prescribed wearing<br>schedule. | | Functionality | The contact lenses act as a<br>refractive medium that<br>focus light rays from near<br>and distant objects on the<br>retina | The contact lenses<br>act as a refractive<br>medium that focus<br>light rays from<br>near and distant<br>objects on the<br>retina | The contact lenses act<br>as a refractive<br>medium that focus<br>light rays from near<br>and distant objects on<br>the retina | The contact lenses act<br>as a refractive<br>medium that focus<br>light rays from near<br>and distant objects on<br>the retina | | Indications | Daily Wear | Daily Wear | Daily Wear | Daily Wear | | Production<br>Method | Lathe-Cut, custom<br>manufactured | Lathe-Cut, custom<br>manufactured | Lathe-Cut, custom<br>manufactured | Lathe-Cut, custom<br>manufactured | | USAN name | hexafocon A | hexafocon A | roflufocon C, D, E | roflufocon D, E | | Water Content<br>(%) | <1% | <1% | <1% | <1% | | Specific Gravity | 1.266 | 1.265 | Roflufocon C: 1.178<br>Roflufocon D: 1.166<br>Roflufocon E: 1.155 | Roflufocon D: 1.166<br>Roflufocon E: 1.155 | | Oxygen<br>Permeability<br>(cm /sec) (ml O /ml x mm<br>Hg @ 35°C) | Uncoated: 113 x 10-11<br>Hydra-PEG Coated: 118 x<br>10-11 | 108 x 10-11 | Roflufocon C: 65x10-11<br>Roflufocon D: 100x10-11<br>Roflufocon E: 125x10-11 | Roflufocon D: 100x10-11<br>Roflufocon E: 125x10-11 | | Wettability<br>(sessile drop<br>contact angle) | Hydra-PEG Coated: 49.1°<br>Uncoated: 96.4° | 96.4° | Roflufocon C: 40.28°<br>Roflufocon D: 40.40°<br>Roflufocon E: 36.90°<br>(measured by captive<br>bubble) | Roflufocon D: 93.28°<br>Roflufocon E: 93.64°<br>(measured by captive<br>bubble) | | UV<br>Absorber/Blocker<br>Available | Yes, Optional | Yes | Yes, Optional | Yes, Optional | | Includes Hydra-<br>PEG<br>Surface Coating | Yes. Optional | No | Yes | No | {6}------------------------------------------------ {7}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries. {8}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 1, 2017 CONTAMAC Ltd. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068 Re: K171077 Trade/Device Name: HEXA100 (hexafocon A) Daily Wear Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD; MUW Dated: June 28, 2017 Received: June 29, 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. Iisting 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. {9}------------------------------------------------ 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 devicerelated 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 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 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 yours, 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