OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 13, 2016 Contamac Ltd. % Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068 Re: K160859 Trade/Device Name: OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens (roflufocon D & E) Regulation Number: 21 CFR 886.5916 Regulation Name: Daily Wear Rigid Gas Permeable (hydrophobic) Contact Lens (Orthokeratology) Regulatory Class: Class II Product Code: MUW Dated: May 25, 2016 Received: June 1, 2016 Dear Mr. 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 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. # Denise E. 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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) ### K160859 Device Name OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens (roflufocon D & E) ### Indications for Use (Describe) The OPTIMUM GP OK 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 wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system. ### Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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: | K160859 | |--------------------------------|--------------------------------------------------------------------------------------------------| | Applicant information: | | | Date Prepared: | March 23 ^rd , 2016 | | Name: | Contamac Ltd. | | Address | Carlton House<br>Shire Hill<br>Saffron Walden<br>Essex CB11 3AU | | Contact Person: | Robert McGregor | | | Managing Director | | Phone number: | 44-1799 542 000 | | Consultant: | EyeReg Consulting, Inc. | | | Bret Andre<br>6119 Canter Ln<br>West Linn, OR 97068 | | Phone number | (503) 372-5226 | | Fax number | (503) 419-4475 | | Device Information: | | | Device Classification: | Class II | | Product Code: | MUW | | Classification Name: | Daily Wear Rigid Gas Permeable (hydrophobic) Contact<br>Lens (Orthokeratology) (21 CFR 886.5916) | | Trade Name: | OPTIMUM GP OK (Orthokeratology)<br>Daily Wear Contact Lens (roflufocon D & E) | {4}------------------------------------------------ ## Purpose of Submission: ~ New Indication ~ ## Predicate Devices: The OPTIMUM GP OK for daily wear is substantially equivalent to the following predicate device(s) Predicate device: | Predicate device<br>manufacturer | Device name | 510(k) number | |----------------------------------|-----------------------------------------------------------------------------------------|---------------| | Contamac Ltd. | OPTIMUM GP (Oxygen Permeable) Daily Wear<br>Contact Lenses (roflufocon A, B, C, D, & E) | K033594 | | Contex, Inc. | CONTEX OK (orthokeratology) contact lens | K973697 | | Polymer Technology | Boston X02 (hexafocon B) Daily Wear Contact<br>Lens | K071266 | ## Device Description: The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3 - Hexafluoroisopropy] Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acid cross-linked with Ethylene Glycol Dimethacrylate. The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP OK lenses is the PolyVial /PolyPack Contact Lens Case. When shipped "wet", the OPTIMUM GP OK lenses may be packaged and shipped in the Optimum Cleaning, Disinfecting and Storage (CDS) GP solution. The active ingredients in Optimum GP Cleaning Disinfecting and Storage solution are Lauryl salt of imidazoline, octylphenoxypolyethoxyethanol, and preserved with benzyl alcohol 0.3% and disodium edetate 0.5%. The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) 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. and FD&C Red No. 17. ## In the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV Blocker is 2,2 -Dihydroxy-4,4'dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280nm – 315nm and 95% in the UVA range of 316 – 380nm. The physical properties of the OPTIMUM GP OK Contact Lens are as follows: {5}------------------------------------------------ | | (roflufocon d) | (roflufocon e) | |-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------| | Refractive Index | 1.4333 | 1.4332 | | Light Transmission (clear) | >97% | >97% | | Light Transmission (tinted) | >90% | >90% | | Wetting Angle (Dynamic contact<br>receding angle) | 3° | 6° | | Specific Gravity | 1.166 | 1.155 | | Oxygen Permeability<br>(Dk)<br>ISO/FATT Method | $100 \times 10^{-11} \frac{cm^2}{sec} (ml O_2/ml x mm \newline Hg @ 35°C)$ | $125 \times 10^{-11} \frac{cm^2}{sec} (ml O_2/ml x mm \newline Hg @ 35°C)$ | | Visitint lenses contain one or more of<br>the following color additives<br>conforming to:<br>21 CFR Part 73 & 74, Subpart D | D & C Green No. 6, FD & C Red<br>No. 17,<br>CI Solvent Yellow 18 | D & C Green No. 6, FD & C Red<br>No. 17,<br>CI Solvent Yellow 18 | The lens parameters of the OPTIMUM GP OK Contact Lens are as follows: - 米 Chord Diameter: - ન્ન્સ Center Thickness: - 米 Base Curve (BC): - 米 Secondary Curves: - 米 Peripheral Curves: - 米 Spherical Powers: 6.5 to 11.5 mm 0.10 to 0.70 mm 6.5 to 11.0 mm 0.10 to 2.0 mm (flatter or steeper than BC) 0.10 to 2.0 mm (flatter or steeper than BC) -10.00 to +3.00 D ## Indication for Use: The OPTIMUM GP OK 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. ## Description of Safety: The safety profile for finished lenses manufactured from the (roflufocon D & E) rigid gas permeable (RGP) materials is demonstrated in K033594-which addresses the following areas: - · Biocompatibility - · Shelf Life (Wet Shipping) - · Solution Compatibility - · Clinical Performance {6}------------------------------------------------ ## Substantial Equivalence: Comparison to Predicate Device(s): The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is substantially equivalent to the OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses (roflufocon A, B, C, D, & E)cleared under K033594-in terms of the following: - · contact lens material (roflufocon D. & E)—including physicochemical and mechanical properties of finished lenses - · lathe cut manufacturing process - manufacturing facility - · final packaging and wet shipping procedures The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is substantially equivalent to the Boston X02 (hexafocon B) Daily Wear Contact Lens and CONTEX OK-cleared under K071266 and K973697, respectively-in terms of the following: - · indications for use (daily wear orthokeratology) - orthokeratology lens design The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) are substantially equivalent to the predicate device as depicted in the following table, and do not raise different questions of safety and effectiveness than the predicate device identified previously. {7}------------------------------------------------ The following table depicts the pre-clinical characteristics of the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E), as well as the predicate device. | | OPTIMUM GP OK<br>(Orthokeratology) | OPTIMUM GP | CONTEX OK | BOSTON XO2 | |-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Predicate Device | Predicate Device | Predicate Device | | Indication for Use | Indicated for daily wear in an<br>orthokeratology fitting<br>program for the temporary<br>reduction of myopia of up to<br>5.00 diopters in non-diseased<br>eyes. To maintain the<br>orthokeratology effect of<br>myopia reduction, lens wear<br>must be continued on a<br>prescribed wearing schedule. | May be prescribed in<br>otherwise non-diseased eyes<br>that require a rigid gas<br>permeable lens for the<br>management of irregular<br>corneal conditions such as;<br>keratoconus, pellucid<br>marginal degeneration of<br>following penetrating<br>keratoplasty or following<br>refractive (e.g. LASIK)<br>surgery. | Indicated for daily<br>wear in an<br>orthokeratology<br>fitting program for<br>the temporary<br>reduction of myopia<br>of up to 3.00 diopters<br>in non-diseased eyes.<br>To maintain the<br>orthokeratology<br>effect of myopia<br>reduction, lens wear<br>must be continued on<br>a prescribed wearing<br>schedule. | Indicated for daily wear<br>in an orthokeratology<br>fitting program for the<br>temporary reduction of<br>myopia of up to 5.00<br>diopters in non-diseased<br>eyes. To maintain the<br>orthokeratology effect of<br>myopia reduction, lens<br>wear must be continued<br>on a prescribed wearing<br>schedule. | | Device and<br>Classification | Class II<br>Daily Wear Rigid Gas<br>Permeable (hydrophobic)<br>Contact Lens (21 CFR<br>886.5916) | Class II<br>Daily Wear Rigid Gas<br>Permeable (hydrophobic)<br>Contact Lens (21 CFR<br>886.5916) | Class II<br>Daily Wear Rigid<br>Gas Permeable<br>(hydrophobic)<br>Contact Lens (21<br>CFR 886.5916) | Class II<br>Daily Wear Rigid Gas<br>Permeable<br>(hydrophobic) Contact<br>Lens (21 CFR<br>886.5916) | | Product Code | MUW | HQD | MUW | MUW | | Production Method | Lathe-cut | Lathe-cut | Lathe-cut | Lathe-cut | | USAN | roflufocon D, & E | roflufocon A, B, C, D, &<br>E | siflufocon A | hexafocon B | | FDA Group # | Group # 3 Fluoro Silicone<br>Acrylate | Group # 3 Fluoro Silicone<br>Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | | Oxygen Permeability<br>x 10-11 (cm2/sec)<br>(ml O2/ml x mm Hg @ 35°C) | Roflufocon D: 100<br>Roflufocon E: 125 | Roflufocon D: 100<br>Roflufocon E: 125 | 81 | 141 | | Water Content | <1% | <1% | <1% | <1% | | UV Absorber/Blocker<br>available | YES | YES | NO | YES |