Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)

{0}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 20, 2017 Art Optical Contact Lens, Inc. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068 Re: K172314 Trade/Device Name: Ampleye Scleral RGP Lens (roflufocon D. roflufocon E. hexafocon A, paflufocon D) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: July 28, 2017 Received: August 1, 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. {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 (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 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 {2}------------------------------------------------ # 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. {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: | K172314 | |--------------------------------|---------| |--------------------------------|---------| #### Applicant information: Date Prepared: July 28th, 2017 3175 3 Mile Rd NW Grand Rapids, MI 49534 Mike Johnson, FCLSA Name: Address Contact Person: Phone number: (616) 559-5167 Director Consultant/Correspondent: Bret Andre EyeReg Consulting, Inc. Art Optical Contact Lens, Inc. Phone number (503) 372-5226 Fax number (503) 419-4475 #### Device Information: | Regulatory Class: | Class II | |--------------------|------------------------------------------------------------------------------------| | Regulation Number: | 21 CFR 886.5916 | | Product Code: | HQD | | Regulation Name: | Rigid Gas Permeable Contact Lens | | Common Name: | Lens, Contact (Other Material) - Daily | | Trade/Device Name: | Ampleye Scleral RGP Lens (roflufocon D<br>roflufocon E, hexafocon A, paflufocon D) | {4}------------------------------------------------ ### Predicate Devices: The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is substantially equivalent to the following predicate device(s) - "BostonSight PD Prosthetic Device" ● Manufactured by Boston Foundation for Sight 510(k) number; K161461 - "Custom Stable" Rigid Gas Permeable Scleral Contact Lens" ● Manufactured by Valley Contax, Inc. 510(k) number; K170335 #### Device Description: The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Ampleye Scleral RGP Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, or paflufocon D. | | ROFLUFOCON D | ROFLUFOCON E | HEXAFOCON A | PAFLUFOCON D | |-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------| | Refractive Index | 1.4333 | 1.4332 | 1.415 | 1.442 | | Light Transmission (clear) | >97% | >97% | - | >98% | | Light Transmission (tinted) | >90% | >90% | >89% | >93% | | Water Content | <1% | <1% | <1% | <1% | | Dynamic Contact Angle<br>(Receding) | 3° | 6° | 23° | 70° | | Specific Gravity | 1.166 | 1.155 | 1.27 | 1.10 | | Shore D Hardness | 75 | 77 | 80 | 79 | | Oxygen Permeability<br>(Dk)<br>ISO/FATT Method | $100 x 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C)$ | $125 x 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C)$ | $111 x 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C)$ | $101 x 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C)$ | | Contain one or more of the<br>following color additives<br>conforming to:<br>21 CFR Part 73 & 74, Subpart D | D & C Green No. 6, FD &<br>C Red No. 17,<br>CI Solvent Yellow 18 | D & C Green No. 6, FD<br>& C Red No. 17,<br>CI Solvent Yellow 18 | D&C Green No. 6;<br>D&C Yellow No.<br>18; D&C Violet No.<br>2; | D&C Green No. 6:<br>D&C Yellow No. 10:<br>D&C, Perox Yellow<br>No. 9 | | UV Light Blocking<br>(UVB - 280nm – 315nm; UVA<br>316nm - 380nm) | >98% UVB<br>>95% UVA | >98% UVB<br>>95% UVA | >95% UVB<br>>97% UVA | >95% UVB<br>>97% UVA | The physical properties of the Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) are as follows: {5}------------------------------------------------ | Parameter | Range | Tolerance | |-------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Base Curve | 5.57mm to 9.64mm | ± 0.10 mm | | Center Thickness | 0.20mm to 0.50mm | ± 0.02 mm | | Diameter | 15.00mm to 17.00mm | ± 0.10mm | | Spherical Power | -30.00 D to +30.00 D<br>(in 0.25D steps) | ± 0.12 (0 to = 5D)<br ± 0.18 (5 to = 10.0D)<br ± 0.25 (10 to = 15D)<br ± 0.37 (15 to = 20D)<br ± 0.50 (over 20D) | | Cylindrical Power | Up to -5.00 D<br>(in 0.25 D steps) | ± 0.25 (0 to = 2D)<br ± 0.37 (2 to = 4D)<br ± 0.50 (over 4D) | | Cylindrical Axis | 1º to 180º (in 1º steps) | ± 5° | | Multifocal Power | +1.00 D to 3.50 D<br>(in 0.25 D steps) | ± 0.25D | The available parameters for the Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) are as follows: The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) may be shipped "dry" or "wet". The primary container for shipping the Ampleye Scleral RGP Lens is the Sauflon Flat Coloured Lens Case by Sauflon Pharmaceuticals Ltd. When shipped "wet", the Ampleye Scleral RGP Lenses are packaged and shipped in Boston Simplus Multi-Action Solution by Bausch & Lomb, Inc. ## Indication for Use: The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is indicated for use for the management of irregular astigmatism, corneal degeneration or dystrophy caused by keratoconus, keratoglobus, pellucid marginal degeneration (PMD), post corneal trauma/scaring, post keratoplasty, post K-Pro, post RK, post LASIK, Salzmann's nodular degeneration. Cogan's dystrophy, granular corneal dystrophy, lattice corneal dystrophy or Reis-Bucklers dystrophy. The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is also indicated for therapeutic management of ocular surface disease from dry eye including ocular pemphigoid, Stevens-Johnson syndrome, symblepharon formation, graft vs host disease, persistent epithelial defect, exposure keratitis, neurotrophic keratopathy( herpes zoster, familial dysautonomia), Sjogern's syndrome, filamentary keratitis, limbal stem cell deficiency, atopy, ectodermal dysplasia. When prescribed for therapeutic use for irregular astigmatism or ocular surface diseases, the Ampleye Scleral RGP Lens may also provide correction of refractive error including myopia, presbyopia and regular astigmatism. Eye care 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. {6}------------------------------------------------ #### Description of Testing: #### ~ Non-Clinical Studies ~ Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, and paflufocon D has been addressed by reference to 510(k) K033594, K162005, and K052983. Additionally, the following testing was performed on finished Ampleye Scleral RGP Lenses (roflufocon D, roflufocon E, hexafocon A, paflufocon D): Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Art Optical Contact Lens, Inc. to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20-2016 tolerance. Bioburden Testing-bioburden testing conducted on rigid gas permeable lenses manufactured at Art Optical Contact Lens, Inc. demonstrated that the colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens. - ~ Clinical Studies ~ Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, paflufocon D has been previously addressed. - ~ Conclusions Drawn from Testing ~ Testing presented in this submission for the Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) demonstrate no significant differences from the predicate devices-supporting the substantial equivalence claim. {7}------------------------------------------------ ### Substantial Equivalence: The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is substantially equivalent to the predicate device(s), and does not raise different questions of safety and effectiveness. The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is substantially equivalent to the BostonSight PD Prosthetic Device (predicate device) in the following key areas: - Components/Materials/Formulation (roflufocon and hexafocon contact lens materials) ● - Storage solution for wet shipping ● - FDA classification and group number (Class 2, Group #3 Fluoro Silicone Acrylate) ● - Lathe cut manufacturing process ● - Scleral (large diameter) design - Actions and intended use ● - Therapeutic indications for use ● The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is substantially equivalent to the Custom Stable Rigid Gas Permeable Scleral Contact Lens (predicate device) in the following key areas: - Components/Materials/Formulation (roflufocon contact lens materials) ● - FDA classification and group number (Class 2, Group #3 Fluoro Silicone Acrylate) ● - Lathe cut manufacturing process ● - Scleral (large diameter) design - Actions and intended use ● - Therapeutic indications for use ● {8}------------------------------------------------ | | Ampleye Scleral RGP Lens | Custom Stable™ Rigid Gas<br>Permeable Scleral Contact Lens<br>K170335 | BostonSight PD Prosthetic<br>Device<br>K161461 | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Predicate Device | Predicate Device | | Indication for Use | Indicated for use for the management of<br>irregular astigmatism, corneal<br>degeneration or dystrophy caused by<br>keratoconus, keratoglobus, pellucid<br>marginal degeneration (PMD), post<br>corneal trauma/scaring, post<br>keratoplasty, post K-Pro, post RK, post<br>PRK, post LASIK, Salzmann's nodular<br>degeneration, Cogan's dystrophy,<br>granular corneal dystrophy, lattice<br>corneal dystrophy or Reis-Bucklers<br>dystrophy. Also indicated for therapeutic<br>management of ocular surface disease<br>from dry eye including ocular<br>pemphigoid, Stevens-Johnson syndrome,<br>symblepharon formation, graft vs host<br>disease, persistent epithelial defect,<br>exposure keratitis, neurotrophic<br>keratopathy( herpes simplex, herpes<br>zoster, familial dysautonomia), Sjogern's<br>syndrome, filamentary keratitis, limbal<br>stem cell deficiency, atopy, ectodermal<br>dysplasia.<br>When prescribed for therapeutic use for<br>irregular astigmatism or ocular surface<br>diseases, the Ampleye Scleral RGP Lens<br>may also provide correction of refractive<br>error including myopia, hyperopia,<br>presbyopia and regular astigmatism. | Indicated for use for the management of<br>multiple ocular conditions, such as,<br>degenerations that lead to an irregular<br>corneal shape, dystrophies, post-surgery<br>(e.g. corneal transplant, LASIK, radial<br>keratotomy), and corneal scarring. The lens<br>may also be prescribed for the management<br>of ocular surface diseases (e.g. dry eye<br>syndrome, Keratoconjunctivitis Sicca (Graft<br>vs Host Disease, Sjogren's syndrome,<br>Filamentary Keratitis), limbal stem cell<br>deficiency, epidermal ocular disorders,<br>neurotrophic keratitis, and corneal<br>exposure/lagophthalmos).<br>When prescribed for therapeutic use, the<br>Custom Stable RGP Scleral Lenses is also<br>indicated for correction of refractive error in<br>persons with myopia, hyperopia or<br>presbyopia. | Indicated for therapeutic use in eyes<br>with ocular surface disease from dry<br>eye (e.g. ocular Graft-versus-Host<br>disease, Sjögren's syndrome, dry<br>eye syndrome), limbal stem cell<br>deficiency (e.g.Stevens-Johnson<br>syndrome, chemical and thermal<br>burns, radiation), disorders of the<br>skin (e.g. atopy, ectodermal<br>dysplasia), neurotrophic keratitis<br>(e.g. Herpes simplex, Herpes zoster,<br>Familial Dysautonomia), and<br>corneal exposure (e.g. anatomic,<br>paralytic) that might benefit from<br>the presence of an expanded tear<br>reservoir and protection against an<br>adverse environment. When<br>prescribed for therapeutic use for<br>distorted cornea or ocular surface<br>disease, the BostonSight PD<br>Prosthetic Device may incidentally<br>provide correction of refractive<br>error. | | Device and<br>Classification | Class II<br>Lenses, Rigid Gas Permeable,<br>Daily Wear<br>HQD | Class II<br>Lenses, Rigid Gas Permeable,<br>Daily Wear<br>HQD | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily Wear<br>HQD | | Production Method | Lathe-cut | Lathe-cut | Lathe-cut | | USAN | Roflufocon D<br>Roflufocon E<br>Hexafocon A<br>Paflufocon D | Roflufocon D<br>Roflufocon E | Roflufocon D<br>Roflufocon E<br>Oprifocon A<br>Hexafocon B | | FDA Group # | Group # 3 Fluoro Silicone<br>Acrylate | Group # 3 Fluoro Silicone<br>Acrylate | Group # 3 Fluoro Silicone<br>Acrylate | | Water Content | <1% | <1% | <1% | | UV Absorber/Blocker<br>available | YES | YES | YES | The following table depicts the characteristics of the Ampleye Scleral RGP Lens (rofflufocon D, roflufocon E, hexafocon A, paflufocon D), as well as the predicate device(s).