BostonSight Scleral

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 4, 2019 BostonSight % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn. OR 97068 Re: K183175 Trade/Device Name: BostonSight Scleral Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: November 13, 2018 Received: November 16, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov {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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 mediation-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 yours, # J Angelo Green 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 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ### 510(k) Number (if known) K183175 Device Name BostonSight Scleral #### Indications for Use (Describe) BostonSight Scleral daily wear contact lenses are indicated for the correction of refractive ametropia (myoropia, astigmatism and presbyopia) in aphakic persons. Also, the lenses may be prescribed in eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, keratoglobus, post-LASIK ectasia, or following penetrating keratoplasty or refractive surgery. Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. BostonSight Scleral daily wear contact lenses are indicated for the management of irregular and distorted corneal surfaces where the subject: - 1. cannot be adequately corrected with spectacle lenses - 2. requires a rigid gas permeable contact lens surface to improve vision - 3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities Common causes of corneal distortion include, but are not limited to, corneal infections as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). The BostonSight Scleral daily wear contact lenses are also indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis, limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Scheral daily wear contact lenses may concurrently provide correction of refractive error. The lenses may be disinfected using a chemical disinfection (not heat) system only. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Boston Sight at the top. Below the logo, the text "510(K) Premarket Notification" is displayed in a large, bold font. The text indicates that the document is related to a 510(K) premarket notification, which is a type of submission required by the U.S. Food and Drug Administration (FDA) for certain medical devices. # 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: 183175 #### I. SUBMITTER | Date Prepared: | November 13th, 2018 | |----------------------------------|---------------------------------------------------------------------------------------------------| | Name:<br>Address: | BostonSight<br>464 Hillside Avenue, Suite 205<br>Needham, MA 02494 | | Contact Person:<br>Phone number: | Gene P. Guselli<br>President and CEO<br>781-726-7337 | | Consultant:<br>Phone number: | Bret Andre<br>EyeReg Consulting, Inc.<br>6119 Canter Ln.<br>West Linn, OR 97068<br>(503) 372-5226 | #### II. DEVICE | Trade Name: | BostonSight Scleral | |-------------------------|-----------------------------------------------------| | Common<br>Name: | Daily wear rigid gas permeable contact lens | | Classification<br>Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) | | Regulatory<br>Class: | Class II | | Product Code: | HOD | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Boston Sight logo at the top, which is a stylized sunburst design. Below the logo, the text "510(K) Premarket Notification" is displayed in a clear, bold font. The text indicates that the document is related to a premarket notification, likely for a medical device or product. ~Reason for Submission~ Labeling Changes - Expanded Indications for Use #### III. PREDICATE DEVICE BostonSight Scleral daily wear contact lenses are substantially equivalent to the following predicate devices: - 트 "Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lens" By Bausch + Lomb Inc. 510(k) number; K171404 - 트 "OPTIMUM GP (Roflufocon D, Roflurocon E) Daily Wear Contact Lens" By Contamac Ltd. 510(k) number: K180616 - 트 "BostonSight PD Prosthetic Device" By BostonSight 510(k) number; K161461 #### IV. DEVICE DESCRIPTION The BostonSight Scleral daily wear contact lenses are manufactured with a large diameter RGP lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The BostonSight Scleral daily wear contact lenses are lathe cut and fabricated from one of the following fluoro-silicone acrylate rigid gas permeable (RGP) lens materials: - · roflufocon D supplied by Contamac Ltd. - · roflufocon E supplied by Contamac Ltd. - · oprifocon A supplied by Bausch and Lomb, Inc. - · hexafocon B supplied by Bausch and Lomb, Inc. The BostonSight Scleral daily wear contact lenses may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight Scleral daily wear contact lenses is the Bausch & Lomb Frequent Replacement Contact Lens Case, with clearance under 510(k) K896685. When shipped "wet", The BostonSight Scleral daily wear contact lenses manufactured from material supplied by Bausch & Lomb, inc. may be packaged and shipped in Boston Advance Comfort Formula Conditioning Solution (K974466) or Boston SIMPLUS Multi-Action solution (K024289). The BostonSight Scleral daily wear contact lenses manufactured from material supplied by Contamac, Ltd. may be packaged and shipped "wet" in in the OPTIMUM by Lobob Cleaning and Disinfecting Storage solution, with clearance under 510(k) K014162. {5}------------------------------------------------ | | roflufocon D | roflufocon E | oprifocon A | hexafocon B | |--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | Refractive Index | 1.4333 | 1.4332 | 1.4230 | 1.4240 | | Light Transmission<br>(clear) | >97% | >97% | >95% | >95% | | Light Transmission<br>(tinted) | >90% | >90% | >90% | >83% | | Specific Gravity | 1.166 | 1.155 | 1.24 | 1.19 | | Oxygen<br>Permeability<br>(Dk) | $100 \times 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $125 \times 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $85 \times 10^{-11}$ (cm²/sec)<br>(ml O₂/ml x mm Hg @<br>35°C) | $141 \times 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | | Visitint lenses<br>contain one or more<br>of the following<br>color additives<br>conforming to:<br>21 CFR Part 73 &<br>74, Subpart D | D & C Green No.<br>6, FD & C Red<br>No. 17,<br>CI Solvent<br>Yellow 18 | D & C Green No.<br>6, FD & C Red<br>No. 17,<br>CI Solvent<br>Yellow 18 | D&C Green No.6<br>and D&C Yellow<br>No.10 | D&C Green No.<br>6; C.I. Solvent<br>Yellow No. 18;<br>D&C Violet No.<br>2; D&C Red No.<br>17; C.I. Solvent<br>Yellow No.18 | | UV Light Blocking<br>(UVB - 280nm -<br>315nm; UVA 316nm<br>- 380nm) | >98% UVB<br>>95% UVA | >98% UVB<br>>95% UVA | >95% UVB<br>>97% UVA | >95% UVB<br>>97% UVA | | Dynamic Receding<br>Contact Angle | 3° | 6° | 56° | 40° | # The physical properties of the BostonSight Scleral daily wear contact lenses are as follows: ## The BostonSight Scheral daily wear contact lenses are available in the following lens parameters: | Parameter | Range | Tolerance | |------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Base Curve | 5.00mm to 9.00mm | ± 0.05 mm | | Center Thickness | 0.05mm to 0.60mm | ± 0.02 mm | | Diameter | 8.00mm to 26.00mm | ± 0.10mm | | Spherical Power | -25.00 D to +35.00 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) | #### V. INDICATIONS FOR USE BostonSight Scleral daily wear contact lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non aphakic persons. Also, the lenses may be prescribed in eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, keratoglobus, post-LASIK ectasia, or following penetrating keratoplasty or refractive surgery. BostonSight Scleral {6}------------------------------------------------ Furthermore, eves suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. BostonSight Scleral daily wear contact lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject: - 1. cannot be adequately corrected with spectacle lenses - 2. requires a rigid gas permeable contact lens surface to improve vision - 3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities Common causes of corneal distortion include, but are not limited to, corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoclobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). The BostonSight Scleral daily wear contact lenses are also indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis, limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Scleral daily wear contact lenses may concurrently provide correction of refractive error. The lenses may be disinfected using a chemical disinfection (not heat) system only. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE The BostonSight Scleral daily wear contact lenses are substantially equivalent to the predicate devices (cleared under K171404, K180616, and K161461) in terms of the following: - Intended use daily wear contact lenses ■ - 트 Indications for use - Actions - Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) - 트 FDA material group - group # 3 fluoro silicone acrylate - 트 USAN materials (roflufocon D, roflufocon E, oprifocon A and hexafocon B) - 트 Production method - lathe cut - 트 Final packaging and shipping {7}------------------------------------------------ The following matrix illustrates the production method, lens function and material characteristics of the BostonSight Scleral daily wear contact lenses, as well as the predicate device. | | BostonSight<br>Scleral | Boston XO® and<br>Boston XO2® RGP<br>Contact Lenses | OPTIMUM GP<br>Contact Lens | BostonSight PD<br>Prosthetic Device | |--------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject<br>Device | Predicate Device<br>(K171404) | Predicate Device<br>(K180616) | Predicate Device<br>(K161461) | | Classification | Same as<br>predicate | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily Wear<br>21 CFR 886.5916 | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily Wear<br>21 CFR 886.5916 | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily<br>Wear<br>21 CFR 886.5916 | | Product Code | Same as<br>predicate | HQD | HQD | HQD | | FDA Group # | Same as<br>predicate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | | USAN | roflufocon D,<br>roflufocon E,<br>oprifocon A,<br>hexafocon B | hexafocon A, hexafocon<br>B | roflufocon D,<br>roflufocon E | roflufocon D,<br>roflufocon E,<br>oprifocon A,<br>hexafocon B | | Production<br>Method | Same as<br>predicate | Lathe-Cut | Lathe-Cut | Lathe-Cut | | Actions | Same as<br>predicate | The contact lenses act as<br>a refractive medium that<br>focus light rays from<br>near and distant objects<br>on the retina. When<br>placed on the eye for<br>therapeutic use, the lens<br>replaces or supports<br>impaired ocular surface<br>function. | The contact lenses act<br>as a refractive medium<br>that focus light rays<br>from near and distant<br>objects on the retina.<br>When placed on the eye<br>for therapeutic use, the<br>lens replaces or<br>supports impaired<br>ocular surface function. | The contact lenses act<br>as a refractive medium<br>that focus light rays<br>from near and distant<br>objects on the retina.<br>When placed on the<br>eye for therapeutic<br>use, the lens replaces<br>or supports impaired<br>ocular surface<br>function. | | Intended Use | Same as<br>predicate | Daily Wear | Daily Wear | Daily Wear | | Indication for Use | Same as<br>predicate | Therapeutic (Scleral) | Therapeutic (Scleral) | Therapeutic (Scleral) | | Water Content<br>(%) | <1% | <1% | <1% | <1% | | UV Absorber<br>Available | Yes | Yes | Yes | Yes | {8}------------------------------------------------ #### VIII. PERFORMANCE DATA ### ~ Non-Clinical Studies ~ The purpose of this application is to modify the labeling of previously FDA cleared RGP contact lenses/materials to include therapeutic indications for use. Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E. oprifocon A and hexafocon B materials has been addressed in previous applications. ## ~ Clinical Studies ~ Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, oprifocon A and hexafocon B has been previously addressed. # VIII. CONCLUSIONS ## Substantial Equivalence Information presented in this Premarket Notification establishes that BostonSight Scleral daily wear 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 indications. ### 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.