Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of 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. May 5, 2023 Paragon Vision Sciences, Inc. Vimala Punsammy Global Regulatory Affairs Manager 2120 W. Guadalupe Rd. Gilbert, AZ 52233 Re: K221768 Trade/Device Name: Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: March 30, 2023 Received: March 31, 2023 Dear Vimala Punsammy: 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/cfpmn/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. 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 devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 titled, "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 https://www.fda.gov/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, J Angelo Green -S Image /page/1/Picture/6 description: The image shows the logo of the Food and Drug Administration (FDA). The logo consists of the letters 'FDA' in a bold, sans-serif font. The color of the letters is a light blue or gray, and the background is white. The logo is simple and recognizable, representing the FDA's role in regulating and overseeing food and drug products. J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221768 #### Device Name Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses Indications for Use (Describe) The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non aphakic persons with nondiseased eyes. The lenses may be disinfected using a chemical disinfection system only. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <span style="font-size:14px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:14px">☐</span> 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}------------------------------------------------ | Paragon Vision Sciences, Inc.<br>510(k) Premarket Notification | 510(k) Summary | |----------------------------------------------------------------|----------------| | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | K221768 | ### 510(k) Summary #### 1. SUBMITTER | Date Prepared: | April 27, 2023 | |-------------------|----------------------------------------------------------------------------------------------------| | Name and Address: | Paragon Vision Sciences, Inc.<br>2120 W. Guadalupe Rd.<br>Gilbert, AZ 85233-2810<br>(800) 825-8279 | | Contact Person: | Vimala Punsammy | |-----------------|---------------------------------------| | | Regulatory Affairs Consultant | | | Telephone: (646)-639-5458 | | | E-Mail: vpunsammy@coopervisionsec.com | ## 2. DEVICE | Proprietary/Trade Name: | Oxfore® 100 (hexafocon A) Rigid Gas Permeable Contact<br>Lenses | |-------------------------|-----------------------------------------------------------------| | Regulation Number: | 21 CFR 886.5916 (Rigid Gas Permeable Contact Lenses) | | Device Classification: | Class II | | Device Product Code: | HQD | ### 3. PREDICATE DEVICES The Oxfore®100 (hexafocon A) RGP contact lenses for daily wear are substantially equivalent to the Boston XO™ (hexafocon A) Daily Wear Contact Lens (K171404) in terms of the following: - Intended Use daily wear contact lenses ● - Actions - Classifications Lenses, Rigid Gas Permeable, Daily Wear Contact Lens; Class II (21 ● CFR 886.5916) - FDA material group - group #3 fluoro silicon acrylate - Production method lathe cut ● - USAN hexafocon A ● {4}------------------------------------------------ | Paragon Vision Sciences, Inc.<br>510(k) Premarket Notification | 510(k) Summary | |----------------------------------------------------------------|----------------| | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | K221768 | ## 4. DEVICE DESCRIPTION The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut into the following designs: - Spherical - Aspherical ● - Toric ● - Mulifocal ● - Scleral ● - Semi-scleral ● Oxfore100 (hexafocon A) may incorporate an ultraviolet light absorber and is available in a variety of tints. The material (hexafocon A) from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO (hexafocon A) Material and Contact Lenses described in K171404. These devices will not be marketed with multiple components or any required accessories. ## 5. INDICATION FOR USE The Oxfore® 100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only. ### 6. SUBSTANTIAL EQUIVALENCE Substantial equivalence is based on: For design: The predicate lenses, the Boston XO™ RGP lenses for daily wear, have several designs including spherical, aspherical, toric and scleral.. The new lenses, the Oxfore® 100 RGP lenses for daily wear have the same substantially equivalent designs. For material: The predicate lens materials are comprised of a siloxanyl fluoromethacrylate copolymer (hexafocon A). The new lens material also is comprised of a siloxanyl fluoromethacrylate copolymer (hexafocon A). {5}------------------------------------------------ | Paragon Vision Sciences, Inc.<br>510(k) Premarket Notification | 510(k) Summary | |----------------------------------------------------------------|----------------| | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | K221768 | The new lenses in this submission therefore are substantially equivalent to the lenses cleared under K171404. The table below shows a side-by side comparison of Oxfore®100 with the predicate device | | NEW LENS | PREDICATE LENS | |----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Lens Characteristics | Oxfore®100 (hexafocon A) RGP Lens | Boston XOTM (hexafocn A) RGP Lens | | Manufacturer | Paragon Vision Sciences, Inc. | Bausch + Lomb | | Material | hexafocon A | hexafocon A | | Production method | Lathe Cut | Lathe Cut | | Actions/Operational Principles | When placed on the eye the Rigid Gas<br>Permeable Contact Lens acts as a<br>refracting medium to focus light rays on<br>the retina to improve visual acuity | When placed on the eye the Rigid Gas<br>Permeable Contact Lens acts as a<br>refracting medium to focus light rays on the<br>retina to improve visual acuity | | Product Code | HQD | HQD | | Common Name | Contact Lens, Rigid Gas Permeable | Contact Lens, Rigid Gas Permeable | | Device Class | II | II | | CFR Reference | 21 CFR<br>886.5916 | 21 CFR<br>886.5916 | | FDA Group # | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone Acrylate | | Indications for Use | The Oxfore®100 (hexafocon A) Contact<br>Lenses are indicated for daily wear for the<br>correction of refractive ametropia<br>(myopia, hyperopia, astigmatism and<br>presbyopia) in aphakic and non aphakic<br>persons with non-diseased eyes. The<br>lenses may be disinfected using a chemical<br>disinfection system only. | The Boston XOTM (hexafocon A) Contact<br>Lenses are indicated for daily wear for the<br>correction of refractive ametropia (myopia,<br>hyperopia, astigmatism and presbyopia) in<br>aphakic and non aphakic persons with non-<br>diseased eyes. Also, the lenses may be<br>prescribed in otherwise non-diseased eyes<br>that require a gas permeable contact lens<br>for the management of irregular corneal<br>conditions such as keratoconus, pellucid<br>marginal degeneration, or following<br>penetrating keratoplasty or refractive (e.g.<br>LASIK surgery). The lenses may be<br>disinfected using a chemical disinfection<br>system only.<br>Furthermore, eyes suffering from certain<br>ocular surface disorders may benefit from<br>the physical protection, aqueous hydrated<br>environment and the saline bath provided<br>by scleral lens designs.<br>The Boston XOTM (hexafocon A) Contact<br>Lenses (Scleral) for daily wear are<br>indicated for therapeutic use for the<br>management of irregular and distorted<br>corneal surfaces where the subject:<br>1.cannot be adequately corrected with<br>spectacle lenses<br>2.requires a rigid gas permeable contact<br>lens surface to improve vision | | Paragon Vision Sciences, Inc. | 510(k) Summary | | | 510(k) Premarket Notification | | | | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | | K221768 | | | | | | | 3.is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities<br>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, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).<br>The Boston XOT™ (hexafocon A) Scleral Lens designs for daily wear are also indicated for therapeutic use in eyes with ocular surface disease (e.g. 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 Boston Scleral Lenses may concurrently provide correction of refractive error.<br>The lenses may be disinfected using a chemical disinfection (not heat) system only. | | | Refractive Index (RGP) | 1.415 | 1.415 | | Oxygen Permeability (RGP Center) | 100 | 100 | | Specific Gravity (RGP) | 1.27 | 1.27 | | Hardness (Shore D) | 81 | 81 | | Modulus (MPa) | 1500 | 1500 | | Tint | Visibility Tints – various<br>D&C Green No. 6, D&C Violet No. 2,<br>D&C Yellow No. 18, D&C Red No. 17 | Visibility Tints - various<br>D&C Green No. 6, D&C Violet No. 2,<br>D&C Yellow No. 18 | | Water Content (Soft Skirt) | <1% | <1%…