Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION". June 16, 2023 Acuity Polymers, Inc. Jose Chavez Director, Regulatory Affairs 1667 Lake Ave Building 59, Suite 303 Rochester, NY 14615 Re: K230965 Trade/Device Name: Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens , TYROTM-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: March 31, 2023 Received: April 5, 2023 Dear Jose Chavez: 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. {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/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-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 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 https://www.fda.gov/medical-devices/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 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K230965 #### Device Name Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens #### Indications for Use (Describe) Acuity™ 100 (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact 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 lens may be disinfected using a chemical disinfection system only. TYRO™ 97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyonic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact 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 lenses may be disinfected only by using chemical disinfection. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"><b></b></span> | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® # 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: K230965 #### I. SUBMITTER | Date Prepared: | June 8th, 2023 | |-----------------|------------------------------------------------------------------------| | Name: | Acuity Polymers, Inc. | | Address: | 1667 Lake Ave.<br>Building 59, Suite 303<br>Rochester, NY 14615<br>USA | | Contact Person: | Jose Chavez<br>Director, Regulatory Affairs | | Phone number: | (585) 458-8409 | | Email | Jose.Chavez@Acuitypolymers.com | #### II. DEVICE | Trade Name: | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®<br>Rigid Gas Permeable Contact Lens<br>TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid<br>Gas Permeable Contact Lens | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Daily wear rigid gas permeable contact lens | | Classification Name: | Rigid gas permeable contact lens. (21 CFR§886.5916) | | Regulatory Class: | Class II | | Product Code: | HQD | {4}------------------------------------------------ #### Purpose of the 510(k) Submission: Acuity 100™ (hexafocon A) and TYRO™-97 (hofocon A) Rigid Gas Permeable Contact Lenses, cleared under 510(k) K162005, K180988, K052507 and K102154 are modified to include Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer designed to improve the wettability of the contact lenses. Specifically, Tangible™ Hydra-PEG® treated contact lenses demonstrate a measurable improvement in the contact angle compared to untreated lenses. ## III,PREDICATE DEVICE Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® is substantially equivalent to predicate devices: Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens 510(k) numbers K162005 and K180988. TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® is substantially equivalent to predicate devices: TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses for Daily Wear, 510(k) numbers K052507 and K102154 Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® are substantially equivalent to predicate device: Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses with Tangible™ Hydra-PEG Rigid Gas Permeable Contact Lenses, 510(k) number K183167. # IV. DEVICE DESCRIPTION Acuity 100™ (hexafocon A) are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from a currently marketed contact lens material, hexafocon A. comprised of a siloxanyl fluoromethacrylate copolymer (fluorosilicone acrylate monomers), tinted for visibility, and with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN). Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG® surface coating, 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™ Hydra-PEC® , the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. TYRO" -97 (hofocon A) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from currently marketed contact lens material. hofocon A. polymer of trifluoroethyl methacrylate and silicone {5}------------------------------------------------ | Acuity Polymers<br>510(k) Premarket Notification | 510(k) Summary | |--------------------------------------------------------------------------------------------------------|----------------| | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® | | methacrylate (fluorosilicone acrylate monomers), tinted for visibility, with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN). TYRO""-97 (hofocon A) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG® surface coating, 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™ Hydra-PEG® .the underlying material is encapsulated in a thin laver of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The surface properties of: Acuity 100™ (hexafocon A), and TYRO™-97 (hofocon A) materials uncoated and coated with Tangible™ Hydra-PEG® are depicted in the following table: | | Acuity 100™ (hexafocon A) | TYRO™-97 (hofocon A) | |-------------------------------|---------------------------|----------------------| | Sessile Drop<br>Contact Angle | Coated: $<10°$ | Coated: $<10°$ | | | Uncoated: 56° | Uncoated:23.3° | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are available in the same design configurations and available parameters as the predicate devices, cleared under K162005 and K180988. TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are available in the same design configurations and available parameters as the predicate devices, cleared under K052507 and K102154. # V. INDICATION FOR USE Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eves. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact 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 lens may be disinfected using a chemical disinfection system only. TYRO™-97 (hofocon A) with Tangible™ Hydra PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with nondiseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas {6}------------------------------------------------ | Acuity Polymers | 510(k) Summary | |-------------------------------|----------------| | 510(k) Premarket Notification | | Acuity 100^TM (1-focon A) with Tranquil^TM Hydro-PEG^® and TYRO^TM 97 (1-focon A) with Tranquil^TM Hydro-PEG^® Acuity 100" (hexatocon A) with Tangible " Hydra-PEG" and TYRO" -97 (hotocon A) with Tangible " Hvdra-PEG permeable contact 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 lenses may be disinfected only by using chemical disinfection. ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE ### ACUITY 100™ (hexafocon A) WITH TANGIBLE™ HYDRA-PEG® Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® surface coating technology is substantially equivalent to Acuity 100™ (hexafocon A) uncoated lenses (primary predicate devices cleared under K162005 and K180988 in terms of the following: - 1. Proprietary contact lens material formulation and USAN - 2. Intended Use- Daily wear contact lens. - 3. Indication for Use - 4. Lens Designs and available parameters Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® surface coating technology is substantially equivalent to Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses with Tangible™ Hydra-PEG (secondary Predicate device cleared under K183167) in terms of the following: - 1. USAN name - 2. Intended use- Daily wear contact lens. - 3. Indication for use- similar - 4. Tangible™ HYDRA-PEG® surface coating #### TYRO™-97 (hofocon A) WITH TANGIBLE™ HYDRA-PEG® TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® surface coating technology is substantially equivalent to TYRO™-97 (hofocon A) uncoated lenses (primary predicate devices cleared under K052507 and K102154) in terms of the following: - 1. Proprietary contact lens material formulation and USAN - 2. Intended Use- Daily wear contact lens. - 3. Indication for Use - 4. Lens Designs and available parameters TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® surface coating technology is substantially equivalent to Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses with Tangible™ Hydra-PEG (Secondary Predicate device cleared under K183167) in terms of the following: {7}------------------------------------------------ | Acuity Polymers<br>510(k) Premarket Notification | 510(k) Summary | |---------------------------------------------------------------------------------------------------------|----------------| | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™ -97 (hofocon A) with Tangible™ Hydra-PEG® | | - 1. Thermoset copolymers derived from fluorosilicone acrylate monomers. - 2. Intended Use- Daily wear contact lens. - 3. Indication for use- similar - 4. Tangible™ Hydra-PEG® surface coating The following Substantial Equivalence Matrix illustrates the production method, intended use, and material characteristics of Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses as well as the predicate devices. | | Acuity 100™<br>(hexafocon A)<br>with Tangible™<br>Hydra-PEG®, | Acuity 100™<br>(hexafocon A) Rigid Gas<br>Permeable Contact Lens | TYRO™ -97<br>(hofocon A)<br>Rigid Gas<br>Permeable<br>Contact Lens | Boston XO®<br>(hexafocon A)<br>with Tangible™<br>Hydra-PEG | Indication for Use | Acuity 100™<br>(hexafocon A) with Tangible™<br>Hydra-PEG® Rigid Gas<br>Permeable Contact Lenses are<br>indicated for daily wear for the<br>correction of refractive error<br>(myopia, hyperopia, presbyopia<br>and/or astigmatism) in aphakic<br>and non-aphakic persons with<br>non-diseased eyes. The lenses<br>may be prescribed for daily wear<br>in otherwise non-diseased eyes<br>that require a rigid contact lens<br>for the management of irregular<br>corneal conditions such as<br>keratoconus, pellucid marginal<br>degeneration, or following<br>penetrating keratoplasty or<br>refractive (e.g., LASIK) surgery.<br><br>The lens may be disinfected<br>using a chemical disinfection<br>system only.<br><br>TYRO™-97 (hofocon A) with<br>Tangible™ Hydra-PEG® Rigid<br>Gas Permeable Contact Lens are<br>indicated for daily wear for the<br>correction of visual acuity in<br>non-aphakic persons with non-<br>diseased eyes that are myopic,<br>hyperopic or presbyopic and<br>which may exhibit corneal<br>astigmatism. Also, the lenses<br>may be prescribed in otherwise<br>non-diseased eyes that require a<br>gas permeable contact lens for<br>the management of irregular<br>corneal conditions such as<br>keratoconus, pellucid marginal<br>degeneration, or following<br>penetrating keratoplasty or<br>refractive (e.g., LASIK) surgery.<br><br>The lenses may be disinfected<br>only by using chemical<br>disinfection. | The Acuity 100™ (hexafocon<br>A) Rigid Gas Permeable<br>Contact Lenses are indicated<br>for daily wear for the<br>correction of refractive error<br>(myopia, hyperopia, presbyopia<br>and/or astigmatism) in aphakic<br>and non-aphakic persons with<br>non-diseased eyes. The lens<br>may be prescribed in spherical<br>and aspheric powers ranging<br>from -20.00 D to +20.00 D for<br>daily wear. The lenses may be<br>prescribed for daily wear in<br>otherwise non-diseased eyes<br>that require a rigid contact lens<br>for the management of irregular<br>corneal conditions such as<br>keratoconus, pellucid marginal<br>degeneration, or following<br>penetrating keratoplasty or<br>refractive (e.g., LASIK)<br>surgery.<br><br>The lens may be disinfected<br>using a chemical disinfection<br>system only.<br><br>The lenses may be stored in a<br>multipurpose solution<br>(BOSTON SIMPLUS or<br>Menicon Unique pH) solution<br>up to 30 days. | TYRO™-97 (hofocon<br>A) Rigid Gas<br>Permeable Spherical,<br>Aspheric, Toric and<br>Bifocal Contact Lens<br>is indicated for daily<br>wear for the<br>correction of visual<br>acuity in not-aphakic<br>persons with non-<br>diseased eyes that are<br>myopic, hyperopic or<br>presbyopic and which<br>may exhibit corneal<br>astigmatism.<br><br>The lenses may be<br>disinfected only by<br>using chemical<br>disinfection.<br><br>TYRO™-97 (hofocon<br>A) Rigid Gas<br>Permeable Contact<br>Lenses is indicated for<br>daily wear for the<br>correction of visual<br>acuity in non-aphakic<br>persons with non-<br>diseased eyes that are<br>myopic, hyperopic or<br>presbyopic and which<br>may exhibit corneal<br>astigmatism. Also, the<br>lenses may be<br>prescribed in<br>otherwise non-<br>diseased eyes that<br>require a gas<br>permeable contact<br>lens for the<br>management of<br>irregular corneal<br>conditions such as<br>keratoconus, pellucid<br>marginal<br>degeneration, or<br>following penetrating<br>keratoplasty or<br>refractive (e.g.,<br>LASIK) surgery.<br><br>The lenses may be<br>disinfected only by<br>using chemical<br>disinfection | The Boston XO®<br>(hexafocon A) with<br>Tangible™ Hydra-PEG<br>Contact Lens is<br>indicated for daily wear<br>for the correction of<br>refractive ametropia<br>(myopia, hyperopia,<br>astigmatism, and<br>presbyopia) in aphakic<br>and non aphakic persons<br>with non-diseased eyes.<br>Also, the lenses may be<br>prescribed in otherwise<br>non diseased eyes that<br>require a gas permeable<br>contact lens for the<br>management of irregular<br>corneal conditions such<br>as keratoconus, pellucid<br>marginal degeneration,<br>or following penetrating<br>keratoplasty or refractive<br>(e.g., LASIK) surgery.<br><br>The Boston XO®<br>(hexafocon A) with<br>Tangible™ Hydra-PEG<br>lens may be disinfected<br>using a chemical<br>disinfection system (not<br>heat) only. | | < 1% | < 1% | < 1% | < 1% | | | | | | 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| | TYRO™ -97<br>(hofocon A)<br>with Tangible™<br>Hydra-PEG® | | | | Power Range | Production<br>Method | hexafocon A<br>-20.00 D to +20.00 D<br>hofocon A<br>-20.00 D to +12.00 D | Lathe Cut | hexafocon A<br>-20.00 D to +20.00 D | Lathe Cut | hofocon A<br>-20.00 D to +12.00 D | Lathe Cut | hexafocon A<br>-20.00 D to +20.00 D | Lathe Cut | Water Content<br>(%) | | | | | | | New Device | Predicate Device<br>(K162005, K180988) | Predicate Device<br>(K052507,<br>K102154) | Predicate Device<br>K183167 | USAN Name | hexafocon A<br>hofocon A | hexafocon A | hofocon A | hexafocon A | Wettability<br>(Sessile Drop<br>Advancing<br>Contact<br>Angle) | hexafocon A: <10°<br>hofocon A: <10° | hexafocon A: 56° | hofocon A: 23.3° | (uncoated)<br>hexafocon A: 63.4°<br>(coated)<br>hexafocon A: 10° | | | | | | | Intended Use | Daily Wear | Daily Wear | Daily Wear | Daily Wear | Lens Type | RGP | RGP | RGP | RGP | | | | | | | | | | | | Device Name | Acuity 100™<br>(hexafocon A) with<br>Tangible™ Hydra-PEG®<br>Rigid Gas Permeable<br>Contact Lens | Acuity 100™<br>(hexafocon A) Rigid Gas<br>Permeable Contact Lens | TYRO™-97<br>(hofocon A)<br>Rigid Gas<br>Permeable<br>Spherical,<br>Aspheric, Toric<br>and Bifocal<br>Contact Lenses<br>for Daily Wear | Boston XO®<br>(hexafocon A)<br>Rigid Gas<br>Permeable Contact<br>Lenses with<br>Tangible™ Hydra-<br>PEG Rigid Gas<br>Permeable Contact<br>Lenses | Available with<br>or without UV<br>Blocker | Yes | Yes | Yes | Yes | | | | | | | | | | | | | TYRO™ -97<br>(Hofocon A) with<br>Tangible™ Hydra PEG®<br>Rigid Gas Permeable<br>Contact Lenses | | | | Lenses may be<br>disinfected<br>using a<br>Chemical<br>Disinfection<br>System | Yes | Yes | Yes | Yes | | | | | | | | | | | | Includes<br>Tangible™<br>Hydra PEG® | Yes | No | No | Yes | | | | | | | | | | | | | | | | {8}------------------------------------------------ # Acuity Polymers 510(k) Summary 510(k) Premarket Notification Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® {9}------------------------------------------------ # uity Polymers 510(k) Premarket Notification Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® #### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses. 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 device demonstrate that: Performance Testing- Bench - 1. The physical properties of the lenses are stable following 30 (thirty) disinfection cycles in Boston Simplus disinfection solution at ambient temperatures. - The physicochemical and mechanical properties of the contact lenses are unchanged after 2. the addition of Tangible™ Hydra-PEG®, with the exception of wettability (contact angle). - 3. The surface properties of the lens are stable following 30 (thirty) days of accelerated aging. - 4. Bioburden levels are below the acceptance criteria (<100 CFU/lens) initially and following 30 (thirty) days of storage in solution at ambient temperatures. Performance Testing- Animal {10}------------------------------------------------ Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® - 5. Acute Ocular Irritation testing per ISO 10993-23 and Acute Systemic Toxicity testing per ISO 10993-11 were performed for both the final finished subject devices. #### Performance Testing- In Vitro - 6. Cytotoxicity testing per ISO 10993-5 was performed for both the final finished subject devices. #### Performance Testing -Clinical The clinical safety and effectiveness of finished rigid gas permeable contact lenses manufactured from Acuity™ 100 (hexafocon A) and TYRO™-97 (hofocon A) Rigid Gas Permeable Contact Lenses materials have been demonstrated by predicate devices. Additionally, the clinical safety and effectiveness for contact lenses treated with Tangible™ Hydra-PEG® has been previously demonstrated. #### VIII. CONCLUSIONS #### 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 510(k) Premarket Notification establishes that the Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are as safe and effective as the predicate devices 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.