Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses
Device Facts
| Record ID | K242393 |
|---|---|
| Device Name | Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses |
| Applicant | Acuity Polymers, Inc. |
| Product Code | HQD · Ophthalmic |
| Decision Date | Nov 1, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5916 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hvperopia. The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable 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 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. 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. Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) SCLERAL 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, keratoglobus, pellucid marqinal degeneration. Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjogren'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 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error. Eyecare practitioners may prescribe the lenses or 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.
Device Story
Acuity 181™ is a lathe-cut, rigid gas permeable (RGP) contact lens made of siloxanyl fluoromethacrylate copolymer (tisilfocon A). Available in spherical, toric, multifocal, orthokeratology, and scleral designs. Optional surface treatment with Tangible™ Hydra-PEG® (polyethylene glycol-based polymer) enhances wettability. Used by eyecare practitioners to correct refractive errors or manage irregular corneas and ocular surface diseases. Lenses provide vision correction, physical protection, and an expanded tear reservoir. Patients benefit from improved visual acuity and ocular surface protection. Lenses are cleaned/disinfected via chemical systems.
Clinical Evidence
Bench testing only. Biocompatibility (ISO 10993-5, -11, -23), physicochemical, mechanical, and optical properties were evaluated. Results confirm non-cytotoxicity, lack of systemic toxicity, and stability in care solutions. Clinical performance for tisilfocon A material is previously established.
Technological Characteristics
Material: Tisilfocon A (fluoro silicone acrylate, FDA Group III). Dk: 181 x 10^-11. Hardness: 81 Shore D. Flex Modulus: 1488 MPa. Manufacturing: Lathe cut. Surface: Optional Tangible™ Hydra-PEG® coating or plasma treatment. Dimensions: 7.00-26.00mm diameter, 4.00-12.00mm base curve. Connectivity: None. Sterilization: Not specified (shipped dry or wet in Boston Simplus).
Indications for Use
Indicated for daily wear correction of refractive error (myopia, hyperopia, astigmatism, presbyopia) in aphakic/non-aphakic persons; management of irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-surgical/transplant); orthokeratology for temporary myopia reduction (up to 5.00D) and astigmatism (up to 1.50D); and therapeutic use for ocular surface disease/corneal distortion (e.g., GvHD, Sjogren's, limbal stem cell deficiency, neurotrophic keratitis).
Regulatory Classification
Identification
A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.
Predicate Devices
- Hyper GP (tisilfocon A) Daily Wear Contact Lens (K182304)
- Visionary Optics Scleral Contact Lens (tisilfocon A) (K223394)
- Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens (K240618)
Related Devices
- K213538 — Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens · Acuity Polymers, Inc. · Dec 30, 2021
- K240618 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens · Acuity Polymers, Inc. · Apr 3, 2024
- K212631 — Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses · Contamac, Ltd. · Mar 17, 2022
- K183167 — Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens · Bausch & Lomb, Incorporated · Feb 12, 2019
- K241398 — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses · Tianjin Mastervision Technology Co., Ltd. · Oct 22, 2024
Submission Summary (Full Text)
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November 01, 2024
Acuity Polymers, Inc. Chris Naivar Regulatory Affairs 1667 Lake Ave. Building 59, Suite 303 Rochester, NY 14615
Re: K242393
Trade/Device Name: Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® 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, MUW Dated: August 8. 2024 Received: August 13, 2024
Dear Chris Naivar:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/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 Quality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
Submission Number (if known)
K242393
Device Name
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
Indications for Use (Describe)
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hvperopia.
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable 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 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
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.
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
l . 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,
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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 marqinal degeneration. Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjogren'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 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error.
Eyecare practitioners may prescribe the lenses or 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
r-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Premarket Notification
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
## 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: K242393
#### I. SUBMITTER
| Date Prepared: | November 1, 2024 |
|-----------------|----------------------------------------------------------------|
| Name: | Acuity Polymers, Inc |
| Address: | 1667 Lake Ave<br>Building 59, Suite 303<br>Rochester, NY 14615 |
| Contact Person: | Chris Naivar |
| Contact Person: | Chris Narval<br>Regulatory Affairs |
| Phone number: | (512) 203-3684 |
#### II. DEVICE
| Trade Name: | Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| 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; MUW |
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510(k) Premarket Notification
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
#### III. PREDICATE DEVICE
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens is substantially equivalent to the following predicate devices:
- Hyper GP (tisilfocon A) Daily Wear Contact Lens, 510(k) K182304 ●
- Visionary Optics Scleral Contact Lens (tisilfocon A), 510(k) K223394 ●
- Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon ● A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens, 510(k) K240618
#### DEVICE DESCRIPTION IV.
Acuity 181™ (tisilfocon A) Rigid Gas Permeable Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process.
Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Contact Lenses are treated to incorporate Hydra-PEG® Technology (HPT), which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) 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 coated with Tangible™ Hydra-PEG® the underlying material, tisilfocon A, is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle compared to untreated lenses).
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens are available in spherical, toric, multifocal/bifocal, orthokeratology, and scleral design for daily wear only.
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510(k) Premarket Notification
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
| | Acuity 181™ (tisilfocon A) | | |
|-------------------------------------------------------|----------------------------|-----------------------------|----------------|
| | Uncoated | Tangible™ Hydra-PEG® Coated | Plasma Treated |
| Average Sessile Drop Wetting<br>Angle (degrees), n=30 | 95.4 | 48.8 | 19.2 |
| Standard Deviation | 3.89 | 3.64 | 6.45 |
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case (510(k) K171539). The primary container for shipping the Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens is the deep-well contact lens case (510(k) K171539). When shipped "wet," the Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens may be packaged and shipped in the Bausch & Lomb's Boston Simplus Multi-Action Solution (510(k) K181627).
The physical properties of the Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens is as follows:
| USAN | Tisilfocon A |
|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Refractive Index | 1.434 |
| Specific Gravity | 1.22 |
| Water Content | < 1.0% |
| Oxygen Permeability, Dk, ISO/Fatt Method<br>10-11 (cm³ O₂ x cm/ (cm² x sec x mmHg)@ 35°C | 181 |
| Hardness, Shore D<br>[±2 D] | 81 |
| Flex Modulus, MPa | 1488 |
| Maximum, Flexural Strength, MPa | 55.6 |
| Toughness, J/m³ | 2.23 |
| Visible Tints<br>(Lenses contain one or more of the following color additives conforming to 21 CFR Part 73 & 74 Subpart D) | D&C Green No. 6,<br>Solvent Yellow No. 18,<br>D&C Violet No. 2,<br>D&C Red No. 17 |
| Wet Shipping Compatible Solution | Bausch & Lomb's Boston Simplus Multi-Action Solution |
| FDA Group | Group III, Fluoro Silicone Acrylate |
| | Acuity 181™ (tisilfocon A)<br>Luminous Transmittance | |
|--------------------------------|------------------------------------------------------|-----------------------------|
| | Uncoated | Tangible™ Hydra-PEG® Coated |
| Light Transmission (380-780nm) | 87.0% | 87.4% |
| UVA Transmission (315- 380nm) | 15.1% | 17.1% |
| UVB Transmission (280-315nm) | 0.033% | 0.034% |
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510(k) Premarket Notification
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® are available in the following lens design parameters and tolerances:
| Parameter | Range | Tolerance |
|-------------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Base Curve | 4.00mm to 12.00mm | ± 0.05mm<br>±0.10mm (Scleral) |
| Center Thickness | .08mm to 3.00mm | ± 0.02mm<br>±0.10mm (Scleral) |
| Diameter | 7.00mm to 26.00mm | ± 0.10mm<br>±0.25mm (Scleral) |
| Spherical Power | -35.00 D TO 35.00 D<br>(in .12D 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 | +10.00 D TO -10.00 D<br>(in .12 D steps) | ± 0.25 (0 to </= 2D)<br>± 0.37 (2 to </= 4D)<br>± 0.50 (over 4D) |
| Cylindrical Axis | 1° to 180° (in 1° steps) | ± 5° |
| Bifocal Add | +12.00 D to 6.00 D<br>(in 0.12 D steps) | ± 0.25D |
| Multifocal Power | +1.00 D to 4.00 D (in<br>.012 D steps) | ± 0.25D |
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510(k) Premarket Notification
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® are hemispherical shells of the following dimensions:
| SPHERICAL AND ASPHERIC LENS | |
|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Range<br>Diameter<br>Base Curve Range | -35.00D to +35.00D in 0.25D increments 7.0mm to<br>26.0mm<br>4.00mm to 12.00 mm in 0.01mm increments |
| MULTIFOCAL/BIFOCAL LENS | |
| (CENTERED, DECENTERED, CRESCENT) | |
| Power Range<br>Diameter<br>Base Curve Range<br>Segment Heights<br>Add Powers<br>Prism Ballast | -35.00D to +35.00D in 0.25D increments<br>7.0mm to 26.0mm<br>4.00mm to 12.00mm in 0.01mm increments<br>-2.00mm to +1.00mm in 0.5 increments<br>+1.00D to +4.00D in 0.25D increments<br>0.5 to 3.5 prism diopters in 0.5D increments |
| TORIC LENS | |
| Power Range<br>Diameter<br>Base Curve Range<br>Toricity | -35.00D to +35.00D in 0.25D increments<br>7.0mm to 26.0mm<br>4.00mm to 12.00mm in 0.01mm increments<br>Up to 10.00 Diopters |
| SCLERAL CONTACT LENS | |
| Power Range<br>Diameter<br>Normalized Vaults | -35.00D to +35.00D in 0.25D increments 16mm to<br>26.0mm<br>2.50mm to 6.00mm |
| ORTHOKERATOLOGY LENS | |
| Power Range<br>Diameter<br>Base Curve Range<br>Reverse Curve<br>Alignment Curve 1<br>Alignment Curve 2<br>Peripheral Curve | -5.00D to +1.50D in 0.25D<br>9.6mm to 11.6mm<br>7.30mm to 10.15mm<br>5.00mm to 9.00mm (Steeper than the base curve)<br>7.00mm to 9.0mm (Steeper than the base curve but<br>flatter than the Reverse Curve<br>7.25mm to 9.25mm (Steeper than the base curve but<br>flatter than the Alignment Curve 1 and Reserve<br>Curve)<br>9.00mm to 15.00mm |
{10}------------------------------------------------
#### INDICATIONS FOR USE V.
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia.
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable 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 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
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.
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon
A) SCLERAL 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, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
{11}------------------------------------------------
510(k) Premarket Notification
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjogren'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 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error.
Eyecare practitioners may prescribe the lenses or 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.
{12}------------------------------------------------
510(k) Premarket Notification
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE VI. DEVICE
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses is substantially equivalent to Hyper GP (tisilfocon A) Daily Wear Contact Lens (cleared under K182304) in terms of the following:
- Intended Use- Daily Wear
- Indication for Use ●
- USAN- contact lens material composition ●
- Contact Lens Design ●
- Classification Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) ●
- FDA material group group # 3 fluoro silicone acrylate ●
- May be surface coated with Tangible Hydra-PEG ●
- Product Method- Lathe Cut ●
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses is substantially equivalent to Visionary Optics Scleral Contact Lens (tisilfocon A) cleared under K223394 in terms of the following:
- Intended Use- Daily Wear
- Indication for Use ●
- USAN- contact lens material composition ●
- Classification Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) ●
- FDA material group group # 3 fluoro silicone acrylate ●
- Product Method- Lathe Cut ●
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses is substantially equivalent to Acuity200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens cleared under K240618 in terms of the following:
- Intended Use- Daily Wear ●
- Indication for Use ●
- Classification Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) ●
- FDA material group group # 3 fluoro silicone acrylate ●
- May be surface coated with Tangible Hydra-PEG ●
- Product Method- Lathe Cut .
Any differences in technological characteristics between the two devices do not raise any safety or effectiveness questions.
{13}------------------------------------------------
510(k) Premarket Notification
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
The following matrix illustrates the production method, intended use, indication for use, lens function and material characteristics of the Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses, as well as the predicate devices.
| | Acuity 181™<br>(tisilfocon A)<br>and Acuity 181™<br>(tisilfocon A)<br>with Tangible™<br>Hydra-PEG®<br>Rigid Gas Permeable<br>Contact Lenses | Hyper GP<br>(tisilfocon A)<br>Daily Wear<br>Contact Lens | Visionary Optics<br>Scleral Contact Lens<br>(tisilfocon A) | Acuity200™<br>(fluoroxyfocon A) Rigid<br>Gas Permeable Contact<br>Lens; Acuity 100™<br>(hexafocon A) Rigid Gas<br>Permeable Contact Lens;<br>Acuity 200™ with<br>Tangible® Hydra-PEG®<br>(fluoroxyfocon A) Rigid<br>Gas Permeable Contact<br>Lens; Acuity 100™ with<br>Tangible® Hydra-PEG®<br>(hexafocon A) Rigid Gas<br>Permeable Contact Lens |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject Device | Predicate Device | Predicate Device | Predicate Device |
| | | K182304 | K223394 | K240618 |
| Functionality | The contact lenses act as a<br>refractive medium that focus<br>light rays from near and distant<br>objects on the retina | The contact lenses act as a<br>refractive medium that<br>focus light rays from near<br>and distant objects on the<br>retina | The contact lenses act as a<br>refractive medium that<br>focus light rays from near<br>and distant objects on the<br>retina | The contact lenses act as a<br>refractive medium that<br>focus light rays from near<br>and distant objects on the<br>retina |
| Intended Use | Daily Wear | Daily Wear | Daily Wear | Daily Wear |
| Indication for<br>Use | The Acuity 181™ (tisilfocon A)<br>and Acuity 181™ (tisilfocon A)<br>with Tangible™ Hydra-PEG®<br>SPHERICAL Rigid Gas<br>Permeable (RGP) Contact Lens<br>is indicated for daily wear for the<br>correction of refractive error in<br>aphakic and not aphakic persons<br>with non-diseased eyes with<br>myopia or hyperopia.<br><br>The Acuity 181™ (tisilfocon A)<br>and Acuity 181™ (tisilfocon A)<br>with Tangible™ Hydra-PEG®<br>TORIC Rigid Gas Permeable<br>(RGP) Contact Lens is indicated<br>for daily wear for the correction<br>of refractive error in aphakic and<br>not aphakic persons with non-<br>diseased eyes with myopia or<br>hyperopia and/or possesses<br>refractive astigmatism not<br>exceeding 10.00 diopters.<br><br>The Acuity 181™ (tisilfocon A)<br>and Acuity 181™ (tisilfocon A)<br>with Tangible™ Hydra-PEG®<br>MULTIFOCAL/BIFOCAL Rigid<br>Gas Permeable (RGP) Contact<br>Lens is indicated for daily wear<br>for the correction of refractive<br>error in aphakic and not aphakic<br>persons with non-diseased eyes<br>with myopia or hyperopia and/or<br>possesses refractive astigmatism<br>not exceeding 4.00 diopters and<br>are presbyopic requiring add<br>power of up to +4.00 diopters.<br><br>The Acuity 181™ (tisilfocon A)<br>and Acuity 181™ (tisilfocon A)<br>with Tangible™ Hydra-PEG®<br>IRREGULAR CORNEA Daily<br>Wear Contact Lens may be | The Hyper GP (tisilfocon A)<br>SPHERICAL Rigid Gas<br>Permeable (RGP) Contact Lens<br>is indicated for daily wear for<br>the correction of refractive<br>error in aphakic and not<br>aphakic persons with non-<br>diseased eyes with myopia or<br>hyperopia.<br><br>The Hyper GP (tisilfocon A)<br>TORIC Rigid Gas Permeable<br>(RGP) Contact Lens is<br>indicated for daily wear for the<br>correction of refractive error in<br>aphakic and not aphakic<br>persons with non- diseased<br>eyes with myopia or hyperopia<br>and/or possesses refractive<br>astigmatism not exceeding<br>10.00 diopters.<br><br>The Hyper GP (tisilfocon A)<br>MULTIFOCAL/BIFOCAL<br>Rigid Gas Permeable (RGP)<br>Contact Lens is indicated for<br>daily wear for the correction of<br>refractive error in aphakic and<br>not aphakic persons with non-<br>diseased eyes with myopia or<br>hyperopia and/or possesses<br>refractive astigmatism not<br>exceeding 4 diopters and are<br>presbyopic requiring add<br>power of up to +4.00 diopters.<br><br>The Hyper GP (tisilfocon A)<br>IRREGULAR CORNEA Daily<br>Wear Contact Lens may be<br>prescribed in otherwise non-<br>diseased eyes that require a<br>rigid gas permeable lens for the<br>management of irregular | The Visionary Optics Scleral<br>Contact Lens for daily wear is<br>indicated for use for the<br>management of multiple ocular<br>conditions, such as,<br>degenerations that lead to an<br>irregular corneal shape (e.g.<br>keratoconus, keratoglobus,<br>pellucid marginal<br>degeneration, Salzmann's<br>Nodular Degeneration),<br>dystrophies (e.g. Cogan's<br>dystrophy, Granular Corneal<br>Dystrophy, Lattice Corneal<br>Dystrophy,),<br>post-surgery (e.g. corneal<br>transplant, LASIK, radial<br>keratotomy), and corneal<br>scarring from infection<br>or trauma.<br><br>The Visionary Optics Scleral<br>Contact Lens for daily wear is<br>also indicated for therapeutic.<br>management of ocular surface<br>disease including dry eye (e.g.<br>ocular manifestations of Graft-<br>versus- Host disease, Sjogren's<br>syndrome, dry eye syndrome),<br>limbal stem cell deficiency<br>(e.g. Stevens- Johnson<br>syndrome, chemical and<br>thermal burns, radiation,<br>filamentary keratitis),<br>epidermal ocular disorders,<br>disorders of the skin (e.g.<br>atopy, ectodermal dysplasia), | The Acuity 200™<br>(fluoroxyfocon A),<br>Acuity 100™<br>(hexafocon A), Acuity<br>200™ with<br>Tangible® Hydra-<br>PEG® (fluoroxyfocon<br>A), and Acuity 100™<br>with Tangible®<br>Hydra-PEG® Rigid<br>Gas Permeable<br>Contact Lenses are<br>indicated for daily<br>wear for the<br>correction of<br>refractive error<br>(myopia, hyperopia,<br>presbyopia and/or<br>astigmatism) in<br>aphakic and non-<br>aphakic persons with<br>non-diseased eyes.<br><br>The lenses may be<br>prescribed for daily<br>wear in otherwise<br>non-diseased eyes that<br>require a rigid 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., |
{14}------------------------------------------------
510(k) Premarket Notification
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
Rigid Gas Permeable Contact Lenses
prescribed in otherwise non-
diseased eyes that require a rigid
gas permeable 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 Acuity 181™ (tisilfocon A)
and Acuity 181™ (tisilfocon A)
with Tangible™ Hydra-PEG®
ORTHOKERATOLOGY contact
lenses are indicated for daily
wear in an orthokeratology fitting
program for the temporary
reduction of myopia of up to 5.00
diopters with eyes having
astigmatism up to 1.50 diopters
in non-diseased eyes. To
maintain the orthokeratology
effect of myopia reduction, lens
wear must be continued on a
prescribed wearing schedule.
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.
Acuity 181™ (tisilfocon A) and
Acuity 181™ (tisilfocon A) with
Tangible™ Hydra-PEG®
(tisilfocon A) SCLERAL 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, 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 Acuity 181™ (tisilfocon A)
and Acuity 181™ (tisilfocon A)
with Tangible™ Hydra-PEG®
(tisilfocon A) SCLERAL lenses
are indicated for therapeutic use
in eyes with ocular surface
disease (e.g. ocular Graft-versus-
Host disease, Sjogren's
syndrome, dry eye syndrome and
Filamentary Keratitis}, limbal
stem cell deficiency (e.g.
Stevens-Johnson syndrome,
corneal conditions such as;
keratoconus, pellucid marginal
degeneration or following
penetrating keratoplasty or
refractive (e.g. LASIK)
surgery.
The Hyper GP (tisilfocon A)
ORTHOKERATOLOGY
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.
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
distorted cornea or ocular
surface disease, the Visionary
Optics Scleral Contact Lens
may incidentally provide
correction of refractive error in
persons with myopia,
hyperopia, astigmatism or
presbyopia.
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.
LASIK) surgery.
The Acuity 200™
(fluoroxyfocon A),
Acuity 100™
(hexafocon A), Acuity
200™ with
Tangible® Hydra-
PEG® (fluoroxyfocon
A), and Acuity 100™
with Tangible®
Hydra-PEG® Rigid
Gas Permeable
Contact Lenses 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 lens may
concurrently provide
correction of
refractive error.
The Acuity 200™
(fluoroxyfocon A), Acuity
100™ (hexafocon A),
Acuity 200™ with
Tangible® Hydra-PEG®
(fluoroxyfocon A), and
Acuity 100™ with
Tangible® Hydra-PEGⓇ
Rigid Gas Permeable
Contact Lenses may be
cleaned and disinfected
using a chemical (not heat)
lens care system.
{15}------------------------------------------------
510(k) Premarket Notification
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
| Product Code | HQD, MUW | HQD, MUW | HQD | HQD |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|
| FDA Group # | Group # 3 Fluoro Silicone<br>Acrylate | Group # 3 Fluoro Silicone<br>Acrylate | Group # 3 Fluoro Silicone<br>Acrylate | Group # 3 Fluoro Silicone<br>Acrylate |
| Classification | Class II Lenses, Rigid Gas<br>Permeable, Daily Wear 21<br>CFR 886.5916 | Class II Lenses, Rigid Gas<br>Permeable, Daily Wear 21<br>CFR 886.5916 | Class II Lenses, Rigid Gas<br>Permeable, Daily Wear 21<br>CFR 886.5916 | Class II Lenses, Rigid Gas<br>Permeable, Daily Wear 21<br>CFR 886.5916 |
| Material (USAN) | Tisilfocon A | Tisilfocon A | Tisilfocon A | Fluoroxyfocon A |
| Production<br>Method | Lathe Cut | Lathe Cut | Lathe Cut | Lathe Cut |
| Water Content<br>(%) | <1% | <1% | <1% | <1% |
| Specific Gravity | 1.22 | 1.20 | 1.20 | 1.18 |
| Oxygen Permeability,<br>Dk, ISO/Fatt Method<br>10-11 (cm3 O2 x cm/ (cm2<br>x sec x mmHg)@ 35°C | 181 x10-11 | 180 x10-11 | 180 x10-11 | 200 x10-11 |
| UV Absorber<br>Available | Yes | Yes | Yes | Yes |
| Plasma<br>Treatment | Yes, Optional | Yes, Optional | Yes, Optional | Yes, Optional |
| Hydra-PEG<br>Surface Coating | Yes, Optional | Yes, Optional | Yes, Optional | Yes, Optional |
{16}------------------------------------------------
510(k) Premarket Notification
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
#### PERFORMANCE DATA VII.
### Non-Clinical Studies
A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses. All nonclinical 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 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses demonstrate that:
- The finished lenses (uncoated and coated with Tangible™ Hydra-PEG®) are not . cytotoxic per ISO 10993-5, not acutely systemically toxic per ISO 10993-11, and does not solicit an acute ocular irritation response per ISO 10993-23,
- The physicochemical, mechanical, and optical properties of the Tangible™ Hydra-PEG® coated and uncoated lenses are substantially equivalent to the predicate devices.
- Bioburden levels are below the acceptance criteria (<100 CFU/lens) initially and following 30 days of storage in Bausch & Lomb's Boston® Simplus Multi-Action Solution at ambient temperatures,
- Physical parameters are stable following 30 days…
