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

requires a rigid gas permeable contact lens surface to improve vision
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 Description

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a pass/fail sense for its non-clinical studies. Instead, it reports the results of various tests and asserts that the device meets safety and effectiveness requirements. The table below compiles the reported physical properties and biocompatibility findings.

Test/Property	Acceptance Criteria (Implied by equivalence/safety standards)	Reported Device Performance (Acuity 181™ (tisilfocon A))
Cytotoxicity	Not cytotoxic (per ISO 10993-5)	Not cytotoxic
Acute Systemic Toxicity	Not acutely systemically toxic (per ISO 10993-11)	Not acutely systemically toxic
Acute Ocular Irritation	Does not solicit acute ocular irritation (per ISO 10993-23)	Does not solicit an acute ocular irritation response
Physicochemical Properties (general)	Substantially equivalent to predicate devices	Substantially equivalent to predicate devices
Mechanical Properties (general)	Substantially equivalent to predicate devices	Substantially equivalent to predicate devices
Optical Properties (general)	Substantially equivalent to predicate devices	Substantially equivalent to predicate devices
Bioburden Level	<100 CFU/lens (initially and after 30 days storage)	Below acceptance criteria
Physical Parameters Stability	Stable after 30 days storage	Stable after 30 days storage
Care Solutions Compatibility	Physically compatible with currently marketed solutions	Physically compatible with currently marketed solutions
Specific Physical Properties
Refractive Index	(Not explicitly stated as criteria, but measured)	1.434
Specific Gravity	(Not explicitly stated as criteria, but measured)	1.22
Water Content	(Not explicitly stated as criteria, but measured)	< 1.0%
Oxygen Permeability (Dk)	(Not explicitly stated as criteria, but measured)	181 x10^-11 (cm³ O₂ x cm/ (cm² x sec x mmHg)@ 35°C)
Hardness, Shore D	(Not explicitly stated as criteria, but measured)	81 [±2 D]
Flex Modulus, MPa	(Not explicitly stated as criteria, but measured)	1488
Maximum, Flexural Strength, MPa	(Not explicitly stated as criteria, but measured)	55.6
Toughness, J/m³	(Not explicitly stated as criteria, but measured)	2.23
Light Transmission (380-780nm)	(Not explicitly stated as criteria, but measured)	87.0% (Uncoated), 87.4% (Coated)
UVA Transmission (315-380nm)	(Not explicitly stated as criteria, but measured)	15.1% (Uncoated), 17.1% (Coated)
UVB Transmission (280-315nm)	(Not explicitly stated as criteria, but measured)	0.033% (Uncoated), 0.034% (Coated)
Average Sessile Drop Wetting Angle	(Not explicitly stated as criteria, but measured)	95.4 (Uncoated), 48.8 (Coated), 19.2 (Plasma Treated)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- For the "Average Sessile Drop Wetting Angle," the sample size was n=30.
- For most other non-clinical tests (cytotoxicity, systemic toxicity, ocular irritation, physicochemical, mechanical, optical properties, bioburden, physical parameter stability, care solutions compatibility), a specific sample size is not provided in the document. It generally states that "a series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed."
Data Provenance: The document does not specify the country of origin for the data. The studies were non-clinical toxicology and biocompatibility tests, conducted "in vitro and in vivo." It states that "All nonclinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols." This suggests these were laboratory-based studies. The document does not mention any human clinical trials for primary performance evaluation of this specific device, instead referring to prior clinical performance data for the material. The studies listed are retrospective in the sense that they are presented as completed tests rather than ongoing prospective trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The document describes non-clinical laboratory testing, not studies requiring expert consensus for ground truth determination.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The non-clinical tests primarily involved objective measurements and adherence to standards (e.g., ISO 10993). There is no mention of a human adjudication process for the results of these tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. The device is a rigid gas permeable contact lens, not an AI-powered diagnostic or decision-support system involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. The device is a medical device (contact lens) and not an algorithm or software.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" implicitly refers to established scientific standards and regulations (e.g., ISO 10993 standards for biocompatibility). For example, "not cytotoxic" is the ground truth based on the criteria in ISO 10993-5. There is no mention of expert consensus, pathology, or outcomes data as a ground truth in the context of these specific non-clinical performance studies.

The document states: "Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from tisilfocon A has been previously addressed." This implies that prior clinical studies on the material (tisilfocon A) have established its ground truth for safety and effectiveness in human use. However, the details of those past clinical studies (e.g., how their ground truth was established – e.g., expert clinical assessment, patient outcomes) are not provided in this document.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a physical medical device (contact lens), not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/not provided, as the device is not an AI/ML system requiring a training set.

Summary

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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.

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)

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.

l . cannot be adequately corrected with spectacle lenses

requires a rigid gas permeable contact lens surface to improve vision
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).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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 AveBuilding 59, Suite 303Rochester, NY 14615
Contact Person:	Chris Naivar
Contact Person:	Chris NarvalRegulatory 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.

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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 WettingAngle (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 Method10-11 (cm³ O₂ x cm/ (cm² x sec x mmHg)@ 35°C	181
Hardness, Shore D[±2 D]	81
Flex Modulus, MPa	1488
Maximum, Flexural Strength, MPa	55.6
Toughness, J/m³	2.23
Visible Tints(Lenses contain one or more of the following color additives conforming to 21 CFR Part 73 & 74 Subpart D)	D&C Green No. 6,Solvent Yellow No. 18,D&C Violet No. 2,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)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±0.10mm (Scleral)
Center Thickness	.08mm to 3.00mm	± 0.02mm±0.10mm (Scleral)
Diameter	7.00mm to 26.00mm	± 0.10mm±0.25mm (Scleral)
Spherical Power	-35.00 D TO 35.00 D(in .12D steps)	± 0.12 (0 to </= 5D)± 0.18 (5 to </= 10.0D)±0.25 (10 to </= 15D)± 0.37 (15 to </= 20D)± 0.50 (over 20D)
Cylindrical Power	+10.00 D TO -10.00 D(in .12 D steps)	± 0.25 (0 to </= 2D)± 0.37 (2 to </= 4D)± 0.50 (over 4D)
Cylindrical Axis	1° to 180° (in 1° steps)	± 5°
Bifocal Add	+12.00 D to 6.00 D(in 0.12 D steps)	± 0.25D
Multifocal Power	+1.00 D to 4.00 D (in.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 RangeDiameterBase Curve Range	-35.00D to +35.00D in 0.25D increments 7.0mm to26.0mm4.00mm to 12.00 mm in 0.01mm increments
MULTIFOCAL/BIFOCAL LENS
(CENTERED, DECENTERED, CRESCENT)
Power RangeDiameterBase Curve RangeSegment HeightsAdd PowersPrism Ballast	-35.00D to +35.00D in 0.25D increments7.0mm to 26.0mm4.00mm to 12.00mm in 0.01mm increments-2.00mm to +1.00mm in 0.5 increments+1.00D to +4.00D in 0.25D increments0.5 to 3.5 prism diopters in 0.5D increments
TORIC LENS
Power RangeDiameterBase Curve RangeToricity	-35.00D to +35.00D in 0.25D increments7.0mm to 26.0mm4.00mm to 12.00mm in 0.01mm incrementsUp to 10.00 Diopters
SCLERAL CONTACT LENS
Power RangeDiameterNormalized Vaults	-35.00D to +35.00D in 0.25D increments 16mm to26.0mm2.50mm to 6.00mm
ORTHOKERATOLOGY LENS
Power RangeDiameterBase Curve RangeReverse CurveAlignment Curve 1Alignment Curve 2Peripheral Curve	-5.00D to +1.50D in 0.25D9.6mm to 11.6mm7.30mm to 10.15mm5.00mm to 9.00mm (Steeper than the base curve)7.00mm to 9.0mm (Steeper than the base curve butflatter than the Reverse Curve7.25mm to 9.25mm (Steeper than the base curve butflatter than the Alignment Curve 1 and ReserveCurve)9.00mm to 15.00mm

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INDICATIONS FOR USE V.

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
1. requires a rigid gas permeable contact lens surface to improve vision
1. 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).

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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

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.

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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

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™(tisilfocon A)and Acuity 181™(tisilfocon A)with Tangible™Hydra-PEG®Rigid Gas PermeableContact Lenses	Hyper GP(tisilfocon A)Daily WearContact Lens	Visionary OpticsScleral Contact Lens(tisilfocon A)	Acuity200™(fluoroxyfocon A) RigidGas Permeable ContactLens; Acuity 100™(hexafocon A) Rigid GasPermeable Contact Lens;Acuity 200™ withTangible® Hydra-PEG®(fluoroxyfocon A) RigidGas Permeable ContactLens; Acuity 100™ withTangible® Hydra-PEG®(hexafocon A) Rigid GasPermeable Contact Lens
510(k) Number	Subject Device	Predicate Device	Predicate Device	Predicate Device
		K182304	K223394	K240618
Functionality	The contact lenses act as arefractive medium that focuslight rays from near and distantobjects on the retina	The contact lenses act as arefractive medium thatfocus light rays from nearand distant objects on theretina	The contact lenses act as arefractive medium thatfocus light rays from nearand distant objects on theretina	The contact lenses act as arefractive medium thatfocus light rays from nearand distant objects on theretina
Intended Use	Daily Wear	Daily Wear	Daily Wear	Daily Wear
Indication forUse	The Acuity 181™ (tisilfocon A)and Acuity 181™ (tisilfocon A)with Tangible™ Hydra-PEG®SPHERICAL Rigid GasPermeable (RGP) Contact Lensis indicated for daily wear for thecorrection of refractive error inaphakic and not aphakic personswith non-diseased eyes withmyopia or hyperopia.The Acuity 181™ (tisilfocon A)and Acuity 181™ (tisilfocon A)with Tangible™ Hydra-PEG®TORIC Rigid Gas Permeable(RGP) Contact Lens is indicatedfor daily wear for the correctionof refractive error in aphakic andnot aphakic persons with non-diseased eyes with myopia orhyperopia and/or possessesrefractive astigmatism notexceeding 10.00 diopters.The Acuity 181™ (tisilfocon A)and Acuity 181™ (tisilfocon A)with Tangible™ Hydra-PEG®MULTIFOCAL/BIFOCAL RigidGas Permeable (RGP) ContactLens is indicated for daily wearfor the correction of refractiveerror in aphakic and not aphakicpersons with non-diseased eyeswith myopia or hyperopia and/orpossesses refractive astigmatismnot exceeding 4.00 diopters andare presbyopic requiring addpower of up to +4.00 diopters.The Acuity 181™ (tisilfocon A)and Acuity 181™ (tisilfocon A)with Tangible™ Hydra-PEG®IRREGULAR CORNEA DailyWear Contact Lens may be	The Hyper GP (tisilfocon A)SPHERICAL Rigid GasPermeable (RGP) Contact Lensis indicated for daily wear forthe correction of refractiveerror in aphakic and notaphakic persons with non-diseased eyes with myopia orhyperopia.The Hyper GP (tisilfocon A)TORIC Rigid Gas Permeable(RGP) Contact Lens isindicated for daily wear for thecorrection of refractive error inaphakic and not aphakicpersons with non- diseasedeyes with myopia or hyperopiaand/or possesses refractiveastigmatism not exceeding10.00 diopters.The Hyper GP (tisilfocon A)MULTIFOCAL/BIFOCALRigid Gas Permeable (RGP)Contact Lens is indicated fordaily wear for the correction ofrefractive error in aphakic andnot aphakic persons with non-diseased eyes with myopia orhyperopia and/or possessesrefractive astigmatism notexceeding 4 diopters and arepresbyopic requiring addpower of up to +4.00 diopters.The Hyper GP (tisilfocon A)IRREGULAR CORNEA DailyWear Contact Lens may beprescribed in otherwise non-diseased eyes that require arigid gas permeable lens for themanagement of irregular	The Visionary Optics ScleralContact Lens for daily wear isindicated for use for themanagement of multiple ocularconditions, such as,degenerations that lead to anirregular corneal shape (e.g.keratoconus, keratoglobus,pellucid marginaldegeneration, Salzmann'sNodular Degeneration),dystrophies (e.g. Cogan'sdystrophy, Granular CornealDystrophy, Lattice CornealDystrophy,),post-surgery (e.g. cornealtransplant, LASIK, radialkeratotomy), and cornealscarring from infectionor trauma.The Visionary Optics ScleralContact Lens for daily wear isalso indicated for therapeutic.management of ocular surfacedisease including dry eye (e.g.ocular manifestations of Graft-versus- Host disease, Sjogren'ssyndrome, dry eye syndrome),limbal stem cell deficiency(e.g. Stevens- Johnsonsyndrome, chemical andthermal burns, radiation,filamentary keratitis),epidermal ocular disorders,disorders of the skin (e.g.atopy, ectodermal dysplasia),	The Acuity 200™(fluoroxyfocon A),Acuity 100™(hexafocon A), Acuity200™ withTangible® Hydra-PEG® (fluoroxyfoconA), and Acuity 100™with Tangible®Hydra-PEG® RigidGas PermeableContact Lenses areindicated for dailywear for thecorrection ofrefractive error(myopia, hyperopia,presbyopia and/orastigmatism) inaphakic and non-aphakic persons withnon-diseased eyes.The lenses may beprescribed for dailywear in otherwisenon-diseased eyes thatrequire a rigid contactlens for themanagement ofirregular cornealconditions such askeratoconus, pellucidmarginaldegeneration, orfollowing penetratingkeratoplasty orrefractive (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:

cannot be adequately corrected
with spectacle lenses
requires a rigid gas permeable
contact lens surface to improve
vision
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 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 SiliconeAcrylate	Group # 3 Fluoro SiliconeAcrylate	Group # 3 Fluoro SiliconeAcrylate	Group # 3 Fluoro SiliconeAcrylate
Classification	Class II Lenses, Rigid GasPermeable, Daily Wear 21CFR 886.5916	Class II Lenses, Rigid GasPermeable, Daily Wear 21CFR 886.5916	Class II Lenses, Rigid GasPermeable, Daily Wear 21CFR 886.5916	Class II Lenses, Rigid GasPermeable, Daily Wear 21CFR 886.5916
Material (USAN)	Tisilfocon A	Tisilfocon A	Tisilfocon A	Fluoroxyfocon A
ProductionMethod	Lathe Cut	Lathe Cut	Lathe Cut	Lathe Cut
Water Content(%)	<1%	<1%	<1%	<1%
Specific Gravity	1.22	1.20	1.20	1.18
Oxygen Permeability,Dk, ISO/Fatt Method10-11 (cm3 O2 x cm/ (cm2x sec x mmHg)@ 35°C	181 x10-11	180 x10-11	180 x10-11	200 x10-11
UV AbsorberAvailable	Yes	Yes	Yes	Yes
PlasmaTreatment	Yes, Optional	Yes, Optional	Yes, Optional	Yes, Optional
Hydra-PEGSurface 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 of storage in Bausch & Lomb's ● Boston® Simplus Multi-Action Solution at ambient temperatures, and
The Tangible™ Hydra-PEG® coated and uncoated tisilfocon A lenses are physically ● compatible with currently marketed care solutions.

Clinical Studies

Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from tisilfocon A has been previously addressed.

VIII. CONCLUSIONS

Substantial Equivalence

Lastly, information presented in this Premarket Notification establishes Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses as safe and effective as the predicate device(s) when used in accordance with the labeled instructions for use and for the proposed indications.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of rigid gas permeable (RGP) daily wear contact lenses. The benefits to the patient are the same as those for other RGP contact lenses.

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
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.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.