Acuity™ 100 (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only.

TYRO™ 97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyonic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected only by using chemical disinfection.

Device Description

Acuity 100™ (hexafocon A) are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from a currently marketed contact lens material, hexafocon A. comprised of a siloxanyl fluoromethacrylate copolymer (fluorosilicone acrylate monomers), tinted for visibility, and with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN).

Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEC® , the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

TYRO" -97 (hofocon A) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from currently marketed contact lens material. hofocon A. polymer of trifluoroethyl methacrylate and silicone methacrylate (fluorosilicone acrylate monomers), tinted for visibility, with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN).

TYRO""-97 (hofocon A) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG® .the underlying material is encapsulated in a thin laver of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

AI/ML Overview

This document describes the premarket notification (510(k)) for Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses. The submission seeks to demonstrate substantial equivalence to previously cleared predicate devices.

The acceptance criteria and device performance information related to this submission are described below.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test Category	Specific Test/Characteristic	Acceptance Criteria (from text)	Reported Device Performance (from text)
Bench Performance Testing
Disinfection Stability	Physical properties after 30 disinfection cycles in Boston Simplus solution at ambient temperatures	Stable physical properties	Physical properties stable
Material Properties	Physicochemical and mechanical properties after Tangible™ Hydra-PEG® addition	Unchanged (except wettability)	Unchanged (except wettability)
Wettability (Contact Angle)	Sessile Drop Contact Angle - Coated	<10°	Acuity 100™ (hexafocon A) Coated: <10°TYRO™-97 (hofocon A) Coated: <10°
Wettability (Contact Angle)	Sessile Drop Contact Angle - Uncoated (for comparison)	Not explicitly stated as acceptance criteria but used for comparison	Acuity 100™ (hexafocon A) Uncoated: 56°TYRO™-97 (hofocon A) Uncoated: 23.3°
Aging Stability	Surface properties after 30 days of accelerated aging	Stable surface properties	Surface properties stable
Bioburden	Bioburden levels initially and after 30 days storage in solution	<100 CFU/lens	Below acceptance criteria
Animal Performance Testing
Acute Ocular Irritation	Per ISO 10993-23	Not explicitly stated, but implies compliance with standard	Performed for both final finished subject devices
Acute Systemic Toxicity	Per ISO 10993-11	Not explicitly stated, but implies compliance with standard	Performed for both final finished subject devices
In Vitro Performance Testing
Cytotoxicity	Per ISO 10993-5	Not explicitly stated, but implies compliance with standard	Performed for both final finished subject devices
Clinical Performance Testing
Clinical Safety and Effectiveness	For finished rigid gas permeable contact lenses manufactured from Acuity™ 100 and TYRO™-97 materials	Demonstrated by predicate devices	Demonstrated by predicate devices
Clinical Safety and Effectiveness	For contact lenses treated with Tangible™ Hydra-PEG®	Previously demonstrated	Previously demonstrated

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

The document does not explicitly state specific sample sizes for each test set or the exact country of origin for the data. However, it indicates that preclinical toxicology and biocompatibility tests were performed "in vitro and in vivo."

Bench Performance Testing: The testing involved various batches of "lenses" (e.g., 30 disinfection cycles, 30 days of accelerated aging) but specific numbers of lenses per test are not stated.
Animal Performance Testing: "Both the final finished subject devices" were tested, implying at least one sample of each type.
In Vitro Performance Testing: "Both the final finished subject devices" were tested, implying at least one sample of each type.
Clinical Performance Testing: This relied on the clinical safety and effectiveness previously demonstrated by predicate devices and prior submissions for Tangible™ Hydra-PEG® treated lenses. This suggests a retrospective reliance on existing clinical data rather than a new prospective clinical study for this specific submission.

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

This document describes a 510(k) submission for rigid gas permeable contact lenses, which primarily relies on bench testing, animal testing, and in vitro testing, along with demonstrated equivalence to predicate devices for clinical performance. The establishment of "ground truth" in the context of expert review for image-based diagnostic AI models or similar scenarios is not directly applicable here. The performance evaluation is based on objective, quantifiable physical, chemical, and biological tests following recognized ISO standards and GLP regulations.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective laboratory measurements and biological assessments rather than subjective assessments requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

Not applicable. This is not a submission for an AI-assisted diagnostic device, but rather for a physical medical device (contact lenses).

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

Not applicable. This is not an algorithm or AI-based device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is established by:

Objective measurement standards: For physical properties, wettability (sessile drop contact angle), and bioburden.
Compliance with recognized standards (ISO): For biocompatibility (acute ocular irritation, acute systemic toxicity, cytotoxicity).
Previous regulatory clearances: For the clinical safety and effectiveness of the base contact lens materials and the Tangible™ Hydra-PEG® coating, demonstrated through prior predicate device submissions.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

June 16, 2023

Acuity Polymers, Inc. Jose Chavez Director, Regulatory Affairs 1667 Lake Ave Building 59, Suite 303 Rochester, NY 14615

Re: K230965

Trade/Device Name: Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens , TYROTM-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: March 31, 2023 Received: April 5, 2023

Dear Jose Chavez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

J Angelo Green -S

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230965

Device Name

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

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG®

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K230965

I. SUBMITTER

Date Prepared:	June 8th, 2023
Name:	Acuity Polymers, Inc.
Address:	1667 Lake Ave.Building 59, Suite 303Rochester, NY 14615USA
Contact Person:	Jose ChavezDirector, Regulatory Affairs
Phone number:	(585) 458-8409
Email	Jose.Chavez@Acuitypolymers.com

II. DEVICE

Trade Name:	Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®Rigid Gas Permeable Contact LensTYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® RigidGas Permeable Contact Lens
Common Name:	Daily wear rigid gas permeable contact lens
Classification Name:	Rigid gas permeable contact lens. (21 CFR§886.5916)
Regulatory Class:	Class II
Product Code:	HQD

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Purpose of the 510(k) Submission:

Acuity 100™ (hexafocon A) and TYRO™-97 (hofocon A) Rigid Gas Permeable Contact Lenses, cleared under 510(k) K162005, K180988, K052507 and K102154 are modified to include Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer designed to improve the wettability of the contact lenses. Specifically, Tangible™ Hydra-PEG® treated contact lenses demonstrate a measurable improvement in the contact angle compared to untreated lenses.

III,PREDICATE DEVICE

Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® is substantially equivalent to predicate devices: Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens 510(k) numbers K162005 and K180988.

TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® is substantially equivalent to predicate devices: TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses for Daily Wear, 510(k) numbers K052507 and K102154

Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® are substantially equivalent to predicate device:

Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses with Tangible™ Hydra-PEG Rigid Gas Permeable Contact Lenses, 510(k) number K183167.

IV. DEVICE DESCRIPTION

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Acuity Polymers510(k) Premarket Notification	510(k) Summary
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG®

methacrylate (fluorosilicone acrylate monomers), tinted for visibility, with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN).

The surface properties of: Acuity 100™ (hexafocon A), and TYRO™-97 (hofocon A) materials uncoated and coated with Tangible™ Hydra-PEG® are depicted in the following table:

	Acuity 100™ (hexafocon A)	TYRO™-97 (hofocon A)
Sessile DropContact Angle	Coated: $<10°$	Coated: $<10°$
	Uncoated: 56°	Uncoated:23.3°

Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are available in the same design configurations and available parameters as the predicate devices, cleared under K162005 and K180988.

TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are available in the same design configurations and available parameters as the predicate devices, cleared under K052507 and K102154.

V. INDICATION FOR USE

Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eves. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only.

TYRO™-97 (hofocon A) with Tangible™ Hydra PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with nondiseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas

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Acuity Polymers	510(k) Summary
510(k) Premarket Notification

Acuity 100TM (1-focon A) with TranquilTM Hydro-PEG® and TYROTM 97 (1-focon A) with TranquilTM Hydro-PEG®

Acuity 100" (hexatocon A) with Tangible " Hydra-PEG" and TYRO" -97 (hotocon A) with Tangible " Hvdra-PEG

permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected only by using chemical disinfection.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

ACUITY 100™ (hexafocon A) WITH TANGIBLE™ HYDRA-PEG®

Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® surface coating technology is substantially equivalent to Acuity 100™ (hexafocon A) uncoated lenses (primary predicate devices cleared under K162005 and K180988 in terms of the following:

1. Proprietary contact lens material formulation and USAN
1. Intended Use- Daily wear contact lens.
1. Indication for Use
1. Lens Designs and available parameters

Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® surface coating technology is substantially equivalent to Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses with Tangible™ Hydra-PEG (secondary Predicate device cleared under K183167) in terms of the following:

1. USAN name
1. Intended use- Daily wear contact lens.
1. Indication for use- similar
1. Tangible™ HYDRA-PEG® surface coating

TYRO™-97 (hofocon A) WITH TANGIBLE™ HYDRA-PEG®

TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® surface coating technology is substantially equivalent to TYRO™-97 (hofocon A) uncoated lenses (primary predicate devices cleared under K052507 and K102154) in terms of the following:

1. Proprietary contact lens material formulation and USAN
1. Intended Use- Daily wear contact lens.
1. Indication for Use
1. Lens Designs and available parameters

TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® surface coating technology is substantially equivalent to Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses with Tangible™ Hydra-PEG (Secondary Predicate device cleared under K183167) in terms of the following:

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Acuity Polymers510(k) Premarket Notification	510(k) Summary
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™ -97 (hofocon A) with Tangible™ Hydra-PEG®

1. Thermoset copolymers derived from fluorosilicone acrylate monomers.
1. Intended Use- Daily wear contact lens.
1. Indication for use- similar
1. Tangible™ Hydra-PEG® surface coating

The following Substantial Equivalence Matrix illustrates the production method, intended use, and material characteristics of Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses as well as the predicate devices.

	Acuity 100™(hexafocon A)with Tangible™Hydra-PEG®,	Acuity 100™(hexafocon A) Rigid GasPermeable Contact Lens	TYRO™ -97(hofocon A)Rigid GasPermeableContact Lens	Boston XO®(hexafocon A)with Tangible™Hydra-PEG	Indication for Use	Acuity 100™(hexafocon A) with Tangible™Hydra-PEG® Rigid GasPermeable Contact Lenses areindicated for daily wear for thecorrection of refractive error(myopia, hyperopia, presbyopiaand/or astigmatism) in aphakicand non-aphakic persons withnon-diseased eyes. The lensesmay be prescribed for daily wearin otherwise non-diseased eyesthat require a rigid contact lensfor the management of irregularcorneal conditions such askeratoconus, pellucid marginaldegeneration, or followingpenetrating keratoplasty orrefractive (e.g., LASIK) surgery.The lens may be disinfectedusing a chemical disinfectionsystem only.TYRO™-97 (hofocon A) withTangible™ Hydra-PEG® RigidGas Permeable Contact Lens areindicated for daily wear for thecorrection of visual acuity innon-aphakic persons with non-diseased eyes that are myopic,hyperopic or presbyopic andwhich may exhibit cornealastigmatism. Also, the lensesmay be prescribed in otherwisenon-diseased eyes that require agas permeable contact lens forthe management of irregularcorneal conditions such askeratoconus, pellucid marginaldegeneration, or followingpenetrating keratoplasty orrefractive (e.g., LASIK) surgery.The lenses may be disinfectedonly by using chemicaldisinfection.	The Acuity 100™ (hexafoconA) Rigid Gas PermeableContact Lenses are indicatedfor daily wear for thecorrection of refractive error(myopia, hyperopia, presbyopiaand/or astigmatism) in aphakicand non-aphakic persons withnon-diseased eyes. The lensmay be prescribed in sphericaland aspheric powers rangingfrom -20.00 D to +20.00 D fordaily wear. The lenses may beprescribed for daily wear inotherwise non-diseased eyesthat require a rigid contact lensfor the management of irregularcorneal conditions such askeratoconus, pellucid marginaldegeneration, or followingpenetrating keratoplasty orrefractive (e.g., LASIK)surgery.The lens may be disinfectedusing a chemical disinfectionsystem only.The lenses may be stored in amultipurpose solution(BOSTON SIMPLUS orMenicon Unique pH) solutionup to 30 days.	TYRO™-97 (hofoconA) Rigid GasPermeable Spherical,Aspheric, Toric andBifocal Contact Lensis indicated for dailywear for thecorrection of visualacuity in not-aphakicpersons with non-diseased eyes that aremyopic, hyperopic orpresbyopic and whichmay exhibit cornealastigmatism.The lenses may bedisinfected only byusing chemicaldisinfection.TYRO™-97 (hofoconA) Rigid GasPermeable ContactLenses is indicated fordaily wear for thecorrection of visualacuity in non-aphakicpersons with non-diseased eyes that aremyopic, hyperopic orpresbyopic and whichmay exhibit cornealastigmatism. Also, thelenses may beprescribed inotherwise non-diseased eyes thatrequire a gaspermeable contactlens for themanagement ofirregular cornealconditions such askeratoconus, pellucidmarginaldegeneration, orfollowing penetratingkeratoplasty orrefractive (e.g.,LASIK) surgery.The lenses may bedisinfected only byusing chemicaldisinfection	The Boston XO®(hexafocon A) withTangible™ Hydra-PEGContact Lens isindicated for daily wearfor the correction ofrefractive ametropia(myopia, hyperopia,astigmatism, andpresbyopia) in aphakicand non aphakic personswith non-diseased eyes.Also, the lenses may beprescribed in otherwisenon diseased eyes thatrequire a gas permeablecontact lens for themanagement of irregularcorneal conditions suchas keratoconus, pellucidmarginal degeneration,or following penetratingkeratoplasty or refractive(e.g., LASIK) surgery.The Boston XO®(hexafocon A) withTangible™ Hydra-PEGlens may be disinfectedusing a chemicaldisinfection system (notheat) only.		< 1%	< 1%	< 1%	< 1%
	TYRO™ -97(hofocon A)with Tangible™Hydra-PEG®				Power Range	ProductionMethod	hexafocon A-20.00 D to +20.00 Dhofocon A-20.00 D to +12.00 D	Lathe Cut	hexafocon A-20.00 D to +20.00 D	Lathe Cut	hofocon A-20.00 D to +12.00 D	Lathe Cut	hexafocon A-20.00 D to +20.00 D	Lathe Cut	Water Content(%)
	New Device	Predicate Device(K162005, K180988)	Predicate Device(K052507,K102154)	Predicate DeviceK183167	USAN Name	hexafocon Ahofocon A	hexafocon A	hofocon A	hexafocon A	Wettability(Sessile DropAdvancingContactAngle)	hexafocon A: <10°hofocon A: <10°	hexafocon A: 56°	hofocon A: 23.3°	(uncoated)hexafocon A: 63.4°(coated)hexafocon A: 10°
Intended Use	Daily Wear	Daily Wear	Daily Wear	Daily Wear	Lens Type	RGP	RGP	RGP	RGP
Device Name	Acuity 100™(hexafocon A) withTangible™ Hydra-PEG®Rigid Gas PermeableContact Lens	Acuity 100™(hexafocon A) Rigid GasPermeable Contact Lens	TYRO™-97(hofocon A)Rigid GasPermeableSpherical,Aspheric, Toricand BifocalContact Lensesfor Daily Wear	Boston XO®(hexafocon A)Rigid GasPermeable ContactLenses withTangible™ Hydra-PEG Rigid GasPermeable ContactLenses	Available withor without UVBlocker	Yes	Yes	Yes	Yes
	TYRO™ -97(Hofocon A) withTangible™ Hydra PEG®Rigid Gas PermeableContact Lenses				Lenses may bedisinfectedusing aChemicalDisinfectionSystem	Yes	Yes	Yes	Yes
IncludesTangible™Hydra PEG®	Yes	No	No	Yes

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Acuity Polymers

510(k) Summary

510(k) Premarket Notification

Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG®

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uity Polymers

510(k) Premarket Notification

Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG®

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols.

Test results of the non-clinical testing on the device demonstrate that:

Performance Testing- Bench

1. The physical properties of the lenses are stable following 30 (thirty) disinfection cycles in Boston Simplus disinfection solution at ambient temperatures.
The physicochemical and mechanical properties of the contact lenses are unchanged after 2. the addition of Tangible™ Hydra-PEG®, with the exception of wettability (contact angle).
1. The surface properties of the lens are stable following 30 (thirty) days of accelerated aging.
1. Bioburden levels are below the acceptance criteria (<100 CFU/lens) initially and following 30 (thirty) days of storage in solution at ambient temperatures.

Performance Testing- Animal

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Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG®

1. Acute Ocular Irritation testing per ISO 10993-23 and Acute Systemic Toxicity testing per ISO 10993-11 were performed for both the final finished subject devices.

Performance Testing- In Vitro

1. Cytotoxicity testing per ISO 10993-5 was performed for both the final finished subject devices.

Performance Testing -Clinical

The clinical safety and effectiveness of finished rigid gas permeable contact lenses manufactured from Acuity™ 100 (hexafocon A) and TYRO™-97 (hofocon A) Rigid Gas Permeable Contact Lenses materials have been demonstrated by predicate devices. Additionally, the clinical safety and effectiveness for contact lenses treated with Tangible™ Hydra-PEG® has been previously demonstrated.

VIII. CONCLUSIONS

Validity of Scientific Data

Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR §860.7.

Substantial Equivalence

Information presented in this 510(k) Premarket Notification establishes that the Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are as safe and effective as the predicate devices when used in accordance with the labeled directions for use and for the proposed indication.

Risks and Benefits

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

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.