The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) 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 nondiseased 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 Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) 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 eve 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 reservor 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.

Device Description

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 manufactured from machine latheable rigid gas permeable materials composed of siloxanyl fluoromethacrylate copolymers that are tinted for visibility and available with or without an ultraviolet (UV) light absorbers.

Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are treated to incorporate Hydra-PEG Technology developed by Tangible Sciences. This PEG polymer is permanently attached to the surface and is designed to enhance surface (wetting) properties while not affecting the mechanical or optical properties of the underlying material.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for a medical device (Rigid Gas Permeable Contact Lenses). It is not a study proving the device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product.

Therefore, I cannot extract the requested information about acceptance criteria, study sizes, expert ground truth establishment, MRMC studies, or training sets, as these concepts are not applicable to the type of device and submission described in the provided document. The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for contact lenses based on material properties, manufacturing methods, and intended use.

The "PERFORMANCE DATA VII." section specifically mentions "Non-Clinical Studies" and "Clinical Studies". However, these sections refer to studies that were "addressed through previously cleared 510(k) premarket notifications" for the materials and existing uses of the contact lenses, rather than a new study demonstrating the performance of an AI-powered device.

If you have a document describing an AI/SaMD study, I would be happy to analyze it for the criteria you've outlined.

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.

April 3, 2024

Bret Andre, Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn, OR 97068

Re: K240618

Trade/Device Name: 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 Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: February 26, 2024 Received: March 6, 2024

Dear Bret Andre:

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/cdrb/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.

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Page 2

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.

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 (OS) 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.

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 medical devices and radiation-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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240618

Device Name

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, Acuity 100™ (hexatocon A) Rigid Gas Permeable Contact Lens, Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens

Indications for Use (Describe)

The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) 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 eve 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 reservor 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.

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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SPECIAL 510 (k) SUMMARY

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: K240618

I. SUBMITTER

Date Prepared:	March 30, 2024
Name:	Acuity Polymers, Inc.
Address:	1667 Lake Avenue, Suite 354Rochester, NY 14615United States
Contact Person:	James A. Bonafini, JrPresident
Phone number:	(585) 458-8409
Consultant:	Bret AndreAndre Vision and Device Research6119 Canter Ln.West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	Acuity 200 TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lens;Acuity 100 TM (hexafocon A) Rigid Gas Permeable Contact Lens;Acuity 200 TM with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid GasPermeable Contact Lens;Acuity 100 TM with Tangible® Hydra-PEG® (hexafocon A) Rigid GasPermeable Contact Lens
CommonName:	Daily wear rigid gas permeable contact lens
ClassificationName:	Rigid gas permeable contact lens. (21 CFR 886.5916)
RegulatoryClass:	Class II
Product Code:	HQD
~~Reason for Submission~~	Indications for Use Change

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III. PREDICATE DEVICE

. "Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)" By Visionary Optics LLC 510(k) number: K233325 Product Code: HQD
l "Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lens" By Acuity Polymers, Inc. 510(k) number; K201194 Product Code: HQD
. "Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens" By Acuity Polymers, Inc. 510(k) number; K162005 Product Code: HQD
I Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens By Acuity Polymers, Inc. 510(k) number; K213538
- Product Code: HQD
"Acuity 100™ (hexafocon A) with Tangible® Hydra-PEG®, TYRO™-97 (hofocon A) . with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lens" By Acuity Polymers, Inc. 510(k) number; K230965 Product Code: HQD
. "OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA 100 (hexafocon A) Daily Wear Contact Lens" By Contamac Ltd. 510(k) number; K180616 Product Code: HQD

DEVICE DESCRIPTION IV.

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 manufactured from machine latheable rigid gas permeable materials composed of siloxanyl fluoromethacrylate copolymers that are tinted for visibility and available with or without an ultraviolet (UV) light absorbers.

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mechanical or optical properties of the underlying material.

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 for daily wear are made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:

Parameter	Range	Tolerance
Base Curve	4.00mm to 11.50mm	$\pm$ 0.05 mm
Center Thickness	0.08mm to 0.75mm	$\pm$ 0.02 mm
Diameter	7.0mm to 21.0mm	$\pm$ 0.10mm
Spherical Power	-20.00D to +20.00D	$\pm$ 0.12 (0 to = 5D)<br $\pm$ 0.18 (5 to = 10.0D)<br $\pm$ 0.25 (10 to = 15D)<br $\pm$ 0.37 (15 to = 20D)<br $\pm$ 0.50 (over 20D)
Cylindrical Power	Up to 9.00D	$\pm$ 0.25 (0 to = 2D)<br $\pm$ 0.37 (2 to = 4D)<br $\pm$ 0.50 (over 4D)
Multifocal Power	+1.00D to 4.00D	$\pm$ 0.25D
Surface Appearance		Lenses should be clear with no surfacedefect

The following table depicts the physical properties of the Acuity 200™ (fluoroxyfocon A) and Acuity 200TM with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lens:

	Fluoroxyfocon A Rigid Gas Permeable Contact Lens
Refractive Index	1.430
Modulus (MPa)	1194
Hardness (Shore D)	78
Specific Gravity	1.18
Oxygen Permeability(Dk)	200 x 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C)
Color Additives	Visibility Tints – D&C Green #6, D&C Violet #2, Solvent Yellow 18, D&C Red #17

The following table depicts the physical properties of the Acuity 100™ and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens:

	Hexafocon A Rigid Gas Permeable Contact Lens
Refractive Index	1.415
Modulus (MPa)	1496
Hardness (Shore D)	80
Specific Gravity	1.27
Oxygen Permeability(Dk)	$111 \times 10^{-11}$ (cm²/sec) (ml O2/ml x mm Hg @ 35°C)
Color Additives	Visibility Tints — D&C Green #6, D&C Violet #2, Solvent Yellow 18

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MODEL	Acuity 200(fluoroxyfocon A)	Acuity 100 (hexafocon A)	Acuity 200 (fluoroxyfocon A) with Tangible Hydra-PEG	Acuity 100 (hexafocon A) with Tangible Hydra-PEG
Ship Method	Dry	Dry	Dry or Wet*	Dry or Wet*
Storage Solution	N/A	N/A	Menicon Unique pH Multi-purpose Solution (K130805) &Boston Simplus® Multi-Action Solution (K024289)	Menicon Unique pH Multi-purpose Solution (K130805) &Boston Simplus® Multi-Action Solution (K024289)
Shipping Case	Deep Well Lens Case (K171539)	Deep Well Lens Case (K171539)	Deep Well Lens Case (K171539)	Deep Well Lens Case (K171539)

The following table depicts the shipping method, storage solution for wet shipping, and shipping case used for each lens model:

Lenses coated with Tangible Hydra-PEG are stored wet.

INDICATIONS FOR USE V.

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 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 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. Siögren's syndrome, dry eve 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.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses and Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to the predicate device (cleared under K233325) in terms of the following:

Intended use - daily wear contact lenses
트 Indications for use - Therapeutic (irregular cornea and ocular surface disease)
트 Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
트 FDA material group - group # 3 fluoro silicone acrylate
USAN materials (fluoroxyfocon A and hexafocon A)
Production method - lathe cut

The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to the predicate device (cleared under K201194) in terms of the following:

I Intended use - daily wear contact lenses
트 Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
트 FDA material group - group # 3 fluoro silicone acrylate
USAN material (fluoroxyfocon A)
Lens designs
Production method - lathe cut (same facility, processes, and quality control procedures)
트 Final packaging and shipping

The Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to the predicate device (cleared under K162005) in terms of the following:

Intended use daily wear contact lenses ■
트 Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
FDA material group - group # 3 fluoro silicone acrylate
USAN material (hexafocon A)
Lens designs
Production method lathe cut (same facility, processes, and quality control procedures) 트
I Final packaging and shipping

The Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to the predicate device (cleared under K213538) in terms of the following:

Intended use - daily wear contact lenses
트 Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
FDA material group – group # 3 fluoro silicone acrylate
트 USAN material (fluoroxyfocon A)
트 Available with Tangible® Hydra-PEG®
Lens designs

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' Production method - lathe cut (same facility, processes, and quality control procedures)
트 Final packaging and shipping

The Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to the predicate device (cleared under K230965) in terms of the following:

트 Intended use - daily wear contact lenses
트 Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
FDA material group group # 3 fluoro silicone acrylate ■
트 USAN material (hexafocon A)
Available with Tangible® Hydra-PEG®
트 Lens designs
트 Production method - lathe cut (same facility, processes, and quality control procedures)
I Final packaging and shipping

The Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to the predicate device (cleared under K180616) in terms of the following:

Intended use - daily wear contact lenses
트 Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
FDA material group – group # 3 fluoro silicone acrylate
트 USAN material (hexafocon A)
트 Available with Tangible® Hydra-PEG®
트 Indications for use - Therapeutic (irregular cornea and ocular surface disease)

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The following matrix illustrates the production method, lens function and materistics of 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, as well as the predicate devices.

	Acuity 200™Acuity 100™Rigid GasPermeableContact Lens	Visionary OpticsScleral ContactLens	Acuity 200™Rigid GasPermeableContact Lens	Acuity 100™Rigid GasPermeableContact Lens	Acuity 200™withTangible®Hydra-PEG®	Acuity 100™TYRO™ 97withTangible®Hydra-PEG®	OPTIMUMGPHEXA100Daily WearContactLens		Indications for Use
	Subject Device	Predicate Device(K233325)	Predicate Device(K201194)	PredicateDevice(K162005)	PredicateDevice(K213538)	PredicateDevice(K230965)	PredicateDevice(K180616)	Acuity 200™(fluoroxyfoconA), Acuity 100™(hexafocon A),Acuity 200™with Tangible®Hydra-PEG®(fluoroxyfoconA), and Acuity100™ withTangible®Hydra-PEG®Rigid GasPermeableContact Lenses s	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 PermeableContact 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 eyes. The lensesmay be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for themanagement of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, orfollowing penetrating keratoplasty or refractive (e.g., LASIK) surgery.
Classification	Class IILenses, Rigid GasPermeable, DailyWear21 CFR 886.5916	Class IILenses, Rigid GasPermeable, DailyWear21 CFR 886.5916	Class IILenses, RigidGas Permeable,Daily Wear21 CFR 886.5916	Class IILenses, RigidGas Permeable,Daily Wear21 CFR886.5916	Class IILenses, RigidGas Permeable,Daily Wear21 CFR886.5916	Class IILenses, RigidGasPermeable,Daily Wear21 CFR886.5916	Class IILenses,Rigid GasPermeable,Daily Wear21 CFR886.5916	with Tangible®Hydra-PEG®(fluoroxyfoconA), and Acuity100™ withTangible®Hydra-PEG®Rigid GasPermeableContact Lenses s	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 PermeableContact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocularGraft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbalstem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disordersof 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 thepresence of an expanded tear reservoir and protection against an adverse environment. When prescribedfor therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently providecorrection of refractive error.
Product Code	HQD	HQD	HQD	HQD	HQD	HQD	HQD	(Subject Device)	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 PermeableContact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.
FDA Group #	Group # 3 FluoroSilicone Acrylate	Group # 3 FluoroSilicone Acrylate	Group # 3 FluoroSilicone Acrylate	Group # 3Fluoro SiliconeAcrylate	Group # 3Fluoro SiliconeAcrylate	Group # 3FluoroSiliconeAcrylate	Group # 3FluoroSiliconeAcrylate	Visionary OpticsScleral ContactLens (roflufoconD, roflufocon E,hexafocon A,hexafocon B,tisilfocon A,fluoroxyfocon A)(K233325)	The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management ofmultiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g.keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration),dystrophies (e.g. Cogan's dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring from infection ortrauma.The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic managementof ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease,Sjogren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome,chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders, disorders of theskin (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 thepresence of an expanded tear reservoir and protection against an adverse environment. When prescribedfor therapeutic use for distorted cornea or ocular surface disease, the Visionary Optics Scleral ContactLens 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, thelens may be cleaned and disinfected using a chemical (not heat) lens care system.
Material (USAN)	fluoroxyfocon A,hexafocon A	roflufocon D.roflufocon E.hexafocon A.hexafocon B.tisilfocon A,fluoroxyfocon A	fluoroxyfocon A	hexafocon A	fluoroxyfoconA	hexafocon A;hofocon A	hexafoconA;roflufoconD;roflufocon E	Acuity 200™(fluoroxyfoconA) Rigid GasPermeableContact Lens(K201194)	The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wearfor the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic andnon-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical and asphericpowers ranging from -20.00 D to +20.00 D for daily wear.
Production Method	Lathe-Cut	Lathe-Cut	Lathe-Cut	Lathe-Cut	Lathe-Cut	Lathe-Cut	Lathe-Cut	Acuity 100™(hexafocon A)Rigid GasPermeableContact Lens(K162005)	The Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for dailywear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) inaphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical andaspheric powers ranging from -20.00 D to +20.00 D for daily wear. The lenses may be prescribed fordaily wear in otherwise non-diseased eyes that require a rigid contact lens for the management ofirregular corneal conditions such as keratoconus, pellucid marginal degeneration, or followingpenetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using achemical disinfection system only.
Intended Use	Daily Wear	Daily Wear	Daily Wear	Daily Wear	Daily Wear	Daily Wear	Daily Wear	Acuity 200™with Tangible®	Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens isindicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or
Water Content (%)	<1%	<1%	<1%	<1%	<1%	<1%	<1%
UV AbsorberAvailable	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Hydra-PEG®Coating Available	Yes	No	No	No	Yes	Yes	Yes

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Hydra-PEG®Rigid GasPermeableContact Lens(K213538)	astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribedfor daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management ofirregular corneal conditions such as keratoconus, pellucid marginal degeneration, or followingpenetrating keratoplasty or refractive (e.g., LASIK) surgery. The Acuity™ 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using achemical (not heat) lens care system.
Acuity 100™ andTYRO™ 97 withTangible®Hydra-PEG®Rigid GasPermeableContact Lenses(K230965)	Acuity™ 100 (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses areindicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/orastigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribedfor daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management ofirregular corneal conditions such as keratoconus, pellucid marginal degeneration, or followingpenetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfectedusing a chemical disinfection system only.TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses areindicated for daily wear for the correction of visual acuity in non-aphakic persons with non-diseasedeyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. Also, thelenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens forthe management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, orfollowing penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfectedonly by using chemical disinfection.
OPTIMUM GP(roflufocon D,roflurocon E)Daily WearContact Lens,HEXA100(hexafocon A)Daily WearContact Lens(K180616)	OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear ContactLenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism andpresbyopia) in aphakic and non aphakic persons with non-diseased eyes. Also, the lenses may beprescribed in otherwise non-diseased eyes that require a rigid contact lens for the management ofirregular corneal conditions such as keratoconus, pellucid marginal degeneration, or followingpenetrating keratoplasty or refractive surgery.Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physicalprotection, aqueous hydrated environment and the saline bath provided by scleral lens designs.OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear ContactLenses are indicated for therapeutic use for the management of irregular and distorted cornealsurfaces where the subject:1. cannot be adequately corrected with spectacle lenses2. requires a rigid gas permeable contact lens surface to improve vision3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surfaceirregularitiesCommon 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 radialkeratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g.keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) andcorneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklersdystrophy, Cogan's dystrophy). The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100(hexafocon A) Daily Wear Contact Lenses are also indicated for therapeutic use in eyes withocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndromeand Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemicalradiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophickeratitis (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 andprotection against an adverse environment. When prescribed for therapeutic use for a distortedcornea or ocular surface disease, the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100(hexafocon A) Daily Wear Contact Lenses may concurrently provide correction of refractive error.

Hydra-PEG®Rigid GasPermeableContact Lens(K213538)

astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribedfor daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management ofirregular corneal conditions such as keratoconus, pellucid marginal degeneration, or followingpenetrating keratoplasty or refractive (e.g., LASIK) surgery. The Acuity™ 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using achemical (not heat) lens care system.

Acuity 100™ andTYRO™ 97 withTangible®Hydra-PEG®Rigid GasPermeableContact Lenses(K230965)

Acuity™ 100 (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses areindicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/orastigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribedfor daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management ofirregular corneal conditions such as keratoconus, pellucid marginal degeneration, or followingpenetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfectedusing a chemical disinfection system only.TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses areindicated for daily wear for the correction of visual acuity in non-aphakic persons with non-diseasedeyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. Also, thelenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens forthe management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, orfollowing penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfectedonly by using chemical disinfection.

OPTIMUM GP(roflufocon D,roflurocon E)Daily WearContact Lens,HEXA100(hexafocon A)Daily WearContact Lens(K180616)

OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear ContactLenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism andpresbyopia) in aphakic and non aphakic persons with non-diseased eyes. Also, the lenses may beprescribed in otherwise non-diseased eyes that require a rigid contact lens for the management ofirregular corneal conditions such as keratoconus, pellucid marginal degeneration, or followingpenetrating keratoplasty or refractive surgery.Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physicalprotection, aqueous hydrated environment and the saline bath provided by scleral lens designs.OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear ContactLenses are indicated for therapeutic use for the management of irregular and distorted cornealsurfaces where the subject:1. cannot be adequately corrected with spectacle lenses2. requires a rigid gas permeable contact lens surface to improve vision3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surfaceirregularitiesCommon 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 radialkeratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g.keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) andcorneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklersdystrophy, Cogan's dystrophy). The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100(hexafocon A) Daily Wear Contact Lenses are also indicated for therapeutic use in eyes withocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndromeand Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemicalradiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophickeratitis (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 andprotection against an adverse environment. When prescribed for therapeutic use for a distortedcornea or ocular surface disease, the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100(hexafocon A) Daily Wear Contact Lenses may concurrently provide correction of refractive error.

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PERFORMANCE DATA VII.

~ Non-Clinical Studies ~

Non-clinical testing to demonstrate the safety and effectiveness of 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 have been addressed through previously cleared 510(k) premarket notifications as described in the following table:

	Acuity 200TM(fluoroxyfocon A)Rigid GasPermeableContact Lens	Acuity 100TM(hexafocon A)Rigid GasPermeableContact Lens	Acuity 200™ withTangible® Hydra-PEG® (fluoroxyfoconA) Rigid Gas PermeableContact Lens	Acuity 100™ withTangible® Hydra-PEG® (hexafocon A)Rigid Gas PermeableContact Lens
ManufacturingDesign Verification	K201194	K162005	K213538	K230965
Physicochemicaland MechanicalProperty Testing	K201194	K162005	K213538	K230965
Extraction Studies	K201194	K162005	K213538	K230965
Bioburden Testing	K201194	K162005	K213538	K230965
SolutionCompatibility	K201194	K162005	K213538	K230965
Shelf-Life Studies	K201194	K162005	K213538	K230965
Biocompatibility	K201194	K162005	K213538	K230965

~ Clinical Studies ~

Clinical performance of the ocular surface disease indication was addressed for fluoroxyfocon A and hexafocon A scleral contact lenses in 510(k) K233325.

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VIII. CONCLUSIONS

Substantial Equivalence

Information presented in this premarket notification establishes that 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 for daily wear are as safe and effective as the predicate devices when used in accordance with the labeled directions for use and for the proposed indications.

Risks and Benefits

The risks of 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 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.