The Hyper GP (tisilfocon A) 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 nondiseased eyes with myopia or hyperopia.

The Hyper GP (tisilfocon A) 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 nondiseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The Hyper GP (tisilfocon A) 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 eves with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Hyper GP (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eves 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 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.

Device Description

The Hyper GP (tisilfocon A) Daily Wear 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.

In the Hyper GP (tisilfocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block >99% of UV radiation in the UVB range (280nm = 315nm) and >85% in the UVA range (316 - 380nm).

The Hyper GP (tisilfocon A) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17.

The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes.

The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible™ Hydra-PEG-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 (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. The resulting layer is hydrophilic and approximately 30nm in thickness.

The Hyper GP (tisilfocon A) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters: Base Curve, Center Thickness, Chord Diameter, Spherical Power, Cylindrical Power, Cylindrical Axis, Multifocal Power.

The Hyper GP (tisilfocon A) Daily Wear Contact Lens for daily wear orthokeratology is available in following lens parameters: Base Curve (BC), Center Thickness, Diameter, Secondary Curves, Peripheral Curves, Spherical Power.

The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the Hyper GP (tisilfocon A) Daily Wear Contact Lens is the Poly Vial Contact Lens Case. When shipped "wet", the Hyper GP (tisilfocon A) Daily Wear Contact Lens may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.

AI/ML Overview

This document describes the Hyper GP (tisilfocon A) Daily Wear Contact Lens and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and a detailed analysis of device performance against those criteria as would be found in a typical AI/ML medical device submission.

However, based on the provided text, I can infer the "acceptance criteria" and "reported device performance" are related to a comparison of technical characteristics and the successful completion of non-clinical and clinical studies for a contact lens.

Here's an interpretation of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in the typical format of quantitative thresholds for a specific study. Instead, it demonstrates acceptance primarily through substantial equivalence to predicate devices and through a series of non-clinical (in vitro and in vivo toxicology/biocompatibility) and clinical studies. The reported device performance is presented as meeting safety and effectiveness expectations, aligning with previously established performance for similar materials and designs.

The key "performance data" highlights can be interpreted as demonstrating the device meets the implied acceptance criteria for a contact lens, specifically in terms of material properties, safety, and physical compatibility.

Table of "Acceptance Criteria" (Implied) and "Reported Device Performance":

Implied Acceptance Criterion	Reported Device Performance
I. Substantial Equivalence to Predicate Devices:
- Intended use and indications for use	Substantially equivalent to "Rigid Gas Permeable Contact Lenses (tisilfocon A)" by Menicon Co., Ltd. (K103561) for daily wear and general indications.
- Orthokeratology indications	Substantially equivalent to "OPTIMUM GP OK Daily Wear Contact Lens" (roflufocon D & E) by Contamac Ltd. (K160859) for daily wear orthokeratology.
- Material composition (USAN)	Hyper GP (tisilfocon A) is made of tisilfocon A, similar to predicate K103561. (Predicate K160859 and K161100 use roflufocon D & E, and roflufocon C, D, and E respectively, with the new device asserting equivalence in the "fluoro silicone acrylate" material group).
- Classification (21 CFR 886.5916)	Class II, consistent with predicate devices.
- FDA material group	Group #3 fluoro silicone acrylate, consistent with predicate K103561. (Predicate K160859 and K161100 are also in this group).
- Production method	Lathe-cut, custom manufactured, consistent with predicate devices.
- Surface coating (Tangible™ Hydra-PEG)	The ability to be optionally surface coated with Tangible™ Hydra-PEG is substantially equivalent to predicate K161100 which also has this option.
- Optical and physical parameters (e.g., UV blocking, Dk)	Comparable or improved parameters: - Average Sessile Drop Contact Angle (coated): 37.34° (improved from 106.2° uncoated) - Oxygen Permeability (Dk): $180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) - Higher Dk than both predicate roflufocon materials, and predicate K103561 at $160 \times 10^{-11}$ - UV blocking (optional) and other physical attributes found to be acceptable and within range typically for RGP lenses.
II. Safety and Effectiveness (Non-Clinical Studies):
- Biocompatibility (non-toxic, non-irritating)	Finished lenses (uncoated and coated with Tangible™ Hydra-PEG) are not toxic and not irritating.
- Physicochemical, mechanical, and optical properties	Substantially equivalent to the predicate device.
- Bioburden levels	Below acceptance criteria (<100 cfu/lens) initially and after 30 days storage.
- Stability of physical parameters	Stable after 30 days of storage.
- Physical compatibility with care solutions	Tangible™ Hydra-PEG coated lenses are physically compatible with currently marketed care solutions.
III. Clinical Performance:
- Safety and effectiveness of tisilfocon A material	Clinical performance data for contact lenses manufactured from tisilfocon A has been previously addressed. (This indicates prior clearance of the material).

Additional Requested Information:

Since this document is a 510(k) summary for a contact lens, it details substantial equivalence to predicates rather than presenting a performance study with specific AI/ML metrics, test sets, or ground truth establishment methods typically associated with AI-driven devices. Therefore, many of the requested points below are not applicable or explicitly stated in this type of submission.

Sample size used for the test set and the data provenance:
- Test Set (Non-Clinical):
  - For Average Sessile Drop Contact Angle: n=30 lenses were tested for both uncoated and Tangible™ Hydra-PEG coated lenses.
  - For Bioburden levels: Not explicitly stated, but tests were conducted.
  - For Stability of physical parameters: Not explicitly stated, but tests were conducted.
  - Data Provenance: Not specified, but likely from in-house or contracted laboratory testing as part of the regulatory submission process.
- Test Set (Clinical): The document states that "Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from tisilfocon A has been previously addressed." This implies that new clinical trials were not conducted for this specific 510(k) submission, but rather referenced existing data for the material. Therefore, no new sample size or provenance for a new clinical test set is provided here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and submission. "Ground truth" in this context refers to standard measurements, not expert annotations of images or other data. Non-clinical tests follow established protocols and standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Standardized laboratory testing methods were used, not expert adjudication panels.
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: Not applicable. This device is a contact lens, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a contact lens.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For non-clinical tests (e.g., Dk, contact angle, toxicity, bioburden), the "ground truth" is defined by established physical, chemical, and biological testing standards and measurements.
- For clinical performance, it refers to previously collected outcomes data and clinical experience with the tisilfocon A material, which established its safety and effectiveness.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/1/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

November 23, 2018

Contamac Ltd. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068

Re: K182304

Trade/Device Name: Hyper GP (tisilfocon A) Daily Wear Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD, MUW Dated: October 24, 2018 Received: October 26, 2018

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 (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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: K182304

I. SUBMITTER

October 24th, 2018 Date Prepared:

Name:	Contamac Ltd.
Address:	Carlton HouseShire HillSaffron WaldenEssex CB11 3AU
Contact Person:	Robert McGregorManaging Director
Phone number:	01799 514800
Consultant:	Bret AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	Hyper GP (tisilfocon A) Daily Wear 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; MUW

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III. PREDICATE DEVICE

The Hyper GP (tisilfocon A) Daily Wear Contact Lens is substantially equivalent to the following predicate devices:

. "Rigid Gas Permeable Contact Lenses (tisilfocon A)" By Menicon Co., Ltd. 510(k) number; K103561
. "OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)" by Contamac Ltd. 510(k) number; K160859
. "Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lenses" by Contamac Ltd. 510(k) number; K161100

IV. DEVICE DESCRIPTION

The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes.

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	Hyper GP tisilfocon A
	Uncoated	Tangible™ Hydra-PEGCoated
Average Sessile Drop Contact Angle(degrees) n=30	106.2	37.34
Standard Deviation	5.31	5.30

The physical properties of the Hyper GP (tisilfocon A) Daily Wear Contact Lens is as follows:

	Hyper GP (tisilfocon A)	Hyper GP (tisilfocon A) withTangibleTM Hydra-PEG
Refractive Index (dry)	1.4378	1.4398
Light Transmission (@380-780nm)	91.694	93.427
UVA Transmission (@316-380nm)	14.241	16.105
UVB Transmission (@280-315nm)	0.011	0.020
Oxygen Permeability(Dk)ISO/FATT Method	$180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @35°C)	$180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @35°C)
Visitint lenses contain one or more of thefollowing color additives conforming to:21 CFR Part 73 & 74, Subpart D	D&C Green No. 6, C.I. SolventYellow No. 18, D&C Violet No. 2 andD&C Red No. 17	D&C Green No. 6, C.I. SolventYellow No. 18, D&C Violet No. 2and D&C Red No. 17

The Hyper GP (tisilfocon A) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:

Parameter	Range	Tolerance
Base Curve	4.00mm to 12.00mm	± 0.05 mm
Center Thickness	Varies	± 0.02 mm
Chord Diameter	7.00mm to 22.00mm	± 0.10mm
Spherical Power	-30.00 D to +30.00 D(in 0.25D steps)	± 0.12 (0 to = 5D)<br ± 0.18 (5 to = 10.0D)<br ± 0.25 (10 to = 15D)<br ± 0.37 (15 to = 20D)<br ± 0.50 (over 20D)
Cylindrical Power	Up to -10.00 D(in 0.25 D steps)	± 0.25 (0 to = 2D)<br ± 0.37 (2 to = 4D)<br ± 0.50 (over 4D)
Cylindrical Axis	1° to 180° (in 1° steps)	± 5°
Multifocal Power	+1.00 D to 4.00 D(in 0.25 D steps)	± 0.25D

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The Hyper GP (tisilfocon A) Daily Wear Contact Lens for daily wear orthokeratology is available in following lens parameters:

Parameter	Range	Tolerance
Base Curve (BC)	4.0mm to 12.00mm	± 0.05 mm
Center Thickness	0.10mm to 0.70mm	±0.02 mm
Diameter	6.50mm to 11.50mm	±0.10mm
Secondary Curves	0.10mm to 2.00mm (flatter or steeper than BC)	±0.10mm
Peripheral Curves	0.10mm to 2.00mm (flatter or steeper than BC)	±0.10mm
Spherical Power	-10.00 D to +3.00 D(in 0.25D steps)	± 0.12 (0 to = 5D)<br ± 0.18 (5 to = 10.0D)<br ± 0.25 (10 to = 15D)<br ± 0.37 (15 to = 20D)<br ± 0.50 (over 20D)

V. INDICATIONS FOR USE

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE VI. DEVICE

The Hyper GP (tisilfocon A) Daily Wear Contact Lens is substantially equivalent to the Rigid Gas Permeable Contact Lenses (tisilfocon A) (cleared under K103561) in terms of the following:

Intended use - daily wear contact lenses
트 Indications for use
Actions
트 USAN - contact lens material composition
I Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
트 FDA material group - group # 3 fluoro silicone acrylate
I Production method - lathe cut

The Hyper GP (tisilfocon A) Daily Wear Contact Lens is substantially equivalent to the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (cleared under K160859) in terms of the following:

I Intended use - daily wear contact lenses
트 Indications for use - daily wear orthokeratology
I Contact lens design - orthokeratology
트 Actions
I Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
트 FDA material group - group # 3 fluoro silicone acrylate
트 Production method - lathe cut

The Hyper GP (tisilfocon A) Daily Wear Contact Lens is substantially equivalent to the Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses (cleared under K161100) in terms of the following:

I Intended use – daily wear contact lenses
트 May be surface coated with Tangible Hydra-PEG
트 Actions
트 Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
트 FDA material group - group # 3 fluoro silicone acrylate
I Production method - lathe cut

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The following matrix illustrates the production method, lens function and material characteristics of the Hyper GP (tisilfocon A) Daily Wear Contact Lens, as well as the predicate devices.

	Hyper GP(tisilfocon A)New Device	Menicon(tisilfocon A)Predicate Device	Optimum GP withHPT(roflufocon C, D, E)Predicate Device	OPTIMUM GP OK(Orthokeratology)(roflufocon D & E)Predicate Device
Intended Use	Indicated for daily wear for thecorrection of visual acuity inaphakic and not aphakicpersons with non-diseasedeyes with myopia or hyperopiaand/or presbyopia. The lensmay also be prescribed formanagement of irregularcorneal conditions such askeratoconus and post graftfitting. Indicated for dailywear in an orthokeratologyfitting program for thetemporary reduction of myopiaof up to 5.00 diopters in non-diseased eyes. To maintain theorthokeratology effect ofmyopia reduction, lens wearmust be continued on aprescribed wearing schedule.	Indicated for daily wear forthe correction ofrefractive error (myopia,hyperopia, presbyopiaand/or astigmatism) inaphakic andnon-aphakic persons withnon-diseased eyes. Thelenses may be prescribedfor daily wear in otherwisenon-diseased eyes thatrequire a rigid contact lensfor the management ofirregular cornealconditions such askeratoconus, pellucidmarginal degeneration, orfollowing penetratingkeratoplasty orrefractive (e.g., LASIK)surgery.	Indicated for daily wear forthe correction of visualacuity in aphakic and notaphakic persons with non-diseased eyes with myopiaor hyperopia and/orpresbyopia. The lens mayalso be prescribed formanagement of irregularcorneal conditions such askeratoconus and post graftfitting.	Indicated for daily wear inan orthokeratology fittingprogram for the temporaryreduction of myopia of upto 5.00 diopters in non-diseased eyes. To maintainthe orthokeratology effectof myopia reduction, lenswear must be continued ona prescribed wearingschedule.
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
Indications	Daily Wear	Daily Wear	Daily Wear	Daily Wear
ProductionMethod	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured
USAN name	tisilfocon A	tisilfocon A	roflufocon C, D, E	roflufocon D, E
Water Content(%)	<1%	<1%	<1%	<1%
Specific Gravity	1.20	1.20	Roflufocon C: 1.178Roflufocon D: 1.166Roflufocon E: 1.155	Roflufocon D: 1.166Roflufocon E: 1.155
OxygenPermeability(cm²/sec) (ml O¸/ml x mm Hg@ 35°C)	180 x10-11	160 x10-11	Roflufocon C: 65x10-11Roflufocon D: 100x10-11Roflufocon E: 125x10-11	Roflufocon D: 100x10-11Roflufocon E: 125x10-11
UV Blocker	Yes, Optional	Yes	Yes. Optional	Yes, Optional
PlasmaTreatment	Yes, Optional	Yes	Yes, Optional	Yes. Optional
Hydra-PEGSurface Coating	Yes, Optional	No	Yes, Optional	No

Substantial Equivalence Matrix

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VII. PERFORMANCE DATA

~ 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 Hyper GP (tisilfocon A) Daily Wear Contact Lens. 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 nonclinical testing on the Hyper GP (tisilfocon A) Daily Wear Contact Lens demonstrate that:

The finished lenses (uncoated and coated with Tangible™ Hydra-PEG) are not toxic and ● not irritating,
The physicochemical, mechanical, and optical properties of the Tangible™ Hydra-PEG ● coated and uncoated lenses are substantially equivalent to the predicate device.
Bioburden levels are below the acceptance criteria (<100 cfu/lens) initially and following 30 days of storage in Unique pH at ambient temperatures,
Physical parameters are stable following 30 days of storage in Menicon Unique pH at ambient temperatures, and
The Tangible "10 HydraPEG coated 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

Information presented in this Premarket Notification establishes that Hyper GP (tisilfocon A) Daily Wear Contact Lenses are as safe and effective as the predicate device 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.