The Optimum Infinite (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 Optimum Infinite (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 non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The Optimum Infinite (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 eyes 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 Optimum Infinite (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

The Optimum Infinite (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.

Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:

cannot be adequately corrected with spectacle lenses
requires a rigid gas permeable contact lens surface to improve vision
is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities

Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).

The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the Optimum Infinite (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error.

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 Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are 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 Optimum Infinite (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 (280mm - 315nm) and >85% in the UVA range (316 - 380nm). The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses incorporate 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 Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of up to 5.00 diopters in nondiseased eyes. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be treated to incorporate Tangible TM 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 30mm in thickness. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses, which doesn't typically follow the same acceptance criteria and study structure as an AI/ML device. Therefore, the specific questions regarding acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not directly applicable in the conventional sense for this type of device submission.

However, I can extract information related to the device's performance, clinical studies conducted, and the basis for its safety and effectiveness.

Here's an adaptation of the request based on the provided text, focusing on the information available:

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission for a contact lens, the "acceptance criteria" are generally based on demonstrating substantial equivalence to predicate devices and proving safety and effectiveness through non-clinical and clinical data. Specific quantitative "acceptance criteria" and "device performance" metrics of an AI/ML device (e.g., sensitivity, specificity thresholds) are not present. Instead, the performance is demonstrated by the absence of serious adverse events and positive clinical outcomes.

Metric/Criteria	Reported Device Performance
Material Properties
Refractive Index (dry)	Uncoated: 1.4378; Tangible™ Hydra-PEG Coated: 1.4398
Light Transmission (@380-780nm)	Uncoated: 91.694; Tangible™ Hydra-PEG Coated: 93.427
UVA Transmission (@316-380nm)	Uncoated: 14.241; Tangible™ Hydra-PEG Coated: 16.105
UVB Transmission (@280-315nm)	Uncoated: 0.011; Tangible™ Hydra-PEG Coated: 0.020
Oxygen Permeability (Dk) (ISO/FATT Method)	Uncoated: $180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C); Tangible™ Hydra-PEG Coated: $180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)
Clinical Outcomes (Therapeutic Use)
Incidence of Serious Adverse Reactions	None reported.
Ocular Condition Stability/Improvement	For all patients, the ocular condition(s) and vision remained stable or improved during management with the Optimum Infinite (tisilfocon A) scleral contact lenses.
Successful Therapeutic Fitting	Successful outcomes for all 115 eyes over a total of 15,017 days.
Wettability (with Tangible™ Hydra-PEG coating)	Uncoated Average Sessile Drop Contact Angle: 106.2 degrees (Standard Deviation 5.31); Tangible™ Hydra-PEG Coated Average Sessile Drop Contact Angle: 37.34 degrees (Standard Deviation 5.30). (Significant measurable improvement in wettability)

2. Sample size used for the test set and the data provenance:

Sample Size (Clinical Study): 62 patients (115 total eyes) were evaluated in the clinical study for therapeutic use of scleral lenses.
- 55 eyes for irregular cornea management.
- 62 eyes for ocular surface disease management.
Data Provenance: The text does not explicitly state the country of origin of the data. The study appears to be prospective in nature, as practitioners were "instructed to review all patients treated... and to report the outcome." The study followed patients for "at least 3 months" over a "treatment follow-up period."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Six (6) independent practitioners.
Qualifications of Experts: The specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed beyond "independent practitioners." For contact lens studies, these would typically be ophthalmologists or optometrists experienced in fitting and managing contact lens patients, particularly those with complex conditions like irregular corneas or ocular surface diseases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The text does not mention an explicit adjudication method. The independent practitioners reported outcomes, and the overall clinical assessment ("remained stable or improved") was the basis for the conclusion. There's no indication of multiple readers adjudicating cases in the manner described for AI/ML studies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study involving AI assistance was not conducted. This is a medical device (contact lens) submission, not an AI/ML diagnostic or assistive device.

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

No, a standalone algorithm performance study was not done. This device is a contact lens and does not involve an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is the clinical diagnosis and assessment of therapeutic outcomes by the independent practitioners based on objective and subjective patient data (e.g., vision improvement, stability of ocular conditions, absence of adverse events). It's essentially expert clinical assessment/outcomes data.

8. The sample size for the training set:

This is not applicable as this is not an AI/ML device that requires a training set in that context. The device's safety and effectiveness are established through non-clinical testing and clinical studies on its material properties and patient outcomes, not through learning from data.

9. How the ground truth for the training set was established:

Not applicable for the reason stated above.

Summary

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

March 17, 2022

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

Re: K212631

Trade/Device Name: Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD, MUW Dated: February 4, 2022 Received: February 7, 2022

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/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 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, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K212631

Device Name

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses

Indications for Use (Describe)

The Optimum Infinite (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia.

The Optimum Infinite (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The Optimum Infinite (tisilfocon A) MULTIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes 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.

Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs.

Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for the management of irregular and distorted corneal surfaces where the subject:

1. cannot be adequately corrected with spectacle lenses
1. requires a rigid gas permeable contact lens surface to improve vision
1. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities

Common causes of corneal distortion include but are not linfections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).

The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome and Filamentary Keratis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratiis (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 Optimum Infinite (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error.

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Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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: K212631

I. SUBMITTER

March 9th, 2022 Date Prepared:
Contamac Ltd. Name: Address: Carlton House Shire Hill Saffron Walden Essex CB11 3AU Contact Person: Robert McGregor
Managing Director Phone number: 01799 514800

Consultant:	Bret Andre
	EyeReg Consulting, Inc
	6119 Canter Ln.West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	Optimum Infinite (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
Reason for Submission~	New Indications for Use

Reason for Submission

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III. PREDICATE DEVICE

The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are substantially equivalent to the following predicate devices:

l "Hyper GP (tisilfocon A) Daily Wear Contact Lens" By Contamac Ltd. 510(k) number; K182304
"OPTIMUM GP (roflufocon D, roflufocon E) Daily Wear Contact Lens; HEXA100 (hexafocon A) Daily Wear Contact Lens" By Contamac Ltd. 510(k) number: K180616
. "BostonSight PD Prosthetic Device" Manufactured by Boston Foundation for Sight 510(k) number: K161461
I "Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)" By Art Optical Contact Lens, Inc. 510(k) number; K172314

IV. DEVICE DESCRIPTION

In the Optimum Infinite (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 (280mm - 315nm) and >85% in the UVA range (316 - 380nm).

The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses incorporate 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 Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of up to 5.00 diopters in nondiseased eyes.

The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be treated to incorporate Tangible TM 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 30mm in thickness. The following table depicts the contact angle of the coated vs. uncoated lenses:

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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 Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the Optimum Infinite (tisilfocon A) Daily Wear Contact Lens is the PolyVial Contact Lens Case. When shipped "wet", the Optimum Infinite (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%.

The physical properties of the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are as follows:

	Hyper GP (tisilfocon A)	Hyper GP (tisilfocon A) withTangible™ 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 Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are 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	$\pm$ 0.05 mm
Center Thickness	Varies	$\pm$ 0.02 mm
Chord Diameter	7.00mm to 22.00mm	$\pm$ 0.10mm
Spherical Power	-30.00 D to +30.00 D(in 0.25D steps)	$\pm$ 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 -10.00 D(in 0.25 D steps)	$\pm$ 0.25 (0 to = 2D)<br $\pm$ 0.37 (2 to = 4D)<br $\pm$ 0.50 (over 4D)
Cylindrical Axis	1° to 180° (in 1° steps)	$\pm$ 5°
Multifocal Power	+1.00 D to 4.00 D(in 0.25 D steps)	$\pm$ 0.25D

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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)

The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses for daily wear orthokeratology is available in following lens parameters:

V. INDICATIONS FOR USE

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1. cannot be adequately corrected with spectacle lenses
1. requires a rigid gas permeable contact lens surface to improve vision
1. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities

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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are substantially equivalent to the predicate devices (cleared under K180616, K161461, and K172314) in terms of the following:

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

The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are substantially equivalent to the Hyper GP (tisilfocon A) Daily Wear Contact Lens predicate device (cleared under K182304) in terms of the following:

. Intended use - daily wear contact lenses
Actions
Classification Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) I

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FDA material group group # 3 fluoro silicone acrylate "
י USAN material (tisilfocon A)
י Production method – lathe cut
. Final packaging and shipping

The following matrix illustrates the production method, lens function and material characteristics of the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses, as well as the predicate device.

	Optimum InfiniteDaily WearContact Lenses	Hyper GPDaily WearContact Lenses	OPTIMUMGP &HEXA100Daily WearContactLenses	BostonSightPD ProstheticDevice	Ampleye ScleralRGP Lens
	Subject Device	Predicate Device(K182304)	PredicateDevice(K180616)	PredicateDevice(K161461)	Predicate Device(K172314)
Classification	Class IILenses, Rigid GasPermeable, DailyWear21 CFR 886.5916	Class IILenses, RigidGas Permeable,Daily Wear21 CFR 886.5916	Class IILenses, RigidGasPermeable,Daily Wear21 CFR886.5916	Class IILenses, RigidGas Permeable,Daily Wear21 CFR886.5916	Class IILenses, Rigid GasPermeable, DailyWear21 CFR 886.5916
Product Code	HQD; MUW	HQD; MUW	HQD; MUW	HQD	HQD
FDA Group #	Group # 3 FluoroSilicone Acrylate	Group # 3 FluoroSilicone Acrylate	Group # 3FluoroSiliconeAcrylate	Group # 3Fluoro SiliconeAcrylate	Group # 3 FluoroSilicone Acrylate
Material (USAN)	tisilfocon A	tisilfocon A	roflufocon D,roflufocon E,hexafocon A,	roflufocon D,roflufocon E,oprifocon A,and hexafoconB	roflufocon D,roflufocon E,hexafocon A,paflufocon D
ProductionMethod	Lathe-Cut	Lathe-Cut	Lathe-Cut	Lathe-Cut	Lathe-Cut
Intended Use	Daily Wear	Daily Wear	Daily Wear	Daily Wear	Daily Wear
Water Content(%)	<1%	<1%	<1%	<1%	<1%
UV AbsorberAvailable	Yes	Yes	Yes	Yes	Yes

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	Indications for Use
OptimumInfiniteDaily WearContact Lenses(Subject Device)	The Optimum Infinite (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated fordaily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes withmyopia or hyperopia.
	The Optimum Infinite (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for dailywear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopiaor hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.
	The Optimum Infinite (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens isindicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseasedeyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and arepresbyopic requiring add power of up to +4.00 diopters.
	The Optimum Infinite (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed inotherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular cornealconditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive(e.g. LASIK) surgery.
	The Optimum Infinite (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in anorthokeratology 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 wearingschedule.
	Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection,aqueous hydrated environment and the saline bath provided by scleral lens designs.Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management ofirregular and distorted corneal surfaces 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 surface irregularities
	Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a resultof scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation.Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration,Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklersdystrophy, Cogan's dystrophy).
	The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocularsurface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and FilamentaryKeratitis), 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 anexpanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for adistorted cornea or ocular surface disease, the Optimum Infinite (tisilfocon A) SCLERAL lenses mayconcurrently provide correction of refractive error.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfectionand scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned anddisinfected using a chemical (not heat) lens care system.
Hyper GPDaily WearContact Lenses(K182304)	The Hyper GP (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wearfor the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia orhyperopia.
	The Hyper GP (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for thecorrection of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopiaand/or possesses refractive astigmatism not exceeding 10.00 diopters.
OPTIMUM GP& HEXA100Daily WearContact Lenses	The Hyper GP (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated fordaily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes withmyopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiringadd power of up to +4.00 diopters.
	The Hyper GP (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwisenon-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions suchas; 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 anorthokeratology 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 wearingschedule.
	Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfectionand scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned anddisinfected using a chemical (not heat) lens care system.
	OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses areindicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakicand non aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseasedeyes 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 surgery.
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection,aqueous hydrated environment and the saline bath provided by scleral lens designs.OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses areindicated for therapeutic use for the management of irregular and distorted corneal surfaces 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 surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a resultof scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation.Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration,Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklersdystrophy, Cogan's dystrophy). The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafoconA) Daily Wear Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g.ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stemcell 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 reservoirand protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea orocular surface disease, the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) DailyWear Contact Lenses may concurrently provide correction of refractive error.
The lenses may be disinfected using a chemical disinfection (not heat) system only.
	The Boston Sight PD Prosthetic Device for daily wear is indicated for therapeutic use for the management of adistorted corneal surface that:
BostonSight PDProsthetic Device(K161461)	1. precludes satisfactory spectacle lens correction2. demonstrates significant improved rigid contact lens corrected vision3. is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lenscentration/stability and/or tolerance to physical contact with a lens
	Causes of corneal distortion include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginaldegeneration, Salzmann's nodular degeneration), corneal dystrophy (e.g. lattice dystrophy, Reis-Bucklersdystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial keratotomy), infection, or trauma.
	The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocularsurface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome),limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns, radiation), disorders ofthe skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, FamilialDysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of anexpanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use fordistorted cornea or ocular surface disease, the BostonSight PD Prosthetic Device may incidentally providecorrection of refractive error.
	The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat) care system.
Ampleye ScleralRGP Lens(roflufocon D,roflufocon E,hexafocon A,paflufocon D)(K172314)	The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear isindicated for use for the management of irregular astigmatism, corneal degeneration or dystrophy caused bykeratoconus, keratoglobus, pellucid marginal degeneration (PMD), post corneal trauma/scaring, post keratoplasty,post K-Pro, post RK, post PRK, post LASIK, Salzmann's nodular degeneration, Cogan's dystrophy, granularcorneal dystrophy, lattice corneal dystrophy or Reis-Bucklers dystrophy.
	The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is also indicated fortherapeutic management of ocular surface disease from dry eye including ocular pemphigoid, Stevens-Johnsonsyndrome, symblepharon formation, graft vs host disease, persistent epithelial defect, exposure keratitis,neurotrophic keratopathy( herpes simplex, herpes zoster, familial dysautonomia), Sjögren's syndrome, filamentarykeratitis, limbal stem cell deficiency, atopy, ectodermal dysplasia. When prescribed for therapeutic use forirregular astigmatism or ocular surface diseases, the Ampleye Scleral RGP Lens may also provide correction ofrefractive error including myopia, hyperopia, presbyopia and regular astigmatism.
	Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfectionand scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned anddisinfected using a chemical (not heat) lens care system.

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VII. PERFORMANCE DATA

~ Non-Clinical Studies ~

Non-clinical testing to demonstrate the safety and effectiveness of the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses have been addressed through previously cleared 510(k) premarket notifications.

~ Clinical Studies ~

Six (6) independent practitioners evaluated 62 patients (115 total eyes) presenting with various conditions therapeutically managed using scleral contact lenses manufactured from Optimum Infinite (tisilfocon A) material. The practitioners were instructed to review all patients treated with the Optimum Infinite (tisilfocon A) scleral contact lenses for at least 3 months, and to report the outcome of each patientincluding any ocular adverse reactions or worsening of the patients' conditions-over the treatment period. All patients were fit with successful outcomes over a treatment follow-up period. Fifty-five (55) of the eyes were treated for irregular cornea, whilst 62 eyes involved management of ocular surface disease. There were no serious or significant adverse reactions reported. For all patients, the ocular condition(s) and vision remained stable or improved during management with the Optimum Infinite (tisilfocon A) scleral contact lenses. The successful therapeutic fitting of 115 eyes over a total of 15,017 days without any serious adverse reaction reported supports the conclusion that the Optimum Infinite (tisilfocon A) scleral contact lenses are safe and effective for therapeutic management of ocular surface diseases and irregular corneal conditions.

VIII. CONCLUSIONS

Substantial Equivalence

Information presented in this premarket notification establishes that the Optimum Infinite (tisilfocon A) Daily Wear 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 indications.

Risks and Benefits

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

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.