Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses

K212631 · Contamac, Ltd. · HQD · Mar 17, 2022 · Ophthalmic

Device Facts

• Record ID: K212631
• Device Name: Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
• Applicant: Contamac, Ltd.
• Product Code: HQD · Ophthalmic
• Decision Date: Mar 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 non-diseased 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: 1. cannot be adequately corrected with spectacle lenses 2. requires a rigid gas permeable contact lens surface to improve vision 3. 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 Story

Optimum Infinite (tisilfocon A) contact lenses; lathe-cut rigid gas permeable (RGP) material; siloxanyl fluoromethacrylate copolymer; tinted for visibility; optional UV absorber. Configurations: spherical, toric, multifocal, irregular cornea, orthokeratology, and scleral designs. Used by eyecare practitioners to correct refractive errors or provide therapeutic management for irregular/distorted corneas and ocular surface diseases. Scleral designs provide physical protection, aqueous hydrated environment, and saline bath via expanded tear reservoir. Patients benefit from improved vision where spectacles fail or corneal distortion prevents standard RGP wear. Lenses may be plasma treated or coated with Tangible Hydra-PEG (polyethylene glycol-based polymer) to enhance wettability. Shipped dry or wet in polypropylene cases. Practitioners prescribe cleaning/disinfection via chemical (non-heat) systems.

Clinical Evidence

Retrospective clinical evaluation of 62 patients (115 eyes) managed with Optimum Infinite (tisilfocon A) scleral lenses. 55 eyes treated for irregular cornea, 62 for ocular surface disease. Follow-up period minimum 3 months. Primary endpoints: ocular adverse reactions and condition stability. Results: 100% successful outcomes; no serious or significant adverse reactions reported over 15,017 total days of wear. Ocular condition and vision remained stable or improved.

Technological Characteristics

Material: siloxanyl fluoromethacrylate copolymer (tisilfocon A); FDA Group #3 fluoro silicone acrylate. Production: machine lathe-cut. Surface: optional plasma treatment or covalently bonded Tangible Hydra-PEG (PEG-based polymer, ~30nm thickness). UV Blocker: Benzophenone monomer (>99% UVB, >85% UVA). Oxygen Permeability (Dk): 180 x 10^-11 (cm²/sec)(ml O₂/ml x mm Hg @ 35°C). Water content: <1%. Dimensions: BC 4.0-12.0mm, Diameter 6.5-22.0mm. Sterilization: chemical disinfection (non-heat).

Indications for Use

Indicated for daily wear in aphakic/non-aphakic persons with non-diseased eyes for correction of myopia, hyperopia, astigmatism, and presbyopia. Also indicated for management of irregular corneal conditions (e.g., keratoconus, post-surgical, post-transplant) and therapeutic management of ocular surface diseases (e.g., dry eye, limbal stem cell deficiency, neurotrophic keratitis, corneal exposure) requiring expanded tear reservoir/protection. Orthokeratology indicated for temporary reduction of myopia up to 5.00D.

Regulatory Classification

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.

Predicate Devices

• Hyper GP (tisilfocon A) Daily Wear Contact Lens (K182304)
• OPTIMUM GP (roflufocon D, roflufocon E) Daily Wear Contact Lens; HEXA100 (hexafocon A) Daily Wear Contact Lens (K180616)
• BostonSight PD Prosthetic Device (K161461)
• Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) (K172314)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.

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 the management of irregular and distorted corneal surfaces where the subject:

- 1. cannot be adequately corrected with spectacle lenses
- 2. requires a rigid gas permeable contact lens surface to improve vision
- 3. 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.<br>West Linn, OR 97068 |
| Phone number: | [phone] |

#### II. DEVICE

| Trade Name: | Optimum Infinite (tisilfocon A) Daily Wear Contact Lens |
|-------------------------|---------------------------------------------------------|
| Common<br>Name: | Daily wear rigid gas permeable contact lens |
| Classification<br>Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| Regulatory<br>Class: | 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

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 following table depicts the contact angle of the coated vs. uncoated lenses:

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| | Hyper GP tisilfocon A | |
|------------------------------------------------------|-----------------------|-------------------------------|
| | Uncoated | Tangible™ Hydra-PEG<br>Coated |
| Average Sessile Drop Contact Angle<br>(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) with<br>Tangible™ 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<br>(Dk)<br>ISO/FATT Method | $180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @<br>35°C) | $180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @<br>35°C) |
| Visitint lenses contain one or more of the<br>following color additives conforming to:<br>21 CFR Part 73 & 74, Subpart D | D&C Green No. 6, C.I. Solvent<br>Yellow No. 18, D&C Violet No. 2 and<br>D&C Red No. 17 | D&C Green No. 6, C.I. Solvent<br>Yellow No. 18, D&C Violet No. 2<br>and 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<br>(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<br>(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<br>(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<br>(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

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:

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- 1. cannot be adequately corrected with spectacle lenses
- 2. requires a rigid gas permeable contact lens surface to improve vision
- 3. 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 dvstrophy, 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.

### 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 Infinite<br>Daily Wear<br>Contact Lenses | Hyper GP<br>Daily Wear<br>Contact Lenses | OPTIMUM<br>GP &<br>HEXA100<br>Daily Wear<br>Contact<br>Lenses | BostonSight<br>PD Prosthetic<br>Device | Ampleye Scleral<br>RGP Lens |
|--------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| | Subject Device | Predicate Device<br>(K182304) | Predicate<br>Device<br>(K180616) | Predicate<br>Device<br>(K161461) | Predicate Device<br>(K172314) |
| Classification | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily<br>Wear<br>21 CFR 886.5916 | Class II<br>Lenses, Rigid<br>Gas Permeable,<br>Daily Wear<br>21 CFR 886.5916 | Class II<br>Lenses, Rigid<br>Gas<br>Permeable,<br>Daily Wear<br>21 CFR<br>886.5916 | Class II<br>Lenses, Rigid<br>Gas Permeable,<br>Daily Wear<br>21 CFR<br>886.5916 | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily<br>Wear<br>21 CFR 886.5916 |
| Product Code | HQD; MUW | HQD; MUW | HQD; MUW | HQD | HQD |
| FDA Group # | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3<br>Fluoro<br>Silicone<br>Acrylate | Group # 3<br>Fluoro Silicone<br>Acrylate | Group # 3 Fluoro<br>Silicone Acrylate |
| Material (USAN) | tisilfocon A | tisilfocon A | roflufocon D,<br>roflufocon E,<br>hexafocon A, | roflufocon D,<br>roflufocon E,<br>oprifocon A,<br>and hexafocon<br>B | roflufocon D,<br>roflufocon E,<br>hexafocon A,<br>paflufocon D |
| Production<br>Method | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| Intended Use | Daily Wear | Daily Wear | Daily Wear | Daily Wear | Daily Wear |
| Water Content<br>(%) | <1% | <1% | <1% | <1% | <1% |
| UV Absorber<br>Available | Yes | Yes | Yes | Yes | Yes |

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| | Indications for Use |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Optimum<br>Infinite<br>Daily Wear<br>Contact Lenses<br>(Subject Device) | The Optimum Infinite (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for<br>daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with<br>myopia or hyperopia. |
| | The Optimum Infinite (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily<br>wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia<br>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<br>indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased<br>eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are<br>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<br>otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal<br>conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive<br>(e.g. LASIK) surgery. |
| | The Optimum Infinite (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an<br>orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes.<br>To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing<br>schedule. |
| | Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection,<br>aqueous hydrated environment and the saline bath provided by scleral lens designs.<br>Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of<br>irregular and distorted corneal surfaces where the subject: |
| | 1. cannot be adequately corrected with spectacle lenses<br>2. requires a rigid gas permeable contact lens surface to improve vision<br>3. 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<br>of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation.<br>Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration,<br>Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-<br>Bucklers<br>dystrophy, Cogan's dystrophy). |
| | The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular<br>surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary<br>Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns),<br>disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster,<br>Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an<br>expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a<br>distorted cornea or ocular surface disease, the Optimum Infinite (tisilfocon A) SCLERAL lenses may<br>concurrently provide correction of refractive error. |
| Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection<br>and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and<br>disinfected using a chemical (not heat) lens care system. | |
| Hyper GP<br>Daily Wear<br>Contact Lenses<br>(K182304) | The Hyper GP (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear<br>for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or<br>hyperopia. |
| | The Hyper GP (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the<br>correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia<br>and/or possesses refractive astigmatism not exceeding 10.00 diopters. |
| OPTIMUM GP<br>& HEXA100<br>Daily Wear<br>Contact Lenses | The Hyper GP (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for<br>daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with<br>myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring<br>add power of up to +4.00 diopters. |
| | The Hyper GP (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise<br>non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such<br>as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK)<br>surgery. |
| | The Hyper GP (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an<br>orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes.<br>To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing<br>schedule. |
| | Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection<br>and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and<br>disinfected using a chemical (not heat) lens care system. |
| | OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are<br>indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic<br>and non aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased<br>eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus,<br>pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery. |
| Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection,<br>aqueous hydrated environment and the saline bath provided by scleral lens designs.<br>OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are<br>indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject: | |
| 1. cannot be adequately corrected with spectacle lenses<br>2. requires a rigid gas permeable contact lens surface to improve vision<br>3. 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<br>of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) o…