Hyper GP (tisilfocon A) Daily Wear Contact Lens

K182304 · Contamac, Ltd. · HQD · Nov 23, 2018 · Ophthalmic

Device Facts

• Record ID: K182304
• Device Name: Hyper GP (tisilfocon A) Daily Wear Contact Lens
• Applicant: Contamac, Ltd.
• Product Code: HQD · Ophthalmic
• Decision Date: Nov 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

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 Story

Hyper GP is a lathe-cut, rigid gas permeable (RGP) contact lens made of siloxanyl fluoromethacrylate copolymer (tisilfocon A). Lenses are tinted for visibility and optionally include a benzophenone UV-blocking monomer or Tangible Hydra-PEG surface coating (a 30nm hydrophilic PEG-based polymer). Lenses are prescribed by eyecare practitioners for daily wear to correct refractive errors or manage irregular corneas; orthokeratology configurations provide temporary myopia reduction. Lenses are shipped dry or wet in polypropylene cases. Practitioners use the lenses to focus light on the retina; patients benefit from improved visual acuity or corneal management. The device is a passive optical refractive medium; no electronic or software components are involved.

Clinical Evidence

No new clinical data provided. Safety and effectiveness of tisilfocon A material previously established. Non-clinical bench testing included biocompatibility, toxicology, and physicochemical characterization (sessile drop contact angle, light transmission, oxygen permeability). Results demonstrate the device is non-toxic, non-irritating, and physically stable.

Technological Characteristics

Material: siloxanyl fluoromethacrylate copolymer (tisilfocon A). Production: lathe-cut. Oxygen Permeability (Dk): 180 x 10^-11 (cm²/sec)(ml O2/ml x mmHg @ 35°C). Optional features: Benzophenone UV blocker, plasma treatment, Tangible Hydra-PEG surface coating (hydrophilic PEG-based polymer, ~30nm thickness). Visibility tints: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2, D&C Red No. 17. Refractive index: 1.4378 (uncoated).

Indications for Use

Indicated for daily wear for correction of myopia, hyperopia, presbyopia, and/or astigmatism (up to 10D) in aphakic/non-aphakic patients with non-diseased eyes. Also indicated for management of irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-graft, post-refractive surgery) and orthokeratology 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

• Rigid Gas Permeable Contact Lenses (tisilfocon A) (K103561)
• OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (K160859)
• Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses (K161100)

Submission Summary (Full Text)

{0}------------------------------------------------

# Please wait...

If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.

You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.

For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.

Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.

{1}------------------------------------------------

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.

{2}------------------------------------------------

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

{3}------------------------------------------------

## 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 House<br>Shire Hill<br>Saffron Walden<br>Essex CB11 3AU |
| Contact Person: | Robert McGregor<br>Managing Director |
| Phone number: | 01799 514800 |
| Consultant: | Bret Andre<br>EyeReg Consulting, Inc.<br>6119 Canter Ln.<br>West Linn, OR 97068 |
| Phone number: | [phone] |

#### II. DEVICE

| Trade Name: | Hyper GP (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 |

{4}------------------------------------------------

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

{5}------------------------------------------------

| | 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 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%.

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

| | Hyper GP (tisilfocon A) | Hyper GP (tisilfocon A) with<br>TangibleTM 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 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<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) |
| Cylindrical Power | Up to -10.00 D<br>(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<br>(in 0.25 D steps) | ± 0.25D |

{6}------------------------------------------------

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<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) |

#### V. INDICATIONS FOR USE

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.

{7}------------------------------------------------

### 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

{8}------------------------------------------------

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<br>(tisilfocon A)<br>New Device | Menicon<br>(tisilfocon A)<br>Predicate Device | Optimum GP with<br>HPT<br>(roflufocon C, D, E)<br>Predicate Device | OPTIMUM GP OK<br>(Orthokeratology)<br>(roflufocon D & E)<br>Predicate Device |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily wear for the<br>correction of visual acuity in<br>aphakic and not aphakic<br>persons with non-diseased<br>eyes with myopia or hyperopia<br>and/or presbyopia. The lens<br>may also be prescribed for<br>management of irregular<br>corneal conditions such as<br>keratoconus and post graft<br>fitting. Indicated for daily<br>wear in an orthokeratology<br>fitting program for the<br>temporary reduction of myopia<br>of up to 5.00 diopters in non-<br>diseased eyes. To maintain the<br>orthokeratology effect of<br>myopia reduction, lens wear<br>must be continued on a<br>prescribed wearing schedule. | Indicated for daily wear for<br>the correction of<br>refractive error (myopia,<br>hyperopia, presbyopia<br>and/or astigmatism) in<br>aphakic and<br>non-aphakic persons with<br>non-diseased eyes. The<br>lenses may be prescribed<br>for daily wear in otherwise<br>non-diseased eyes that<br>require a rigid contact lens<br>for the management of<br>irregular corneal<br>conditions such as<br>keratoconus, pellucid<br>marginal degeneration, or<br>following penetrating<br>keratoplasty or<br>refractive (e.g., LASIK)<br>surgery. | Indicated for daily wear for<br>the correction of visual<br>acuity in aphakic and not<br>aphakic persons with non-<br>diseased eyes with myopia<br>or hyperopia and/or<br>presbyopia. The lens may<br>also be prescribed for<br>management of irregular<br>corneal conditions such as<br>keratoconus and post graft<br>fitting. | Indicated for daily wear in<br>an orthokeratology fitting<br>program for the temporary<br>reduction of myopia of up<br>to 5.00 diopters in non-<br>diseased eyes. To maintain<br>the orthokeratology effect<br>of myopia reduction, lens<br>wear must be continued on<br>a prescribed wearing<br>schedule. |
| Functionality | The contact lenses act as a<br>refractive medium that focus<br>light rays from near and distant<br>objects on the retina | The contact lenses act as a<br>refractive medium that<br>focus light rays from near<br>and distant objects on the<br>retina | The contact lenses act as a<br>refractive medium that<br>focus light rays from near<br>and distant objects on the<br>retina | The contact lenses act as a<br>refractive medium that<br>focus light rays from near<br>and distant objects on the<br>retina |
| Indications | Daily Wear | Daily Wear | Daily Wear | Daily Wear |
| Production<br>Method | Lathe-Cut, custom<br>manufactured | Lathe-Cut, custom<br>manufactured | Lathe-Cut, custom<br>manufactured | Lathe-Cut, custom<br>manufactured |
| USAN name | tisilfocon A | tisilfocon A | roflufocon C, D, E | roflufocon D, E |
| Water Content<br>(%) | <1% | <1% | <1% | <1% |
| Specific Gravity | 1.20 | 1.20 | Roflufocon C: 1.178<br>Roflufocon D: 1.166<br>Roflufocon E: 1.155 | Roflufocon D: 1.166<br>Roflufocon E: 1.155 |
| Oxygen<br>Permeability<br>(cm²/sec) (ml O¸/ml x mm Hg<br>@ 35°C) | 180 x10-11 | 160 x10-11 | Roflufocon C: 65x10-11<br>Roflufocon D: 100x10-11<br>Roflufocon E: 125x10-11 | Roflufocon D: 100x10-11<br>Roflufocon E: 125x10-11 |
| UV Blocker | Yes, Optional | Yes | Yes. Optional | Yes, Optional |
| Plasma<br>Treatment | Yes, Optional | Yes | Yes, Optional | Yes. Optional |
| Hydra-PEG<br>Surface Coating | Yes, Optional | No | Yes, Optional | No |

### Substantial Equivalence Matrix

{9}------------------------------------------------

#### 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.