Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)

K171950 · Visionary Optics, LLC · HQD · Aug 16, 2017 · Ophthalmic

Device Facts

• Record ID: K171950
• Device Name: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)
• Applicant: Visionary Optics, LLC
• Product Code: HQD · Ophthalmic
• Decision Date: Aug 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management of multiple ocular conditions, such as, degenerations that leads to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring from infection or trauma. The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graftversus-Host disease. Sjogren's syndrome, dry eve syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders, 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 distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, hyperopia, astigmatism or presbyopia. Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Story

Large diameter rigid gas permeable (RGP) contact lens; vaults over cornea; rests on scleral conjunctiva. Lathe-cut from fluorosilicone acrylate materials (roflufocon D, roflufocon E, hexafocon A, hexafocon B). Prescribed by eye care practitioners for daily wear; manages irregular corneal shapes and ocular surface diseases; provides expanded tear reservoir and environmental protection. May incidentally correct refractive errors. Shipped dry or wet in Boston Simplus solution. Patient wears lens; cleans/disinfects via chemical system. Benefits include improved vision for irregular corneas and therapeutic protection for diseased ocular surfaces.

Clinical Evidence

No clinical trials performed. Safety and effectiveness supported by reference to previous 510(k) clearances (K033594, K071043, K071266) for the lens materials and a series of clinical case reports demonstrating performance for the proposed indications.

Technological Characteristics

Materials: Roflufocon D, Roflufocon E, Hexafocon A, Hexafocon B (FDA Group #3 Fluoro Silicone Acrylate). Design: Large diameter RGP, lathe-cut. Physical properties: Water content <1%, UV blocking, Dk values 100-141 x 10^-11. Manufacturing: ANSI Z80.20 compliant. Sterilization: Not specified (shipped dry or in chemical solution).

Indications for Use

Indicated for patients with irregular corneal shape (keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's), corneal dystrophies, post-surgical conditions (transplant, LASIK, radial keratotomy), corneal scarring, ocular surface disease (dry eye, Sjogren's, GVHD), limbal stem cell deficiency, epidermal ocular disorders, skin disorders, neurotrophic keratitis, and corneal exposure. May incidentally correct myopia, hyperopia, astigmatism, or presbyopia.

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

• Custom Stable™ Rigid Gas Permeable Scleral Contact Lens (K170335)
• BostonSight PD Prosthetic Device (K161461)

Submission Summary (Full Text)

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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: | K171950 |
|--------------------------------|---------|
|--------------------------------|---------|

Applicant information:

| Date Prepared: | 06/26/2017 |
|---------------------------|----------------------------------------------|
| Name: | Visionary Optics LLC |
| Address | 1325 Progress Drive<br>Front Royal, VA 22630 |
| Contact Person: | Donald R. Sanders |
| Phone number: | Manager and CEO<br>[phone] |
| Consultant/Correspondent: | EyeReg Consulting, Inc.<br>Bret Andre |
| Phone number | [phone] |
| Fax number | [phone] |

Device Information:

| Device Classification: | Class II |
|------------------------|-----------------------------------------|
| Classification Number: | HQD |
| Classification Name: | Lenses, Rigid Gas Permeable, Daily Wear |

Trade Name:

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)

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# Predicate Devices:

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) is substantially equivalent to the following predicate device(s)

- "Custom Stable™ Rigid Gas Permeable Scleral Contact Lens" ● Manufactured by Valley Contax, Inc. 510(k) number; K170335
- "BostonSight PD Prosthetic Device" Manufactured by Boston Foundation for Sight 510(k) number; K161461

# Device Description:

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Visionary Optics Scleral Contact Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluorosilicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, or hexafocon B.

| | ROFLUFOCON D | ROFLUFOCON E | HEXAFOCON A | HEXAFOCON B |
|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Refractive Index | 1.4333 | 1.4332 | 1.415 | 1.4240 |
| Light Transmission (clear) | >97% | >97% | - | >95% |
| Light Transmission (tinted) | >90% | >90% | >92% | >83% |
| Water Content | <1% | <1% | <1% | <1% |
| Dynamic Contact Angle<br>(Receding) | 3° | 6° | 58° | 40° |
| Specific Gravity | 1.166 | 1.155 | 1.27 | 1.19 |
| Modulus | 697 MPa | 77 MPa | 1500 MPa | 1160 MPa |
| Shore D Hardness | 75 | 77 | 81 | 78 |
| Oxygen Permeability<br>(Dk)<br>ISO/FATT Method | $100 \times 10^{-11} \frac{cm^2}{sec} \frac{ml O_2}{ml \times mm Hg @ 35°C}$ | $125 \times 10^{-11} \frac{cm^2}{sec} \frac{ml O_2}{ml \times mm Hg @ 35°C}$ | $140 \times 10^{-11} \frac{cm^2}{sec} \frac{ml O_2}{ml \times mm Hg @ 35°C}$ | $141 \times 10^{-11} \frac{cm^2}{sec} \frac{ml O_2}{ml \times mm Hg @ 35°C}$ |
| Contain one or more of the<br>following color additives<br>conforming to:<br>21 CFR Part 73 & 74,<br>Subpart D | D & C Green No. 6,<br>FD & C Red No. 17,<br>CI Solvent Yellow 18 | D & C Green No. 6,<br>FD & C Red No. 17,<br>CI Solvent Yellow 18 | D&C Green No. 6; D&C Yellow<br>No. 18; D&C<br>Violet No. 2; | D&C Green No. 6; C.I. Solvent<br>Yellow No. 18;<br>D&C Violet No.<br>2; D&C Red<br>No. 17; |
| UV Light Blocking<br>(UVB - 280nm – 315nm;<br>UVA 316nm – 380nm) | >98% UVB<br>>95% UVA | >98% UVB<br>>95% UVA | >95% UVB<br>>97% UVA | >95% UVB<br>>97% UVA |

The physical properties of the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) are as follows:

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| Parameter | Range | Tolerance |
|-------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Base Curve | 5.5mm to 25.00mm | ± 0.2mm |
| Center Thickness | 0.10mm to 3.00mm | ± 0.1mm |
| Diameter | 12.00mm to 26.00mm | ± 0.20mm |
| Spherical Power | -35.00 D to +35.00 D<br>(in .12D 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 | +10.00 D to -10.00 D<br>(in .12 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° |
| Bifocal Add | +.12 D to +6.00 D<br>(in .12 D steps) | ± 0.25D |

The available parameters for the Visionary Optics Scleral Contact Lens are as follows:

The Visionary Optics Scleral Contact Lens may be shipped "dry" or "wet". The primary container for shipping the Visionary Optics Scleral Contact Lens is the PolyVial Contact Lens Case. When shipped "wet", the Visionary Optics Scleral Contact Lenses are packaged and shipped in Boston Simplus Multiaction Solution.

#### Indication for Use:

The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management of multiple ocular conditions, such as, degenerations that leads to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring from infection or trauma.

The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graftversus-Host disease. Sjogren's syndrome, dry eve syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders, 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 distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, hyperopia, astigmatism or presbyopia.

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

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#### Description of Testing:

#### ~ Non-Clinical Studies ~

Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, and hexafocon B has been addressed by reference to 510(k) K033594, K071043 and K071266.

Additionally, the following testing was performed on finished Visionary Optics Scleral Contact Lenses:

Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Visionary Optics LLC to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.

Bioburden Testing-bioburden testing conducted on rigid gas permeable lenses manufactured at Visionary Optics LLC demonstrated that the colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens.

- ~ Clinical Studies ~
Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, and hexafocon B has been addressed by reference to 510(k) K033594, K071043 and K071266.

Additionally, a series of clinical case reports demonstrate the performance of the Visionary Optics Scleral Contact Lens when prescribed for the proposed indications for use.

~ Conclusions Drawn from Testing ~

Testing presented in this submission for the Visionary Optics Scleral Contact Lens demonstrate no significant differences from the predicate devices-supporting the substantial equivalence claim.

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### Substantial Equivalence:

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) is substantially equivalent to the predicate device(s), and does not raise different questions of safety and effectiveness.

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) is substantially equivalent to the Custom Stable Rigid Gas Permeable Scleral Contact Lens (predicate device) in the following key areas:

- Components/Materials/Formulation (roflufocon D & E contact lens materials) ●
- FDA classification and group number (Class 2, Group #3 Fluoro Silicone Acrylate)
- Lathe cut manufacturing process
- Scleral (large diameter) design ●
- Actions and intended use ●
- Therapeutic indications for use .

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A,

hexafocon B) is substantially equivalent to the BostonSight PD Prosthetic Device (predicate device) in the following key areas:

- Components/Materials/Formulation (hexafocon B, roflufocon D & roflufocon E ● contact lens materials)
- FDA classification and group number (Class 2, Group #3 Fluoro Silicone Acrylate) ●
- Lathe cut manufacturing process
- Scleral (large diameter) design ●
- Actions and intended use ●
- Therapeutic indications for use ●

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The following table depicts the characteristics of the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B), as well as the predicate device(s).

| | Visionary Optics Scleral<br>Contact Lens | Custom Stable™ Rigid Gas<br>Permeable Scleral Contact Lens | BostonSight PD Prosthetic<br>Device<br>K161461 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device | Predicate Device |
| Indication for Use | Indicated for use for the<br>management of multiple ocular<br>conditions, such as, degenerations<br>that lead to an irregular corneal<br>shape, dystrophies, post-surgery,<br>and corneal scarring from infection<br>or trauma. Indicated for therapeutic<br>management of ocular surface<br>disease including dry eye, limbal<br>stem cell deficiency, epidermal<br>ocular disorders, disorders of the<br>skin, neurotrophic keratitis, and<br>corneal exposure that might benefit<br>from the presence of an expanded<br>tear reservoir and protection against<br>an adverse environment.<br>When prescribed for therapeutic use<br>for distorted cornea or ocular<br>surface disease, the Visionary<br>Optics Scleral Contact Lens may<br>incidentally provide correction of<br>refractive error in persons with<br>myopia, hyperopia, astigmatism or<br>presbyopia. | Indicated for use for the management<br>of multiple ocular conditions, such as,<br>degenerations that lead to an irregular<br>corneal shape, dystrophies, post-<br>surgery (e.g. corneal transplant,<br>LASIK, radial keratotomy), and<br>corneal scarring. The lens may also be<br>prescribed for the management of<br>ocular surface diseases (e.g. dry eye<br>syndrome, Keratoconjunctivitis Sicca<br>(Graft vs Host Disease, Sjogren's<br>syndrome, Filamentary Keratitis),<br>limbal stem cell deficiency, epidermal<br>ocular disorders, neurotrophic<br>keratitis, and corneal<br>exposure/lagophthalmos).<br>When prescribed for therapeutic use.<br>the Custom Stable RGP Scleral Lenses<br>is also indicated for correction of<br>refractive error in persons with<br>myopia, hyperopia or presbyopia. | Indicated for therapeutic use in<br>eyes with ocular surface disease<br>from dry eye (e.g. ocular Graft-<br>versus-Host disease, Sjögren's<br>syndrome, dry eye syndrome),<br>limbal stem cell deficiency<br>(e.g.Stevens-Johnson<br>syndrome, chemical and<br>thermal burns, radiation),<br>disorders of the skin (e.g.<br>atopy, ectodermal dysplasia),<br>neurotrophic keratitis (e.g.<br>Herpes simplex, Herpes zoster,<br>Familial Dysautonomia), and<br>corneal exposure (e.g.<br>anatomic, paralytic) that might<br>benefit from the presence of an<br>expanded tear reservoir and<br>protection against an adverse<br>environment. When prescribed<br>for therapeutic use for distorted<br>cornea or ocular surface<br>disease, the BostonSight PD<br>Prosthetic Device may<br>incidentally provide correction<br>of refractive error. |
| Device and<br>Classification | Class II<br>Lenses, Rigid Gas Permeable,<br>Daily Wear<br>HQD | Class II<br>Lenses, Rigid Gas Permeable,<br>Daily Wear<br>HQD | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily Wear<br>HQD |
| Production Method | Lathe-cut | Lathe-cut | Lathe-cut |
| USAN | Roflufocon D<br>Roflufocon E<br>Hexafocon A<br>Hexafocon B | Roflufocon D<br>Roflufocon E | Roflufocon D<br>Roflufocon E<br>Oprifocon A<br>Hexafocon B |
| FDA Group # | Group # 3 Fluoro Silicone<br>Acrylate | Group # 3 Fluoro Silicone<br>Acrylate | Group # 3 Fluoro Silicone<br>Acrylate |
| Water Content | <1% | <1% | <1% |
| UV Absorber/Blocker<br>available | YES | YES | YES |

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 16, 2017

Visionary Optics LLC % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn. OR 97068

Re: K171950

Trade/Device Name: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: June 26, 2017

Received: June 29, 2017

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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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