Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)

K202860 · Valley Contax, Inc. · HQD · May 11, 2021 · Ophthalmic

Device Facts

• Record ID: K202860
• Device Name: Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)
• Applicant: Valley Contax, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: May 11, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The Valley Contax SV Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) is indicated for daily wear for the correction of refractive error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. 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. The Valley Contax AFM Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) is indicated for daily wear for the correction of refractive error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. 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. The Valley Contax VK Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) is indicated for daily wear for the correction of refractive error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may also be prescribed in otherwise non-diseased eyes that require a 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. 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

Rigid gas permeable (RGP) contact lenses; lathe-cut from fluorosilicone acrylate materials (roflufocon D/E, tisilfocon A, hexafocon A, enflufocon A). Designed for daily wear; prescribed by eyecare practitioners for refractive error correction or management of irregular corneas. Lenses are shipped dry in a case. Patients perform daily cleaning/disinfection using chemical systems. Provides vision correction; benefits include improved visual acuity for patients with refractive errors or irregular corneal shapes.

Clinical Evidence

No clinical data. Safety and effectiveness supported by reference to previously cleared 510(k) notifications for the same materials and bench testing (bioburden, manufacturing verification).

Technological Characteristics

Rigid gas permeable contact lenses; materials: roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A (Group 3 fluorosilicone acrylate). Lathe-cut production. Water content <1%. UV-blocking available. Dimensions: 6.0-12.5mm diameter, 6.0-10.0mm base curve. Chemical disinfection only.

Indications for Use

Indicated for daily wear in aphakic and non-aphakic persons with non-diseased eyes for correction of myopia, hyperopia, or refractive astigmatism up to 10.00D. AFM and VK models indicated for presbyopia with add power up to +4.00D. VK model also indicated for irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-penetrating keratoplasty, or post-refractive surgery).

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

• Optimum Gp With Hpt (Roflufocon A, B, C, D, & E) Daily Wear Contact Lenses (K161100)
• Hyper Gp (Tisilfocon A) Daily Wear Contact Lens (K182304)
• Hexa100 (Hexafocon A) Daily Wear Contact Lenses (K171077)
• Enflu 18 (Enflufocon A) Daily Wear Contact Lens (K171575)

Reference Devices

• Custom Stable Rigid Gas Permeable Scleral Contact Lens (K170335)
• Amcon CL-5001 (K052809)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

May 11, 2021

Valley Contax, Inc. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068

## Re: K202860

Trade/Device Name: Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens

Regulatory Class: Class II Product Code: HQD Dated: April 1, 2021 Received: April 7, 2021

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.

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

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.

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 (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 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 Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K202860

### Device Name

Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A)

### Indications for Use (Describe)

The Valley Contax SV Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A ) is indicated for daily wear for the corrective error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

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.

| | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|--|
| | | | 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

## Indications for Use

510(k) Number (if known) K202860

### Device Name

Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A)

### Indications for Use (Describe)

The Valley Contax AFM Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A ) is indicated for daily wear for the corrective error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

### Indications for Use

510(k) Number (if known) K202860

### Device Name

Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A)

### Indications for Use (Describe)

The Valley Contax VK Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A ) is indicated for daily wear for the corrective error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may also be prescribed in otherwise non-diseased eyes that require a 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.

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) |
|-------------------------------------------------|
|-------------------------------------------------|

| | <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--|----------------------------------------------------------------------------------------|
| | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 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: K202860

#### I. SUBMITTER

| Date Prepared: | May 6th, 2021 |
|-------------------|---------------------------------------------------------------------------------|
| Name:<br>Address: | Valley Contax, Inc.<br>200 South Mill St.<br>Springfield, Oregon 97477 |
| Contact Person: | Josh Adams<br>Vice President |
| Phone number: | [phone] |
| Consultant: | Bret Andre<br>EyeReg Consulting, Inc.<br>6119 Canter Ln.<br>West Linn, OR 97068 |
| Phone number: | [phone] |

#### II. DEVICE

| Trade Name: | Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon<br>E, tisilfocon A, hexafocon A, enflufocon A);<br>Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact<br>Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A);<br>Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E,<br>tisilfocon A, hexafocon A, enflufocon A) |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |

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

#### III. PREDICATE DEVICE

Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) for daily wear are substantially equivalent to the following predicate devices:

- . "Optimum Gp With Hpt (Roflufocon A, B, C, D, & E) Daily Wear Contact Lenses" (Primary Predicate) By Contamac Ltd. 510(k) number: K161100
- 트 "Hyper Gp (Tisilfocon A) Daily Wear Contact Lens" (Predicate) By Contamac Ltd. 510(k) number; K182304
- I "Hexa100 (Hexafocon A) Daily Wear Contact Lenses" (Predicate) By Contamac Ltd. 510(k) number; K171077
- "Enflu 18 (Enflufocon A) Daily Wear Contact Lens" (Predicate) By Contamac Ltd. 510(k) number; K171575
- . "Custom Stable Rigid Gas Permeable Scleral Contact Lens" (Reference Predicate) By Valley Contax, Inc. 510(k) number: K170335

#### DEVICE DESCRIPTION IV.

## Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)

The Valley Contax SV Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) for daily wear is made-to-order with spherical or aspheric front surfaces, or a prism-ballasted toric front surface. The Valley Contax SV Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, enflufocon A, enflufocon A) is available in the following lens parameters:

| Parameter | Range | Tolerance |
|--------------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Base Curve | 6.00mm to 10.0mm | $\pm$ 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | $\pm$ 0.02 mm |
| Diameter | 6.0mm to 12.5mm | $\pm$ 0.10mm |
| Spherical Power | -30.00D to +30.00D | $\pm$ 0.12 (0 to $\leq$ 5D)<br>$\pm$ 0.18 (5 to $\leq$ 10.0D)<br>$\pm$ 0.25 (10 to $\leq$ 15D)<br>$\pm$ 0.37 (15 to $\leq$ 20D)<br>$\pm$ 0.50 (over 20D) |
| Cylindrical Power | Up to 10.00D | $\pm$ 0.25 (0 to $\leq$ 2D)<br>$\pm$ 0.37 (2 to $\leq$ 4D)<br>$\pm$ 0.50 (over 4D) |
| Surface Appearance | | Lenses should be clear with no surface<br>defect |

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

## Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)

The Valley Contax AFM Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) for daily wear is made-to-order in a range of multifocal strengths and options. The Valley Contax AFM Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) is available in the following lens parameters:

| Parameter | Range | Tolerance |
|--------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Base Curve | 6.00mm to 10.00mm | $\pm$ 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | $\pm$ 0.02 mm |
| Diameter | 6.0mm to 12.5mm | $\pm$ 0.10mm |
| Spherical Power | -30.00D to +30.00D | $\pm$ 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 10.00D | $\pm$ 0.25 (0 to = 2D)<br $\pm$ 0.37 (2 to = 4D)<br $\pm$ 0.50 (over 4D) |
| Multifocal Power | +0.75D to 4.00D | $\pm$ 0.25D |
| Surface Appearance | - | Lenses should be clear with no surface defect |

## Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)

The Valley Contax VK Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) for daily wear is indented for the management of irregular cornea conditions and is made-to-order in spheric, prism-ballasted toric, and multifocal front surface options. The Valley Contax VK Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) is available in the following lens parameters:

| Parameter | Range | Tolerance |
|--------------------|--------------------|------------------------------------------------------------------------------------------------------------------|
| Base Curve | 6.00mm to 10.00 mm | ± 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | ± 0.02 mm |
| Diameter | 6.0mm to 12.5mm | ±0.10mm |
| Spherical Power | -30.00D to +30.00D | ± 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 10.00D | ± 0.25 (0 to = 2D)<br ±0.37 (2 to = 4D)<br ± 0.50 (over 4D) |
| Multifocal Power | +0.75D to 4.00D | ± 0.25D |
| Surface Appearance | - | Lenses should be clear with no surface defect |

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

The Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) are lathe cut from one of the following hydrophobic, fluorosilicone acrylate materials:

- roflufocon D
- roflufocon E
- tisilfocon A
- hexafocon A
- enflufocon A

The physical properties of the Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) are as follows (reported from predicate devices):

| | roflufocon D | roflufocon E | tisilfocon A | hexafocon A | enflufocon<br>A |
|------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Refractive Index | 1.4333 | 1.4332 | 1.4378 | 1.4136 | 1.4436 |
| Light Transmission<br>(tinted) | >90% | >90% | >91% | >91% | >90% |
| Specific Gravity | 1.166 | 1.155 | 1.200 | 1.266 | 1.221 |
| Oxygen Permeability<br>(Dk)<br>ISO/FATT Method | 100 x 10-11 (cm²/sec)<br>(ml O₂/ml x mm Hg @<br>35°C) | 125 x 10-11 (cm²/sec)<br>(ml O₂/ml x mm Hg @<br>35°C) | 180 x 10-11 (cm²/sec)<br>(ml O₂/ml x mm Hg @<br>35°C) | 113 x 10-11 (cm²/sec)<br>(ml O₂/ml x mm Hg @<br>35°C) | 21 x 10-11 (cm²/sec) (ml<br>O₂/ml x mm Hg @<br>35°C) |
| Color Additives | D & C Green No. 6,<br>FD & C Red No.<br>17,<br>CI Solvent Yellow<br>18 | D & C Green No. 6,<br>FD & C Red No.<br>17,<br>CI Solvent Yellow<br>18 | D&C Green No. 6,<br>C.I. Solvent<br>Yellow No. 18,<br>D&C Violet No. 2<br>and D&C Red No.<br>17 | D&C Green No. 6,<br>C.I. Solvent Yellow<br>No. 18, D&C<br>Violet No. 2 and<br>D&C Red No. 17 | D&C Green<br>No. 6, C.I.<br>Solvent<br>Yellow No.<br>18, D&C<br>Violet No. 2<br>and 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 | >98% UVB<br>>86% UVA | >98% UVB<br>>84% UVA | >98% UVB<br>>83% UVA |

The Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) for daily wear are shipped "dry" in a polypropylene contact lens case. The primary container for shipping the Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) is the Amcon CL-5001-with 510(k) clearance under K052809.

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

#### V. INDICATIONS FOR USE

## Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)

The Valley Contax SV Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) is indicated for daily wear for the correction of refractive error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

Evecare 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.

## Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)

The Valley Contax AFM Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) is indicated for daily wear for the correction of refractive error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.

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.

## Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)

The Valley Contax VK Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) is indicated for daily wear for the correction of refractive error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may also be prescribed in otherwise non-diseased eyes that require a 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.

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.

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### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses (roflufocon D, roflufocon E, tisilfocon A. hexafocon A, enflufocon A) are substantially equivalent to the predicate devices (cleared under K161100, K182304, K171077, and K171575) in terms of the following:

- Intended use daily wear contact lenses 트
- Indications for use
- 트 Actions
- 트 Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
- 트 FDA material group - group # 3 fluoro silicone acrylate
- USAN materials (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)
- Production method - lathe cut
- I Final packaging and shipping

The following matrix illustrates the production method, lens function and material characteristics of the Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses, as well as the predicate device.

| | Valley Contax<br>SV, AFM, VK<br>GP Contact<br>Lenses | Optimum GP<br>(roflufocon D &<br>E) RGP Contact<br>Lenses | Hyper Gp<br>(Tisilfocon A)<br>Daily Wear<br>Contact Lens | Hexa100 (Hexafocon<br>A) Daily Wear<br>Contact Lenses | Enflu 18<br>(Enflufocon A)<br>Daily Wear<br>Contact Lens | Custom<br>Stable<br>Scleral<br>Contact Lens |
|--------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device<br>(K161100) | Device<br>(K182304) | (K171077) | Device<br>(K171575) | Device<br>(K170335) |
| Classification | Same as<br>predicate | 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<br>886.5916 | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily Wear<br>21 CFR 886.5916 | Class II<br>Lenses, Rigid<br>Gas Permeable,<br>Daily Wear<br>21 CFR<br>886.5916 | Class II<br>Lenses, Rigid<br>Gas<br>Permeable,<br>Daily Wear<br>21 CFR<br>886.5916 |
| Product Code | Same as<br>predicate | HQD | HQD | HQD | HQD | HQD |
| FDA Group # | Same as<br>predicate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3<br>Fluoro Silicone<br>Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3<br>Fluoro Silicone<br>Acrylate | Group # 3<br>Fluoro<br>Silicone<br>Acrylate |
| Material (USAN) | roflufocon D,<br>roflufocon E,<br>tisilfocon A,<br>hexafocon A,<br>enflufocon A. | roflufocon D,<br>roflufocon E | tisilfocon A | hexafocon A | enflufocon A | roflufocon D,<br>roflufocon E |
| Production Method | Same as<br>predicate | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| Intended Use | Same as<br>predicate | Daily Wear | Daily Wear | Daily Wear | Daily Wear | Daily Wear |
| Water Content (%) | <1% | <1% | <1% | <1% | <1% | <1% |
| UV Absorber<br>Available | Yes | Yes | Yes | Yes | Yes | Yes |

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| | Indications for Use | | | |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, | | | |
| | tisilfocon A, hexafocon A, enflufocon A) | | | |
| Valley<br>Contax SV,<br>AFM, VK<br>GP Contact<br>Lenses<br>(Subject | The Valley Contax SV Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A,<br>hexafocon A, enflufocon A) is indicated for daily wear for the correction of refractive error in aphakic<br>and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive<br>astigmatism not exceeding 10.00 diopters. | | | |
| | Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens<br>may be cleaned and disinfected using a chemical (not heat) lens care system. | | | |
| | Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens<br>(roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) | | | |
| | The Valley Contax AFM Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A,<br>hexafocon A, enflufocon A) is indicated for daily wear for the correction of refractive error in aphakic<br>and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive<br>astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. | | | |
| | Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens<br>may be cleaned and disinfected using a chemical (not heat) lens care system. | | | |
| Device) | Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A,<br>hexafocon A, enflufocon A) | | | |
| | The Valley Contax VK Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A,<br>hexafocon A, enflufocon A) is indicated for daily wear for the correction of refractive error in aphakic<br>and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive<br>astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.<br>The lens may also be prescribed in otherwise non-diseased eyes that require a gas permeable lens for the<br>management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or<br>following penetrating keratoplasty or refractive (e.g. LASIK) surgery. | | | |
| | Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens<br>may be cleaned and disinfected using a chemical (not heat) lens care system. | | | |
| | The Optimum GP with HPT (roflufocon C, D, and E) Spherical Rigid Gas Permeable (RGP) Contact<br>Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons<br>with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical<br>disinfection system only. | | | |
| Optimum<br>GP | The Optimum GP with HPT (roflufocon C, D, and E) Toric Rigid Gas Permeable (RGP) Contact Lens<br>is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with<br>non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 | | | |
| (roflufocon | diopters. The lens may be disinfected with a chemical disinfection system only. | | | |
| D & E) RGP | The Optimum GP with HPT (roflufocon C, D, and E) Multifocal/Bifocal Rigid Gas Permeable (RGP) | | | |
| Contact | Contact Lens is indicated for daily wear for the correction of refractive error in aphakic | | | |
| Lenses | persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not | | | |
| (K161100) | exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be<br>disinfected with a chemical disinfection system only | | | |
| | The Optimum GP with HPT (roflufocon C, D, and E) Irregular Cornea Daily Wear Contact Lens may<br>be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of<br>irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating<br>keratoplasty or refractive (e.g. LASIK) surgery. | | | |

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| | Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens<br>may be cleaned and disinfected using a chemical (not heat) lens care system. |
|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hyper Gp<br>(Tisilfocon<br>A) Daily<br>Wear<br>Contact<br>Lens<br>(K182304) | The Hyper GP (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<br>with myopia or hyperopia. |
| | The Hyper GP (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<br>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<br>indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-<br>diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters<br>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<br>otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular<br>corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating<br>keratoplasty or refractive (e.g. LASIK) 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-<br>diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on<br>a prescribed wearing schedule. |
| | Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens<br>may be cleaned and disinfected using a chemical (not heat) lens care system. |
| Hexa100<br>(Hexafocon<br>A) Daily<br>Wear<br>Contact<br>Lenses<br>(K171077) | The HEXA100 (hexafocon 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<br>with myopia or hyperopia. |
| | The HEXA100 (hexafocon 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<br>myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. |
| | The HEXA100 (hexafocon 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-<br>diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters<br>and are presbyopic requiring add power of up to +4.00 diopters. |
| | The HEXA100 (hexafocon 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<br>corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating<br>keratoplasty or refractive (e.g. LASIK) surgery. |
| | The HEXA100 (hexafocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in<br>an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-<br>diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on<br>a prescribed wearing schedule. |
| | Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens<br>may be cleaned and disinfected using a chemical (not heat) lens care system. |
| Enflu 18<br>(Enflufocon<br>A) Daily<br>Wear<br>Contact<br>Lens<br>(K171575) | The ENFLU 18 (enflufocon 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<br>with myopia or hyperopia.<br>The ENFLU 18 (enflufocon 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<br>myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.<br>The ENFLU 18 (enflufocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens<br>is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with<br>non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4<br>diopters and are presbyopic requiring add power of up to +4.00 diopters.<br>The ENFLU 18 (enflufocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed<br>in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular<br>corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating<br>keratoplasty or refractive (e.g. LASIK) surgery.<br>Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens<br>may be cleaned and disinfected using a chemical (not heat) lens care system. |
| Custom<br>Stable Rigid<br>Gas<br>Permeable<br>Scleral<br>Contact<br>Lens<br>(K170335) | The Custom Stable Rigid Gas Permeable Scleral Contact Lenses for daily wear are indicated for<br>use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular<br>corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular<br>Degeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy, Lattice Corneal<br>Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The<br>lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome,<br>Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal<br>stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal<br>exposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses<br>is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia.<br>Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the<br>lens may be cleaned and disinfected using a chemical (not heat) lens care system.…