(225 days)
No
The summary describes gas permeable contact lenses and their intended use, materials, and manufacturing process. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes.
One of the indicated uses for the Valley Contax VK Gas Permeable Contact Lens is for the "management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery", which describes a therapeutic purpose.
No
The device is a contact lens intended for corrective error in vision, not for diagnosing conditions.
No
The device description clearly states that the device is a physical contact lens made from specific materials and manufactured through a lathe cutting process. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses are medical devices intended for correcting refractive errors in the eye (myopia, hyperopia, astigmatism, presbyopia) and managing irregular corneal conditions. They are worn on the surface of the eye.
- Lack of Diagnostic Purpose: The intended use and device description clearly state that these lenses are for corrective and management purposes, not for diagnosing any disease or condition by analyzing samples from the body.
Therefore, these contact lenses fall under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
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: Base Curve (6.00mm to 10.0mm, Tolerance ± 0.05 mm), Center Thickness (0.08mm to 0.75mm, Tolerance ± 0.02 mm), Diameter (6.0mm to 12.5mm, Tolerance ± 0.10mm), Spherical Power (-30.00D to +30.00D, Tolerance ± 0.12 (0 to ≤ 5D), ± 0.18 (5 to ≤ 10.0D), ± 0.25 (10 to ≤ 15D), ± 0.37 (15 to ≤ 20D), ± 0.50 (over 20D)), Cylindrical Power (Up to 10.00D, Tolerance ± 0.25 (0 to ≤ 2D), ± 0.37 (2 to ≤ 4D), ± 0.50 (over 4D)), Surface Appearance (Lenses should be clear with no surface defect).
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: Base Curve (6.00mm to 10.00mm, Tolerance ± 0.05 mm), Center Thickness (0.08mm to 0.75mm, Tolerance ± 0.02 mm), Diameter (6.0mm to 12.5mm, Tolerance ± 0.10mm), Spherical Power (-30.00D to +30.00D, Tolerance ± 0.12 (0 to = 5D), ± 0.18 (5 to = 10.0D), ± 0.25 (10 to = 15D), ± 0.37 (15 to = 20D), ± 0.50 (over 20D)), Cylindrical Power (Up to 10.00D, Tolerance ± 0.25 (0 to = 2D), ± 0.37 (2 to = 4D), ± 0.50 (over 4D)), Multifocal Power (+0.75D to 4.00D, Tolerance ± 0.25D), Surface Appearance (Lenses should be clear with no surface defect).
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: Base Curve (6.00mm to 10.00 mm, Tolerance ± 0.05 mm), Center Thickness (0.08mm to 0.75mm, Tolerance ± 0.02 mm), Diameter (6.0mm to 12.5mm, Tolerance ±0.10mm), Spherical Power (-30.00D to +30.00D, Tolerance ± 0.12 (0 to = 5D), ± 0.18 (5 to = 10.0D), ± 0.25 (10 to = 15D), ± 0.37 (15 to = 20D), ± 0.50 (over 20D)), Cylindrical Power (Up to 10.00D, Tolerance ± 0.25 (0 to = 2D), ±0.37 (2 to = 4D), ± 0.50 (over 4D)), Multifocal Power (+0.75D to 4.00D, Tolerance ± 0.25D), Surface Appearance (Lenses should be clear with no surface defect).
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 are reported from predicate devices:
roflufocon D: Refractive Index 1.4333, Light Transmission (tinted) >90%, Specific Gravity 1.166, Oxygen Permeability (Dk) ISO/FATT Method 100 x 10-11 (cm²/sec)(ml O₂/ml x mm Hg @ 35°C), Color Additives D & C Green No. 6, FD & C Red No. 17, CI Solvent Yellow 18, UV Light Blocking (UVB - 280nm - 315nm; UVA 316nm - 380nm) >98% UVB >95% UVA.
roflufocon E: Refractive Index 1.4332, Light Transmission (tinted) >90%, Specific Gravity 1.155, Oxygen Permeability (Dk) ISO/FATT Method 125 x 10-11 (cm²/sec)(ml O₂/ml x mm Hg @ 35°C), Color Additives D & C Green No. 6, FD & C Red No. 17, CI Solvent Yellow 18, UV Light Blocking (UVB - 280nm - 315nm; UVA 316nm - 380nm) >98% UVB >95% UVA.
tisilfocon A: Refractive Index 1.4378, Light Transmission (tinted) >91%, Specific Gravity 1.200, Oxygen Permeability (Dk) ISO/FATT Method 180 x 10-11 (cm²/sec)(ml O₂/ml x mm Hg @ 35°C), Color Additives D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17, UV Light Blocking (UVB - 280nm - 315nm; UVA 316nm - 380nm) >98% UVB >86% UVA.
hexafocon A: Refractive Index 1.4136, Light Transmission (tinted) >91%, Specific Gravity 1.266, Oxygen Permeability (Dk) ISO/FATT Method 113 x 10-11 (cm²/sec)(ml O₂/ml x mm Hg @ 35°C), Color Additives D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17, UV Light Blocking (UVB - 280nm - 315nm; UVA 316nm - 380nm) >98% UVB >84% UVA.
enflufocon A: Refractive Index 1.4436, Light Transmission (tinted) >90%, Specific Gravity 1.221, Oxygen Permeability (Dk) ISO/FATT Method 21 x 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), Color Additives D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C red No. 17, UV Light Blocking (UVB - 280nm - 315nm; UVA 316nm - 380nm) >98% UVB >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 them is the Amcon CL-5001-with 510(k) clearance under K052809.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare practitioners may prescribe the lenses.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies: Non-clinical testing to validate safety and effectiveness for finished contact lenses manufactured from roflufocon D, roflufocon E, tisilfocon A, hexafocon A, and enflufocon A blanks has been addressed by reference to previously cleared 510(k) premarket notifications. Additional non-clinical testing was conducted to support the claim that 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 currently marketed predicate devices.
Bioburden: Bioburden testing conducted on gas permeable lenses manufactured at Valley Contax, Inc. demonstrated that the colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens.
Lens Design/Manufacturing Verification: Bench testing was performed to verify the ability of Valley Contax, Inc. to manufacture the Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) to a variety of prescribed parameters within manufacturing tolerances.
Clinical Studies: Clinical performance data to validate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, tisilfocon A, hexafocon A, and enflufocon A has been addressed by reference to previously cleared 510(k) premarket notifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K161100, K182304, K171077, K171575
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
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 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."
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) |
|---|
| ------------------------------------------------- |
| 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."
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: | |
| Address: | Valley Contax, Inc. |
| 200 South Mill St. | |
| Springfield, Oregon 97477 | |
| Contact Person: | Josh Adams |
| Vice President | |
| Phone number: | (541) 744-9393 |
| Consultant: | Bret Andre |
| EyeReg Consulting, Inc. | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 | |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade 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) |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common
Name: | Daily wear rigid gas permeable contact lens |
| Classification
Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| Regulatory
Class: | Class II |
| Product Code: | HQD |
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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) |
| $\pm$ 0.18 (5 to $\leq$ 10.0D) | ||
| $\pm$ 0.25 (10 to $\leq$ 15D) | ||
| $\pm$ 0.37 (15 to $\leq$ 20D) | ||
| $\pm$ 0.50 (over 20D) | ||
| Cylindrical Power | Up to 10.00D | $\pm$ 0.25 (0 to $\leq$ 2D) |
| $\pm$ 0.37 (2 to $\leq$ 4D) | ||
| $\pm$ 0.50 (over 4D) | ||
| Surface Appearance | Lenses should be clear with no surface | |
| 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)90% |
| Specific Gravity | 1.166 | 1.155 |
| Oxygen Permeability | ||
| (Dk) | ||
| ISO/FATT Method | 100 x 10-11 (cm²/sec) | |
| (ml O₂/ml x mm Hg @ | ||
| 35°C) | 125 x 10-11 (cm²/sec) | |
| (ml O₂/ml x mm Hg @ | ||
| 35°C) | 180 x 10-11 (cm²/sec) | |
| (ml O₂/ml x mm Hg @ | ||
| 35°C) | 113 x 10-11 (cm²/sec) | |
| (ml O₂/ml x mm Hg @ | ||
| 35°C) | 21 x 10-11 (cm²/sec) (ml | |
| O₂/ml x mm Hg @ | ||
| 35°C) | ||
| Color Additives | D & C Green No. 6, | |
| FD & C Red No. | ||
| 17, | ||
| CI Solvent Yellow | ||
| 18 | D & C Green No. 6, | |
| FD & C Red No. | ||
| 17, | ||
| CI Solvent Yellow | ||
| 18 | D&C Green No. 6, | |
| C.I. Solvent | ||
| Yellow No. 18, | ||
| D&C Violet No. 2 | ||
| and D&C Red No. | ||
| 17 | D&C Green No. 6, | |
| C.I. Solvent Yellow | ||
| No. 18, D&C | ||
| Violet No. 2 and | ||
| D&C Red No. 17 | D&C Green | |
| No. 6, C.I. | ||
| Solvent | ||
| Yellow No. | ||
| 18, D&C | ||
| Violet No. 2 | ||
| and D&C red | ||
| No. 17 | ||
| UV Light Blocking | ||
| (UVB - 280nm - 315nm; | ||
| UVA 316nm - 380nm) | >98% UVB |
95% UVA | >98% UVB
95% UVA | >98% UVB
86% UVA | >98% UVB
84% UVA | >98% UVB
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.
10
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
SV, AFM, VK
GP Contact
Lenses | Optimum GP
(roflufocon D &
E) RGP Contact
Lenses | Hyper Gp
(Tisilfocon A)
Daily Wear
Contact Lens | Hexa100 (Hexafocon
A) Daily Wear
Contact Lenses | Enflu 18
(Enflufocon A)
Daily Wear
Contact Lens | Custom
Stable
Scleral
Contact Lens |
|--------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device
(K161100) | Device
(K182304) | (K171077) | Device
(K171575) | Device
(K170335) |
| Classification | Same as
predicate | Class II
Lenses, Rigid Gas
Permeable, Daily
Wear
21 CFR 886.5916 | Class II
Lenses, Rigid
Gas Permeable,
Daily Wear
21 CFR
886.5916 | Class II
Lenses, Rigid Gas
Permeable, Daily Wear
21 CFR 886.5916 | Class II
Lenses, Rigid
Gas Permeable,
Daily Wear
21 CFR
886.5916 | Class II
Lenses, Rigid
Gas
Permeable,
Daily Wear
21 CFR
886.5916 |
| Product Code | Same as
predicate | HQD | HQD | HQD | HQD | HQD |
| FDA Group # | Same as
predicate | Group # 3 Fluoro
Silicone Acrylate | Group # 3
Fluoro Silicone
Acrylate | Group # 3 Fluoro
Silicone Acrylate | Group # 3
Fluoro Silicone
Acrylate | Group # 3
Fluoro
Silicone
Acrylate |
| Material (USAN) | roflufocon D,
roflufocon E,
tisilfocon A,
hexafocon A,
enflufocon A. | roflufocon D,
roflufocon E | tisilfocon A | hexafocon A | enflufocon A | roflufocon D,
roflufocon E |
| Production Method | Same as
predicate | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| Intended Use | Same as
predicate | Daily Wear | Daily Wear | Daily Wear | Daily Wear | Daily Wear |
| Water Content (%) |