(225 days)
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.
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 made-to-order with spherical or aspheric front surfaces, or a prism-ballasted toric front surface. The Valley Contax AFM Gas Permeable Contact Lens is made-to-order in a range of multifocal strengths and options. The Valley Contax VK Gas Permeable Contact Lens is intended for the management of irregular cornea conditions and is made-to-order in spheric, prism-ballasted toric, and multifocal front surface options. The lenses are lathe cut from one of the following hydrophobic, fluorosilicone acrylate materials: roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A. The lenses are shipped "dry" in a polypropylene contact lens case.
The provided text describes a 510(k) premarket notification for "Valley Contax Single Vision (SV) Gas Permeable Contact Lens", "Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens", and "Valley Contax V Kone (VK) Gas Permeable Contact Lens." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a novel clinical study for the device's performance against specific acceptance criteria like an AI/ML product would.
As such, the information required to directly answer some of the questions (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not present in this document because it outlines a regulatory submission for contact lenses, not a study validating an AI/ML diagnostic tool.
However, based on the provided text, I can infer and state what is available regarding acceptance criteria and the "study" proving device performance in the context of a contact lens submission:
Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence):
For this type of device (contact lenses), acceptance criteria are not typically expressed as performance metrics like sensitivity/specificity but rather as meeting established physical properties, biocompatibility standards, and manufacturing tolerances that are considered safe and effective, similar to predicate devices. The "performance" is demonstrating these equivalencies.
Here's a table summarizing the physical properties that serve as de-facto performance metrics and acceptance criteria by demonstrating equivalence to previously cleared materials:
| Parameter | Acceptance Criteria (Predicate Values) | Reported Device Performance (Valley Contax Contact Lenses) |
|---|---|---|
| Refractive Index | Roflufocon D: 1.4333Roflufocon E: 1.4332Tisilfocon A: 1.4378Hexafocon A: 1.4136Enflufocon A: 1.4436 | Meets predicate values (implied by "reported from predicate devices") |
| Light Transmission (tinted) | >90% (roflufocon D, E, enflufocon A), >91% (tisilfocon A, hexafocon A) | Meets predicate values (implied by "reported from predicate devices") |
| Specific Gravity | Roflufocon D: 1.166Roflufocon E: 1.155Tisilfocon A: 1.200Hexafocon A: 1.266Enflufocon A: 1.221 | Meets predicate values (implied by "reported from predicate devices") |
| Oxygen Permeability (Dk) | Roflufocon D: 100 x 10⁻¹¹Roflufocon E: 125 x 10⁻¹¹Tisilfocon A: 180 x 10⁻¹¹Hexafocon A: 113 x 10⁻¹¹Enflufocon A: 21 x 10⁻¹¹ | Meets predicate values (implied by "reported from predicate devices") |
| UV Light Blocking (>98% UVB, ≥83% UVA) | UVB: >98% (all materials)UVA: >95% (roflufocon D, E), >86% (tisilfocon A), >84% (hexafocon A), >83% (enflufocon A) | Meets predicate values (implied by "reported from predicate devices") |
| Lens Parameters (e.g., Base Curve, Diameter, Power) | Within specified tolerances (e.g., Base Curve: ±0.05 mm, Diameter: ±0.10mm, Spherical Power: various tolerances) | Verified by "Bench testing" to be within manufacturing tolerances. |
| Bioburden | Less than 100 CFU per lens | Demonstrated to be within the established acceptance criteria. |
| Surface Appearance | Lenses should be clear with no surface defect | Verified by "Bench testing." |
1. A table of acceptance criteria and the reported device performance:
See the table above. The acceptance criteria for contact lenses in a 510(k) submission are implicitly met by demonstrating that the device's characteristics (material properties, manufacturing tolerances) are equivalent to those of legally marketed predicate devices, which are deemed safe and effective. The "performance" is establishing this equivalence through non-clinical (bench) testing and reference to previous clearances.
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated. For bench testing of manufacturing parameters and bioburden, the sample size would be determined by internal quality control protocols, but it is not detailed in this regulatory summary.
- Data provenance: For material properties, it's "reported from predicate devices," meaning the data comes from previously cleared contact lenses using the same materials. For lens design/manufacturing verification and bioburden, the data is generated from testing performed by Valley Contax, Inc. The country of origin is not specified, but the submission is to the U.S. FDA. The testing is likely prospective (i.e., designed specifically for this submission) for the manufacturing verification and bioburden.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically for diagnostic devices, especially AI/ML. For contact lenses, the "truth" is whether the physical properties meet the established specifications and manufacturing tolerances.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable and not provided. Adjudication methods are relevant for subjective interpretations (e.g., reading medical images) requiring multiple reviewers. For objective measurements like contact lens parameters and bioburden, standard quality control and laboratory procedures are followed, not adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this type of study was not done. MRMC studies are specific to evaluating the clinical performance of diagnostic medical devices, particularly those involving human interpretation of data (e.g., images) where AI tools might assist. This submission is for contact lenses, which are Class II physical devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. This refers to the evaluation of AI/ML algorithms, which is not the device being cleared.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench testing / Engineering specifications / Pre-established material properties from predicate devices. The "ground truth" for contact lens regulatory clearance revolves around objective measurements of physical, chemical, and biological properties, as well as adherence to manufacturing tolerances, all supported by existing standards and data from already-cleared, equivalent materials/devices. Clinical performance has been "addressed by reference to previously cleared 510(k) premarket notifications," implying that the safety and effectiveness of the materials in human eyes have already been established and accepted.
8. The sample size for the training set:
- Not applicable / Not provided. The concept of a "training set" applies to machine learning algorithms. This document describes the clearance of physical contact lenses.
9. How the ground truth for the training set was established:
- Not applicable. As explained above, there is no AI/ML training set for this device.
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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.
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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
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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.
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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:
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{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 AdamsVice President |
| Phone number: | (541) 744-9393 |
| Consultant: | Bret AndreEyeReg 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, roflufoconE, tisilfocon A, hexafocon A, enflufocon A);Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable ContactLens (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) |
|---|---|
| CommonName: | Daily wear rigid gas permeable contact lens |
| ClassificationName: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| RegulatoryClass: | 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 surfacedefect |
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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 |
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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 | enflufoconA | |
|---|---|---|---|---|---|
| Refractive Index | 1.4333 | 1.4332 | 1.4378 | 1.4136 | 1.4436 |
| Light Transmission(tinted) | >90% | >90% | >91% | >91% | >90% |
| Specific Gravity | 1.166 | 1.155 | 1.200 | 1.266 | 1.221 |
| 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) (mlO₂/ml x mm Hg @35°C) |
| Color Additives | D & C Green No. 6,FD & C Red No.17,CI Solvent Yellow18 | D & C Green No. 6,FD & C Red No.17,CI Solvent Yellow18 | D&C Green No. 6,C.I. SolventYellow No. 18,D&C Violet No. 2and D&C Red No.17 | D&C Green No. 6,C.I. Solvent YellowNo. 18, D&CViolet No. 2 andD&C Red No. 17 | D&C GreenNo. 6, C.I.SolventYellow No.18, D&CViolet No. 2and D&C redNo. 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.
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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 ContaxSV, AFM, VKGP ContactLenses | Optimum GP(roflufocon D &E) RGP ContactLenses | Hyper Gp(Tisilfocon A)Daily WearContact Lens | Hexa100 (HexafoconA) Daily WearContact Lenses | Enflu 18(Enflufocon A)Daily WearContact Lens | CustomStableScleralContact Lens | |
|---|---|---|---|---|---|---|
| Subject Device | Predicate Device(K161100) | Device(K182304) | (K171077) | Device(K171575) | Device(K170335) | |
| Classification | Same aspredicate | Class IILenses, Rigid GasPermeable, DailyWear21 CFR 886.5916 | Class IILenses, RigidGas Permeable,Daily Wear21 CFR886.5916 | Class IILenses, Rigid GasPermeable, Daily Wear21 CFR 886.5916 | Class IILenses, RigidGas Permeable,Daily Wear21 CFR886.5916 | Class IILenses, RigidGasPermeable,Daily Wear21 CFR886.5916 |
| Product Code | Same aspredicate | HQD | HQD | HQD | HQD | HQD |
| FDA Group # | Same aspredicate | Group # 3 FluoroSilicone Acrylate | Group # 3Fluoro SiliconeAcrylate | Group # 3 FluoroSilicone Acrylate | Group # 3Fluoro SiliconeAcrylate | Group # 3FluoroSiliconeAcrylate |
| 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 aspredicate | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| Intended Use | Same aspredicate | Daily Wear | Daily Wear | Daily Wear | Daily Wear | Daily Wear |
| Water Content (%) | <1% | <1% | <1% | <1% | <1% | <1% |
| UV AbsorberAvailable | 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) | ||||
| ValleyContax SV,AFM, VKGP ContactLenses(Subject | 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 aphakicand non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractiveastigmatism 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 lensmay 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 aphakicand non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractiveastigmatism 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 lensmay 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,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 aphakicand non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractiveastigmatism 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 themanagement of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration orfollowing 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 lensmay 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) ContactLens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic personswith non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemicaldisinfection system only. | ||||
| OptimumGP | The Optimum GP with HPT (roflufocon C, D, and E) Toric Rigid Gas Permeable (RGP) Contact Lensis indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons withnon-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 bedisinfected with a chemical disinfection system only | |||
| The Optimum GP with HPT (roflufocon C, D, and E) Irregular Cornea Daily Wear Contact Lens maybe prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management ofirregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetratingkeratoplasty or refractive (e.g. LASIK) surgery. |
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| Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lensmay be cleaned and disinfected using a chemical (not heat) lens care system. | |
|---|---|
| Hyper Gp(TisilfoconA) DailyWearContactLens(K182304) | The Hyper GP (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated fordaily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyeswith myopia or hyperopia. |
| The Hyper GP (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for dailywear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes withmyopia 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 isindicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 dioptersand 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 inotherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregularcorneal conditions such as; keratoconus, pellucid marginal degeneration or following penetratingkeratoplasty or refractive (e.g. LASIK) surgery. | |
| The Hyper GP (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in anorthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued ona prescribed wearing schedule. | |
| Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lensmay be cleaned and disinfected using a chemical (not heat) lens care system. | |
| Hexa100(HexafoconA) DailyWearContactLenses(K171077) | The HEXA100 (hexafocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated fordaily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyeswith myopia or hyperopia. |
| The HEXA100 (hexafocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for dailywear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes withmyopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. | |
| The HEXA100 (hexafocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens isindicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 dioptersand are presbyopic requiring add power of up to +4.00 diopters. | |
| The HEXA100 (hexafocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed inotherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregularcorneal conditions such as; keratoconus, pellucid marginal degeneration or following penetratingkeratoplasty or refractive (e.g. LASIK) surgery. | |
| The HEXA100 (hexafocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear inan orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued ona prescribed wearing schedule. | |
| Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lensmay be cleaned and disinfected using a chemical (not heat) lens care system. | |
| Enflu 18(EnflufoconA) DailyWearContactLens(K171575) | The ENFLU 18 (enflufocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated fordaily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyeswith myopia or hyperopia.The ENFLU 18 (enflufocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for dailywear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes withmyopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.The ENFLU 18 (enflufocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lensis indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons withnon-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4diopters and are presbyopic requiring add power of up to +4.00 diopters.The ENFLU 18 (enflufocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribedin otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregularcorneal conditions such as; keratoconus, pellucid marginal degeneration or following penetratingkeratoplasty or refractive (e.g. LASIK) surgery.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 lensmay be cleaned and disinfected using a chemical (not heat) lens care system. |
| CustomStable RigidGasPermeableScleralContactLens(K170335) | The Custom Stable Rigid Gas Permeable Scleral Contact Lenses for daily wear are indicated foruse for the management of multiple ocular conditions, such as, degenerations that lead to an irregularcorneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's NodularDegeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy, Lattice CornealDystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. Thelens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome,Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbalstem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and cornealexposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lensesis also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia.Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, thelens may be cleaned and disinfected using a chemical (not heat) lens care system. |
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VII. PERFORMANCE DATA
~ 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. A summary of the results from the non-clinical studies is presented below.
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.
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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 notificaitons.
VIII. CONCLUSIONS
Substantial Equivalence
Information presented in this premarket notification establishes that Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) for daily wear are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indications.
Risks and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of rigid gas permeable (RGP) daily wear contact lenses. The benefits to the patient are the same as those for other RGP contact lenses.
§ 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.