(25 days)
The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens 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), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/ lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is 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, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Custom Stable™ Rigid Gas Permeable (rofflufocon D, roflufocon E) Scleral Contact Lens is lathe cut from one of the following hydrophobic, fluorosilicone acrylate materials: roflufocon D (supplied by Contamac Ltd.) or roflufocon E (supplied by Contamac Ltd.).
This document is a 510(k) premarket notification for a medical device, specifically a type of contact lens. It outlines the manufacturer's claim that their new device is substantially equivalent to a previously cleared predicate device. This type of FDA submission does not involve the rigorous clinical study design typically associated with proving a device meets specific acceptance criteria for AI/ML-based medical devices.
Therefore, I cannot extract the information requested about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement as these concepts are not applicable to this particular 510(k) submission for a physical contact lens.
This document focuses on demonstrating substantial equivalence based on comparable:
- Intended Use
- Indications for Use
- Technological Characteristics (materials, design, production method, physical properties)
- Performance Data (which here refers to non-clinical bench testing for manufacturing verification and reference to previously cleared 510(k)s for material clinical safety/effectiveness, not new clinical trials for this specific device).
The "performance data" sections (VII. PERFORMANCE DATA) specifically state that "Non-clinical testing to validate safety and effectiveness for finished contact lenses manufactured from roflufocon D and roflufocon E blanks has been addressed by reference to previously cleared 510(k) premarket notifications" and "Clinical performance data to validate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to previously cleared 510(k) premarket notifications." This confirms that no new standalone clinical studies were performed for this specific submission to define and meet new acceptance criteria.
In summary, the provided document does not contain the information needed to answer the questions regarding acceptance criteria, study design, sample sizes, ground truth, or expert involvement, as it pertains to a traditional medical device (contact lens) seeking 510(k) clearance based on substantial equivalence, not an AI/ML-based medical device requiring such validation.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 07, 2022
Valley Contax, Inc. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068
Re: K213880
Trade/Device Name: Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: December 10, 2021 Received: December 13, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213880
Device Name
Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens
Indications for Use (Describe)
The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens 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), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/ lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is 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, 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) |
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Special 510 (k) Summary
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.
K213880 The assigned 510(k) number is:
I. SUBMITTER
- December 10th, 2021 Date Prepared: Name: Valley Contax, Inc. 200 South Mill St. Address: Springfield, Oregon 97477 Josh Adams Contact Person: Vice President Phone number: (541) 744-9393 Consultant: Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068 (503) 372-5226 Phone number:
II. DEVICE
| Trade Name: | Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) ScleralContact Lens |
|---|---|
| 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
Custom Stable "11 Rigid Gas Permeable (roflufocon E) Scleral Contact Lens for daily wear is substantially equivalent to the following predicate device:
- "Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens" ■ (Primary Predicate) By Valley Contax, Inc. 510(k) number; K170335
IV. DEVICE DESCRIPTION
The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Custom Stable™ Rigid Gas Permeable (rofflufocon D, roflufocon E) Scleral Contact Lens is lathe cut from one of the following hydrophobic, fluorosilicone acrylate materials:
- · roflufocon D (supplied by Contamac Ltd.)
- · roflufocon E (supplied by Contamac Ltd.)
| ROFLUFOCON D | ROFLUFOCON E | |
|---|---|---|
| Refractive Index | 1.430 | 1.4332 |
| Light Transmission (clear) | >97% | >97% |
| Light Transmission (tinted) | >90% | >90% |
| Water Content | <1% | <1% |
| Dynamic Contact Angle (Receding) | 3° | 6° |
| Specific Gravity | 1.166 | 1.155 |
| Modulus | 697 MPa | 77 MPa |
| Shore D Hardness | 75 | 77 |
| Oxygen Permeability(Dk) | $100 x 10^{-11}$ (cm2/sec) (ml O₂/ml x mmHg @ 35°C) | $125 x 10^{-11}$ (cm2/sec) (ml O₂/ml x mmHg @ 35°C) |
| ISO/FATT Method | ||
| contain one or more of the followingcolor additives conforming to:21 CFR Part 73 & 74, Subpart D | D & C Green No. 6, FD & C RedNo. 17,CI Solvent Yellow 18 | D & C Green No. 6, FD & C RedNo. 17,CI Solvent Yellow 18 |
| UV Light Blocking(UVB - 280nm – 315nm; UVA 316nm- 380nm) | >98% UVB>95% UVA | >98% UVB>95% UVA |
The physical properties of the Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens are as follows:
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The parameters for the Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens are as follows:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 6.6 mm to 11.0 mm | ± 0.05 mm |
| Center Thickness | 0.20 mm to 1.20 mm(0.01mm increments) | ± 0.02 mm |
| Diameter | 13.8 mm to 19.0 mm | ± 0.10mm |
| Spherical Power | -30.00 D to +30.00 D(0.125 D steps) | ± 0.12 (0 to = 5D)<br ± 0.18 (5 to = 10.0D)<br ± 0.25 (10 to = 15D)<br ± 0.37 (15 to = 20D)<br ± 0.50 (over 20D) |
| Cylindrical Power | -0.25D to -6.50D | ± 0.25 (0 to = 2D)<br ± 0.37 (2 to = 4D)<br ± 0.50 (over 4D) |
| Surface Appearance | Lenses should be clear with no surface defect |
The Custom Stable™ Rigid Gas Permeable (roflufocon E) Scleral Contact Lens may be shipped "dry" or "wet". The containers for shipping the Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens are as follows:
- · Bonasse SC 106 (510(k) K991206)
- · Bonasse SC-107 (510(k) K991206)
- · Amcon CL-5001 (510(k) K923458)
- Amcon JC-4013 (510(k) K923458)
When shipped "wet", The Custom Stable"M Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens is packaged and shipped in the Menicon Unique pH multipurpose solution.
V. INDICATIONS FOR USE
The Custom Stable™ Rigid Gas Permeable (roflufocon E) Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens 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), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is 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, 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 Custom Stable™ Rigid Gas Permeable (roflufocon E) Scleral Contact Lenses are substantially equivalent to the predicate device (cleared under K170335) in terms of the following:
- 트 Intended use - daily wear contact lenses
- Indications for use
- Actions
- 트 Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
- FDA material group - group # 3 fluoro silicone acrylate
- 트 USAN materials (roflufocon D, roflufocon E)
- 트 Lens design (Custom Stable)
- Production method - lathe cut
- Final packaging and shipping
The following matrix illustrates the production method, lens function and material characteristics of the Custom Stable TM Rigid Gas Permeable (roflufocon E) Scleral Contact Lenses, as well as the predicate device.
| Custom Stable™ Rigid Gas Permeable(roflufocon D, roflufocon E) ScleralContact Lenses | Custom Stable™ Rigid Gas Permeable(roflufocon D, roflufocon E) ScleralContact Lenses | |
|---|---|---|
| Subject Device | Predicate Device (K170335) | |
| Classification | Same as predicate | Class IILenses, Rigid Gas Permeable, Daily Wear21 CFR 886.5916 |
| Product Code | Same as predicate | HQD |
| FDA Group # | Same as predicate | Group # 3 Fluoro Silicone Acrylate |
| Material (USAN) | Same as predicate | roflufocon D, roflufocon E |
| Production Method | Same as predicate | Lathe-Cut |
| Intended Use | Same as predicate | Daily Wear |
| Water Content (%) | Same as predicate | <1% |
| UV AbsorberAvailable | Same as predicate | Yes |
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| Indications for Use | |
|---|---|
| CustomStable™ RigidGas Permeable(roflufocon D,roflufocon E)Scleral ContactLenses(SubjectDevice) | The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lenses fordaily wear are indicated for use for the management of multiple ocular conditions, such as, degenerationsthat lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration,Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy,Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and cornealscarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eyesyndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis),limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and cornealexposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses isalso 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, the lensmay be cleaned and disinfected using a chemical (not heat) lens care system. |
| CustomStable™ RigidGas Permeable(roflufocon D,roflufocon E)Scleral ContactLenses(PredicateDevice:K170335) | The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lenses fordaily wear are indicated for use for the management of multiple ocular conditions, such as, degenerationsthat lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration,Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy,Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and cornealscarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eyesyndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis),limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and cornealexposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses isalso 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, the lensmay be cleaned and disinfected using a chemical (not heat) lens care system. |
VII. PERFORMANCE DATA
~ Non-Clinical Studies ~
Non-clinical testing to validate safety and effectiveness for finished contact lenses manufactured from roflufocon D and roflufocon E blanks has been addressed by reference to previously cleared 510(k) premarket notifications. To evaluate the changes presented in this 510(k), Valley Contax conducted the following tests:
Lens Design/Manufacturing Verification:
Bench testing was performed to verify the ability of Valley Contax, Inc. to manufacture the Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lenses to a variety of prescribed parameters within manufacturing tolerances. Testing was conducted in accordance with ISO 18369-3.
Refractive Index Testing:
Bench testing was performed to verify the refractive index of the Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lenses. Testing was conducted in accordance with ISO 18369-4.
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~ Clinical Studies ~
Clinical performance data to validate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to previously cleared 510(k) premarket notifications.
VIII. CONCLUSIONS
Substantial Equivalence
Information presented in this premarket notification establishes that Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lenses 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.