(25 days)
No
The summary describes a physical contact lens and its materials, with no mention of AI or ML in its design, manufacturing, or intended use.
Yes
The intended use explicitly states the device is for "management of multiple ocular conditions" and "when prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error".
No
The device is a contact lens used for the management and correction of various ocular conditions and refractive errors; it does not diagnose these conditions.
No
The device description clearly states it is a physical contact lens made from specific materials, not software.
Based on the provided text, 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 description clearly states that this device is a contact lens designed to be worn on the eye for the management of various ocular conditions and correction of refractive error. It is a physical device applied externally to the body.
- Lack of Biological Sample Analysis: There is no mention of this device analyzing any biological samples from the patient.
Therefore, the Custom Stable™ Rigid Gas Permeable Scleral Contact Lens falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
HQD
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.)
The physical properties of the Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens are as follows:
Refractive Index: 1.430 (roflufocon D), 1.4332 (roflufocon E)
Light Transmission (clear): >97%
Light Transmission (tinted): >90%
Water Content: 98% UVB >95% UVA
The parameters for the Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens are as follows:
Base Curve: 6.6 mm to 11.0 mm (Tolerance: ± 0.05 mm)
Center Thickness: 0.20 mm to 1.20 mm (0.01mm increments) (Tolerance: ± 0.02 mm)
Diameter: 13.8 mm to 19.0 mm (Tolerance: ± 0.10mm)
Spherical Power: -30.00 D to +30.00 D (0.125 D steps) (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: -0.25D to -6.50D (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 Custom Stable™ Rigid Gas Permeable (roflufocon E) Scleral Contact Lens may be shipped "dry" or "wet". When shipped "wet", The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens is packaged and shipped in the Menicon Unique pH multipurpose solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare practitioners / Not Found
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:
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.
Bench testing was performed to verify the refractive index of the Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens. Testing was conducted in accordance with ISO 18369-4.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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.
1
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
2
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) Scleral
Contact Lens |
|-------------------------|-----------------------------------------------------------------------------------------|
| 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 |
4
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 | 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) |