(29 days)
Not Found
No
The summary describes a physical contact lens and its materials, indications for use, and performance testing. There is no mention of software, algorithms, AI, or ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the lens is "also indicated for therapeutic management of ocular surface disease."
No
The device is a contact lens used for managing ocular conditions and providing therapeutic benefits, not for diagnosing medical conditions.
No
The device description clearly states it is a "large diameter rigid gas permeable contact lens design," which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Visionary Optics Scleral Contact Lens is a physical device that is placed on the surface of the eye. Its purpose is to manage ocular conditions and provide therapeutic benefits by physically interacting with the eye and creating a tear reservoir. It does not analyze biological specimens.
- Intended Use: The intended use clearly describes the management of various ocular conditions and therapeutic benefits, not the analysis of samples for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics and materials of the contact lens.
- Performance Studies: The performance studies described are related to manufacturing verification, bioburden, and clinical safety and effectiveness of the lens itself when worn on the eye, not the performance of a diagnostic test.
Therefore, based on the provided information, the Visionary Optics Scleral Contact Lens is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Visionary Optics Scleral Contact Lens for daily wear is 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 from infection or trauma.
The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex. Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, astigmatism or presbyopia.
Eye care 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)
HOD
Device Description
The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) 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 Visionary Optics Scleral Contact Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluorosilicone acrylate materials: roflufocon D, roflufocon E, hexafocon B, or tisilfocon A.
The physical properties of the Visionary Optics Scleral Contact Lens are:
Refractive Index: roflufocon D (1.4333), roflufocon E (1.4332), hexafocon A (1.415), hexafocon B (1.4240), tisilfocon A (1.4378)
Light Transmission (clear): roflufocon D (>97%), roflufocon E (>97%), hexafocon A (Not Found), hexafocon B (>95%), tisilfocon A (Not Found)
Light Transmission (tinted): roflufocon D (>90%), roflufocon E (>90%), hexafocon A (>92%), hexafocon B (>83%), tisilfocon A (>91%)
Water Content: -11 cm²/sec) (ml O₂/ml x mm Hg @ 35°C), roflufocon E (125 x 10-11 cm²/sec) (ml O₂/ml x mm Hg @ 35°C), hexafocon A (140 x 10-11 cm²/sec) (ml O₂/ml x mm Hg @ 35°C), hexafocon B (141 x 10-11 cm²/sec) (ml O₂/ml x mm Hg @ 35°C), tisilfocon A (180 x 10-11 cm²/sec) (ml O₂/ml x mm Hg @ 35°C)
Color additives: All materials contain D & C Green No. 6, CI Solvent Yellow 18, and D & C Red No. 17 or similar variants. D&C Violet No. 2 is also present in some.
UV Light Blocking:
roflufocon D: >98% UVB, >95% UVA
roflufocon E: >98% UVB, >95% UVA
hexafocon A: >95% UVB, >97% UVA
hexafocon B: >95% UVB, >97% UVA
tisilfocon A: >98% UVB, >85% UVA
The available parameters for the Visionary Optics Scleral Contact Lens are as follows:
Base Curve: 5.5mm to 25.00mm, Tolerance ± 0.2mm
Center Thickness: 0.10mm to 3.00mm, Tolerance ± 0.1mm
Diameter: 12.00mm to 26.00mm, Tolerance ± 0.20mm
Spherical Power: -35.00 D to +35.00 D (in .12D steps), Tolerances: ± 0.12 (0 to
§ 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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December 7, 2022
Visionary Optics LLC % Bret Andre Principal Consultant EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068
Re: K223394
Trade/Device Name: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: November 4, 2022 Received: November 8, 2022
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 (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 (OS) 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 titled, "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 mediation-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 -S
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) K223394
Device Name
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)
Indications for Use (Describe)
The Visionary Optics Scleral Contact Lens for daily wear is 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 from infection or trauma.
The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex. Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, astigmatism or presbyopia.
Eye care 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) |
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SPECIAL 510 (k) SUMMARY
This special 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K223394 |
|---|---|
| I. SUBMITTER | |
| Date Prepared: | November 4th, 2022 |
| Name: | |
| Address | Visionary Optics LLC |
| 1325 Progress Drive | |
| Front Royal, VA 22630 | |
| Contact Person: | |
| Phone number: | Donald R. Sanders |
| Manager and CEO | |
| (630) 530-9700 | |
| Consultant/ | |
| Correspondent: | EyeReg Consulting, Inc. |
| Bret Andre | |
| 6119 Canter Lane | |
| West Linn, OR 97068 | |
| Phone number | (503) 372-5226 |
| II. DEVICE | |
| Trade Name: | Visionary Optics Scleral Contact Lens (roflufocon D, |
| roflufocon E, hexafocon A, hexafocon B, tisilfocon 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
The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) is substantially equivalent to the following predicate devices:
-
"Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, . hexafocon B)" Manufactured by Visionary Optics LLC
510(k) number; K171950 -
o "Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses" Manufactured by Contamac Ltd. 510(k) number; K212631
DEVICE DESCRIPTION IV.
The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) 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 Visionary Optics Scleral Contact Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluorosilicone acrylate materials: roflufocon D, roflufocon E, hexafocon B, or tisilfocon A.
| ROFLUFOCON D | ROFLUFOCON E | HEXAFOCON A | HEXAFOCON B | TISILFOCON A | |
|---|---|---|---|---|---|
| Refractive Index | 1.4333 | 1.4332 | 1.415 | 1.4240 | 1.4378 |
| Light Transmission | |||||
| (clear) | >97% | >97% | >95% | ||
| Light Transmission | |||||
| (tinted) | >90% | >90% | >92% | >83% | >91% |
| Water Content | 98% UVB |
95% UVA | >98% UVB
95% UVA | >95% UVB
97% UVA | >95% UVB
97% UVA | >98% UVB
85% UVA |
The physical properties of the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) are as follows:
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| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 5.5mm to 25.00mm | ± 0.2mm |
| Center Thickness | 0.10mm to 3.00mm | ± 0.1mm |
| Diameter | 12.00mm to 26.00mm | ± 0.20mm |
| Spherical Power | -35.00 D to +35.00 D | |
| (in .12D steps) | ± 0.12 (0 to |