(145 days)
Not Found
No
The summary describes a physical contact lens and its materials, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The "Intended Use / Indications for Use" section explicitly states that the Visionary Optics Scleral Contact Lens is "also indicated for therapeutic management of ocular surface disease".
No
The device is a contact lens indicated for the management and therapeutic treatment of various ocular conditions, and it may incidentally correct refractive error. It is not described as diagnosing any condition.
No
The device description clearly states it is a "large diameter rigid gas permeable contact lens design," which is a physical hardware component, not software.
Based on the provided information, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Visionary Optics Scleral Contact Lens is a medical device that is placed directly on the eye. Its purpose is to manage various ocular conditions and provide therapeutic benefits by vaulting over the cornea and creating a tear reservoir. It may also incidentally correct refractive error.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It interacts directly with the ocular surface.
Therefore, the Visionary Optics Scleral Contact Lens falls under the category of a therapeutic medical device, not 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, Salzman'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
HQD
Device Description
The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon 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 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, or fluoroxyfocon A.
The Visionary Optics Scleral Contact Lens may be shipped "dry" or "wet". The primary container for shipping the Visionary Optics Scleral Contact Lens is the PolyVial Contact Lens Case. When shipped "wet", the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) are packaged and shipped in Boston Simplus Multiaction Solution. When shipped "wet", the Visionary Optics Scleral Contact Lens (tisilfocon A) is packaged and shipped in Menicon Unique pH Solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular/corneal/scleral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye care practitioners
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
Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Visionary Optics LLC to manufacture lenses, on a repeatable basis, from fluoroxyfocon A supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.
Bioburden Testing-bioburden testing conducted on fluoroxyfocon A rigid gas permeable lenses manufactured at Visionary Optics LLC demonstrated that the colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study. Nine (9) independent practitioners evaluated 33 patients (63 total eyes) presenting with various conditions that were managed using scleral contact lenses manufactured by Visionary Optics from Acuity 200 (fluoroxyfocon A) material. The practitioners reviewed all patients therapeutically managed for ocular surface disease with Visionary Optics Scleral Contact Lens (fluoroxyfocon A) for at least 3 months, and reported the outcome of each patient-including any ocular adverse reactions or worsening of the patients' conditions-over the treatment period. All patients were fit with successful outcomes over a treatment follow-up period of at least 3 months (Min: 90 days; Max: 259 days; Median: 113 days). The total number of days of treatment follow-up for all patients combined was 4,306 days. There were no serious or significant adverse reactions reported. For all patients, the ocular condition(s) and vision remained stable or improved during management with the Visionary Optics Scleral Contact Lens (fluoroxyfocon A).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 21, 2024
Visionary Optics LLC % Bret Andre Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn. OR 97068
Re: K233325
Trade/Device Name: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: September 25, 2023 Received: January 23, 2024
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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-regulatory-
assistance/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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233325
Device Name
Visionary Optics Scleral Contact Lens (roflufocon E. hexafocon A. hexafocon B. tisilfocon A. fluoroxyfocon 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, Salzman'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) |
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
for this collection of information is estimated to average 79 hours per 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
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: | K233325 |
|---|---|
| I. SUBMITTER | |
| Date Prepared: | September 25, 2023 |
| Name: | |
| Address | Visionary Optics LLC |
| 1325 Progress Drive | |
| Front Royal, VA 22630 | |
| Contact Person: | Donald R. Sanders |
| Manager and CEO | |
| Phone number: | (630) 530-9700 |
| Consultant/ | |
| Correspondent: | Andre Vision and Device Research |
| 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, fluoroxyfocon A) | |
| Common | |
| Name: | Daily wear rigid gas permeable contact lens |
| Classification | |
| Name: | |
| 886.5916) | Rigid gas permeable contact lens. (21 CFR) |
| Regulatory | |
| Class: | Class II |
| Product Code: | HQD |
5
III. PREDICATE DEVICE
The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) is substantially equivalent to the following predicate devices:
- · Visionary Optics Scleral Contact Lens (roflufocon E, hexafocon A, hexafocon A, hexafocon B, tisilfocon A) Manufactured by Visionary Optics LLC 510(k) number; K223394
- · Acuity 200 (Fluoroxyfocon A) Rigid Gas Permeable Contact Lens Manufactured by Acuity Polymers, Inc. 510(k) number: K203571
IV. DEVICE DESCRIPTION
The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon 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 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, or fluoroxyfocon A.
| | ROFLUFOCON D | ROFLUFOCON E | HEXAFOCON
A | HEXAFOCON
B | TISILFOCON
A | FLUOROXYFOCON
A |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Refractive Index | 1.4333 | 1.4332 | 1.415 | 1.4240 | 1.4378 | 1.430 |
| Light Transmission
(clear) | >97% | >97% | - | >95% | - | - |
| Light Transmission
(tinted) | >90% | >90% | >92% | >83% | >91% | >87% |
| Water Content |