(48 days)
No
The summary describes a physical contact lens and its materials, intended uses, and performance testing, with no mention of AI or ML technology.
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 the management and therapeutic treatment of various ocular conditions, and it may incidentally correct refractive error. It is not described as diagnosing conditions.
No
The device description clearly states it is a "large diameter rigid gas permeable contact lens design," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The Visionary Optics Scleral Contact Lens is a physical device that is placed on the eye (in vivo) for the management of various ocular conditions and potentially for refractive error correction. It does not examine specimens from the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples. The testing described (Bench Testing, Bioburden Testing) is related to the manufacturing and safety of the physical lens itself, not diagnostic analysis of patient samples.
Therefore, the Visionary Optics Scleral Contact Lens is a medical device, but it falls under a different regulatory category than In Vitro Diagnostics.
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 leads 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 Graftversus-Host disease. Sjogren's syndrome, dry eve syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders, 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, hyperopia, 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/planned replacement 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) 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 A, or hexafocon B.
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 Lenses are packaged and shipped in Boston Simplus Multiaction Solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea, ocular surface
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies:
Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Visionary Optics LLC to manufacture lenses, on a repeatable basis, from 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 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.
Clinical Studies:
A series of clinical case reports demonstrate the performance of the Visionary Optics Scleral Contact Lens when prescribed for the proposed indications for use.
Conclusions Drawn from Testing:
Testing presented in this submission for the Visionary Optics Scleral Contact Lens demonstrate no significant differences from the predicate devices-supporting the substantial equivalence claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
"Custom Stable™ Rigid Gas Permeable Scleral Contact Lens" ● Manufactured by Valley Contax, Inc. 510(k) number; K170335, "BostonSight PD Prosthetic Device" Manufactured by Boston Foundation for Sight 510(k) number; K161461
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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1
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: | K171950 |
|---|---|
| -------------------------------- | --------- |
Applicant information:
| Date Prepared: | 06/26/2017 |
|---|---|
| Name: | Visionary Optics LLC |
| Address | 1325 Progress Drive |
| Front Royal, VA 22630 | |
| Contact Person: | Donald R. Sanders |
| Phone number: | Manager and CEO |
| (630) 530-9700 | |
| Consultant/Correspondent: | EyeReg Consulting, Inc. |
| Bret Andre | |
| Phone number | (503) 372-5226 |
| Fax number | (503) 419-4475 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | HQD |
| Classification Name: | Lenses, Rigid Gas Permeable, Daily Wear |
Trade Name:
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)
2
Predicate Devices:
The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) is substantially equivalent to the following predicate device(s)
- "Custom Stable™ Rigid Gas Permeable Scleral Contact Lens" ● Manufactured by Valley Contax, Inc. 510(k) number; K170335
- "BostonSight PD Prosthetic Device" Manufactured by Boston Foundation for Sight 510(k) number; K161461
Device Description:
The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) 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 A, or hexafocon B.
| ROFLUFOCON D | ROFLUFOCON E | HEXAFOCON A | HEXAFOCON B | |
|---|---|---|---|---|
| Refractive Index | 1.4333 | 1.4332 | 1.415 | 1.4240 |
| Light Transmission (clear) | >97% | >97% | - | >95% |
| Light Transmission (tinted) | >90% | >90% | >92% | >83% |
| Water Content | 98% UVB |
95% UVA | >98% UVB
95% UVA | >95% UVB
97% UVA | >95% UVB
97% UVA |
The physical properties of the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) are as follows:
3
| 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 = 5D) |