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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device, the Visionary Optics Scleral Contact Lens. This type of submission focuses on demonstrating "substantial equivalence" to existing legally marketed devices, rather than conducting new clinical trials to prove safety and effectiveness from scratch. Therefore, the information typically requested about acceptance criteria and detailed study designs for a new device's performance may not be fully present in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense for a new clinical study. Instead, it relies on demonstrating that the physical and material properties of the Visionary Optics Scleral Contact Lens are within established specifications and comparable to predicate devices. The "reported device performance" is largely inferred from meeting these specifications and the substantial equivalence claim.

Parameter	Acceptance Criteria (Implicit from Tolerances & Predicates)	Reported Device Performance (Visionary Optics Scleral Contact Lens)
Bench Testing (Manufacturing Verification)	All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance.	All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.
Bioburden Testing	Less than 100 CFU per lens.	Colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens.
Physical Parameters (Example)
Base Curve	± 0.2mm	Range: 5.5mm to 25.00mm, Tolerance: ± 0.2mm (Implicitly met)
Center Thickness	± 0.1mm	Range: 0.10mm to 3.00mm, Tolerance: ± 0.1mm (Implicitly met)
Diameter	± 0.20mm	Range: 12.00mm to 26.00mm, Tolerance: ± 0.20mm (Implicitly met)
Spherical Power	Various (e.g., ± 0.12 (0 to = 5D))	Range: -35.00 D to +35.00 D, Tolerances as specified (Implicitly met)
Cylindrical Power	Various (e.g., ± 0.25 (0 to = 2D))	Range: +10.00 D to -10.00 D, Tolerances as specified (Implicitly met)
Cylindrical Axis	± 5°	Range: 1° to 180°, Tolerance: ± 5° (Implicitly met)
Bifocal Add	± 0.25D	Range: +.12 D to +6.00 D, Tolerance: ± 0.25D (Implicitly met)
Material Properties (Example - Roflufocon D)
Refractive Index	- (Compared to predicate)	1.4333
Light Transmission (clear)	>97% (Compared to predicate)	>97%
Water Content	<1% (Compared to predicate)	<1%
Oxygen Permeability (Dk)	- (Compared to predicate)	$100 \times 10^{-11} \frac{cm^2}{sec} \frac{ml O_2}{ml \times mm Hg @ 35°C}$
UV Light Blocking	>98% UVB, >95% UVA (Compared to predicate)	>98% UVB, >95% UVA

Note: The acceptance criteria for many of the physical and material properties are implicit in the comparison to the predicate devices and the fact that the new device states these values. The document asserts that the new device "demonstrate no significant differences from the predicate devices-supporting the substantial equivalence claim."

2. Sample Size for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a distinct "test set" sample size for a clinical trial involving human subjects. The non-clinical studies mention "All lenses" for manufacturing verification and "rigid gas permeable lenses manufactured at Visionary Optics LLC" for bioburden testing, implying a representative sample from their production. For clinical evidence, it relies on "a series of clinical case reports" and references previous 510(k) clearances (K033594, K071043, and K071266) for the materials used.
Data Provenance:
- Non-Clinical (Bench & Bioburden): From Visionary Optics LLC's own manufacturing and testing facility. This is prospective for the purpose of this submission (i.e., new tests performed for this device).
- Clinical: Primarily by reference to previous 510(k) submissions for the lens materials. The "series of clinical case reports" would typically be retrospective, gathering outcomes from actual use of the device. No country of origin is explicitly stated for these case reports or the referenced 510(k) clinical data, but for FDA submissions, it's generally assumed to be U.S. or internationally recognized standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable or provided in the context of this 510(k) submission. This is not a study requiring expert-derived ground truth as would be found in a diagnostic AI study. The "ground truth" for the non-clinical tests would be the measured physical properties and bioburden counts. For the clinical case reports, the "ground truth" would be the patient outcomes as documented by the eye care practitioners who prescribed the lenses.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process described for the non-clinical tests or the clinical case reports in this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is common for diagnostic imaging devices involving human readers. For contact lenses, the evaluation focuses on physical parameters, material safety, and clinical performance (patient outcomes), not on the interpretation of images by multiple readers. The submission relies on "substantial equivalence" to predicate devices and existing data for the materials.

6. Standalone Performance (Algorithm Only)

Not applicable. This device is a physical contact lens, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. Type of Ground Truth Used

Non-Clinical (Bench Testing): Established engineering specifications and measurements (e.g., dimensions, powers).
Non-Clinical (Bioburden Testing): Microbiological culture results.
Clinical (Relevant to Referenced 510(k)s and Case Reports): Patient physiological responses, visual acuity, comfort, and other clinical outcomes observed by eye care practitioners.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The materials and manufacturing processes are established based on validated engineering and material science principles.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an algorithm is involved.

Summary

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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 DriveFront 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)

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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:

	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	<1%	<1%	<1%	<1%
Dynamic Contact Angle(Receding)	3°	6°	58°	40°
Specific Gravity	1.166	1.155	1.27	1.19
Modulus	697 MPa	77 MPa	1500 MPa	1160 MPa
Shore D Hardness	75	77	81	78
Oxygen Permeability(Dk)ISO/FATT Method	$100 \times 10^{-11} \frac{cm^2}{sec} \frac{ml O_2}{ml \times mm Hg @ 35°C}$	$125 \times 10^{-11} \frac{cm^2}{sec} \frac{ml O_2}{ml \times mm Hg @ 35°C}$	$140 \times 10^{-11} \frac{cm^2}{sec} \frac{ml O_2}{ml \times mm Hg @ 35°C}$	$141 \times 10^{-11} \frac{cm^2}{sec} \frac{ml O_2}{ml \times mm Hg @ 35°C}$
Contain one or more of thefollowing color additivesconforming to:21 CFR Part 73 & 74,Subpart D	D & C Green No. 6,FD & C Red No. 17,CI Solvent Yellow 18	D & C Green No. 6,FD & C Red No. 17,CI Solvent Yellow 18	D&C Green No. 6; D&C YellowNo. 18; D&CViolet No. 2;	D&C Green No. 6; C.I. SolventYellow No. 18;D&C Violet No.2; D&C RedNo. 17;
UV Light Blocking(UVB - 280nm – 315nm;UVA 316nm – 380nm)	>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:

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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 = 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	+10.00 D to -10.00 D(in .12 D steps)	± 0.25 (0 to = 2D)<br ± 0.37 (2 to = 4D)<br ± 0.50 (over 4D)
Cylindrical Axis	1° to 180° (in 1° steps)	± 5°
Bifocal Add	+.12 D to +6.00 D(in .12 D steps)	± 0.25D

The available parameters for the Visionary Optics Scleral Contact Lens are as follows:

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.

Indication for Use:

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Description of Testing:

~ Non-Clinical Studies ~

Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, and hexafocon B has been addressed by reference to 510(k) K033594, K071043 and K071266.

Additionally, the following testing was performed on finished Visionary Optics Scleral Contact Lenses:

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 ~
Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, and hexafocon B has been addressed by reference to 510(k) K033594, K071043 and K071266.

Additionally, 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.

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Substantial Equivalence:

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) is substantially equivalent to the predicate device(s), and does not raise different questions of safety and effectiveness.

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) is substantially equivalent to the Custom Stable Rigid Gas Permeable Scleral Contact Lens (predicate device) in the following key areas:

Components/Materials/Formulation (roflufocon D & E contact lens materials) ●
FDA classification and group number (Class 2, Group #3 Fluoro Silicone Acrylate)
Lathe cut manufacturing process
Scleral (large diameter) design ●
Actions and intended use ●
Therapeutic indications for use .

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A,

hexafocon B) is substantially equivalent to the BostonSight PD Prosthetic Device (predicate device) in the following key areas:

Components/Materials/Formulation (hexafocon B, roflufocon D & roflufocon E ● contact lens materials)
FDA classification and group number (Class 2, Group #3 Fluoro Silicone Acrylate) ●
Lathe cut manufacturing process
Scleral (large diameter) design ●
Actions and intended use ●
Therapeutic indications for use ●

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The following table depicts the characteristics of the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B), as well as the predicate device(s).

	Visionary Optics ScleralContact Lens	Custom Stable™ Rigid GasPermeable Scleral Contact Lens	BostonSight PD ProstheticDeviceK161461
	Subject Device	Predicate Device	Predicate Device
Indication for Use	Indicated for use for themanagement of multiple ocularconditions, such as, degenerationsthat lead to an irregular cornealshape, dystrophies, post-surgery,and corneal scarring from infectionor trauma. Indicated for therapeuticmanagement of ocular surfacedisease including dry eye, limbalstem cell deficiency, epidermalocular disorders, disorders of theskin, neurotrophic keratitis, andcorneal exposure that might benefitfrom the presence of an expandedtear reservoir and protection againstan adverse environment.When prescribed for therapeutic usefor distorted cornea or ocularsurface disease, the VisionaryOptics Scleral Contact Lens mayincidentally provide correction ofrefractive error in persons withmyopia, hyperopia, astigmatism orpresbyopia.	Indicated for use for the managementof multiple ocular conditions, such as,degenerations that lead to an irregularcorneal shape, dystrophies, post-surgery (e.g. corneal transplant,LASIK, radial keratotomy), andcorneal scarring. The lens may also beprescribed for the management ofocular surface diseases (e.g. dry eyesyndrome, Keratoconjunctivitis Sicca(Graft vs Host Disease, Sjogren'ssyndrome, Filamentary Keratitis),limbal stem cell deficiency, epidermalocular disorders, neurotrophickeratitis, and cornealexposure/lagophthalmos).When prescribed for therapeutic use.the Custom Stable RGP Scleral Lensesis also indicated for correction ofrefractive error in persons withmyopia, hyperopia or presbyopia.	Indicated for therapeutic use ineyes with ocular surface diseasefrom dry eye (e.g. ocular Graft-versus-Host disease, Sjögren'ssyndrome, dry eye syndrome),limbal stem cell deficiency(e.g.Stevens-Johnsonsyndrome, chemical andthermal burns, radiation),disorders of the skin (e.g.atopy, ectodermal dysplasia),neurotrophic keratitis (e.g.Herpes simplex, Herpes zoster,Familial Dysautonomia), andcorneal exposure (e.g.anatomic, paralytic) that mightbenefit from the presence of anexpanded tear reservoir andprotection against an adverseenvironment. When prescribedfor therapeutic use for distortedcornea or ocular surfacedisease, the BostonSight PDProsthetic Device mayincidentally provide correctionof refractive error.
Device andClassification	Class IILenses, Rigid Gas Permeable,Daily WearHQD	Class IILenses, Rigid Gas Permeable,Daily WearHQD	Class IILenses, Rigid GasPermeable, Daily WearHQD
Production Method	Lathe-cut	Lathe-cut	Lathe-cut
USAN	Roflufocon DRoflufocon EHexafocon AHexafocon B	Roflufocon DRoflufocon E	Roflufocon DRoflufocon EOprifocon AHexafocon B
FDA Group #	Group # 3 Fluoro SiliconeAcrylate	Group # 3 Fluoro SiliconeAcrylate	Group # 3 Fluoro SiliconeAcrylate
Water Content	<1%	<1%	<1%
UV Absorber/Blockeravailable	YES	YES	YES

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Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that form the profile of a person's head and neck.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 16, 2017

Visionary Optics LLC % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn. OR 97068

Re: K171950

Trade/Device Name: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: June 26, 2017

Received: June 29, 2017

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Regulation Number and Section

§ 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.