(29 days)
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.
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.
I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria and device performance. The document is a 510(k) summary for a contact lens, primarily focusing on its substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria, sample sizes, expert qualifications, or adjudication methods for performance evaluation.
Here's a breakdown of why I cannot fulfill your request based on the provided text:
- No explicit Acceptance Criteria: The document mentions that lenses were manufactured to "established finished product specifications within the ANSI Z80.20 tolerance" for bench testing, and bioburden testing had an "established acceptance criteria of less than 100 CFU per lens." However, it does not provide a comprehensive table of acceptance criteria for the overall device performance as per your request (e.g., visual acuity, comfort, etc.).
- No detailed Device Performance Results: While it states that manufacturing verification testing demonstrated the ability to manufacture lenses "to a variety of prescribed parameters" and bioburden testing was "within the established acceptance criteria," it does not provide specific numerical results or a comparative performance table against a set of acceptance criteria.
- No information on Test Set Sample Size and Data Provenance: The document does not specify the sample size used for any performance testing, nor does it provide information about the country of origin or whether the data was retrospective or prospective.
- No information on Experts for Ground Truth: There is no mention of experts, their number, or qualifications used to establish ground truth for any testing described.
- No Adjudication Method: The document does not describe any adjudication methods used for a test set.
- No MRMC Comparative Effectiveness Study: The submission primarily relies on substantial equivalence to predicate devices and general claims of safety and effectiveness, not a multi-reader multi-case comparative effectiveness study with AI assistance.
- No Standalone Performance (AI-specific): This device is a contact lens, not an AI algorithm. Therefore, "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable.
- No Ground Truth Type (for performance studies): Since detailed performance studies with ground truth are not presented, this information is not available. The "ground truth" for a contact lens would typically involve clinical measurements by optometrists/ophthalmologists, patient feedback, and objective physiological responses, but these are not quantified or described in the provided text.
- No Training Set Sample Size or Ground Truth Establishment for Training Set: As this is not an AI device, the concepts of training sets and their ground truth establishment are not applicable here.
The section under "VII. PERFORMANCE DATA" explicitly states:
- "Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, hexafocon B and tisilfocon A has been addressed by reference to previous 510(k) clearances."
- "Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, hexafocon B and tisilfocon A with the labeled indications for use has been addressed through previous 510(k) clearances."
This indicates that extensive new performance studies were not conducted for this specific 510(k) clearance, but rather reliance on prior clearances for similar materials and designs. The only specific tests mentioned are:
- Bench Testing: Manufacturing verification to ensure lenses meet ANSI Z80.20 tolerance for established finished product specifications. No specific results table or acceptance criteria other than "within the ANSI Z80.20 tolerance" are provided.
- Bioburden Testing: Demonstrated "colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens."
Therefore, I cannot extract the level of detail you are requesting from this document.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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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 (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
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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 LLC1325 Progress DriveFront Royal, VA 22630 |
| Contact Person:Phone number: | Donald R. SandersManager and CEO(630) 530-9700 |
| Consultant/Correspondent: | EyeReg Consulting, Inc.Bret Andre6119 Canter LaneWest 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) |
| CommonName: | Daily wear rigid gas permeable contact lens |
| ClassificationName: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| RegulatoryClass: | 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 | <1% | <1% | <1% | <1% | <1% |
| Oxygen Permeability(Dk)ISO/FATT Method | $100 x 10^{-11}$ (cm²/sec)(ml O₂/ml x mm Hg @ 35°C) | $125 x 10^{-11}$ (cm²/sec)(ml O₂/ml x mm Hg @ 35°C) | $140 x 10^{-11}$(cm²/sec) (ml O₂/ml xmm Hg @ 35°C) | $141 x 10^{-11}$(cm²/sec) (ml O₂/ml xmm Hg @ 35°C) | $180 x 10^{-11}$(cm²/sec) (ml O₂/ml xmm Hg @ 35°C) |
| Contain one or moreof the following coloradditives conformingto:21 CFR Part 73 & 74,Subpart D | D & C Green No. 6,FD & C Red No. 17,CI Solvent Yellow18 | D & C Green No. 6,FD & C Red No.17,CI Solvent Yellow18 | 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; | D&C Green No.6, C.I. SolventYellow No. 18,D&C Violet No.2 and 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 | >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 </= 5D)± 0.18 (5 to </= 10.0D)± 0.25 (10 to </= 15D)± 0.37 (15 to </= 20D)± 0.50 (over 20D) |
| Cylindrical Power | +10.00 D to -10.00 D(in .12 D steps) | ± 0.25 (0 to </= 2D)± 0.37 (2 to </= 4D)± 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 (rofflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) 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 Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) 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.
V. 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), evidermal 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
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replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. PREDICATE DEVICE
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) is substantially equivalent to the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) (predicate device - K171950) in the following areas:
- Components/Materials/Formulation (roflufocon D, roflufocon E, hexafocon A, and ● hexafocon B contact lens materials)
- Manufacturing facility, procedures and controls o
- Product code (HQD) ●
- Classification (Class II) Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) ●
- FDA material group group # 3 fluoro silicone acrylate ●
- Lathe cut manufacturing process ●
- Scleral (large diameter) design
- Actions and intended use
- Therapeutic indications for use o
The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) is substantially equivalent to the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (predicate device - K212631) in the following areas:
- Components/Materials/Formulation (tisilfocon A contact lens material) ●
- Product code (HOD) ●
- Classification (Class II) Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) ●
- FDA material group group # 3 fluoro silicone acrylate ●
- Lathe cut manufacturing process ●
- Scleral (large diameter) design
- Actions and intended use
- Therapeutic indications for use o
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The following table depicts the classification and technical characteristics of the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) in comparison with the predicate devices.
| Visionary Optics ScleralContact Lens | Visionary Optics ScleralContact Lens | Optimum InfiniteDaily Wear Contact Lenses | |
|---|---|---|---|
| Subject Device | Predicate Device | Predicate Device | |
| 510(k) Number | K171950 | K212631 | |
| Intended Use | Daily Wear | Daily Wear | Daily Wear |
| Device andClassification | Class IILenses, Rigid GasPermeable, Daily WearHQD | Class IILenses, Rigid Gas Permeable,Daily WearHQD | Class IILenses, Rigid Gas Permeable,Daily WearHQD |
| Product Code | HQD | HQD | HQD; MUW |
| Production Method | Lathe-cut | Lathe-cut | Lathe-cut |
| Material (USAN) | Roflufocon DRoflufocon EHexafocon AHexafocon BTisilfocon A | Roflufocon DRoflufocon EHexafocon AHexafocon B | Tisilfocon A |
| 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 |
| Indications for Use | |
|---|---|
| VisionaryOptics ScleralContact Lens(SubjectDevice) | The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management ofmultiple 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'sdystrophy, 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 ofocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren'ssyndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical andthermal 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 tearreservoir and protection against an adverse environment. When prescribed for therapeutic use for distortedcornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally providecorrection 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 lensmay be cleaned and disinfected using a chemical (not heat) lens care system. |
| VisionaryOptics ScleralContact Lens | The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management ofmultiple 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 |
| (PredicateDevice:K171950) | dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant,LASIK, radial keratotomy), and corneal scarring from infection or trauma. |
| OptimumInfiniteDaily WearContact Lenses(PredicateDevice:K212631) | The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management ofocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren'ssyndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical andthermal 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 tearreservoir and protection against an adverse environment. When prescribed for therapeutic use for distortedcornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally providecorrection 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 lensmay be cleaned and disinfected using a chemical (not heat) lens care system. |
| The Optimum Infinite (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for dailywear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia orhyperopia. | |
| The Optimum Infinite (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear forthe correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopiaand/or possesses refractive astigmatism not exceeding 10.00 diopters. | |
| The Optimum Infinite (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens isindicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyeswith myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiringadd power of up to +4.00 diopters. | |
| The Optimum Infinite (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed inotherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditionssuch as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK)surgery. | |
| The Optimum Infinite (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in anorthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. Tomaintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. | |
| Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueoushydrated environment and the saline bath provided by scleral lens designs.Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of irregularand distorted corneal surfaces where the subject: | |
| 1. cannot be adequately corrected with spectacle lenses | |
| 2. requires a rigid gas permeable contact lens surface to improve vision | |
| 3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities | |
| Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scarformation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may alsoinclude corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodulardegeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklersdystrophy, Cogan's dystrophy). | |
| The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surfacedisease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome and Filamentary Keratitis), limbalstem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), 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 might benefit from the presence of an expanded tear reservoir andprotection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surfacedisease, the Optimum Infinite (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error. | |
| Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection andscheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned anddisinfected using a chemical (not heat) lens care system. |
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VII. PERFORMANCE DATA
~ Non-Clinical Studies ~
Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, hexafocon B and tisilfocon A has been addressed by reference to previous 510(k) clearances.
Additionally, the following testing was performed on finished Visionary Optics Scleral Contact Lenses (tisilfocon A):
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, hexafocon B and tisilfocon A with the labeled indications for use has been addressed through previous 510(k) clearances.
~ Conclusions Drawn from Testing ~
Results from testing presented in this premarket notification for the Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) demonstrate no relevant differences from the predicate devices and supports the substantial equivalence claim.
VIII. CONCLUSIONS
Substantial Equivalence
Information presented in this premarket notification establishes that Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon B, tisilfocon A) for daily wear are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indications.
Risks and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of rigid gas permeable (RGP) daily wear contact lenses. The benefits to the patient are the same as those for other RGP contact lenses.
§ 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.