(75 days)
The BostonSight® Specialty Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A) for daily wear are indicated for the correction of refractive ametropia (myopia, astigmatism, and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed in otherwise nondiseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery.
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment, and the saline bath provided by scleral lens designs.
The BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Siögren's syndrome, dry eve syndrome and Filamentary Kerattis, limbal stem 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), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment.
Additionally, the BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use for the management of irregular and distorted corneal surfaces. Common causes of corneal distorion include, but are not limited to, corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy). When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Specialty Scleral Lenses for daily wear may concurrently provide correction of refractive error.
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.
The BostonSight® Specialty Lenses for daily wear are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate rigid gas permeable (RGP) lens materials: roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A. The lenses fabricated from roflufocon D, roflufocon E, tisilfocon A, hexafocon B, fluoroxyfocon A are available with or without Tangible® Hydra-PEG coating. The lenses fabricated from oprifocon A are not available with Tangible® Hydra-PEG. The lenses may be shipped "dry" or "wet" in a polypropylene contact lens case. When shipped "wet", the lenses are packaged non-sterile in Boston SIMPLUS® Multi-Action Solution.
The provided document is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the BostonSight® Specialty Lenses to existing predicate devices. It does not present a study proving the device meets specific acceptance criteria based on performance data. Instead, it relies on the predicate pathway, meaning the device is considered safe and effective because it is similar in design, materials, and intended use to devices already on the market.
Therefore, many of the requested elements for a study proving the device meets acceptance criteria (such as sample size, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this type of regulatory submission.
However, based on the information provided, here's what can be inferred or stated regarding "acceptance criteria" through the lens of substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
The "acceptance criteria" in this context are primarily the material properties and physical parameters that establish similarity to predicate devices already cleared by the FDA. The performance is assessed by demonstrating these properties are within acceptable ranges, consistent with the predicates.
| Acceptance Criteria (Based on Predicate Equivalence) | Reported Device Performance (BostonSight® Specialty Lenses) |
|---|---|
| Intended Use | Daily Wear, Correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic/non-aphakic persons with non-diseased eyes, and therapeutic use for irregular corneal conditions/ocular surface disorders. |
| Classification | Class II, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) |
| Product Code | HQD |
| FDA Material Group | Group #3 Fluoro Silicone Acrylate |
| USAN Materials | roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A |
| Production Method | Lathe Cut |
| Water Content | <1% |
| UV Absorber | Yes |
| Oxygen Permeability (Dk) | Varies by material (e.g., roflufocon D: 100, roflufocon E: 125, tisilfocon A: 180, hexafocon B: 141, oprifocon A: 85, fluoroxyfocon A: 200) - All values are consistent with the ranges of predicate devices and their established safety/effectiveness. |
| Refractive Index | Varies by material (e.g., roflufocon D: 1.4333, tisilfocon A: 1.4378) - Consistent with predicate materials. |
| Light Transmission (clear) | >97% (roflufocon D, E), >95% (hexafocon B, oprifocon A) - Consistent with predicate materials. |
| Light Transmission (tinted) | >90% (roflufocon D, E, oprifocon A), >91% (tisilfocon A), >83% (hexafocon B), >87% (fluoroxyfocon A) - Consistent with predicate materials. |
| Dynamic Receding Contact Angle | Varies by material (e.g., roflufocon D: 3°, hexafocon B: 40°, oprifocon A: 56°) - Consistent with predicate materials. |
| Tangible® Hydra-PEG Availability | Yes (for all materials except oprifocon A) |
| Base Curve Range | 5.00mm to 11.5mm |
| Center Thickness Range | 0.05mm to 0.75mm |
| Chord Diameter Range | 7.00mm to 26.00mm |
| Spherical Power Range | -25.00 D to +35.00 D |
| Cylindrical Power Range | Up to -10.00 D |
| Cylindrical Axis Range | 1° to 180° |
| Multifocal Power Range | +1.00 D to 4.00 D |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This submission relies on "Non-Clinical Studies" and "Clinical Studies" sections where it explicitly states that the safety and effectiveness have been "addressed by reference to previous 510(k) clearances." No new specific test set or clinical study data is presented for this particular submission.
- Data Provenance: The underlying data for the predicate devices would have come from their respective clearance processes. This document does not provide details on the provenance (country of origin, retrospective/prospective) of those original predicate studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no new test set data is presented. The "ground truth" for the predicate pathway is essentially the FDA's prior determination of safety and effectiveness for the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no new test set data is presented.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted device. Also, this is a substantial equivalence submission, not a new clinical trial comparing performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a contact lens, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this 510(k) submission, the "ground truth" is the established safety and effectiveness of the identified predicate devices, as previously determined by the FDA. The manufacturer is asserting that their new device is fundamentally similar in materials, design, and intended use, and therefore shares that established safety and effectiveness profile.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device.
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Image /page/0/Picture/0 description: The image shows 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.
August 14, 2024
Boston Foundation for Sight, Inc. d/b/a BostonSight Sara Yost President & CEO 464 Hillside Ave Suite 205 Needham, MA 02494
Re: K241571
Trade/Device Name: BostonSight® Specialty Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: May 31, 2024 Received: June 18, 2024
Dear Sara Yost:
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.
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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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 (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/postmarketingsafety-reporting-combination-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-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.
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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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241571
Device Name
BostonSight® Specialty Lenses (roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A)
Indications for Use (Describe)
The BostonSight® Specialty Lenses (roflufocon D, roflufocon A. hexafocon B, oprifocon A, fluoroxyfocon A) for daily wear are indicated for the correction of refractive ametropia (myopia, astigmatism, and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed in otherwise nondiseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery.
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment, and the saline bath provided by scleral lens designs.
The BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Siögren's syndrome, dry eve syndrome and Filamentary Kerattis, limbal stem 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), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment.
Additionally, the BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use for the management of irregular and distorted corneal surfaces. Common causes of corneal distorion include, but are not limited to, corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy). When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Specialty Scleral Lenses for daily wear may concurrently provide correction of refractive error.
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.
| 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.
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K241571
I. SUBMITTER
| Date Prepared: | May 31, 2024 |
|---|---|
| Name:Address: | BostonSight464 Hillside Avenue, Suite 205Needham, MA 02494 |
| Contact Person: | Sara A. YostPresident and CEO |
781-726-7337
II. DEVICE
Phone number:
| Trade Name: | BostonSight® Specialty Lenses(roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifoconA, fluoroxyfocon 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 |
III. REASON FOR SUBMISSION
The reason for submitting this 510(k) application for the BostonSight® Specialty Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A) for daily wear is to combine all approved FDA Group #3 fluoro-silicone acrylate rigid gas permeable (RGP) lens materials and Tangible® Hydra-PEG coating for the approved materials (roflufocon D, roflufocon E, tisilfocon A, hexafocon B, fluoroxyfocon A) into one 510(k), Package Insert and Patient Information Booklet. Additionally, the Package Insert and Patient Information Booklet have been reorganized and clarified to provide a more structured approach to care, disinfection, and handling of BostonSight Specialty Lenses.
IV. PREDICATE DEVICES
The BostonSight® Specialty Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A. fluoroxyfocon A) for daily wear are substantially equivalent to the following predicate devices:
- "BostonSight Scleral" By BostonSight 510(k) number: K183175
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Product Code: HQD
- o "OPTIMUM GP (roflufocon D, roflufocon E) Daily Wear Contact Lens; HEXA100 (hexafocon A) Daily Wear Contact Lens" By Contamac Ltd. 510(k) number: K180616 Product Code: HQD
- "Hyper GP (tisilfocon A) Daily Wear Contact Lens" By Contamac Ltd. 510(k) number: K212631 Product Code: HQD
- "Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon ● A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses" By Bausch + Lomb Inc. 510(k) number; K183167 Product Code: HQD
- "Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ ● (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG (hexafocon A) Rigid Gas Permeable Contact Lens" By Acuity Polymers, Inc. 510(k) number; K240618 Product Code: HQD
V. DEVICE DESCRIPTION
The BostonSight® Specialty Lenses for daily wear are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate rigid gas permeable (RGP) lens materials:
- roflufocon D supplied by Contamac Ltd.
- roflufocon E supplied by Contamac Ltd. ●
- tisilfocon A supplied by Contamac Ltd ●
- hexafocon B supplied by Bausch and Lomb, Inc.
- oprifocon A supplied by Bausch and Lomb, Inc. ●
- fluoroxyfocon A supplied by Acuity Polymers, Inc. o
The BostonSight Specialty Lenses for daily wear fabricated from roflufocon D, roflufocon E, tisilfocon A, hexafocon B, fluoroxyfocon A are available with or without Tangible® Hydra-PEG, which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical and optical properties of the underlying material. The BostonSight Specialty Lenses for daily wear fabricated from oprifocon A are not available with Tangible® Hydra-PEG.
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The BostonSight Specialty Lenses for daily wear may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight Specialty Lenses for daily wear is the Bausch & Lomb "US Lens Case W&B", with clearance under 510(k) K013232. When shipped "wet", the BostonSight Specialty Lenses for daily wear are packaged non-sterile in Boston SIMPLUS® Multi-Action Solution (K024289).
| roflufocon D | roflufocon E | tisilfocon A | hexafocon B | oprifocon A | fluoroxyfocon A | |
|---|---|---|---|---|---|---|
| Refractive Index | 1.4333 | 1.4332 | 1.4378 | 1.4240 | 1.4230 | 1.430 |
| LightTransmission(clear) | >97% | >97% | - | >95% | >95% | - |
| LightTransmission(tinted) | >90% | >90% | >91% | >83% | >90% | >87% |
| Water Content | <1% | <1% | <1% | <1% | <1% | <1% |
| Specific Gravity | 1.166 | 1.155 | 1.20 | 1.19 | 1.24 | 1.18 |
| OxygenPermeability(Dk)ISO/FATT Method | $100 x 10^{-11}$(cm²/sec) (mlO₂/ml x mm Hg@ 35°C) | $125 x 10^{-11}$(cm²/sec) (mlO₂/ml x mm Hg@ 35°C) | $180 x 10^{-11}$(cm²/sec) (mlO₂/ml x mm Hg@ 35°C) | $141 x 10^{-11}$(cm²/sec) (mlO₂/ml x mm Hg@ 35°C) | $85 x 10^{-11}$(cm²/sec) (mlO₂/ml x mm Hg@ 35°C) | $200 x 10^{-11}$(cm²/sec) (mlO₂/ml x mm Hg@ 35°C) |
| Contain one ormore of thefollowing coloradditivesconforming to: 21CFR Part 73 & 74,Subpart D | D & C GreenNo. 6, FD & CRed No. 17,CI SolventYellow 18 | D & C GreenNo. 6, FD & CRed No. 17, CISolvent Yellow18 | D&C GreenNo. 6, C.I.SolventYellow No.18, D&CViolet No. 2,D&C RedNo. 17 | D&C GreenNo. 6, C.I.SolventYellow No.18, D&CViolet No. 2,D&C RedNo.17 | D&C GreenNo.6, D&CYellowNo.18 | D&C GreenNo. 6, D&CViolet No. 2,SolventYellow 18,D&C Red No.17 |
| UV Light Blocking | Yes | Yes | Yes | Yes | Yes | Yes |
| DynamicRecedingContact Angle | 3° | 6° | - | 40° | 56° | - |
| Tangible®Hydra-PEGAvailable | Yes | Yes | Yes | Yes | No | Yes |
The physical properties of the BostonSight Specialty Lenses for daily wear are as follows:
The BostonSight Specialty Lenses for daily wear are available in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 5.00mm to 11.5mm | ± 0.05 mm |
| Center Thickness | 0.05mm to 0.75mm | ±0.02 mm |
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| Chord Diameter | 7.00mm to 26.00mm | ± 0.10mm |
|---|---|---|
| Spherical Power | -25.00 D to +35.00 D(in 0.25D 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 | Up to -10.00 D(in 0.25 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° |
| Multifocal Power | +1.00 D to 4.00 D(in 0.25 D steps) | ± 0.25D |
VI. INDICATIONS FOR USE
The BostonSight® Specialty Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A) for daily wear are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery.
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment, and the saline bath provided by scleral lens designs.
The BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graftversus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis, limbal stem 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), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment.
Additionally, the BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use for the management of irregular and distorted corneal surfaces. Common causes of corneal distortion include, but are not limited to, corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy,
{9}------------------------------------------------
Reis-Bucklers dystrophy, Cogan's dystrophy). When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Specialty Scleral Lenses for daily wear may concurrently provide correction of refractive error.
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.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
The BostonSight® Specialty Lenses for daily wear are substantially equivalent to the predicate device, BostonSight SCLERAL, cleared under K183175, in terms of the following:
| Intended Use: | Daily wear contact lenses |
|---|---|
| Classification: | Class II, Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) |
| Product Code: | HQD |
| FDA Material Group: | Group # 3 fluoro silicone acrylate |
| USAN Materials: | roflufocon D, roflufocon E, oprifocon A and hexafocon B |
| Production method: | Lathe cut |
| Actions | |
| Indications for use | |
| Final Packing and Shipping | |
| Manufacturing facility, procedures, and controls |
The BostonSight Specialty Lenses for daily wear are substantially equivalent to the predicate device, OPTIMUM GP (roflufocon D, roflufocon E) Daily Wear Contact Lens; HEXA100 (hexafocon A) Daily Wear Contact Lens, cleared under K180616, in terms of the following:
| Intended Use: | Daily wear contact lenses |
|---|---|
| Classification: | Class II, Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) |
| Product Code: | HQD |
| FDA Material Group: | Group # 3 fluoro silicone acrylate |
| USAN Materials: | roflufocon D, roflufocon E |
| Production method: | Lathe cut |
| Actions: | |
| Indications for use: |
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The BostonSight Specialty Lenses for daily wear are substantially equivalent to the predicate device, Hyper GP (tisilfocon A) Daily Wear Contact Lens, cleared under K212631, in terms of the following:
| Intended Use: | Daily wear contact lenses |
|---|---|
| Classification: | Class II, Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) |
| Product Code: | HQD |
| FDA Material Group: | Group # 3 fluoro silicone acrylate |
| USAN Materials: | tisilfocon A |
| Production method: | Lathe cut |
The BostonSight Specialty Lenses for daily wear are substantially equivalent to the predicate device, Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses, cleared under K183167, in terms of the following:
| Intended Use: | Daily wear contact lenses |
|---|---|
| Classification: | Class II, Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) |
| Product Code: | HQD |
| FDA Material Group: | Group # 3 fluoro silicone acrylate |
| USAN Materials: | hexafocon B |
| Production method: | Lathe cut |
| Actions | |
| Indications for use |
The BostonSight Specialty Lenses for daily wear are substantially equivalent to the predicate device, Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG (hexafocon A) Rigid Gas Permeable Contact Lens, cleared under K240618, in terms of the following:
| Intended Use: | Daily wear contact lenses |
|---|---|
| Classification: | Class II, Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916) |
| Product Code: | HQD |
| FDA Material Group: | Group # 3 fluoro silicone acrylate |
| USAN Materials: | fluoroxyfocon A |
| Production method: | Lathe cut |
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Actions Indications for use
The following matrix illustrates the production method, lens function and material characteristics of the BostonSight Specialty Lenses for daily wear, as well as the predicate devices.
| Predicate | Predicate | Predicate | Predicate | Predicate | ||
|---|---|---|---|---|---|---|
| Subject Device | Device | Device | Device | Device | Device | |
| Trade Name | BostonSight®SpecialtyLenses | BostonSightSCLERAL | OPTIMUM GPDaily WearContact Lens;HEXA100 DailyWear ContactLens | Hyper GP DailyWear ContactLens | Boston ES®,Boston EO®,Boston XO®, andBoston XO2®Rigid GasPermeableContact Lenses | Acuity 200™Rigid GasPermeableContact Lens;Acuity 100™Rigid GasPermeableContact Lens;Acuity 200™ withTangible®Hydra-PEG RigidGas PermeableContact Lens;Acuity 100™ withTangible®Hydra-PEG RigidGas PermeableContact Lens |
| 510(K)Number | - | K183175 | K180616 | K212631 | K183167 | K240618 |
| Intended Use | Daily Wear | Daily Wear | Daily Wear | Daily Wear | Daily Wear | Daily Wear |
| Classification | Class II Lenses,Rigid GasPermeable,Daily Wear 21CFR 886.5916 | Class II Lenses,Rigid GasPermeable,Daily Wear 21CFR 886.5916 | Class II Lenses,Rigid GasPermeable,Daily Wear 21CFR 886.5916 | Class II Lenses,Rigid GasPermeable,Daily Wear 21CFR 886.5916 | Class II Lenses,Rigid GasPermeable,Daily Wear 21CFR 886.5916 | Class II Lenses,Rigid GasPermeable,Daily Wear 21CFR 886.5916 |
| Product Code | HQD | HQD | HQD | HQD | HQD | HQD |
| FDA Group # | Group # 3Fluoro SiliconeAcrylate | Group # 3Fluoro SiliconeAcrylate | Group # 3Fluoro SiliconeAcrylate | Group # 3Fluoro SiliconeAcrylate | Group # 3Fluoro SiliconeAcrylate | Group # 3Fluoro SiliconeAcrylate |
Substantial Equivalence Matrix
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| Material(USAN) | roflufocon D,roflufocon E,oprifocon A,hexafocon B,tisilfocon A,fluoroxyfocon A | roflufocon D,roflufocon E,oprifocon A,hexafocon B | roflufocon D,roflufocon E,hexafocon A | tisilfocon A | enflufocon A,enflufocon B,hexafocon A,hexafocon B | fluoroxyfocon A,hexafocon A |
|---|---|---|---|---|---|---|
| WaterContent (%) | <1% | <1% | <1% | <1% | <1% | <1% |
| UV AbsorberAvailable | Yes | Yes | Yes | Yes | Yes | Yes |
| Actions | The contact lensesact as a refractivemedium that focuslight rays from nearand distant objectson the retina. Whenplaced on the eyefor therapeutic use,the lens replaces orsupports impairedocular surfacefunction. | The contact lensesact as a refractivemedium that focuslight rays from nearand distant objectson the retina. Whenplaced on the eyefor therapeutic use,the lens replaces orsupports impairedocular surfacefunction. | The contact lensesact as a refractivemedium that focuslight rays from nearand distant objectson the retina. Whenplaced on the eyefor therapeutic use,the lens replaces orsupports impairedocular surfacefunction. | The contact lensesact as a refractivemedium that focuslight rays from nearand distant objectson the retina. Whenplaced on the eyefor therapeutic use,the lens replaces orsupports impairedocular surfacefunction. | The contact lensesact as a refractivemedium that focuslight rays from nearand distant objectson the retina. Whenplaced on the eyefor therapeutic use,the lens replaces orsupports impairedocular surfacefunction. | The contact lensesact as a refractivemedium that focuslight rays from nearand distant objectson the retina. Whenplaced on the eyefor therapeutic use,the lens replaces orsupports impairedocular surfacefunction. |
| ProductionMethod | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| IncludesHydra-PEGSurfaceCoating | Yes | No | Yes | Yes | Yes | Yes |
| BostonSight® SpecialtyLenses(Subject Device) | Indications for Use |
|---|---|
| The BostonSight Specialty Lenses for daily wear are indicated for the correction of refractiveametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and non-aphakic personswith non-diseased eyes. The lenses may be prescribed in otherwise non-diseased eyes that require agas permeable contact lens for the management of irregular corneal conditions such askeratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractivesurgery. | |
| Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physicalprotection, aqueous hydrated environment, and the saline bath provided by scleral lens designs. | |
| The BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated fortherapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis, limbal stemcell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders ofthe skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpeszoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefitfrom the presence of an expanded tear reservoir and protection against an adverse environment. | |
| Additionally, the BostonSight Specialty Lenses for daily wear in the scleral lens designs areindicated for therapeutic use for the management of irregular and distorted corneal surfaces.Common causes of corneal distortion include, but are not limited to, corneal infections, trauma, | |
| tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Specialty Scleral Lenses for daily wear may concurrently provide | |
| correction of refractive error. | |
| The lens may be disinfected using a chemical disinfection (not heat) system only. | |
| BostonSight SCLERAL(K183175) | BostonSight Scleral daily wear contact lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non aphakic persons. Also, the lenses may be prescribed in eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, keratoglobus, post-LASIK ectasia, or following penetrating keratoplasty or refractive surgery. |
| Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. BostonSight Scleral daily wear contact lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject: | |
| 1. cannot be adequately corrected with spectacle lenses2. requires a rigid gas permeable contact lens surface to improve vision3. 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 scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and | |
| corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). | |
| The BostonSight Scleral daily wear contact lenses are also indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis, limbal stem 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), 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 a distorted cornea or ocular surface disease, the BostonSight Scleral daily wear contact lenses may concurrently provide correction of refractive error. | |
| The lenses may be disinfected using a chemical disinfection (not heat) system only. | |
| OPTIMUM GP Daily WearContact Lens; HEXA100Daily Wear Contact Lens(K180616) | OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery. |
| Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. | |
| Optimum Infinite(tisilfocon A) Daily WearContact Lenses(K212631) | are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:1. cannot be adequately corrected with spectacle lenses2. requires a rigid gas permeable contact lens surface to improve vision3. 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 scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). | |
| The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem 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), 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 a distorted cornea or ocular surface disease, the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses may concurrently provide correction of refractive error. | |
| The lenses may be disinfected using a chemical disinfection (not heat) system only. | |
| The Optimum Infinite (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. | |
| The Optimum Infinite (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. | |
| The Optimum Infinite (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. | |
| The Optimum Infinite (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. | |
| The Optimum Infinite (tisilfocon A) ORTHOKERA TOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. | |
| Boston ES®, Boston EO®,Boston XO® and BostonXO2® Rigid GasPermeable ContactLenses(K183167) | Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physicalprotection, aqueous hydrated environment and the saline bath provided by scleral lens designs.Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for themanagement of irregular and distorted corneal surfaces where the subject:1. cannot be adequately corrected with spectacle lenses2. requires a rigid gas permeable contact lens surface to improve vision3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surfaceirregularitiesCommon causes of corneal distortion include but are not limited to corneal infections, trauma,tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radialkeratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g.keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) andcorneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy,Cogan's dystrophy).The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes withocular surface disease (e.g. ocular Graft-versus-Host disease, Sjogren's syndrome, dry eyesyndrome and Filamentary Keratitis), limbal stem 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), and cornealexposure (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 adistorted cornea or ocular surface disease, the Optimum Infinite (tisilfocon A) SCLERAL lenses mayconcurrently provide correction of refractive error.Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, withcleaning, disinfection and scheduled replacement. When prescribed for frequent/plannedreplacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens caresystem.The Boston ES® (enflufocon A) and Boston EO® (enflufocon B), Contact Lenses are indicated for dailywear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) inaphakic and non-aphakic persons with non-diseased eyes. Also, the lenses may be prescribed inotherwise non-diseased eyes that require a gas permeable contact lens for the management ofirregular corneal conditions such as keratoconus, pellucid marginal degeneration, or followingpenetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected using achemical disinfection system only.The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses are indicated fordaily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism andpresbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Also, the lenses may beprescribed in otherwise non-diseased eyes that require a gas permeable contact lens for themanagement of irregular corneal conditions such as keratoconus, pellucid marginal degeneration,or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may bedisinfected using a chemical disinfection system only.Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physicalprotection, aqueous hydrated environment and the saline bath provided by scleral lens designs. |
| The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses (Scleral) for dailywear are indicated for therapeutic use for the management of irregular and distorted cornealsurfaces where the subject: | |
| 1. cannot be adequately corrected with spectacle lenses2. requires a rigid gas permeable contact lens surface to improve vision3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surfaceirregularities | |
| Common causes of corneal distortion include but are not limited to corneal infections, trauma,tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radialkeratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g.keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) andcorneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy,Cogan's dystrophy). | |
| The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Scleral Lens designs for daily wearare also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versusHost disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stemcell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders ofthe skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpeszoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefitfrom the presence of an expanded tear reservoir and protection against an adverse environment.When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonScleral Lenses may concurrently provide correction of refractive error. | |
| The lenses may be disinfected using a chemical disinfection (not heat) system only. | |
| Acuity 200™, Acuity 100™,Acuity 200™ withTangible® Hydra-PEG,and Acuity 100™ withTangible® Hydra-PEGRigid Gas PermeableContact Lenses(K240618) | The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG(fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG Rigid Gas Permeable Contact Lensesare indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopiaand/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses maybe prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for themanagement of irregular corneal conditions such as keratoconus, pellucid marginal degeneration,or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. |
| The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG(fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG Rigid Gas Permeable Contact Lensesare also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem celldeficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of theskin (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 thepresence of an expanded tear reservoir and protection against an adverse environment. Whenprescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens mayconcurrently provide correction of refractive error. | |
| The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG(fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG Rigid Gas Permeable Contact Lensesmay be cleaned and disinfected using a chemical (not heat) lens care system. |
Indications for Use
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VIII. PERFORMANCE DATA
~ Non-Clinical Studies ~
Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, and fluoroxyfocon A materials has been addressed by reference to previous 510(k) clearances.
~ Clinical Studies ~
Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A with the labeled indications for use has been addressed through previous 510(k) clearances.
IX. CONCLUSIONS
Substantial Equivalence
Information presented in this premarket notification establishes that BostonSight® Specialty Lenses for daily wear are as safe and effective as the predicate devices 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.