BostonSight® Specialty Lenses

K241571 · Boston Foundation For Sight, Inc. D/B/A Bostonsight · HQD · Aug 14, 2024 · Ophthalmic

Device Facts

• Record ID: K241571
• Device Name: BostonSight® Specialty Lenses
• Applicant: Boston Foundation For Sight, Inc. D/B/A Bostonsight
• Product Code: HQD · Ophthalmic
• Decision Date: Aug 14, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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. 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, 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.

Device Story

Lathe-cut rigid gas permeable (RGP) contact lenses; fabricated from fluoro-silicone acrylate materials (roflufocon D/E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A). Some variants include Tangible® Hydra-PEG surface coating to enhance wettability. Used by eye care practitioners to correct refractive error or provide therapeutic protection for irregular corneas and ocular surface diseases. Lenses provide physical protection, aqueous hydrated environment, and expanded tear reservoir. Prescribed for daily wear; cleaned/disinfected via chemical systems. Benefits include improved vision for distorted corneas and protection against adverse environments for diseased ocular surfaces.

Clinical Evidence

No clinical data presented. Safety and effectiveness are established by reference to previous 510(k) clearances for the constituent materials and lens designs.

Technological Characteristics

Lathe-cut RGP lenses; FDA Group #3 fluoro-silicone acrylate materials. Available with/without Tangible® Hydra-PEG (PEG-based polymer) surface coating. UV blocking included. Water content <1%. Oxygen permeability (Dk) varies by material (85-200 x 10^-11). Chemical disinfection only.

Indications for Use

Indicated for correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic/non-aphakic persons. Also indicated for therapeutic use in eyes with irregular corneal conditions (e.g., keratoconus, pellucid marginal degeneration, post-surgical/trauma distortion) and ocular surface diseases (e.g., GVHD, Sjögren's, dry eye, limbal stem cell deficiency, neurotrophic keratitis, corneal exposure).

Regulatory Classification

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.

Predicate Devices

• BostonSight Scleral (K183175)
• OPTIMUM GP (roflufocon D, roflufocon E) Daily Wear Contact Lens; HEXA100 (hexafocon A) Daily Wear Contact Lens (K180616)
• Hyper GP (tisilfocon A) Daily Wear Contact Lens (K212631)
• Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses (K183167)
• 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 (K240618)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size:10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# K241571

# I. SUBMITTER

| Date Prepared: | May 31, 2024 |
|-------------------|--------------------------------------------------------------------|
| Name:<br>Address: | BostonSight<br>464 Hillside Avenue, Suite 205<br>Needham, MA 02494 |
| Contact Person: | Sara A. Yost<br>President and CEO |

781-726-7337

# II. DEVICE

Phone number:

| Trade Name: | BostonSight® Specialty Lenses<br>(roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon<br>A, 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 |
| Light<br>Transmission<br>(clear) | >97% | >97% | - | >95% | >95% | - |
| Light<br>Transmission<br>(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 |
| Oxygen<br>Permeability<br>(Dk)<br>ISO/FATT Method | $100 x 10^{-11}$<br>(cm²/sec) (ml<br>O₂/ml x mm Hg<br>@ 35°C) | $125 x 10^{-11}$<br>(cm²/sec) (ml<br>O₂/ml x mm Hg<br>@ 35°C) | $180 x 10^{-11}$<br>(cm²/sec) (ml<br>O₂/ml x mm Hg<br>@ 35°C) | $141 x 10^{-11}$<br>(cm²/sec) (ml<br>O₂/ml x mm Hg<br>@ 35°C) | $85 x 10^{-11}$<br>(cm²/sec) (ml<br>O₂/ml x mm Hg<br>@ 35°C) | $200 x 10^{-11}$<br>(cm²/sec) (ml<br>O₂/ml x mm Hg<br>@ 35°C) |
| Contain one or<br>more of the<br>following color<br>additives<br>conforming to: 21<br>CFR Part 73 & 74,<br>Subpart D | D & C Green<br>No. 6, FD & C<br>Red No. 17,<br>CI Solvent<br>Yellow 18 | D & C Green<br>No. 6, FD & C<br>Red No. 17, CI<br>Solvent Yellow<br>18 | D&C Green<br>No. 6, C.I.<br>Solvent<br>Yellow No.<br>18, D&C<br>Violet No. 2,<br>D&C Red<br>No. 17 | D&C Green<br>No. 6, C.I.<br>Solvent<br>Yellow No.<br>18, D&C<br>Violet No. 2,<br>D&C Red<br>No.<br>17 | D&C Green<br>No.6, D&C<br>Yellow<br>No.18 | D&C Green<br>No. 6, D&C<br>Violet No. 2,<br>Solvent<br>Yellow 18,<br>D&C Red No.<br>17 |
| UV Light Blocking | Yes | Yes | Yes | Yes | Yes | Yes |
| Dynamic<br>Receding<br>Contact Angle | 3° | 6° | - | 40° | 56° | - |
| Tangible®<br>Hydra-PEG<br>Available | 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<br>(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<br>(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<br>(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,

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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®<br>Specialty<br>Lenses | BostonSight<br>SCLERAL | OPTIMUM GP<br>Daily Wear<br>Contact Lens;<br>HEXA100 Daily<br>Wear Contact<br>Lens | Hyper GP Daily<br>Wear Contact<br>Lens | Boston ES®,<br>Boston EO®,<br>Boston XO®, and<br>Boston XO2®<br>Rigid Gas<br>Permeable<br>Contact Lenses | Acuity 200™<br>Rigid Gas<br>Permeable<br>Contact Lens;<br>Acuity 100™<br>Rigid Gas<br>Permeable<br>Contact Lens;<br>Acuity 200™ with<br>Tangible®<br>Hydra-PEG Rigid<br>Gas Permeable<br>Contact Lens;<br>Acuity 100™ with<br>Tangible®<br>Hydra-PEG Rigid<br>Gas Permeable<br>Contact Lens |
| 510(K)<br>Number | - | K183175 | K180616 | K212631 | K183167 | K240618 |
| Intended Use | Daily Wear | Daily Wear | Daily Wear | Daily Wear | Daily Wear | Daily Wear |
| Classificatio<br>n | Class II Lenses,<br>Rigid Gas<br>Permeable,<br>Daily Wear 21<br>CFR 886.5916 | Class II Lenses,<br>Rigid Gas<br>Permeable,<br>Daily Wear 21<br>CFR 886.5916 | Class II Lenses,<br>Rigid Gas<br>Permeable,<br>Daily Wear 21<br>CFR 886.5916 | Class II Lenses,<br>Rigid Gas<br>Permeable,<br>Daily Wear 21<br>CFR 886.5916 | Class II Lenses,<br>Rigid Gas<br>Permeable,<br>Daily Wear 21<br>CFR 886.5916 | Class II Lenses,<br>Rigid Gas<br>Permeable,<br>Daily Wear 21<br>CFR 886.5916 |
| Product Code | HQD | HQD | HQD | HQD | HQD | HQD |
| FDA Group # | Group # 3<br>Fluoro Silicone<br>Acrylate | Group # 3<br>Fluoro Silicone<br>Acrylate | Group # 3<br>Fluoro Silicone<br>Acrylate | Group # 3<br>Fluoro Silicone<br>Acrylate | Group # 3<br>Fluoro Silicone<br>Acrylate | Group # 3<br>Fluoro Silicone<br>Acrylate |

# Substantial Equivalence Matrix

{12}------------------------------------------------

| Material<br>(USAN) | roflufocon D,<br>roflufocon E,<br>oprifocon A,<br>hexafocon B,<br>tisilfocon A,<br>fluoroxyfocon A | roflufocon D,<br>roflufocon E,<br>oprifocon A,<br>hexafocon B | roflufocon D,<br>roflufocon E,<br>hexafocon A | tisilfocon A | enflufocon A,<br>enflufocon B,<br>hexafocon A,<br>hexafocon B | fluoroxyfocon A,<br>hexafocon A |
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| Water<br>Content (%) | <1% | <1% | <1% | <1% | <1% | <1% |
| UV Absorber<br>Available | Yes | Yes | Yes | Yes | Yes | Yes |
| Actions | The contact lenses<br>act as a refractive<br>medium that focus<br>light rays from near<br>and distant objects<br>on the retina. When<br>placed on the eye<br>for therapeutic use,<br>the lens replaces or<br>supports impaired<br>ocular surface<br>function. | The contact lenses<br>act as a refractive<br>medium that focus<br>light rays from near<br>and distant objects<br>on the retina. When<br>placed on the eye<br>for therapeutic use,<br>the lens replaces or<br>supports impaired<br>ocular surface<br>function. | The contact lenses<br>act as a refractive<br>medium that focus<br>light rays from near<br>and distant objects<br>on the retina. When<br>placed on the eye<br>for therapeutic use,<br>the lens replaces or<br>supports impaired<br>ocular surface<br>function. | The contact lenses<br>act as a refractive<br>medium that focus<br>light rays from near<br>and distant objects<br>on the retina. When<br>placed on the eye<br>for therapeutic use,<br>the lens replaces or<br>supports impaired<br>ocular surface<br>function. | The contact lenses<br>act as a refractive<br>medium that focus<br>light rays from near<br>and distant objects<br>on the retina. When<br>placed on the eye<br>for therapeutic use,<br>the lens replaces or<br>supports impaired<br>ocular surface<br>function. | The contact lenses<br>act as a refractive<br>medium that focus<br>light rays from near<br>and distant objects<br>on the retina. When<br>placed on the eye<br>for therapeutic use,<br>the lens replaces or<br>supports impaired<br>ocular surface<br>function. |
| Production<br>Method | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| Includes<br>Hydra-PEG<br>Surface<br>Coating | Yes | No | Yes | Yes | Yes | Yes |

| BostonSight® Specialty<br>Lenses<br>(Subject Device) | Indications for Use |
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| | The BostonSight Specialty Lenses for daily wear are indicated for the correction of refractive<br>ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and non-aphakic persons<br>with non-diseased eyes. The lenses may be prescribed in otherwise non-diseased eyes that require a<br>gas permeable contact lens for the management of irregular corneal conditions such as<br>keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive<br>surgery. |
| | Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical<br>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<br>therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-<br>versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis, limbal stem<br>cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of<br>the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes<br>zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit<br>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<br>indicated for therapeutic use for the management of irregular and distorted corneal surfaces.<br>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 <b>BostonSight Specialty Scleral Lenses</b> for daily wear may concurrently provide…