Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens

K183167 · Bausch & Lomb, Incorporated · HQD · Feb 12, 2019 · Ophthalmic

Device Facts

• Record ID: K183167
• Device Name: Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens
• Applicant: Bausch & Lomb, Incorporated
• Product Code: HQD · Ophthalmic
• Decision Date: Feb 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Boston ES® (enflufocon A) and Boston EO® (enflufocon B), Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, 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 gas permeable contact 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 lenses may be disinfected using a chemical disinfection system only. The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, 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 gas permeable contact 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 lenses may be disinfected using a chemical disinfection system only. 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 Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses (Scleral) for daily wear are indicated for therapeutic use for the management of irregular and 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 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 Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Scleral Lens designs for daily wear 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 Boston Scleral Lenses may concurrently provide correction of refractive error. The lenses may be disinfected using a chemical disinfection (not heat) system only.

Device Story

Lathe-cut rigid gas permeable (RGP) contact lenses; manufactured from fluorosilicone acrylate copolymers (enflufocon A/B, hexafocon A/B); treated with Tangible Hydra-PEG, a covalently bonded polyethylene glycol (PEG)-based polymer coating. Coating enhances surface wettability (reduced contact angle) while maintaining mechanical properties of base material. Prescribed by eye care professionals for daily wear; used for refractive correction or therapeutic management of corneal irregularities and ocular surface diseases. Provides physical protection, expanded tear reservoir, and saline bath (scleral designs). Patient benefits include improved vision and ocular surface protection. Chemical disinfection only.

Clinical Evidence

No new clinical data provided. Clinical safety and effectiveness were established by predicate devices and previous clinical demonstrations of Hydra-PEG treated lenses. Non-clinical testing included GLP-compliant toxicology, biocompatibility, bioburden, and accelerated aging stability studies.

Technological Characteristics

Lathe-cut thermoset fluorosilicone acrylate copolymers. Surface modified with covalently bonded polyethylene glycol (PEG)-based polymer (Tangible Hydra-PEG). Water content <1%. Sessile drop contact angle reduced from ~60° (uncoated) to ~10° (coated). Chemical disinfection only; heat disinfection contraindicated.

Indications for Use

Indicated for daily wear for correction of refractive ametropia (myopia, astigmatism, presbyopia) in aphakic/non-aphakic persons with non-diseased eyes; management of irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-keratoplasty, post-refractive surgery); and therapeutic use for ocular surface disease, limbal stem cell deficiency, neurotrophic keratitis, and 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

• Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses (K053124, K013762, K071266, K071043, K171404)
• Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses (K161100)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 12, 2019

Bausch & Lomb, Incorporated % Mr. Bret Andre Principal Consultant EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068

Re: K183167

Trade/Device Name: Boston ES® (enflufocon A); Boston EO® (enflufocon B); Boston XO® (hexafocon A); and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: January 11, 2019 Received: January 15, 2019

Dear Mr. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely yours,

# J Angelo Green -S

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

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K183167

### Device Name

Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses

### Indications for Use (Describe)

The Boston ES® (enflufocon A) and Boston EO® (enflufocon B), Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, 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 gas permeable contact 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 lenses may be disinfected using a chemical disinfection system only.

The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, 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 gas permeable contact 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 lenses may be disinfected using a chemical disinfection system only.

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 Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses (Scleral) for daily wear are indicated for therapeutic use for the management of irregular and 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 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 Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Scleral Lens designs for daily wear 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 Keratits), 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 Boston Scleral Lenses may concurrently provide correction of refractive error.

The lenses may be disinfected using a chemical disinfection (not heat) system only.

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### Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# BAUSCH- Health 510(k) Premarket Notification

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

K183167 The assigned 510(k) number is:

#### I. SUBMITTER

| Date Prepared: | November 1st, 2018 |
|----------------|--------------------|
|----------------|--------------------|

| Name:<br>Address: | Bausch & Lomb Incorporated<br>1400 North Goodman St.<br>Rochester, NY 14609<br>United States |
|-------------------|----------------------------------------------------------------------------------------------|
| Contact Person: | Glenn A. Davies<br>Director Global Regulatory Affairs |
| Phone number: | [phone] |
| Consultant: | Bret Andre<br>EyeReg Consulting, Inc.<br>6119 Canter Ln.<br>West Linn, OR 97068 |
| Phone number: | [phone] |

#### II. DEVICE

| Trade Name: | Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon<br>A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Common<br>Name: | Daily wear rigid gas permeable contact lens |
| Classification<br>Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| Regulatory<br>Class: | Class II |
| Product Code: | HQD |

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# Purpose of 510(k) Submission:

Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses-cleared under 510(k) K053124, K013762. K071266. K071043 and K171404-are modified to include the Tangible™ Hydra-PEG surface coating-which is a thin, polyethylene glycol (PEG)-based polymer designed to improve the wettability of the contact lenses. Specifically, Tangible Hydra-PEG treated contact lenses demonstrate a measurable improvement in the contact angle compared to untreated lenses.

#### III. PREDICATE DEVICE

The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses with Tangible™ Hydra-PEG are substantially equivalent to the following predicate devices:

- "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 Incorporated 510(k) numbers; K053124, K013762, K071266, K071043 and K171404
- . "Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lenses" By Contamac Ltd. 510(k) number; K161100 -reference predicate

#### IV. DEVICE DESCRIPTION

Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from the currently marketed contact lens materials: enflufocon A, enflufocon B, and hexafocon B. Non-proprietary names were assigned by the United States Adopted Names Council (USAN). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lenses may be available with an ultraviolet absorber.

The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are treated to incorporate 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 properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

The surface properties of: enflufocon A, enflufocon B, and hexafocon B materials uncoated and coated with Tangible Hydra-PEG are depicted in the following table:

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K183167

# BAUSCH Health

510(k) Premarket Notification

| | enflufocon A | enflufocon B | hexafocon A | hexafocon B |
|-------------------------------------------------------|--------------------------------------------|--------------------------------------------|--------------------------------------------|--------------------------------------------|
| Sessile Drop Contact<br>Angle ± Standard<br>Deviation | Coated: 10.2°±1.2°<br>Uncoated: 59.6°±5.9° | Coated: 10.0°±0.0°<br>Uncoated: 62.7°±6.0° | Coated: 10.0°±0.0°<br>Uncoated: 63.4°±4.0° | Coated: 10.0°±0.0°<br>Uncoated: 65.4°±3.3° |

The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are available in the same design configurations and available parameters as the predicate devices, cleared under K053124, K013762, K071266, K071043 and K171404.

#### V. INDICATIONS FOR USE

The Boston ES® (enflufocon A) and Boston EO® (enflufocon B), Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, 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 gas permeable contact 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 lenses may be disinfected using a chemical disinfection system only.

The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, 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 gas permeable contact 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 lenses may be disinfected using a chemical disinfection system only.

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 Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses (Scleral) for daily wear are indicated for therapeutic use for the management of irregular and 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 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

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# BAUSCH- Health

510(k) Premarket Notification

corneal 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 wear 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 Boston Scleral Lenses may concurrently provide correction of refractive error.

The lenses may be disinfected using a chemical disinfection (not heat) system only.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE VI. DEVICE

The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses with Tangible™ Hydra-PEG surface technology are substantially equivalent to the uncoated lenses (predicate devices cleared under K053124. K013762. K071266. K071043 and K171404) in terms of the following:

- Proprietary contact lens material formulation and USAN
- Intended use - daily wear contact lenses
- Actions
- 트 Indications for use / Contraindications
- 트 Lens designs and available parameters

The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston X02® (hexafocon B) Contact Lenses with Tangible™ Hydra-PEG surface technology are substantially equivalent to the Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses (cleared under K161100) in terms of the following:

- 트 Thermoset copolymers derived from fluorosilicone acrylate monomers
- Tangible™ Hydra-PEG surface coating .

The following matrix illustrates the production method, lens function and material characteristics of the Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses with Tangible™ Hydra-PEG surface technology, as well as the predicate devices.

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# BAUSCH-Health
510(k) Premarket Notification

510(k) Premarket Notification

| | Boston ES® (enflufocon A),<br>Boston EO® (enflufocon B),<br>Boston XO® (hexafocon A) and<br>Boston XO2® (hexafocon B)<br>with Tangible™ Hydra-PEG | Boston ES® (enflufocon A),<br>Boston EO® (enflufocon B),<br>Boston XO® (hexafocon A)<br>and Boston XO2® (hexafocon<br>B) | Optimum GP with<br>Tangible™ Hydra-<br>PEG<br>(roflufocon C, D, E) |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | New Device | Predicate Device<br>(K053124, K013762, K071266,<br>K071043 and K171404) | Predicate Device<br>(K161100) |
| Functionality | The contact lenses act as a refractive<br>medium that focus light rays from near<br>and distant objects on the retina | The contact lenses act as a<br>refractive medium that focus light<br>rays from near and distant objects<br>on the retina | The contact lenses act<br>as a refractive medium<br>that focus light rays<br>from near and distant<br>objects on the retina |
| Intended Use | Daily Wear | Daily Wear | Daily Wear |
| Indication for Use | The Boston ES® (enflufocon A) and Boston EO®<br>(enflufocon B), Contact Lenses are indicated for<br>daily wear for the correction of refractive<br>ametropia (myopia, hyperopia, astigmatism and<br>presbyopia) in aphakic and non-aphakic persons<br>with non-diseased eyes. Also, the lenses may be<br>prescribed in otherwise non-diseased eyes that<br>require a gas permeable contact lens for the<br>management of irregular corneal conditions such<br>as keratoconus, pellucid marginal degeneration, or<br>following penetrating keratoplasty or refractive<br>(e.g., LASIK) surgery. The lenses may be<br>disinfected using a chemical disinfection system<br>only.<br><br>The Boston XO® (hexafocon A) and Boston<br>XO2® (hexafocon B) Contact Lenses are<br>indicated for daily wear for the correction of<br>refractive ametropia (myopia, hyperopia,<br>astigmatism and presbyopia) in aphakic and non-<br>aphakic persons with non-diseased eyes. Also, the<br>lenses may be prescribed in otherwise non-<br>diseased eyes that require a gas permeable contact<br>lens for the management of irregular corneal<br>conditions such as keratoconus, pellucid marginal<br>degeneration, or following penetrating<br>keratoplasty or refractive (e.g., LASIK) surgery.<br>The lenses may be disinfected using a chemical<br>disinfection system only.<br><br>Furthermore, eyes suffering from certain ocular<br>surface disorders may benefit from the physical<br>protection, aqueous hydrated environment and the<br>saline bath provided by scleral lens designs.<br><br>The Boston XO® (hexafocon A) and Boston<br>XO2® (hexafocon B) Contact Lenses (Scleral) for<br>daily wear are indicated for therapeutic use for the<br>management of irregular and distorted corneal<br>surfaces where the subject:<br>1.cannot be adequately corrected with spectacle<br>lenses<br>2.requires a rigid gas permeable contact lens<br>surface to improve vision<br>3.is unable to wear a corneal rigid gas permeable<br>lens due to corneal distortion or surface<br>irregularities<br><br>Common causes of corneal distortion include but<br>are not limited to corneal infections, trauma,<br>tractions as a result of scar formation secondary to<br>refractive surgery (e.g. LASIK or radial<br>keratotomy) or corneal transplantation. Causes<br>may also include corneal degeneration (e.g.<br>keratoconus, keratoglobus, pellucid marginal<br>degeneration, Salzmann's nodular degeneration)<br>and corneal dystrophy (e.g., lattice dystrophy,<br>granular corneal dystrophy, Reis-Bucklers | The Boston ES® (enflufocon A) and Boston<br>EO® (enflufocon B), Contact Lenses are<br>indicated for daily wear for the correction of<br>refractive ametropia (myopia, hyperopia,<br>astigmatism and presbyopia) in aphakic and<br>non-aphakic persons with non-diseased eyes.<br>Also, the lenses may be prescribed in<br>otherwise non-diseased eyes that require a<br>gas permeable contact lens for the<br>management of irregular corneal conditions<br>such as keratoconus, pellucid marginal<br>degeneration, or following penetrating<br>keratoplasty or refractive (e.g., LASIK)<br>surgery. The lenses may be disinfected using<br>a chemical disinfection system only.<br><br>The Boston XO® (hexafocon A) and Boston<br>XO2® (hexafocon B) Contact Lenses are<br>indicated for daily wear for the correction of<br>refractive ametropia (myopia, hyperopia,<br>astigmatism and presbyopia) in aphakic and<br>non-aphakic persons with non-diseased eyes.<br>Also, the lenses may be prescribed in<br>otherwise non-diseased eyes that require a<br>gas permeable contact lens for the<br>management of irregular corneal conditions<br>such as keratoconus, pellucid marginal<br>degeneration, or following penetrating<br>keratoplasty or refractive (e.g., LASIK)<br>surgery. The lenses may be disinfected using<br>a chemical disinfection system only.<br><br>Furthermore, eyes suffering from certain<br>ocular surface disorders may benefit from the<br>physical protection, aqueous hydrated<br>environment and the saline bath provided by<br>scleral lens designs.<br><br>The Boston XO® (hexafocon A) and Boston<br>XO2® (hexafocon B) Contact Lenses<br>(Scleral) for daily wear are indicated for<br>therapeutic use for the management of<br>irregular and distorted corneal surfaces where<br>the subject:<br>1.cannot be adequately corrected with<br>spectacle lenses<br>2.requires a rigid gas permeable contact lens<br>surface to improve vision<br>3.is unable to wear a corneal rigid gas<br>permeable lens due to corneal distortion or<br>surface irregularities<br><br>Common causes of corneal distortion include<br>but are not limited to corneal infections,<br>trauma, tractions as a result of scar formation<br>secondary to refractive surgery (e.g. LASIK<br>or radial keratotomy) or corneal<br>transplantation. Causes may also include | Indicated for daily wear for<br>the correction of visual acuity<br>in aphakic and not aphakic<br>persons with non-diseased<br>eyes with myopia or hyperopia<br>and/or presbyopia. The lens<br>may also be prescribed for<br>management of irregular<br>corneal conditions such as<br>keratoconus and post graft<br>fitting. |
| | dystrophy, Cogan's dystrophy).<br>The Boston XO® (hexafocon A) and Boston<br>XO2® (hexafocon B) Scleral Lens designs for<br>daily wear are also indicated for therapeutic use in<br>eyes with ocular surface disease (e.g. ocular Graft-<br>versus-Host disease, Sjögren's syndrome, dry eye<br>syndrome and Filamentary Keratitis), limbal stem<br>cell deficiency (e.g. Stevens-Johnson syndrome,<br>chemical radiation and thermal burns), disorders<br>of the skin (e.g. atopy, ectodermal dysplasia),<br>neurotrophic keratitis (e.g. Herpes simplex,<br>Herpes zoster, Familial Dysautonomia), and<br>corneal exposure (e.g. anatomic, paralytic) that<br>might benefit from the presence of an expanded<br>tear reservoir and protection against an adverse<br>environment. When prescribed for therapeutic use<br>for a distorted cornea or ocular surface disease,<br>the Boston Scleral Lenses may concurrently<br>provide correction of refractive error.<br>The lenses may be disinfected using a chemical<br>disinfection (not heat) system only. | corneal degeneration (e.g. keratoconus,<br>keratoglobus, pellucid marginal degeneration,<br>Salzmann's nodular degeneration) and<br>corneal dystrophy (e.g., lattice dystrophy,<br>granular corneal dystrophy, Reis-Bucklers<br>dystrophy, Cogan's dystrophy).<br>The Boston XO® (hexafocon A) and Boston<br>XO2® (hexafocon B) Scleral Lens designs<br>for daily wear are also indicated for<br>therapeutic use in eyes with ocular surface<br>disease (e.g. ocular Graft-versus-Host<br>disease, Sjögren's syndrome, dry eye<br>syndrome and Filamentary Keratitis), limbal<br>stem cell deficiency (e.g. Stevens-Johnson<br>syndrome, chemical radiation and thermal<br>burns), disorders of the skin (e.g. atopy,<br>ectodermal dysplasia), neurotrophic keratitis<br>(e.g. Herpes simplex, Herpes zoster, Familial<br>Dysautonomia), and corneal exposure (e.g.<br>anatomic, paralytic) that might benefit from<br>the presence of an expanded tear reservoir<br>and protection against an adverse<br>environment. When prescribed for<br>therapeutic use for a distorted cornea or<br>ocular surface disease, the Boston Scleral<br>Lenses may concurrently provide correction<br>of refractive error.<br>The lenses may be disinfected using a<br>chemical disinfection (not heat) system only. | |
| Production Method | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| USAN name | enflufocon A<br>enflufocon B<br>hexafocon A<br>hexafocon B | enflufocon A<br>enflufocon B<br>hexafocon A<br>hexafocon B | roflufocon C, D, E |
| Water Content (%) | <1% | <1% | <1% |
| Wettability<br>(sessile drop<br>advancing contact<br>angle) | enflufocon A: 10.2°<br>enflufocon B: 10.0°<br>hexafocon A: 10.0°<br>hexafocon B: 10.0° | enflufocon A: 59.6°<br>enflufocon B: 62.7°<br>hexafocon A: 63.4°<br>hexafocon B: 65.4° | - |
| Includes Hydra-<br>PEG | Yes…