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:

cannot be adequately corrected with spectacle lenses
requires a rigid gas permeable contact lens surface to improve vision
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 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for Bausch & Lomb's Boston ES®, Boston EO®, Boston XO®, and Boston XO2® Rigid Gas Permeable Contact Lenses with a new Tangible™ Hydra-PEG surface coating. This document details the company's claim of substantial equivalence to previously cleared predicate devices, rather than presenting a study for a novel AI/software as a medical device (SaMD).

Therefore, the information requested for acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a device proving AI/software performance is not present in this document.

This submission focuses on demonstrating the safety and effectiveness of a modified contact lens product by comparing its technological characteristics and performance (primarily wettability and biocompatibility) to already cleared devices. The "performance data" sections refer to non-clinical (toxicology, biocompatibility, stability) and clinical (based on predicate device history) testing relevant to contact lenses, not AI model performance.

The only "acceptance criteria" explicitly mentioned and met are related to quality control for the contact lenses:

Acceptance Criteria	Reported Device Performance
Bioburden levels <100 cfu/lens (initially)	Bioburden levels below the acceptance criteria (<100 cfu/lens) initially
Bioburden levels <100 cfu/lens (30 days storage)	Bioburden levels below the acceptance criteria (<100 cfu/lens) following 30 days of storage in solution (Boston Simplus and Boston Advance) at ambient temperatures

Other "performance" details provided are for the material properties related to the new coating, not AI performance metrics:

Material	Sessile Drop Contact Angle ± Standard Deviation (Coated)	Sessile Drop Contact Angle ± Standard Deviation (Uncoated)
enflufocon A	10.2° ± 1.2°	59.6° ± 5.9°
enflufocon B	10.0° ± 0.0°	62.7° ± 6.0°
hexafocon A	10.0° ± 0.0°	63.4° ± 4.0°
hexafocon B	10.0° ± 0.0°	65.4° ± 3.3°

Summary of missing information (as it pertains to AI/SaMD):

1. A table of acceptance criteria and the reported device performance: Only general biocompatibility and bioburden criteria for the contact lens are mentioned. AI-specific performance criteria (e.g., sensitivity, specificity, F1 score) are not applicable or provided.
2. Sample sized used for the test set and the data provenance: No test set for AI performance is described. The document refers to "non-clinical testing" (in vitro and in vivo toxicology/biocompatibility) but does not provide specific sample sizes in a test set context for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth for AI model testing is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" for this device would refer to established biological and material science standards for contact lens safety and performance.
8. The sample size for the training set: Not applicable; this is a physical medical device, not an AI/ML model being trained.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, this document is a regulatory submission for a contact lens modification and does not contain the type of AI/SaMD performance study details requested in the prompt.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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.

1. cannot be adequately corrected with spectacle lenses
1. requires a rigid gas permeable contact lens surface to improve vision
1. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities

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:Address:	Bausch & Lomb Incorporated1400 North Goodman St.Rochester, NY 14609United States
Contact Person:	Glenn A. DaviesDirector Global Regulatory Affairs
Phone number:	(585) 338-8215
Consultant:	Bret AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafoconA) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses
CommonName:	Daily wear rigid gas permeable contact lens
ClassificationName:	Rigid gas permeable contact lens. (21 CFR 886.5916)
RegulatoryClass:	Class II
Product Code:	HQD

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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

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 ContactAngle ± StandardDeviation	Coated: 10.2°±1.2°Uncoated: 59.6°±5.9°	Coated: 10.0°±0.0°Uncoated: 62.7°±6.0°	Coated: 10.0°±0.0°Uncoated: 63.4°±4.0°	Coated: 10.0°±0.0°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

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.

1. cannot be adequately corrected with spectacle lenses
1. requires a rigid gas permeable contact lens surface to improve vision
1. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities

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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 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

	Boston ES® (enflufocon A),Boston EO® (enflufocon B),Boston XO® (hexafocon A) andBoston XO2® (hexafocon B)with Tangible™ Hydra-PEG	Boston ES® (enflufocon A),Boston EO® (enflufocon B),Boston XO® (hexafocon A)and Boston XO2® (hexafoconB)	Optimum GP withTangible™ Hydra-PEG(roflufocon C, D, E)
	New Device	Predicate Device(K053124, K013762, K071266,K071043 and K171404)	Predicate Device(K161100)
Functionality	The contact lenses act as a refractivemedium that focus light rays from nearand distant objects on the retina	The contact lenses act as arefractive medium that focus lightrays from near and distant objectson the retina	The contact lenses actas a refractive mediumthat focus light raysfrom near and distantobjects on the retina
Intended Use	Daily Wear	Daily Wear	Daily Wear
Indication for Use	The Boston ES® (enflufocon A) and Boston EO®(enflufocon B), Contact Lenses are indicated fordaily wear for the correction of refractiveametropia (myopia, hyperopia, astigmatism andpresbyopia) in aphakic and non-aphakic personswith non-diseased eyes. Also, the lenses may beprescribed in otherwise non-diseased eyes thatrequire a gas permeable contact lens for themanagement of irregular corneal conditions suchas keratoconus, pellucid marginal degeneration, orfollowing penetrating keratoplasty or refractive(e.g., LASIK) surgery. The lenses may bedisinfected using a chemical disinfection systemonly.The Boston XO® (hexafocon A) and BostonXO2® (hexafocon B) Contact Lenses areindicated for daily wear for the correction ofrefractive ametropia (myopia, hyperopia,astigmatism and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Also, thelenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contactlens for the management of irregular cornealconditions such as keratoconus, pellucid marginaldegeneration, or following penetratingkeratoplasty or refractive (e.g., LASIK) surgery.The lenses may be disinfected using a chemicaldisinfection system only.Furthermore, eyes suffering from certain ocularsurface disorders may benefit from the physicalprotection, aqueous hydrated environment and thesaline bath provided by scleral lens designs.The Boston XO® (hexafocon A) and BostonXO2® (hexafocon B) Contact Lenses (Scleral) fordaily wear are indicated for therapeutic use for themanagement of irregular and distorted cornealsurfaces where the subject:1.cannot be adequately corrected with spectaclelenses2.requires a rigid gas permeable contact lenssurface to improve vision3.is unable to wear a corneal rigid gas permeablelens due to corneal distortion or surfaceirregularitiesCommon causes of corneal distortion include butare not limited to corneal infections, trauma,tractions as a result of scar formation secondary torefractive surgery (e.g. LASIK or radialkeratotomy) or corneal transplantation. Causesmay also include corneal degeneration (e.g.keratoconus, keratoglobus, pellucid marginaldegeneration, Salzmann's nodular degeneration)and corneal dystrophy (e.g., lattice dystrophy,granular corneal dystrophy, Reis-Bucklers	The Boston ES® (enflufocon A) and BostonEO® (enflufocon B), Contact Lenses areindicated for daily wear for the correction ofrefractive ametropia (myopia, hyperopia,astigmatism and presbyopia) in aphakic andnon-aphakic persons with non-diseased eyes.Also, the lenses may be prescribed inotherwise non-diseased eyes that require agas permeable contact lens for themanagement of irregular corneal conditionssuch as keratoconus, pellucid marginaldegeneration, or following penetratingkeratoplasty or refractive (e.g., LASIK)surgery. The lenses may be disinfected usinga chemical disinfection system only.The Boston XO® (hexafocon A) and BostonXO2® (hexafocon B) Contact Lenses areindicated for daily wear for the correction ofrefractive ametropia (myopia, hyperopia,astigmatism and presbyopia) in aphakic andnon-aphakic persons with non-diseased eyes.Also, the lenses may be prescribed inotherwise non-diseased eyes that require agas permeable contact lens for themanagement of irregular corneal conditionssuch as keratoconus, pellucid marginaldegeneration, or following penetratingkeratoplasty or refractive (e.g., LASIK)surgery. The lenses may be disinfected usinga chemical disinfection system only.Furthermore, eyes suffering from certainocular surface disorders may benefit from thephysical protection, aqueous hydratedenvironment and the saline bath provided byscleral lens designs.The Boston XO® (hexafocon A) and BostonXO2® (hexafocon B) Contact Lenses(Scleral) for daily wear are indicated fortherapeutic use for the management ofirregular and distorted corneal surfaces wherethe subject:1.cannot be adequately corrected withspectacle lenses2.requires a rigid gas permeable contact lenssurface to improve vision3.is unable to wear a corneal rigid gaspermeable lens due to corneal distortion orsurface irregularitiesCommon causes of corneal distortion includebut are not limited to corneal infections,trauma, tractions as a result of scar formationsecondary to refractive surgery (e.g. LASIKor radial keratotomy) or cornealtransplantation. Causes may also include	Indicated for daily wear forthe correction of visual acuityin aphakic and not aphakicpersons with non-diseasedeyes with myopia or hyperopiaand/or presbyopia. The lensmay also be prescribed formanagement of irregularcorneal conditions such askeratoconus and post graftfitting.
	dystrophy, Cogan's dystrophy).The Boston XO® (hexafocon A) and BostonXO2® (hexafocon B) Scleral Lens designs fordaily wear are also indicated for therapeutic use ineyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eyesyndrome and Filamentary Keratitis), limbal stemcell deficiency (e.g. Stevens-Johnson syndrome,chemical radiation and thermal burns), disordersof the skin (e.g. atopy, ectodermal dysplasia),neurotrophic keratitis (e.g. Herpes simplex,Herpes zoster, Familial Dysautonomia), andcorneal exposure (e.g. anatomic, paralytic) thatmight benefit from the presence of an expandedtear reservoir and protection against an adverseenvironment. When prescribed for therapeutic usefor a distorted cornea or ocular surface disease,the Boston Scleral Lenses may concurrentlyprovide correction of refractive error.The lenses may be disinfected using a chemicaldisinfection (not heat) system only.	corneal degeneration (e.g. keratoconus,keratoglobus, pellucid marginal degeneration,Salzmann's nodular degeneration) andcorneal dystrophy (e.g., lattice dystrophy,granular corneal dystrophy, Reis-Bucklersdystrophy, Cogan's dystrophy).The Boston XO® (hexafocon A) and BostonXO2® (hexafocon B) Scleral Lens designsfor daily wear are also indicated fortherapeutic use in eyes with ocular surfacedisease (e.g. ocular Graft-versus-Hostdisease, Sjögren's syndrome, dry eyesyndrome and Filamentary Keratitis), limbalstem cell deficiency (e.g. Stevens-Johnsonsyndrome, chemical radiation and thermalburns), disorders of the skin (e.g. atopy,ectodermal dysplasia), neurotrophic keratitis(e.g. Herpes simplex, Herpes zoster, FamilialDysautonomia), and corneal exposure (e.g.anatomic, paralytic) that might benefit fromthe presence of an expanded tear reservoirand protection against an adverseenvironment. When prescribed fortherapeutic use for a distorted cornea orocular surface disease, the Boston ScleralLenses may concurrently provide correctionof refractive error.The lenses may be disinfected using achemical disinfection (not heat) system only.
Production Method	Lathe-Cut	Lathe-Cut	Lathe-Cut
USAN name	enflufocon Aenflufocon Bhexafocon Ahexafocon B	enflufocon Aenflufocon Bhexafocon Ahexafocon B	roflufocon C, D, E
Water Content (%)	<1%	<1%	<1%
Wettability(sessile dropadvancing contactangle)	enflufocon A: 10.2°enflufocon B: 10.0°hexafocon A: 10.0°hexafocon B: 10.0°	enflufocon A: 59.6°enflufocon B: 62.7°hexafocon A: 63.4°hexafocon B: 65.4°	-
Includes Hydra-PEG	Yes	No	Yes

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Usch Health

510(k) Premarket Notification

PERFORMANCE DATA VII.

The following performance data were provided in support of the substantial equivalence determination.

Non-clinical Testing

A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses with Tangible TM Hydra-PEG surface technology. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols. Test results of the non-clinical testing on the device demonstrate that:

트 The finished lenses are not toxic and not irritating,
. Bioburden levels are below the acceptance criteria (<100 cfu/lens) initially and following 30 days of storage in solution (Boston Simplus and Boston Advance) at ambient temperatures,

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BAUSCH Health

510(k) Premarket Notification

The surface properties of the lens are stable following 30 days of accelerated aging, and
The physicochemical and mechanical properties of the contact lenses are unchanged after the addition of Tangible" Hydra-PEG, with the exception of wettability (contact angle).

Clinical Testing

The clinical safety and effectiveness of finished rigid gas permeable contact lenses manufactured from Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) materials have been demonstrated by predicate devices. Additionally, the clinical safety and effectiveness for contact lenses treated with Hydra-PEG has been previously demonstrated.

VIII. CONCLUSIONS

Validity of Scientific Data

Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

Substantial Equivalence

Information presented in this 510(k) Premarket Notification establishes that the Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon XO2® (hexafocon B) rigid gas permeable contact lenses with Tangible™ Hydra-PEG are as safe and effective as the predicate devices when used in accordance with the labeled directions for use and for the proposed indication.

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.

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.