BostonSight Scleral daily wear contact lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non aphakic persons. Also, the lenses may be prescribed in eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, keratoglobus, post-LASIK ectasia, or following penetrating keratoplasty or refractive surgery.

Furthermore, eves suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. BostonSight Scleral daily wear contact lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:

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, keratoclobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).

The BostonSight Scleral daily wear contact lenses are also indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis, limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Scleral daily wear contact lenses may concurrently provide correction of refractive error.

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

Device Description

The BostonSight Scleral daily wear contact lenses are manufactured with a large diameter RGP lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The BostonSight Scleral daily wear contact lenses are lathe cut and fabricated from one of the following fluoro-silicone acrylate rigid gas permeable (RGP) lens materials:

roflufocon D supplied by Contamac Ltd.
roflufocon E supplied by Contamac Ltd.
oprifocon A supplied by Bausch and Lomb, Inc.
hexafocon B supplied by Bausch and Lomb, Inc.

The BostonSight Scleral daily wear contact lenses may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight Scleral daily wear contact lenses is the Bausch & Lomb Frequent Replacement Contact Lens Case, with clearance under 510(k) K896685.

When shipped "wet", The BostonSight Scleral daily wear contact lenses manufactured from material supplied by Bausch & Lomb, inc. may be packaged and shipped in Boston Advance Comfort Formula Conditioning Solution (K974466) or Boston SIMPLUS Multi-Action solution (K024289). The BostonSight Scleral daily wear contact lenses manufactured from material supplied by Contamac, Ltd. may be packaged and shipped "wet" in in the OPTIMUM by Lobob Cleaning and Disinfecting Storage solution, with clearance under 510(k) K014162.

AI/ML Overview

The provided document is a 510(k) summary for the BostonSight Scleral daily wear contact lenses. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving the device meets specific acceptance criteria through a clinical study with a defined test set, ground truth, and expert adjudication in the manner typically seen for novel AI/ML-based medical devices.

Therefore, the information required to populate a table of acceptance criteria and the details of a study proving the device meets these criteria (including sample sizes, expert qualifications, and adjudication methods) are not present in this document. The document explicitly states that the purpose of the application is "to modify the labeling of previously FDA cleared RGP contact lenses/materials to include therapeutic indications for use." It further clarifies that non-clinical and clinical testing to demonstrate safety and effectiveness for the materials used "has been addressed in previous applications."

Here's a breakdown of why the requested information cannot be extracted from this document, and what is provided instead:

1. Table of Acceptance Criteria and Reported Device Performance:

Not present. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use compared to predicate devices, not on meeting predefined performance criteria with quantitative results.

2. Sample size used for the test set and the data provenance:

Not present. There is no mention of a dedicated "test set" or a new clinical study conducted for this specific 510(k) submission. The document states that clinical performance data "has been previously addressed" in prior applications for the materials used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not present. Since no new dedicated test set or clinical study is detailed, there's no mention of experts involved in establishing ground truth for such a study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not present. No test set or corresponding adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document describes a physical medical device (contact lenses), not an AI/ML-based device that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not present. No new ground truth establishment is described for this submission. The equivalence relies on the established safety and performance of the materials and predicate devices.

8. The sample size for the training set:

Not applicable/Not present. Contact lenses are physical devices, not AI models that require training sets.

9. How the ground truth for the training set was established:

Not applicable/Not present. As above, no training set for an AI model is involved.

What the document does provide:

Device Name: BostonSight Scleral
Regulation Number: 21 CFR 886.5916 (Rigid Gas Permeable Contact Lens)
Regulatory Class: Class II
Indications for Use: (Detailed on pages 2 and 5-6)
- Correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic and non-aphakic persons.
- Management of irregular corneal conditions (e.g., keratoconus, pellucid marginal degeneration, post-LASIK ectasia, post-keratoplasty/refractive surgery).
- Therapeutic use for ocular surface disorders (e.g., GvHD, Sjögren's, dry eye, Filamentary Keratitis, limbal stem cell deficiency, disorders of the skin, neurotrophic keratitis, corneal exposure) benefiting from an expanded tear reservoir and protection.
Predicate Devices:
- "Boston XO® and Boston XO2® Rigid Gas Permeable Contact Lens" (K171404)
- "OPTIMUM GP Daily Wear Contact Lens" (K180616)
- "BostonSight PD Prosthetic Device" (K161461)
Device Materials: roflufocon D, roflufocon E, oprifocon A, hexafocon B.
Physical Properties: Refractive Index, Light Transmission, Specific Gravity, Oxygen Permeability (Dk), UV Light Blocking, Dynamic Receding Contact Angle (all listed with values for each material on page 5).
Lens Parameters: Base Curve, Center Thickness, Diameter, Spherical Power (with ranges and tolerances on page 5).
Basis for Clearance: Substantial equivalence to predicate devices based on intended use, indications for use, actions, classification, FDA material group, USAN materials, production method, and final packaging/shipping. The safety and effectiveness of the materials themselves were addressed in prior applications.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for 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.

January 4, 2019

BostonSight % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn. OR 97068

Re: K183175

Trade/Device Name: BostonSight Scleral Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: November 13, 2018 Received: November 16, 2018

Dear Bret Andre:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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

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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K183175

Device Name BostonSight Scleral

Indications for Use (Describe)

BostonSight Scleral daily wear contact lenses are indicated for the correction of refractive ametropia (myoropia, astigmatism and presbyopia) in aphakic persons. Also, the lenses may be prescribed in eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, keratoglobus, post-LASIK ectasia, or following penetrating keratoplasty or refractive surgery.

Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs.

BostonSight Scleral daily wear contact lenses are indicated for the management of irregular and distorted corneal surfaces where the subject:

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

Common causes of corneal distortion include, but are not limited to, corneal infections as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).

The BostonSight Scleral daily wear contact lenses are also indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis, limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Scheral daily wear contact lenses may concurrently provide correction of refractive error.

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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image shows the logo for Boston Sight at the top. Below the logo, the text "510(K) Premarket Notification" is displayed in a large, bold font. The text indicates that the document is related to a 510(K) premarket notification, which is a type of submission required by the U.S. Food and Drug Administration (FDA) for certain medical devices.

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.

The assigned 510(k) number is: 183175

I. SUBMITTER

Date Prepared:	November 13th, 2018
Name:Address:	BostonSight464 Hillside Avenue, Suite 205Needham, MA 02494
Contact Person:Phone number:	Gene P. GuselliPresident and CEO781-726-7337
Consultant:Phone number:	Bret AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068(503) 372-5226

II. DEVICE

Trade Name:	BostonSight Scleral
CommonName:	Daily wear rigid gas permeable contact lens
ClassificationName:	Rigid gas permeable contact lens. (21 CFR 886.5916)
RegulatoryClass:	Class II
Product Code:	HOD

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Image /page/4/Picture/1 description: The image shows the Boston Sight logo at the top, which is a stylized sunburst design. Below the logo, the text "510(K) Premarket Notification" is displayed in a clear, bold font. The text indicates that the document is related to a premarket notification, likely for a medical device or product.

~~Reason for Submission~~ Labeling Changes - Expanded Indications for Use

III. PREDICATE DEVICE

BostonSight Scleral daily wear contact lenses are substantially equivalent to the following predicate devices:

트 "Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lens" By Bausch + Lomb Inc. 510(k) number; K171404
트 "OPTIMUM GP (Roflufocon D, Roflurocon E) Daily Wear Contact Lens" By Contamac Ltd. 510(k) number: K180616
트 "BostonSight PD Prosthetic Device" By BostonSight 510(k) number; K161461

IV. DEVICE DESCRIPTION

· roflufocon D supplied by Contamac Ltd.
· roflufocon E supplied by Contamac Ltd.
· oprifocon A supplied by Bausch and Lomb, Inc.
· hexafocon B supplied by Bausch and Lomb, Inc.

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	roflufocon D	roflufocon E	oprifocon A	hexafocon B
Refractive Index	1.4333	1.4332	1.4230	1.4240
Light Transmission(clear)	>97%	>97%	>95%	>95%
Light Transmission(tinted)	>90%	>90%	>90%	>83%
Specific Gravity	1.166	1.155	1.24	1.19
OxygenPermeability(Dk)	$100 \times 10^{-11}$(cm²/sec) (ml O₂/ml xmm Hg @ 35°C)	$125 \times 10^{-11}$(cm²/sec) (ml O₂/ml xmm Hg @ 35°C)	$85 \times 10^{-11}$ (cm²/sec)(ml O₂/ml x mm Hg @35°C)	$141 \times 10^{-11}$(cm²/sec) (ml O₂/ml xmm Hg @ 35°C)
Visitint lensescontain one or moreof the followingcolor additivesconforming to:21 CFR Part 73 &74, Subpart D	D & C Green No.6, FD & C RedNo. 17,CI SolventYellow 18	D & C Green No.6, FD & C RedNo. 17,CI SolventYellow 18	D&C Green No.6and D&C YellowNo.10	D&C Green No.6; C.I. SolventYellow No. 18;D&C Violet No.2; D&C Red No.17; C.I. SolventYellow No.18
UV Light Blocking(UVB - 280nm -315nm; UVA 316nm- 380nm)	>98% UVB>95% UVA	>98% UVB>95% UVA	>95% UVB>97% UVA	>95% UVB>97% UVA
Dynamic RecedingContact Angle	3°	6°	56°	40°

The physical properties of the BostonSight Scleral daily wear contact lenses are as follows:

The BostonSight Scheral daily wear contact lenses are available in the following lens parameters:

Parameter	Range	Tolerance
Base Curve	5.00mm to 9.00mm	± 0.05 mm
Center Thickness	0.05mm to 0.60mm	± 0.02 mm
Diameter	8.00mm to 26.00mm	± 0.10mm
Spherical Power	-25.00 D to +35.00 D(in 0.25D steps)	± 0.12 (0 to = 5D)<br ± 0.18 (5 to = 10.0D)<br ± 0.25 (10 to = 15D)<br ± 0.37 (15 to = 20D)<br ± 0.50 (over 20D)

V. INDICATIONS FOR USE

BostonSight Scleral

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

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The BostonSight Scleral daily wear contact lenses are substantially equivalent to the predicate devices (cleared under K171404, K180616, and K161461) in terms of the following:

Intended use daily wear contact lenses ■
트 Indications for use
Actions
Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
트 FDA material group - group # 3 fluoro silicone acrylate
트 USAN materials (roflufocon D, roflufocon E, oprifocon A and hexafocon B)
트 Production method - lathe cut
트 Final packaging and shipping

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The following matrix illustrates the production method, lens function and material characteristics of the BostonSight Scleral daily wear contact lenses, as well as the predicate device.

	BostonSightScleral	Boston XO® andBoston XO2® RGPContact Lenses	OPTIMUM GPContact Lens	BostonSight PDProsthetic Device
	SubjectDevice	Predicate Device(K171404)	Predicate Device(K180616)	Predicate Device(K161461)
Classification	Same aspredicate	Class IILenses, Rigid GasPermeable, Daily Wear21 CFR 886.5916	Class IILenses, Rigid GasPermeable, Daily Wear21 CFR 886.5916	Class IILenses, Rigid GasPermeable, DailyWear21 CFR 886.5916
Product Code	Same aspredicate	HQD	HQD	HQD
FDA Group #	Same aspredicate	Group # 3 FluoroSilicone Acrylate	Group # 3 FluoroSilicone Acrylate	Group # 3 FluoroSilicone Acrylate
USAN	roflufocon D,roflufocon E,oprifocon A,hexafocon B	hexafocon A, hexafoconB	roflufocon D,roflufocon E	roflufocon D,roflufocon E,oprifocon A,hexafocon B
ProductionMethod	Same aspredicate	Lathe-Cut	Lathe-Cut	Lathe-Cut
Actions	Same aspredicate	The contact lenses act asa refractive medium thatfocus light rays fromnear and distant objectson the retina. Whenplaced on the eye fortherapeutic use, the lensreplaces or supportsimpaired ocular surfacefunction.	The contact lenses actas a refractive mediumthat focus light raysfrom near and distantobjects on the retina.When placed on the eyefor therapeutic use, thelens replaces orsupports impairedocular surface function.	The contact lenses actas a refractive mediumthat focus light raysfrom near and distantobjects on the retina.When placed on theeye for therapeuticuse, the lens replacesor supports impairedocular surfacefunction.
Intended Use	Same aspredicate	Daily Wear	Daily Wear	Daily Wear
Indication for Use	Same aspredicate	Therapeutic (Scleral)	Therapeutic (Scleral)	Therapeutic (Scleral)
Water Content(%)	<1%	<1%	<1%	<1%
UV AbsorberAvailable	Yes	Yes	Yes	Yes

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VIII. PERFORMANCE DATA

~ Non-Clinical Studies ~

The purpose of this application is to modify the labeling of previously FDA cleared RGP contact lenses/materials to include therapeutic indications for use. Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E. oprifocon A and hexafocon B materials has been addressed in previous applications.

~ Clinical Studies ~

Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, oprifocon A and hexafocon B has been previously addressed.

VIII. CONCLUSIONS

Substantial Equivalence

Information presented in this Premarket Notification establishes that BostonSight Scleral daily wear contact lenses are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indications.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of rigid gas permeable (RGP) daily wear contact lenses. The benefits to the patient are the same as those for other RGP contact lenses.

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.