The BostonSight IC Corneal & Scleral Lenses for Daily Wear are indicated for the correction of refractive error in aphakic and not aphakic persons. The lenses may be prescribed in otherwise non-diseased eves that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Description

The BostonSight Irregular Cornea (IC) Corneal & Scleral Lenses are lathe cut and fabricated from one of the following hydrophobic 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 description of the roflufocon D. roflufocon E. oprifocon A. and hexafocon B RGP materials are addressed in K033594, K022128, and K071266 respectively.

The BostonSight IC Corneal & Scleral Lenses for daily wear may be prescribed in otherwise nondiseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or following refractive (e.g. LASIK) surgery.

The BostonSight IC Scleral Lens is a large diameter RGP lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera.

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

When shipped "wet". The BostonSight IC Corneal & Scleral 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 IC Corneal & Scleral 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

Here's an analysis of the provided text to extract information about acceptance criteria and study details.

Important Note: The provided text is a 510(k) Summary of Safety and Effectiveness for the BostonSight IC Corneal & Scleral Lenses. It claims substantial equivalence to predicate devices, meaning it relies heavily on the safety and effectiveness data of those previously cleared devices rather than extensive new studies directly evaluating the performance of the BostonSight IC lenses against specific acceptance criteria in a standalone or comparative effectiveness study. As such, many of the requested data points (like sample size for a test set, number of experts for ground truth, MRMC study details) are not present for the BostonSight IC lenses themselves, but rather for the predicate devices as referenced.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate Devices):

This section summarizes the "performance" of the BostonSight IC lenses by demonstrating their equivalence to predicate devices, particularly regarding physical properties, material composition, and intended use. The acceptance criteria, in this context, are implicitly met if the BostonSight IC lenses are shown to be equivalent to devices already deemed safe and effective by the FDA.

Criteria Category	Acceptance Criteria (Implied by Predicate Devices)	Reported BostonSight IC Corneal & Scleral Lens Performance
Physical Properties	Consistent with predicate device materials (roflufocon D, E; oprifocon A; hexafocon B) for:	Roflufocon D: Refractive Index 1.4333, Light Transmission (>97% clear, >90% tinted), Specific Gravity 1.166, Oxygen Permeability 100 Dk, Dynamic Receding Contact Angle 3°, >98% UVB, >95% UVA.
	- Refractive Index	Roflufocon E: Refractive Index 1.4332, Light Transmission (>97% clear, >90% tinted), Specific Gravity 1.155, Oxygen Permeability 125 Dk, Dynamic Receding Contact Angle 6°, >98% UVB, >95% UVA.
	- Light Transmission (clear/tinted)	Oprifocon A: Refractive Index 1.4230, Light Transmission (>95% clear, >90% tinted), Specific Gravity 1.24, Oxygen Permeability 85 Dk, Dynamic Receding Contact Angle 56°, >95% UVB, >97% UVA.
	- Specific Gravity	Hexafocon B: Refractive Index 1.4240, Light Transmission (>95% clear, >83% tinted), Specific Gravity 1.19, Oxygen Permeability 141 Dk, Dynamic Receding Contact Angle 40°, >95% UVB, >97% UVA.
	- Oxygen Permeability (Dk)
	- UV Light Blocking (UVB, UVA)
	- Dynamic Receding Contact Angle
Lens Parameters	Within specified ranges	Chord Diameter: 8.0 mm to 26.0 mmCenter Thickness: 0.05mm to 0.60 mmBase Curve: 5.0 mm to 9.0 mmSpherical Powers: -25.00 Diopters to +35.00 Diopters
Biocompatibility	Demonstrated for predicate devices and inferred for BostonSight IC lenses.	Safe profile demonstrated in predicate device clearances (K033594, K071266, K022128).
Shelf Life (Wet Shipping)	Demonstrated for predicate devices and inferred for BostonSight IC lenses.	Safe profile demonstrated in predicate device clearances (K033594, K071266, K022128).
Solution Compatibility	Demonstrated for predicate devices and inferred for BostonSight IC lenses.	Safe profile demonstrated in predicate device clearances (K033594, K071266, K022128). Shipped with cleared solutions.
Clinical Evaluation	Demonstrated for predicate devices and inferred for BostonSight IC lenses.	Clinical evaluation in predicate device clearances (K033594, K071266, K022128). The BostonSight IC lenses leverage this existing data.
Manufacturing Verification	Lenses can be manufactured to established finished product specifications within ANSI Z80.20 tolerance.	All lenses manufactured met established finished product specifications within the ANSI Z80.20 tolerance.
Bioburden	Less than 100 CFU per lens	Colony-forming units (CFU) per lens was less than 1, meeting the acceptance criteria.
Indication for Use	Consistent with predicate devices.	Correction of refractive error in aphakic and not aphakic persons, with management of irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-penetrating keratoplasty or refractive surgery).

Study Details (Directly for BostonSight IC Corneal & Scleral Lenses):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate clinical "test set" in the traditional sense for the BostonSight IC lenses. The submission focuses on bench testing and bioburden testing for the new device, and relies on the clinical data of the predicate devices.
- Data Provenance: Bench testing and bioburden testing were conducted by Boston Foundation for Sight. The clinical safety and effectiveness data are primarily sourced from the predicate device clearances (K033594, K022128, K071266), which would have involved prospective clinical trials in their respective submissions. The country of origin for the predicate device studies is not specified in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for the bench testing or bioburden testing. For the clinical data referenced from predicate devices, this information is not provided in the 510(k) summary for the BostonSight IC lenses.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the bench testing or bioburden testing. For the clinical data referenced from predicate devices, this information is not provided.
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 device is a contact lens, not an AI-assisted diagnostic tool or imaging system.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a contact lens, not an algorithm. Bench testing (e.g., manufacturing verification, bioburden) represents standalone performance of the physical product.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench testing described (manufacturing verification, bioburden), the "ground truth" would be the established engineering specifications (e.g., ANSI Z80.20 tolerance for lens parameters) and microbial limits (e.g., <100 CFU per lens).
- For the clinical safety and effectiveness data on which the substantial equivalence is based, the ground truth would have been established through methods typical for contact lens clinical trials, likely involving clinical outcomes (visual acuity, comfort, adverse events, slit lamp examination findings, etc.) compared against established metrics or control devices.
The sample size for the training set:
- Not applicable. This product is a physical medical device (contact lens) and not an AI/machine learning algorithm that requires a "training set" in the computational sense. The manufacturing verification involved testing lenses produced by Boston Foundation for Sight. The "training" for the manufacturing process would be the internal process development and quality control validations.
How the ground truth for the training set was established:
- Not applicable for the reason stated above. If interpreting "training set" as the data used to validate the manufacturing process, the ground truth would be the defined product specifications and quality standards (e.g., ANSI Z80.20, ISO standards).

Summary

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 9, 2016

Boston Foundation for Sight c/o Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068

Re: K153066

Trade/Device Name: BostonSight IC Corneal Lens; BostonSight IC Scleral Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD Dated: December 29, 2015 Received: December 31, 2015

Dear Mr. 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. 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.

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

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(21 CFR Part 807); labeling (21 CFR: Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or 301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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)

K153066

Device Name BostonSight IC Corneal Lens BostonSight IC Scleral Lens

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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: K153066 Applicant information: Date Prepared: 11/11/2015 Name: Boston Foundation for Sight Address 464 Hillside Avenue, Suite 205 Needham, MA 02494 Contact Person: Eugene A. Bonte President & CEO Phone number: 781-726-7503 Correspondent/Consultant: EyeReg Consulting, Inc. Bret Andre Phone number (503) 372-5226 Fax number (503) 419-4475

Device Information:

Device Classification:	Class II
Classification Number:	HQD
Classification Name:	Lenses, Rigid Gas Permeable, Daily Wear
Trade Name:	BostonSight IC Corneal LensBostonSight IC Scleral Lens

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Purpose of Submission:

~ New Device ~

Equivalent Devices:

The BostonSight IC Corneal & Scleral Lenses for daily wear are substantially equivalent to the following predicate device(s)

Predicate device:

Predicate devicemanufacturer	Device name	510(k) number
Contamac Ltd.	OPTIMUM EXTRA (Oxygen Permeable) Daily WearContact Lenses (roflufocon D)OPTIMUM EXTREME (Oxygen Permeable) DailyWear Contact Lenses (roflufocon E)	K033594
Bausch & Lomb, Inc.	Boston EQUALENS II (oprifocon A)Rigid Gas Permeable Contact Lenses	K022128
Bausch & Lomb, Inc.	Boston XO2 (hexafocon B) Daily Wear ContactLens	K071266

Device Description:

The BostonSight Irregular Cornea (IC) Corneal & Scleral Lenses are lathe cut and fabricated from one of the following hydrophobic 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 description of the roflufocon D. roflufocon E. oprifocon A. and hexafocon B RGP materials are addressed in K033594, K022128, and K071266 respectively.

The BostonSight IC Scleral Lens is a large diameter RGP lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera.

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The physical properties of the BostonSight IC Corneal & Scleral Lenses manufactured from the various materials are as follows:

	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 xmm Hg @ 35°C)	$141 \times 10^{-11}$(cm²/sec) (ml O₂/ml xmm Hg @ 35°C)
ISO/FATT Method
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°

Lens parameters:

米 Chord Diameter:
米 Center Thickness:
米 Base Curve:
米 Spherical Powers:

8.0 mm to 26.0 mm 0.05mm to 0.60 mm 5.0 mm to 9.0 mm -25.00 Diopters to +35.00 Diopters

Indication for Use:

The BostonSight IC Corneal & Scleral Lenses for Daily Wear are indicated for the correction of refractive error in aphakic and not aphakic persons. The lenses may be prescribed in otherwise nondiseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the

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lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Description of Safety:

The safety profiles for finished lenses manufactured from the roflufocon D, roflufocon A, and hexafocon B rigid gas permeable (RGP) materials are demonstrated in K033594, K071266, and K022128 respectively-which address the following areas:

· Biocompatibility
· Shelf Life (Wet Shipping)
· Solution Compatibility
Clinical Evaluation

Additionally, the following testing was performed:

Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Boston Foundation for Sight to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.

Bioburden Testing-bioburden testing conducted on rigid gas permeable lenses manufactured at Boston Foundation for Sight demonstrated that the colony forming units (CFU) per lens was less than 1. which is within the established acceptance criteria of less than 100 CFU per lens.

~ Conclusions Drawn from Testing ~

Testing presented in this submission demonstrate no significant differences from the predicate devicessupporting the substantial equivalence claim of these BostonSight IC Corneal & Scleral Lenses to the already marketed roflufocon D. roflufocon E. oprifocon A. and hexafocon B RGP contact lenses.

Substantial Equivalence:

The BostonSight IC Corneal & Scleral Lenses for Daily Wear are substantially equivalent to the predicate devices and do not raise different questions of safety and effectiveness than the predicate devices identified previously.

~ Discussion of Similarities and Differences ~

The BostonSight IC Corneal & Scleral Lenses are identical to the predicate devices in terms of material (USAN), indications, lens design, and production method. There are no significant differences to report between the BostonSight IC Corneal & Scleral Lenses and the predicate devices.

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The following table depicts the pre-clinical characteristics of the BostonSight IC Corneal & Scleral Lenses, as well as the predicate device.

	BostonSight ICCorneal & ScleralLenses	OPTIMUM GP(OPTIMUM EXTRA &OPTIMUM EXTREME)	BOSTON EqualensII	BOSTON XO2
	Subject Device	Predicate Device	Predicate Device	Predicate Device
Indication for Use	The BostonSight ICCorneal & ScleralLenses for Daily Wearare indicated for thecorrection of refractiveerror in aphakic and notaphakic persons. Thelenses may be prescribedin otherwise non-diseasedeyes that require a rigidgas permeable lens for themanagement of irregularcorneal conditions such askeratoconus, pellucidmarginal degeneration orfollowing penetratingkeratoplasty or refractive(e.g. LASIK) surgery.	The OPTIMUM GP(roflufocon D & E)Daily Wear Contact Lensmay be prescribedin otherwise non-diseasedeyes that requirea rigid gas permeable lensfor the managementof irregular cornealconditions such as;keratoconus, pellucidmarginal degenerationof following penetratingkeratoplasty or followingrefractive (e.g. LASIK)surgery.	The BOSTONEqualens II may beprescribed in otherwisenon-diseased eyes thatrequire a rigid contactlens for themanagement ofirregular cornealconditions such askeratoconus, pellucidmarginal degenerationor followingpenetratingkeratoplasty orrefractive (e.g. LASIK)surgery.	The Boston XO2(hexafocon B) RGPcontact lenses may beprescribed in otherwisenon-diseased eyes thatrequire a rigid contactlens for management ofirregular cornealconditions such askeratoconus, pellucidmarginal degeneration, orfollowing penetratingkeratoplasty or refractive(e.g. LASIK) surgery.
Device andClassification	Class IIDaily wear, RigidGas Permeable RGPContact LensHQD	Class IIDaily wear, Rigid GasPermeable RGPContact LensHQD	Class IIDaily wear, RigidGas PermeableRGP Contact LensHQD	Class IIDaily wear, RigidGas Permeable RGPContact LensHQD
Production Method	Lathe-cut	Lathe-cut	Lathe-cut	Lathe-cut
FDA Group #	Group # 3 FluoroSilicone Acrylate	Group # 3 FluoroSilicone Acrylate	Group # 3 FluoroSilicone Acrylate	Group # 3 FluoroSilicone Acrylate
Water Content	<1%	<1%	<1%	<1%
UV Absorber/Blockeravailable	YES	YES	YES	YES

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.