Bausch + Lomb Boston® Scleral Lens Case is indicated for storage of gas permeable (fluoro scrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.

Device Description

Bausch + Lomb Boston® Scleral Lens Case consists of a polypropylene cap and polypropylene body for storage of gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.

AI/ML Overview

The provided document is a 510(k) summary for the Bausch + Lomb Boston® Scleral Lens Case, intended for storage of gas permeable contact lenses during chemical disinfection. This document describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical study establishing acceptance criteria and device performance based on a specific algorithm or AI.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and AI performance metrics are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (a contact lens case) undergoing a 510(k) clearance process based on substantial equivalence.

However, I can extract information related to the preclinical testing that was performed to demonstrate the safety and effectiveness of the device.

Here's a summary of the available information:

1. A table of acceptance criteria and the reported device performance:

The document doesn't outline specific numerical acceptance criteria in the way one might expect for a quantitative performance study (e.g., accuracy, sensitivity, specificity thresholds). Instead, safety and effectiveness are established through biocompatibility testing against established ISO standards and comparison to a predicate device.

Test Category	Acceptance Criteria (Implicit from ISO Standards)	Reported Device Performance
Toxicology	Systemic Toxicity: Device materials should not cause systemic toxic effects (ISO 10993-11).	Demonstrated biocompatibility. Met requirements for ISO 10993-11.
	Cytotoxicity: Device materials should not be toxic to cells (ISO 10993-5).	Demonstrated biocompatibility. Met requirements for ISO 10993-5.
	Ocular Irritation/Sensitization: Device materials should not cause ocular irritation or skin sensitization (ISO 10993-10).	Demonstrated biocompatibility. Met requirements for ISO 10993-10.
Microbiology	Microbial Contamination: While not a performance metric for the device itself, the labeling must include warnings about contact lens cases being a source of microbial contamination.	Labeling includes a warning statement regarding cleanliness and replacement of contact lens cases to prevent eye infections.
Volume	Sufficient volume to ensure the lens remains completely immersed under conditions of use.	6.5mL fill volume, which is greater than the predicate device's 3.3mL. (Implies sufficient volume)

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

Sample Size: Not specified in the document. Biocompatibility tests typically involve a certain number of samples, but the exact count is not given here.
Data Provenance: The preclinical testing was "sponsored by Bausch + Lomb." The document does not specify country of origin for the data, but it's internal company testing. It is retrospective in the sense that the results were submitted after the tests were concluded.

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

Not applicable. This is not a study requiring expert readers or ground truth establishment in the context of imaging or diagnostic accuracy. Biocompatibility testing relies on standardized laboratory protocols and analyses, not expert consensus on interpretations.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the case for the preclinical tests mentioned.

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 is not an AI/algorithm-based device and no MRMC study was conducted. The document explicitly states: "Clinical studies involving the Bausch + Lomb Boston® Scleral Lens Case were unnecessary for this application."

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

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

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

For biocompatibility: The "ground truth" is based on the results of standardized laboratory assays (e.g., cell viability in cytotoxicity tests, observation of reactions in irritation tests, systemic effects in systemic toxicity tests) as defined by the referenced ISO 10993 standards. These are objective measures rather than expert consensus on interpretations.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that would require a training set.

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

Not applicable. No training set was used.

Summary

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November 17, 2017

Bausch & Lomb Incorporated Nancy Fehrman Senior Manager Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609

Re: K173365

Trade/Device Name: Bausch + Lomb Boston® Scleral Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: October 25, 2017 Received: October 26, 2017

Dear Nancy Fehrman:

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.

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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 of medical devicerelated 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.

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Denise L. Hampton -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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Indications for Use

510(k) Number (if known) K173365

Device Name

Bausch + Lomb Boston® Scleral Lens Case

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Bausch + Lomb Boston® Scleral Lens Case

1. Submitter Information

Primary	Alternate
Nancy Fehrman	Glenn Davies, O.D.
Senior Manager, Regulatory Affairs	Sr. Director Regulatory Affairs,
1400 North Goodman Street	1400 North Goodman Street
Rochester, NY 14609	Rochester, NY 14609
Tel. (585) 338-5310	Tel. (585) 338-8215
Fax (585) 338-0702	Email: Glenn.Davies@bausch.com
Email: Nancy.Fehrman@bausch.com

Summary Prepared: October 25, 2017

2. Device Name

Common Name:	Contact Lens Case
Trade Name:	Bausch + Lomb Boston® Scleral Lens Case
Classification:	Case, Contact Lens
Device classification:	Class II (21 CFR §886.5928)
Product Code:	LRX

3. Predicate Device

CyberCases™ by Bausch & Lomb® (K013232)

4. Description of the Device

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5. Intended Use

Bausch + Lomb Boston® Scleral Lens Case is indicated for storage of gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.

6. Description of Safety and Substantial Equivalence

A series of preclinical testing was performed to demonstrate the safety and effectiveness of Bausch + Lomb Boston® Scleral Lens Case as described in Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997. A brief summary of the test results is provided below:

Microbiology

Microbiology issues pertaining to contact lens cases are covered by the warning included in the labelling which states:

Contact lens cases can be a significant source of microbial contamination. To help prevent eye infections, contact lens cases should be cleaned, rinsed and air dried every day, and replaced at least every three months.

Toxicology

Systemic toxicity, cytotoxicity, and ocular irritation studies were completed for Bausch + Lomb Boston® Scleral Lens Case The test results demonstrated the biocompatibility of the Bausch + Lomb Boston® Scleral Lens Case.

Clinical Data

Clinical studies involving the Bausch + Lomb Boston® Scleral Lens Case were unnecessary for this application. The Bausch + Lomb Boston® Scleral Lens Case is similar in design, materials and intended use to the predicate device, which has been commercially available in the market for over 15 years with well demonstrated safety and efficacy.

7. Substantial Equivalence

The cumulative results of laboratory testing sponsored by Bausch + Lomb demonstrate that the safety, effectiveness and performance of Bausch + Lomb Boston® Scleral Lens Case are substantially equivalent to the CyberCases™ by Bausch & Lomb® (K013232).

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Feature	CyberCases™ byBausch & Lomb®(K013232)	Bausch + LombBoston® Scleral LensCase(Subject of this 510(k))
Product Code	LRX	LRX
Regulation Number	21 CFR 886.5928	21 CFR 886.5928
Indications For Use	Indicated for use in thestorage of hard, rigidgas permeable (fluorosilicone acrylate andsilicone acrylate) andsoft (hydrophilic) contactlenses during chemicaldisinfection	Indicated for use in thestorage of gaspermeable (fluorosilicone acrylate andsilicone acrylate)contact lenses duringchemical disinfection
TechnologyFeatures	Differentiate betweenthe right and left wellsfor lens storage usingright lens cap colors	Differentiate betweenthe right and left wellsfor lens storage usingright lens cap colors
Materials	Polypropylene cap andbody	Polypropylene cap andbody
Colorants	Orange, 2%Magenta (pink), 1%Teal, 1%Green, 2%Purple, 1%	Orange, up to 3%Magenta, up to 3%Teal, up to 3%Green, up to 4%Purple, up to 6%White, up to 3%Blue, up to 4%Bright Green, up to 3%Lime Green, up to 3%
Volume	3.3mL fill volumeSufficient volume toassure that the lensremains completelyimmersed underconditions of use	6.5mL fill volumeSufficient volume toassure that the lensremains completelyimmersed underconditions of use
Right capembossment	"R"	None
Left cap embossment	"L"	"L"
Biocompatibility	Met the Requirementsfor:ISO 10993-5 Biologicalevaluation of medicaldevices, Part 5: Testsfor in vitro cytotoxicity;ISO 10993-10 Biologicalevaluation of medicaldevices, Part 10: Testsfor irritation and skinsensitization	Met the Requirementsfor:ISO 10993-5 Biologicalevaluation of medicaldevices, Part 5: Testsfor in vitro cytotoxicity;ISO 10993-10 Biologicalevaluation of medicaldevices, Part 10: Testsfor irritation and skinsensitization
ISO 10993-11 Biologicalevaluation of medicaldevices, Part 11: Testsfor systemic toxicity.	ISO 10993-11 Biologicalevaluation of medicaldevices, Part 11: Testsfor systemic toxicity.

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Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”