Bausch + Lomb Sensitive Eyes Plus Salinon is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.

Device Description

Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, isotonic, buffered solution that contains boric acid, sodium borate, potassium chloride, sodium chloride, preserved with polyaminopropyl biguanide (0.00003%) and edetate disodium (0.025%). The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Bausch + Lomb Sensitive Eyes Plus Saline Solution, which is a sterile, preserved solution for rinsing contact lenses. The study mainly focuses on demonstrating substantial equivalence to predicate devices and expanding its indications for use to include gas permeable contact lenses.

Here's an analysis of the provided text in the context of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance metrics for a diagnostic device. Instead, it refers to standards and general requirements for contact lens care products. The "acceptance criteria" are implied by adherence to these standards and the demonstration of safety and effectiveness.

Here's a summary of the performance claims based on the described studies:

Acceptance Criteria (Implied)	Reported Device Performance
Microbiology: Antimicrobial Preservative Efficacy for Discard Dating (Meets requirements of ISO 14730, Annex C Procedure II for a 90-day discard date)	Sensitive Eyes Plus Saline Solution meets the requirements of ISO 14730, Annex C Procedure II for the designation of a 90-day discard date. The test articles were evaluated initially and again following simulated use for the proposed discard date of 90 days, demonstrating efficacy.
Microbiology: Regimen Evaluation (Modified Regimen)(Meets FDA performance criteria for regimen evaluation as described in the May 1, 1997 Guidance for Industry, Pre-market Notification (510(k)) Guidance Document for Contact Lens Care Products when used in a 10-second rub, 5-second rinse regimen, and ISO Standard 14729: 2001/Amd. 1:2010 (E))	A modified regimen procedure (rinse with Sensitive Eyes Plus Saline Solution in place of tap water) for Boston Conditioning Solution and Boston Advance Conditioning Solution demonstrated that the modified regimen with Sensitive Eyes Plus Saline Solution meets FDA performance criteria (1997 Guidance) and ISO Standard 14729:2001/Amd. 1:2010 (E) when used in a 10-second rub, 5-second rinse (per lens side) regimen.
Biocompatibility(No new testing required as per previous clearance for use and no new indications that necessitated new testing)	Biocompatibility tests were deemed unnecessary for this application because the Sensitive Eyes Plus Saline Solution was previously cleared for use, and the expansion of the indication (to include gas permeable lenses) did not trigger the need for new testing. This implies that the product's biocompatibility was already established and met previous criteria.
Lens Compatibility(Meets ISO 11981 for rigid gas permeable contact lenses)	Results of lens compatibility studies per ISO 11981 demonstrate Bausch + Lomb Sensitive Eyes Plus Saline Solution is compatible with rigid gas permeable contact lenses.
Clinical Data / Overall Safety and Efficacy(Established safety and efficacy, substantial equivalence to predicate)	Clinical studies were deemed unnecessary for this application as the Sensitive Eyes Plus Saline Solution has been commercially available for over 25 years with "well demonstrated safety and efficacy." The cumulative results of laboratory testing sponsored by Bausch + Lomb demonstrate substantial equivalence in safety, effectiveness, and performance when used with gas permeable contact lenses to the current product indicated for soft contact lenses.

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

The document does not specify the sample sizes used for the microbiology, biocompatibility, or lens compatibility test sets.
Data provenance: The studies were performed by or sponsored by Bausch + Lomb. The specific country of origin for the data is not mentioned but appears to be part of a submission to the U.S. FDA, indicating the data would be accepted under U.S. regulatory standards. These are preclinical (laboratory) studies, not typically categorized as retrospective or prospective in the same way clinical trials are.

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

This information is not provided in the document. The studies are primarily laboratory-based (microbiology, lens compatibility) and a declaration of no new biocompatibility testing needed due to prior clearance. Expert consensus for "ground truth" as typically understood in diagnostic device evaluations is not applicable here.

4. Adjudication method for the test set

This information is not provided and is not applicable for the type of laboratory and preclinical studies presented. Adjudication methods are typically used in clinical studies involving human observers or subjective assessments.

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

No, an MRMC comparative effectiveness study was not done. This device is a saline solution and not an AI-powered diagnostic device. Therefore, a study involving human readers and AI assistance is not relevant or described.

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

No, a standalone algorithm performance study was not done. This device is a physical product (saline solution), not an algorithm or AI.

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

For the microbiology studies, the "ground truth" would be defined by the established laboratory methods and criteria in ISO 14730 and the FDA Guidance document. This involves direct measurement of antimicrobial efficacy against specified microorganisms.
For lens compatibility, the "ground truth" is defined by the objective standards and methods outlined in ISO 11981, which assess physical characteristics of lenses after exposure to the solution.
For biocompatibility, the "ground truth" was established by previous testing and regulatory clearance of the device/components, meaning it met established safety standards.
The absence of clinical studies for this submission means no direct "outcomes data" or "pathology" was generated for new approval, relying instead on historical data and preclinical testing.

8. The sample size for the training set

This is not applicable as this submission is for a medical device (saline solution), not an AI/machine learning model that requires a "training set."

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

This is not applicable for the same reason as point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one in front of the other.

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

April 11, 2017

Bausch & Lomb Incorporated Ms. Melissa Thomas Senior Manager, Regulatory Affairs 1400 North Goodman Street Rochester, New York 14609

Re: K170483

Trade/Device Name: Bausch + Lomb Sensitive Eyes Plus Saline Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN, MRC Dated: February 14, 2017 Received: February 16, 2017

Dear Ms. Thomas:

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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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.

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.

Denise L. Hampton -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K170483

Device Name Bausch + Lomb Sensitive Eyes Plus Saline

Indications for Use (Describe)

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY K170483

Bausch + Lomb Sensitive Eyes Plus Saline Solution

1. Submitter Information

Primary	Alternate
Melissa Thomas	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) 338-6045	Tel. (585) 338-8215
Fax (585) 338-0702	Email: Glenn.Davies@bausch.com
Email: Melissa.Thomas@bausch.com

Summary Prepared: April 2017

2. Device Name

Trade Name:	Bausch + Lomb Sensitive Eyes Plus Saline Solution
Classification:	Accessories, Contact Lens Care Products
Device classification:	Class II
Regulation Number:	886.5928 Soft Contact Lens Care Products886.5918 Rigid Gas Permeable Contact Lens Care Products
Product Code:	LPN, MRC

3. Predicate Device

Bausch + Lomb Sensitive Eyes Plus Saline Solution (P800024/S16) Menicon Saline Rinse Solution (K151768)

4. Description of the Device

{4}------------------------------------------------

5. Intended Use

Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.

6. Description of Safety and Substantial Equivalence

A series of preclinical testing was performed to demonstrate the safety and effectiveness of Bausch + Lomb Sensitive Eyes Plus Saline Solution 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

Studies were performed to establish discard dating of 90 days for Sensitive Eves Plus Saline Solution. The test articles were evaluated initially and again following simulated use for the proposed discard date of 90 days.

The results of these evaluations demonstrate that Sensitive Eyes Plus Saline Solution meets the requirements of ISO 14730, Annex C Procedure II. Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard for the designation of a 90 day discard date.

Additionally a modified regimen procedure allowing for a rinse with Sensitive Eves Plus Saline Solution In Place of Tap Water was conducted for both Boston Conditioning Solution and Boston Advance Conditioning Solution. The results of both evaluations demonstrate that modified regimen with Sensitive Eyes Plus Saline Solution meets the FDA performance criteria for reqimen evaluation as described in the May 1, 1997 Guidance for Industry, Pre-market Notification (510(k)) Guidance Document for Contact Lens Care Products when used in a 10 second rub, 5 second rinse (per lens side) regimen. The products used in this regimen also meet the performance criteria established in ISO Standard 14729: 2001/Amd. 1:2010: (E) for regimen testing.

Biocompatibility

Biocompatibility tests were unnecessary for this application. The Sensitive Eyes Plus Saline Solution was previously cleared for use and expansion of the indication did not prompt the need for new testing.

Lens Compatibility

The results of lens compatibility studies per ISO 11981 demonstrate Bausch + Lomb Sensitive Eyes Plus Saline Solution is compatible with rigid gas permeable contact lenses.

Clinical Data

Clinical studies involving Sensitive Eyes Plus Saline Solution were unnecessary for this application. The Sensitive Eyes Plus Saline Solution has been commercially available in the market for over 25 years with well demonstrated safety and efficacy.

{5}------------------------------------------------

7. Substantial Equivalence

The cumulative results of laboratory testing sponsored by Bausch + Lomb demonstrate that the safety, effectiveness and performance of Bausch + Lomb Sensitive Eyes Plus Saline Solution when used with gas permeable contact lenses are substantially equivalent to the current product which is indicated for use with soft contact lenses.

Feature	Menicon Saline RinseSolution (K151768)	Sensitive Eyes PlusSaline Solution(P800024/S16)	Sensitive Eyes PlusSaline Solution(K170483)
Product Code	LPN, MRC	LPN	LPN, MRC
Regulation Number	21 CFR 886.591821 CFR 886.5928	21 CFR 886.5928	21 CFR 886.591821 CFR 886.5928
Indicated for SoftLenses	Yes	Yes	Yes
Indicated for RigidGas PermeableLenses	Yes	No	Yes
Rinse Required forCleaning	Unknown	Thoroughly Rinse5 Seconds Each Side	Thoroughly Rinse5 Seconds Each Side
Discard After Opening	Unknown	NA	90 day Discard Date
Primary Container	Plastic resin containerwith twist off cap	Plastic BottleMultiple Sizes	Plastic BottleMultiple Sizes
Container Usage	Single Use	Multi Use	Multi Use
Preserved	No	Yes	Yes
Sterile	Yes	Yes	Yes
TechnologyFeatures	IsotonicAqueous Solution	IsotonicAqueous Solution	IsotonicAqueous Solution
Materials	Plastic Resin ContainerWith Twist Off Cap	Plastic Resin ContainerWith Cap	Plastic Resin ContainerWith Cap
Principles ofOperation	Mechanical Rinsing	Mechanical Rinsing	Mechanical Rinsing
Directions for Use	Unknown	Rinse After Cleaning(5 sec. per side)Rinse After Disinfection(20 seconds)Carton OnsertBausch.com	Rinse After Cleaning(5 sec. per side)Rinse After Disinfection(20 seconds)Carton OnsertBausch.com

SUBSTANTIAL EQUIVALENCE SUMMARY TABLE

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.”