Bausch + Lomb® NNR06 Multi-Purpose Solution is indicated for use in the daily conditioning, cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.

Device Description

Bausch + Lomb NNR06 Multi-Purpose Solution is a sterile, isotonic solution containing a triple disinfection system (polyaminopropyl biguanide 0.00005%, polyquaternium 0.00015% and alexidine 0.0002%), dual surfactants, poloxamine, poloxamer 181, and a novel buffering system consisting of edetate disodium, sodium citrate, and diglycine. The formulation also contains boric acid, sodium borate, sodium chloride and purified water. 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

The provided text describes the Bausch + Lomb NNR06 Multi-Purpose Solution, a soft contact lens care product. It outlines the testing performed to demonstrate its safety and effectiveness for substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like a typical AI/ML medical device submission might. Instead, it describes a series of preclinical and clinical tests whose results demonstrated that the device met the requirements for safety and effectiveness.

Here's an interpretation of the implied acceptance criteria and reported performance based on the provided text:

Acceptance Criterion (Implied)	Reported Device Performance
Biocompatibility:
Cytotoxicity	Met
Ocular irritation	Met
Oral toxicity	Met
Sensitization	Met
In vivo ocular biocompatibility	Met
Microbiology:
Disinfection efficacy	Exceeds criteria
Preservative efficacy	Exceeds criteria
Acanthamoeba encystment	Demonstrated efficacy (implied)
Sterilization method for production	Assessed and implies effectiveness
Lens Compatibility:
Physical compatibility with soft contact lenses	Compatible
Compatibility with silicone hydrogel contact lenses	Compatible
Preservative uptake and release	Demonstrated (implies acceptable levels)
Cleaning Efficacy:
Critical Micelle Concentration	Surfactant concentrations well above CMC
Protein deposit removal (in vitro)	Demonstrated cleaning properties
Clinical Safety:
Slit lamp findings (primary endpoint)	Achieved (implies acceptable findings)
Adverse events	No reported adverse events
Visual acuities	Similar between eyes of both groups
Slit lamp findings, symptoms requiring medical treatment, comparison of visual acuities, absence of adverse events	Indicate safety
Clinical Effectiveness:
Comfort-related symptoms/complaints	Indicate effectiveness
Investigator-assessed lens wettability	Indicate effectiveness
Investigator-assessed lens deposits	Indicate effectiveness
Overall Comparison to Predicate:	Similar safety and effectiveness profiles

2. Sample Size and Data Provenance

Test Set Sample Size: The document states that a "controlled clinical study" was conducted with "habitual contact lens wearers." However, it does not specify the exact sample size for the clinical study.
Data Provenance: The document does not explicitly state the country of origin where the clinical study was conducted. It mentions that the study was "a three-month, active control, parallel group, masked randomized study of habitual contact lens wearers," indicating it was a prospective clinical study.

3. Number and Qualifications of Experts for Ground Truth

This information is not applicable as the document describes a contact lens solution, not an AI/ML device that would typically rely on expert-established ground truth for its performance assessment. The "ground truth" for this device's performance comes from validated laboratory tests and clinical outcomes assessed by investigators (e.g., observing slit lamp findings, assessing comfort).

4. Adjudication Method for the Test Set

Not applicable in the context of this type of device and study. The clinical study involved investigator assessments, which would follow a protocol but not an independent adjudication method for ground truth as seen in AI/ML performance studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools to assess performance with and without AI assistance for human readers, which is not the nature of this device.

6. Standalone Performance Study

The reported clinical study is effectively a "standalone" outcome study for the device, in the sense that it evaluates the device's performance on its own (in comparison to an active control, rather than an AI-assisted human). The device itself (NNR06 Multi-Purpose Solution) is not an AI algorithm, so the concept of an "algorithm only without human-in-the-loop performance" doesn't directly apply here. The safety and effectiveness were assessed based on user experience and clinical findings.

7. Type of Ground Truth Used

For the clinical study, the "ground truth" (or outcome measures) included:

Clinical Observations: Graded slit lamp findings, visual acuities, investigator-assessed lens wettability, investigator-assessed lens deposits.
Patient Reported Outcomes: Comfort-related symptoms/complaints.
Adverse Events Reporting: Absence or presence of adverse events.

For the preclinical studies, the "ground truth" was established by validated laboratory test methods and international standards (e.g., ISO, EN ISO standards) for biocompatibility, microbiology, cleaning efficacy, and lens compatibility.

8. Sample Size for the Training Set

Not applicable. This device is a contact lens solution, not an AI/ML algorithm that requires a training set. The "development" of the solution would involve chemical formulation and laboratory testing, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this is not an AI/ML device, and therefore no training set or its associated ground truth establishment methods are relevant.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, which is a symbol often associated with healthcare.

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

November 25, 2016

Bausch & Lomb Incorporated Glenn Davies, O.D. Senior Director Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609

Re: K161819

Trade/Device Name: NNR06 Multi-purpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: October 19, 2016 Received: October 20, 2016

Dear Dr. Davies:

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 (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

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Page 2 - Glenn Davies, O. D.

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 yours,

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)

K161819

Device Name NNR06 Multi-Purpose Solution

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)

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K161819

510(k) SUMMARY

1. Submitter Information

Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609

Contact Person Glenn A. Davies, O.D. Senior Director Requlatory Affairs

Telephone Number

(585) 338-8215

Summary Prepared: November 2016

2. Device Name

Common Name:	Soft (hydrophilic) Contact Lens Care Solution
Trade Name:	NNR06 Multi-Purpose Solution
Classification:	Accessories, Soft Lens Products
Device classification:	Class II (21 CFR §886.5928)
Product Code:	LPN

3. Predicate Device

COMPLETE Multi-Purpose Solution Easy Rub Formula (K030092)

4. Description of the Device

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5. Intended Use

Bausch + Lomb NNR06 Multi-Purpose Solution is indicated for use in the daily cleaning, conditioning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.

6. Description of Safety and Substantial Equivalence

A series of preclinical and clinical testing was performed to demonstrate the safety and effectiveness of Bausch + Lomb NNR06 Multi-Purpose 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:

Biocompatibility

Cytotoxicity, ocular irritation, oral toxicity, sensitization and in vivio ocular biocompatibility studies were completed for Bausch + Lomb NNR06 Multi-Purpose Solution. The test results demonstrated the biocompatibility of NNR06 Multi-Purpose Solution.

Testing was conducted according to Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997 and ISO Standard 10993-1 Biological evaluation of medical devices and related biocompatibility standards (ISO 9394. ISO 10993-5. ISO 10993-10. ISO 10993-11).

Microbiology

The sponsor conducted a series of studies according to EN ISO 14729:2001 Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses, including Amendment 1 (2010), and EN ISO 14730:2014 Antimicrobial preservative efficacy testing and guidance on determining discard date, ISO18259 Method to assess contact lens care products with contact lens care products with contact lenses in a lens case, and ISO 19045 Method for evaluating Acanthamoeba encystment by contact lens care products and demonstrate Bausch + Lomb NNR06 Multi-Purpose Solution exceeds the criteria for disinfection and preservative efficacy.

In addition, ISO 17665-1 Sterilization of Health Care Products - Moist Heat and ISO 11137 Sterilization of Health Care Products - Radiation were used to assess the sterilization method for production.

Lens Compatibility

The results of lens compatibility studies demonstrate Bausch + Lomb NNR06 Multi-Purpose Solution is compatible with soft contact lenses including silicone hydrogel contact lenses.

Testing was conducted according to Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997 and ISO Standard 11981

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Determination of physical compatibility of contact lens care products with contact lenses, ISO 11986 Determination of preservative uptake and release.

Cleaning Efficacy

The cleaning efficacy of the solution was evaluated through the determination of the Critical Micelle Concentration. The surfactant concentrations are well above the CMC for the individual surfactants. In vitro laboratory studies demonstrated the cleaning properties of NNR06 Multi-Purpose Solution with contact lenses artificially deposited with protein.

Clinical Study

Bausch + Lomb conducted a controlled clinical study with soft (hydrophilic) contact lenses, including silicone hydrogel lenses, comparing the safety and effectiveness of Bausch + Lomb NNR06 Multi-Purpose Solution to Complete Multi-Purpose Solution Easy Rub Formula. The study was a three-month, active control, parallel group, masked randomized study of habitual contact lens wearers.

Testing was conducted according to Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997 and ISO Standard 11980 Guidance for clinical investigations.

Safety

The primary endpoint of interest for slit lamp findings was achieved. There were no reported adverse events in either treatment group during the study. Visual acuities were similar between eyes of both groups.

Graded slit lamp findings; the incidence and type of slit lamp findings and symptoms requiring medical treatment; the comparison of visual acuities; and the absence of adverse events indicate that the NNR06 Solution is safe for use with soft contact lenses, including silicone hydrogel lenses.

Effectiveness

Comfort-related symptoms/complaints, Investigator-assessed lens wettability, and Investigator-assessed lens deposits indicate that the NNR06 Multi-Purpose Solution is effective for use with soft contact lenses including silicone hydrogel lenses.

The results of the study demonstrated similar safety and effectiveness profiles and support a substantial equivalence determination.

7. Substantial Equivalence

Bausch + Lomb NNR06 Multi-Purpose Solution has the same technological characteristics, sterile, isotonic, aqueous chemical disinfecting solution, as the predicate device. Bausch + Lomb NNR06 Multi-Purpose Solution does not raise new questions of safety and effectiveness.

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The cumulative results of laboratory, in vivo, and clinical testing sponsored by Bausch + Lomb demonstrate that the safety, effectiveness and performance of Bausch + Lomb NNR06 Multi-Purpose Solution are substantially equivalent to AMO Complete Multi-Purpose Solution Easy Rub Formula for soft contact lenses, including silicone hydrogel contact lenses.

The similarities and differences between Bausch + Lomb NNR06 Multi-Purpose Solution and the predicate device, AMO Complete Multi-Purpose Solution Easy Rub Formula, are described in the following table.

Feature	Bausch + LombNNR06 Multi-PurposeSolution	AMOComplete Multi-Purpose SolutionEasy Rub Formula
Indicated for Soft Lenses	Yes	Yes
Indicated for SiliconeHydrogel Lenses	Yes	No
Indicated for use inconditioning, cleaning,removal of protein rinsing,disinfection and storage ofcontact lenses	Yes	YesExcept Conditioning
Rub Regimen	3 Drops20 Seconds	3 Or More Drops20 Seconds
Optional No-Rub Regimen	No	No
Rinse Required forCleaning	Thoroughly Rinse5 Seconds Each Side	Rinse5 Seconds Each Side
Minimum Disinfection Time	4 hours	6 hours
Triple Disinfection System	Yes	No
Preservatives /Disinfectants	Polyaminopropyl Biguanide0.5ppmPolyquaternium1.5ppmAlexidine2.0ppm	Polyhexamethylene Biguanide1ppm

SUBSTANTIAL EQUIVALENCE SUMMARY TABLE

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SUBSTANTIAL EQUIVALENCE SUMMARY TABLE (CONTINUED)

Feature	Bausch + LombNNR06 Multi-PurposeSolution	AMOComplete Multi-Purpose SolutionEasy Rub Formula
Dual Surfactants	Yes	No
Surfactants	Poloxamer 181Poloxamine	Poloxamer 237
Lens Storage Period	30 Days	30 Days
Discard After Opening	90 Days	NoUse Before Expiration Date
Primary Container	Clear Plastic BottleMultiple Sizes	White Plastic BottleMultiple Sizes

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.”