Bausch & Lomb Multi-Purpose Solution NRC03 is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

Device Description

Bausch & Lomb Multi-Purpose Solution NRC03 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranate® (hydroxyalkylphosphonate), poloxamer 407, polyquaternium-10, poloxamine 1107, purified water and preserved with polyaminopropyl biguanide (0.0001%). The product is indicated for use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is contained in a plastic bottle with a tamper evident seal and is labeled with a lot number and expiration date.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Bausch & Lomb Multi-Purpose Solution NRC03, based on the provided text:

Important Note: This document is a 510(k) summary, which often provides high-level information. Therefore, specific details like exact sample sizes for all studies, ground truth methodologies for certain tests, and expert qualifications are not fully elaborated in this summary.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes a series of studies designed to demonstrate effectiveness and safety, and then concludes with a statement of "satisfactory levels" or "statistical significance/equivalence." The primary "acceptance criteria" here are implied to be the achievement of safety and efficacy levels comparable to existing predicate devices, as well as adherence to FDA Guidance for disinfection.

Here's an attempt to structure the information based on the provided text, recognizing the limitations of the summary format:

Study/Criterion Category	Implied Acceptance Criteria (Goal)	Reported Device Performance
Toxicology	No evidence of cytotoxicity or eye irritation with the solution or lenses cycled in it.	"there was no evidence of toxicity."
Lens Compatibility	Lenses should remain compatible with the solution after cycling.	"The results indicated that lenses were compatible with the solution."
Microbiology	Satisfactory levels of disinfection efficacy (per FDA Guidance documents and modifications to established procedures).	"The results indicate satisfactory levels of disinfection efficacy."
Cleaning Efficacy	Prevention of Protein Deposition: Significant prevention of protein deposition during a no-rub with rinse regimen and 4-hour disinfection.	"Protein deposition was significantly prevented as measured by Image Analysis."
	Removal of Protein Deposits: Statistical equivalence to control in removing protein from deposited lenses.	"The results indicated statistical equivalence between Test and Control."
	General Cleaning (Surfactant): Surfactant concentrations well above Critical Micelle Concentration (CMC).	"The surfactant concentrations are well above the CMC for the individual surfactants." This is a foundational aspect that supports cleaning efficacy.
Cleanliness Analysis (Clinical Lens Returns)	Substantial equivalence in lens cleanliness between test and control regimens.	"The analysis of lens cleanliness from both Test and Control regimens indicates that these regimens are substantially equivalent when evaluated by Image Analysis." This suggests that the clinical performance regarding cleanliness was comparable to the control, likely a predicate device.
Lens Wettability	Continued presence of wetting agents over time; statistically significant longer wetting ability compared to controls.	"The results indicated statistical significance for longer wetting ability over the controls." This implies the solution improves or maintains lens wettability effectively.
Clinical Studies	Demonstration of safety and efficacy, and substantial equivalence to control (predicate device).	A 3-month controlled, randomized study designed to evaluate safety and efficacy was completed, "to demonstrate the safety and efficacy of the solution and substantial equivalence to the Control." The overall conclusion of the 510(k) is that the device is "substantially equivalent" to predicate devices.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size:
  - Clinical Study: A "3-month controlled, randomized study" was conducted. However, the exact number of participants (sample size) for this clinical study is not specified in the provided text.
  - Other Studies (Toxicology, Lens Compatibility, Microbiology, Cleaning Efficacy, Wettability): The sample sizes for these preclinical/laboratory studies are also not specified.
- Data Provenance: The document does not explicitly state the country of origin for the data. Given Bausch & Lomb's location (Rochester, New York, USA) and the FDA submission, it's highly probable the studies were conducted in or overseen by US-based operations. The studies described are original investigations conducted by the submitter, making them prospective for the purpose of this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the number or qualifications of experts used to establish ground truth for any of the studies (e.g., for microscopy, image analysis, or clinical assessments). Ground truth for these types of products typically relies on standardized laboratory assays and clinical observations by trained personnel, but specific "experts" for ground truth adjudication are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method (like 2+1 or 3+1) is mentioned in the summary, as it's not typically relevant for the type of objective laboratory tests described or for the high-level summary of a clinical trial for a contact lens solution. Ground truth is generally established through the direct results of assays or clinical assessments.
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 type of study is relevant for AI systems interpreting medical images, which is not the nature of this medical device (a contact lens solution). The device itself does not involve "readers" or "AI assistance" in the typical diagnostic sense.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a solution, not an algorithm. Performance is measured directly through its chemical, biological, and clinical effects, not through an algorithm's output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth varied depending on the specific study:
  - Toxicology: Likely based on objective measures of cell viability (cytotoxicity assays) and macroscopic/microscopic observation of ocular tissues (eye irritation studies).
  - Lens Compatibility: Likely based on physical inspection of lenses after cycling, possibly optical properties, or other material science tests.
  - Microbiology: Based on standardized quantitative microbial reduction assays as per FDA Guidance (e.g., log reduction of specific organisms).
  - Cleaning Efficacy:
    - Protein Deposition: Measured by "Image Analysis" of lenses, implying quantitative assessment of protein stains or residues.
    - Protein Removal: Measured by "chemical analysis" of protein from deposited lenses.
    - Surfactant Concentration: Measured by analytical chemistry methods (e.g., to determine CMC).
  - Cleanliness Analysis (Clinical Lens Returns): "Evaluated by Image Analysis," similar to cleaning efficacy, but on clinically used lenses.
  - Lens Wettability: Measured by "contact angle" and likely visual or physical assessments of wetting over time.
  - Clinical Studies: Based on clinical observations (e.g., adverse events, comfort, visual acuity, lens condition) by eye care practitioners following established protocols.
- Overall, the ground truth leans heavily on objective laboratory measurements/assays and clinical observations/assessments, rather than expert consensus on a subjective measure.
The sample size for the training set:
- Not applicable. This device is a chemical solution, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set for this type of device, no ground truth was established for it.

Summary

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510(k) Premarket Notification Bausch & Lomb® Multi-Purpose Solution NRC03

K031646 510 (k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

NOV 1 4 2003

FOR

BAUSCH & LOMB® MULTI-PURPOSE SOLUTION NRC03

(TRADENAME TO BE DETERMINED)

1. Submitter Information

Bausch & Lomb Incorporated 1 400 North Goodman Street Rochester, New York 14609

Contact Person: Paul G. Stapleton Director, Regulatory Affairs

585-338-8172 Telephone Number:

2. Device Name

Classification Name: Soft (hydrophilic) Contact Lens Care Solution

Proprietary Name: Bausch & Lomb Multi-Purpose Solution NRC03

Predicate Devices 3.

Bausch & Lomb ReNu Multi-Purpose Solution, Alcon Opti-Free Express Multi-Purpose Disinfecting Solution and AMO Complete brand Multi-Purpose Solution have been selected as the predicate devices for Bausch & Lomb Multi-Purpose Solution NRC03.

Description of the Device 4.

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contained in a plastic bottle with a tamper evident seal and is labeled with a lot number and expiration date.

Indications for Use ડ.

Bausch & Lomb Multi-Purpose Solution NRC03 is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) lenses as recommended by your eye care practitioner.

Description of Safety and Substantial Equivalence Q.

A series of preclinical and clinical studies were completed on this product. The following studies have been completed:

Toxicology

A series of cytotoxicity and eye irritation studies of the Bausch & Lomb Multi-Purpose Solution NRC03 and lenses cycled in the solution were undertaken. In these studies, there was no evidence of toxicity.

Lens Compatibility

Lens compatibility studies were undertaken after cycling lenses in the solution. The results indicated that lenses were compatible with the solution.

Microbiology

Disinfection efficacy was evaluated according to the FDA Guidance document as well as modifications to established procedures. The results indicate satisfactory levels of disinfection efficacy.

Cleaning Efficacy

The cleaning efficacy of the solution has been evaluated through the determination of the Critical Micelle Concentration. The surfactant concentrations are well above the CMC for the individual surfactants.

The ability of the solution to prevent the deposition of protein has been established by the evaluation of protein present on the lens following solution usage in a no rub with a rinse regimen with a four (4) hour disinfection time. Protein deposition was significantly prevented as measured by Image Analysis.

The efficacy of the product to remove protein deposits measured by chemical analysis was evaluated with protein deposited lenses. The results indicated statistical equivalence between Test and Control.

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Cleanliness Analysis of Clinical Lens Returns

The analysis of lens cleanliness from both Test and Control regimens indicates that these regimens are substantially equivalent when evaluated by Image Analysis.

Lens Wettability

Lens wettability over time has been assessed by measurement of contact angle and continued presence of wetting agents over time. The results indicated statistical significance for longer wetting ability over the controls.

Clinical Studies

A 3-month controlled, randomized study designed to evaluate the safety and efficacy of the Multi-Purpose Solution NRC03 was completed to demonstrate the safety and efficacy of the solution and substantial equivalence to the Control.

Substantial Equivalence

Bausch & Lomb Multi-Purpose Solution NRC03 is substantially equivalent to Bausch & Lomb ReNu Multi-Purpose Solution, Opti-Free Express Multi-Purpose Disinfecting Solution and Complete brand Multi-Purpose Solution.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

NOV 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bausch & Lomb C/O Paul G. Stapleton Director. Global Regulatory Affairs 1400 N. Goodman St. Rochester, NY 14609

Re: K031646 Trade/Device Name: Bausch & Lomb Multi-Purpose Solution NRC03 Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: October 14, 2003 Received: October 15, 2003

Dear Mr. Stapleton:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Paul G. Stapleton

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, 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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Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14692-0450

Indications for Use Statement

0311646 510(k) Number (if known):

Device Name: Bausch & Lomb Multi-Purpose Solution NRC03 (Tradename to be determined)

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter-Use

-Use
^

Kane Wahabik

510(k) Number K031646

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.”