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

Device Description

Bausch & Lomb ReNu Multi-Purpose Solution is a sterile, isotonic solution that contains HYDRANATES (hydroxyalkyl phosphonate) as a protein deposit remover, poloxamine as a surface active agent and salts as tonicity and buffering agents; preserved with DYMED" (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 and is labeled with a lot number and expiration date.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the studies that demonstrate the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied by studies)	Reported Device Performance
Protein Cleaning Efficacy	Statistical equivalence to predicate device (Alcon OPTI-FREE EXPRESS No Rub) in removing protein deposits from soiled lenses. (No specific quantitative criteria provided).	Both the Test (ReNu MultiPlus) and Control (Alcon OPTI-FREE EXPRESS No Rub) were statistically equivalent in the in-vitro protein cleaning study using soiled Group 1 and 4 lenses and "no rub" regimens.
Microbiological Efficacy	Performance criteria established by FDA for Stand-alone Procedure for Disinfecting Products, Primary Criteria and Regimen Test. (Specific quantitative criteria not provided in this document but implied to be regulatory standards for disinfection).	The results of the Stand-alone Procedure for Disinfecting Products and Regimen Test indicated that the "performance criteria established by FDA have been met." An additional microbiological test with organic soil also "met the requirements of the test." Previous submissions (K974723, K-002823, P860023/S12) also demonstrated efficacy.
Clinical Safety and Efficacy	Demonstration of clinically acceptable lens cleanliness, safety, and efficacy in a clinical setting when used with a 5-second cleaning rinse. Substantial equivalence to the predicate device in terms of safety and efficacy.	A multi-site randomized, controlled clinical study demonstrated "clinically acceptable lens cleanliness" for ReNu MultiPlus. "Safety and efficacy were demonstrated," and the product was found to be "substantially equivalent" to Alcon OPTI-FREE EXPRESS No Rub.
Biocompatibility	No new biocompatibility testing required due to unchanged formulation from previously cleared product. (Implied: previously cleared product met biocompatibility standards).	ReNu MultiPlus Multi-Purpose Solution "remains unchanged from the previously cleared product" and thus "the labeling changes do not require new biocompatibility testing."

2. Sample Size Used for the Test Set and Data Provenance

Protein Cleaning Study: "Groups 1 and 4 lenses artificially soiled with lysozyme." The exact number of lenses or replicates is not specified.
- Provenance: Not explicitly stated, but assumed to be laboratory-based (in-vitro).
Microbiology Studies: Not explicitly stated for the "additional microbiological testing." Reference is made to previous submissions (K974723, K-002823, P860023/S12) for earlier studies.
- Provenance: In-vitro laboratory studies.
Clinical Studies: "A multi-site randomized, controlled clinical study." The exact number of subjects or lenses is not specified.
- Provenance: Prospective clinical study. Country of origin not specified, but likely US-based given the FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document for any of the studies. No mention of expert review or reconciliation for ground truth is made.

4. Adjudication Method (for the test set)

This information is not provided in the document. The studies described are either in-vitro technical tests or a clinical trial where clinical outcomes would likely be assessed by investigators and measured against pre-defined criteria, rather than using an adjudication panel in the sense often applied to AI model evaluations.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This device is a contact lens solution, not an AI or imaging diagnostic tool that would typically involve human "readers" or AI assistance in that context. The "clinical study" evaluates the solution's performance on its own, not in conjunction with human interpretation of results.

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

Protein Cleaning Study: Yes, this was an in-vitro standalone test comparing the solution's cleaning efficacy against a control solution. There is no human interpretation component beyond observing the results.
Microbiology Studies: Yes, these were standalone in-vitro tests (Stand-alone Procedure for Disinfecting Products) evaluating the solution's antimicrobial efficacy. There is no human user involvement in the performance evaluation itself.
Clinical Studies: No, the clinical study involved human subjects using the product. While the performance of the solution itself is standalone (it disinfects/cleans on its own), the evaluation of its safety and efficacy is within a human-in-the-loop setting (patients using the product and being monitored). However, it's not a "standalone algorithm" in the typical sense of AI evaluation.

7. The Type of Ground Truth Used

Protein Cleaning Study: The "ground truth" was established by artificially soiling lenses with lysozyme and then quantitatively or qualitatively assessing protein removal.
Microbiology Studies: The "ground truth" was established by using standardized microbial challenges (specific types and concentrations of microorganisms) and measuring log reductions or kill rates according to established FDA-recognized test procedures.
Clinical Studies: The "ground truth" for clinical safety and efficacy would have been based on clinical endpoints and observations (e.g., visual acuity, comfort, adverse events, lens deposition levels as assessed by ophthalmologists/optometrists) and objective measures of lens cleanliness.

8. The Sample Size for the Training Set

This information is not applicable as this is a contact lens solution and not an AI/machine learning device that requires a "training set." The studies performed are traditional chemistry, microbiology, and clinical performance evaluations.

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

This information is not applicable for the same reason as above.

Summary

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K 011796

510 (k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BAUSCH & LOMB ReNu MultiPlus® MULTI-PURPOSE SOLUTION

Submitter Information 1. Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, New York 14603-0450

Contact Person:	Paul G. StapletonDirector, Regulatory Affairs
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716-338-8172 Telephone Number:

Device Name 2.

Classification Name: Soft (hydrophilic) Contact Lens Solution

BAUSCH & LOMB ReNu MultiPlus Multi-Purpose Proprietary Name: Solution

ਤੇ . Predicate Devices

Alcon OPTI-FREE EXPRESS No Rub has been selected as the predicate device for Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution

4. Description of the Device

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Indications for Use 5.

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

Description of Safety and Substantial Equivalence ર.

A series of preclinical and clinical studies were completed on this product and have previously been submitted under Premarket Approval Application P860023/ S12, K974723 and K002823. No concerns were raised at the time of clearance.

In addition, the following studies have been completed:

Cleaning Studies

An in-vitro protein cleaning study was conducted with Groups 1 and 4 lenses artificially soiled with lysozyme. Deposited lenses were subjected to the no rub regimens for both the Test and Control based on labeled direction for use. These results indicated that both the Test and Control were statistically equivalent.

Microbiology Studies

A series of studies were completed to demonstrate the microbiological efficacy of ReNu MultiPlus Multi-Purpose Solution; these studies have previously been submitted in 510(k) clearances for K974723 and K-002823 and P860023/S12.

Additional microbiological testing has been completed based on the labeled directions for use. The results of the Stand-alone Procedure for Disinfecting Products, Primary Criteria and Regimen Test indicate that the performance criteria established by FDA have been met.

An additional microbiological test was completed employing the Stand-alone Procedure for Disinfecting Products, Primary Criteria that incorporated the use of organic soil. The results met the requirements of the test.

Clinical Studies

A multi-site randomized, controlled clinical study was conducted to evaluate the safety and efficacy of ReNu MultiPlus solution when used with a 5 second cleaning rinse prior to the disinfection cycle; no post-disinfection rinse was required. The Control solution was Alcon Opti-Free Express Multi-Purpose Disinfecting Solution No Rub which employed a 5 second cleaning rinse per side both before and after disinfection. Both regimens demonstrated clinically acceptable lens cleanliness. Safety and efficacy were demonstrated.

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ReNu MultiPlus Multi-Purpose Solution is substantially equivalent to Alcon Opti-Free Express No Rub.

Biocompatability Testing

ReNu MultiPlus Multi-Purpose Solution remains unchanged from the previously cleared product except for the Directions for Use. The labeling changes do not require new biocompatibility testing.

Substantial Equivalence

Bausch & Lomb ReNu Multi-Purpose Solution for use in a no rub regimen for lenses replaced at intervals of 30 days or less is substantially equivalent to Alcon OPTI-FREE EXPRESS No Rub.

The ReNu MultiPlus Multi-Purpose Solution will be sold in plastic bottles as a sterile solution; each bottle will be marked by a lot number and expiration date.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 1 2001

Mr. Paul G. Stapleton Director. Global Regulatory Affairs BAUSCH & LOMB 1400 N Goodman Street P.O. Box 30450 Rochester, NY 14603-0450

Re: K011796

Trade/Device Name: Bausch & Lomb® ReNu MultiPlus® 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: September 14, 2001 Received: September 17, 2001

Dear Mr. Stapleton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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

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K011796
NOV 01 2001

Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14603-0450

Indications for Use Statement

011796 510(k) Number (if known):

Device Name: ReNu MultiPlus® Multi-Purpose Solution

Indications for Use:

Indications for USC.
ReNu Multi-Purpose Solution is indicated for use in daily cleaning, removing Recrui Multi 100 Munical (not heat) disinfection and storage of soft (hydrophilic) protem deposits, recommended by your eye care practitioner.

(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_

510(k) Number

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.”