Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution is indicated for use in daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. It is also indicated for the in-office cleaning, rinsing and chemical (not heat) disinfection and storage of trial soft (hydrophilic) lenses for up to thirty (30) days.

Device Description

Bausch & Lomb ReNu Multi-Purpose Solution is a sterile, isotonic solution that contains HYDRANATE™ (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. Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution is also indicated for use in the in-office chemical (not heat) disinfection of trial soft (hydrophilic) contact lenses. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.

AI/ML Overview

The provided text describes the regulatory clearance of "BAUSCH & LOMB ReNu MultiPlusTM MULTI-PURPOSE SOLUTION" and its substantial equivalence to a predicate device. It details the product's indications for use and mentions certain preclinical and clinical studies, as well as adherence to specific ISO/CEN and FDA regimen procedures for disinfecting products.

However, the document does not contain the detailed information typically found in acceptance criteria and a study report for a medical device's performance characteristics in the context of an AI/algorithm-driven device. Specifically, it lacks:

A table of acceptance criteria with reported device performance metrics like sensitivity, specificity, accuracy, or other quantitative measures.
Information on sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth establishment.
Adjudication methods, MRMC studies, standalone performance details, training set size, or how ground truth for training data was established.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, particularly regarding safety and effectiveness for its intended use as a contact lens solution. The efficacy outlined is related to its biocidal properties against specific microorganisms.

Based on the provided text, here is an attempt to address your request, highlighting what is available and what is missing:

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

The document refers to adherence to specific standards rather than specific quantitative performance metrics like sensitivity or specificity.

Acceptance Criteria (Standard Reference)	Reported Device Performance
Primary performance criteria of the draft ISO/CEN Stand-alone Procedure for Disinfecting Products (March 23, 1995)	Results met the primary performance criteria
Draft Stand-alone Procedure for Disinfecting Products (June 7, 1995) from the draft Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products	Results met the primary performance criteria
ISO FDA Regimen Procedure for Disinfecting Regimens (for Herpes simplex Virus, Type 1 and Adenovirus Type 7)	Satisfactory results at thirty (30) days for both viruses tested

Device Performance Details:

Biocidal Efficacy: Demonstrated against S. aureus, Ps. aeruginosa, S. marcescens, C. albicans, and F. solani at thirty (30) days, with and without lenses, in glass vials.
Viral Efficacy: Demonstrated against Herpes simplex Virus, Type 1 and Adenovirus Type 7 at thirty (30) days.

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

Sample Size for Test Set: Not specified in the provided text for the biocidal and viral efficacy tests. The text mentions these tests were performed "in glass vials," implying laboratory-based testing rather than patient data.
Data Provenance: The efficacy tests were laboratory-based (in vitro), conducted to meet international and FDA draft standards. The country of origin for the underlying data is not specified beyond "preclinical and clinical studies were completed on this product and have previously been submitted under Premarket Approval Application P860023/ S12." These previous submissions likely contain more detailed provenance.

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

Not applicable/Not specified. The "ground truth" for biocidal efficacy and viral efficacy tests would be determined by laboratory methods and established microbiological standards, not typically by human experts in the way that clinical imaging or diagnostic AI is assessed.

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

Not applicable/Not specified. Adjudication methods are typically associated with human expert review of clinical cases. For laboratory efficacy studies, the results are typically quantitative and objective.

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 document pertains to a contact lens solution, not an AI or algorithm-driven diagnostic device that would involve human readers or AI assistance.

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

A standalone performance (algorithmic only) was effectively demonstrated for the solution's biocidal efficacy. The solution itself is the "algorithm" in this context, acting upon microorganisms without human intervention in its primary function. The reference to "ISO Stand Alone Procedure for Disinfecting Products" directly supports this.

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

Type of Ground Truth: The ground truth for the efficacy studies was based on established laboratory testing methods for microbiological and virological reduction/inactivation, as defined by ISO/CEN and FDA draft standards. This is a form of objective, standardized laboratory measurement against known pathogens.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device. The efficacy studies described are validation studies for the chemical solution itself, not for training a model.

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

Not applicable. As noted above, this is not an AI/machine learning device using a training set.

Summary

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4/27/99

K990422z

510 (k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BAUSCH & LOMB ReNu MultiPlusTM MULTI-PURPOSE SOLUTION

PROFESSIONAL LABELING

1. Submitter Information

Bausch & Lomb Incorporated Global Vision Care 1400 North Goodman Street Rochester, New York 14692-0450

Contact Person:	Paul G. Stapleton
	Director, Regulatory Affairs

Telephone Number: 716-338-8172

2. Device Name

Classification Name: Soft (hydrophilic) Contact Lens Solution

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

3. Predicate Devices

Bausch & Lomb ReNud Multi-Purpose Solution has been selected as the predicate device for Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution, Professional Labeling.

4. Description of the Device

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Indications for Use - Professional Labeling 5.

Bausch & Lomb ReNu Multi-Purpose Solution is indicated for use in daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. It is also indicated for the in-office cleaning, rinsing and chemical (not heat) disinfection and storage of trial soft (hydrophilic) lenses for up to thirty (30) days.

Description of Safety and Substantial Equivalence 6.

A series of preclinical and clinical studies were completed on this product and have previously been submitted under Premarket Approval Application P860023/ S12. No concerns were raised at the time of approval. In addition, ISO Stand Alone Procedure for Disinfecting Products was performed in glass vials to demonstrate the biocidal efficacy of ReNu MultiPlus Multi-Purpose Solution at thirty (30) days with and without lenses using S. aureus. Ps. aeruginosa. S. marcescens, C. albicans, and F. solani. The results met the primary performance criteria of the draft ISO/CEN Stand-alone Procedure for Disinfecting Products (March 23, 1995) and the draft Stand-alone Procedure for Disinfecting Products contained in the draft Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products (June 7, 1995). The ISO FDA Regimen Procedure for Disinfecting Regimens has been performed with Herpes simplex Virus, Type 1 and Adenovirus Type 7 with satisfactory results at thirty (30) days.

Substantial Equivalence

Bausch & Lomb ReNu Multipurpose Solution is substantially equivalent to Bausch & Lomb ReNu Multi-Purpose Solution for the in-office cleaning, rinsing and chemical (not heat) disinfection and storage of trial soft (hydrophilic) lenses for up to thirty (30) days.

The ReNu MultiPlus Multipurpose 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 1999

Mr. Paul G. Stapleton Director, Regulatory Affairs Bausch & Lomb Global Vision Care 1400 N. Goodman St Rochester, NY 14603-0450

Re: K990422

Trade Name: Bausch & Lomb ReNu MultiPlus ® Multi-Purpose Solution (for in office use with trial lenses) Regulatory Class: II Product Code: 86 LPN Dated: February 10, 1999 Received: February 11, 1999

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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Page 2 - Mr. Paul G. Stapleton

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K-990422

Device Name: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution

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

(Division Sign-Off)
Division of Ophthalmic Devices
10(k) Number K990422

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.”