Bausch & Lomb ReNu MultiPlus™ Lubricating & Rewetting Drops are indicated for use to lubricate and rewet soft (hydrophilic) contact lenses during wear. The product may be used with daily wear or extended wear lenses and with disposable lenses or lenses prescribed for frequent replacement.

Device Description

Bausch & Lomb ReNu MultiPlus Lubricating & Rewetting Drops is a sterile, buffered, isotonic solution containing the demulcent povidone. The solution is preserved with edetate disodium and sorbic acid, both at a concentration of 0.1%. Boric acid, potassium chloride, sodium borate and sodium chloride act as buffering and tonicity agents. The solution is supplied sterile in a low density polyethylene bottle labeled with a lot number and expiration date.

AI/ML Overview

The provided document describes the safety and effectiveness of Bausch & Lomb ReNu MultiPlus™ Lubricating & Rewetting Drops, an in-eye soft contact lens solution. Since this is a medical device (a lubricating/rewetting drop for contact lenses) and not an AI/ML device, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone AI performance, sample size for training set, and how ground truth for training set was established) are not applicable.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from FDA Guidance and Predicate Equivalence)	Reported Device Performance
Safety: Non-toxic to ocular tissue, no significant adverse events, no significant differences in slit lamp evaluations or physiological response compared to predicate.	Demonstrated as non-toxic to ocular tissue in in-vivo preclinical testing. No adverse events reported in clinical study. No significant differences between Test and Control regimens for slit lamp evaluations or physiological response.
Effectiveness (Lubricating & Rewetting): Efficacy in lubricating and rewetting soft (hydrophilic) contact lenses during wear, comparable to predicate.	Demonstrated efficacy for lubricating and rewetting soft (hydrophilic) contact lenses during wear. No significant differences between Test and Control Groups with respect to patient symptoms, visual acuity, and average daily wear times.
Substantial Equivalence: Physical, chemical, and microbiological properties, indications for use, safety, and effectiveness substantially equivalent to predicate devices.	Physical, chemical, and microbiological properties substantially equivalent to predicate devices (ReNu Lubricating & Rewetting Drops and Sterile Lens Lubricant). Indications for use, safety, and effectiveness also found substantially equivalent.
Compatibility with Contact Lenses: Demonstrated compatibility with soft (hydrophilic) contact lenses.	In-vitro lens compatibility testing conducted, establishing product compatibility with soft (hydrophilic) contact lenses.

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

Test Set Sample Size: 87 subjects (174 eyes) successfully completed the clinical study. 59 subjects (93.7%) were in the Test Group (ReNu MultiPlus™) and 28 subjects (90.3%) were in the Control Group (predicate device, ReNu Lubricating & Rewetting Drops).
Data Provenance: The document does not explicitly state the country of origin, but it is a submission to the US FDA for a product by Bausch & Lomb Incorporated in Rochester, New York. The study was likely conducted in the USA or under US clinical trial guidelines. The study was prospective as it was a clinical evaluation conducted to demonstrate safety and efficacy.

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

This is not applicable as the study involves a medical device (contact lens solution) and not an AI/ML diagnostic system requiring expert interpretation for ground truth. The "ground truth" here is derived from clinical observations, patient-reported symptoms, and physiological measurements assessed by clinical investigators. The document does not specify the number or qualifications of the clinical investigators, beyond stating a "one (1) month study was conducted to clinically evaluate the safety and efficacy."

4. Adjudication method for the test set

This is not applicable for this type of medical device study. Data was collected via slit lamp evaluations, patient symptom reports, physiological responses, visual acuity checks, and wear times. Adverse events were also monitored. A formal adjudication method in the context of expert review for AI/ML ground truth is not relevant here.

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

This is not applicable as the study is for a contact lens care product, not an AI/ML diagnostic device, and does not involve "human readers" or "AI assistance."

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

This is not applicable as the device is a contact lens solution, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context was established through:
- Clinical Observations: Slit lamp evaluations (physiological response of the eye).
- Patient-Reported Outcomes: Patient symptoms (e.g., comfort, dryness).
- Physiological Measurements: Visual acuity, average daily wear times.
- Adverse Event Monitoring.

8. The sample size for the training set

This is not applicable as the device is a contact lens solution and does not involve an AI/ML algorithm that requires a training set.

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

This is not applicable.

Summary

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JUN 2 4 1998

510 (k) PREMARKET NOTIFICATION BAUSCH & LOMB ReNu MultiPlus™ Lubricating & Rewetting Drops

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

BAUSCH & LOMB ReNu MultiPlus™ Lubricating & Rewetting Drops

1. Submitter Information:

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

Kim S. DeVitto Contact Person: Manager, Regulatory Affairs

(716) 338-6401 Telephone Number:

2. Device Name:

In-Eye Soft (hydrophilic) Contact Lens Solution (Lubricating Classification Name: and/or Rewetting Drops

ReNu MultiPlus™ Lubricating & Rewetting Drops Proprietary Name:

3. Predicate Device:

The Bausch & Lomb products, ReNu Lubricating & Rewetting Drops and Sterile Lens Lubricant were selected as the predicate devices for ReNu MultiPlus™ Lubricating & Rewetting Drops.

4. Description of the Device

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Indications for Use: પં

Description of Safety and Substantial Equivalence 6.

A series of preclinical tests and clinical testing was performed to demonstrate the safety and effectiveness of ReNu MultiPlus Lubricating & Rewetting Drops. A summary of the test results is provided below.

Preclinical Testing

A series of in-vitro and in-vivo preclinical chemical, toxicological and microbiological studies were performed to assess the safety and effectiveness of the product in accordance with the guidelines set forth in FDA's May 1, 1997 Guidance for Industry - Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.

The results of these studies indicate that the physical, chemical and microbiological properties of Bausch & Lomb ReNu MultiPlus Lubricating & Rewetting Drops are substantially equivalent to the predicate devices, Bausch & Lomb ReNu Lubricating & Rewetting Drops and Sterile Lens Lubricant.

The solution is non-toxic to the ocular tissue as demonstrated by in-vivo preclinical testing in laboratory animals. In-vitro lens compatibility testing was conducted to establish product compatibility with soft (hydrophilic) contact lenses.

Clinical Testing

A one (1) month study was conducted to clinically evaluate the safety and efficacy of Bausch & Lomb ReNu MultiPlus Lubricating & Rewetting Drops for use in the lubricating and rewetting of soft (hydrophilic) contact lenses during wear. The clinical study was designed in accordance with the Premarket Notification (510 (k)) Guidance for Contact Lens Care Products of May 1, 1997. The test cell included Bausch & Lomb ReNu MultiPlus™ Lubricating & Rewetting Drops. The control cell consisted of the predicate device, Bausch & Lomb ReNut Lubricating & Rewetting Drops.

A total of 87 subjects (174 eyes) successfully completed the study, 59 subjects (93,7%) from the Test Group and 28 subjects (90.3%) from the Control Group. During this study, no adverse events were reported; there were not significant differences between Test and Control regimens for slit lamp evaluations or patient symptoms. Significant differences were not seen between the Test and Control Groups with respect to physiological response, visual acuity and average daily wear times.

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Results of the clinical study demonstrate the safety, effectiveness and substantial equivalence of Bausch & Lomb ReNu MultiPlus™ Lubricating & Rewetting Drops to the predicate device for lubricating and rewetting soft (hydrophilic) contact lenses.

7. Substantial Equivalence

Bausch & Lomb ReNu MultiPlus Lubricating & Rewetting Drops are substantially equivalent in terms of indications for use, safety and effectiveness to the predicate devices: Bausch & Lomb ReNu Lubricating & Rewetting Drops (approved for marketing under PMA P820031) and Bausch & Lomb Sterile Lens Lubricant (approved for marketing under NDA N17-945). Any differences between the new device and its predicates do not effect the use of this product.

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Image /page/3/Picture/1 description: The image shows a partial view of a logo or emblem. The logo features a stylized depiction of an eagle or bird-like figure, rendered in a minimalist, abstract style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged around the upper portion of the emblem, suggesting it represents a governmental organization related to health and human services in the United States. The image is in black and white, with the logo appearing to be a stamp or printed graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 24 1998

Kim S. DeVitto Manager, Regulators Affairs Baush & Lomb Inc. 1400 North Goodman St. Rochester, NY 14692-0450

Re: K980591 Trade Name: ReNu Multiplus ™ Lubricating & Rewetting Drops Regulatory Class: II Product Code: 86 LPN Dated: May 21, 1998 Received: May 22, 1998

Dear Ms. DeVitto:

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 - Ms. Kim S. Devitto

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 Roerl lorentbal

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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ausch & Lamb 0(k) Premarket Notificution File K980591

Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14692-0450

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K980591

Device Name:

ReNu MultiPlus™ Lubricating & Rewetting Drops

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 UseUse X(Per 21 CFR 801.109)	Daniel W. Brown Ph.D. (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number K980591	Over-The-Counter X

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.”