BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care provider. It is also indicated for use in dissolving enzymatic cleaning tablets.

Device Description

BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution is a multi-purpose solution used in the care of soft (hydrophilic) contact lenses and is indicated for the cleaning, rinsing, disinfection and storage of soft (hydrophilic) contact lenses. It may also be used as a diluent for enzymatic cleaning tablets which are to be used in conformance to the established labeling directions of the enzymatic cleaning tablets. The solution is contained in a plastic bottle and consists of a sterile isotonic solution that contains boric acid, edetate disodium, poloxamine. sodium borate and sodium chloride; it is preserved with alexidine dihydrochloride 4 ppm. Each plastic bottle is supplied sterile and is labeled with a lot number and expiration date.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the structure you requested.

Device: BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Disinfection Cycle Time: Disinfection equivalent to predicate device with a 10-minute cycle time.	Satisfactory microbiological testing results at time periods ranging from 10 minutes to 240 minutes.
Cleaning, Rinsing, Disinfection, and Storage: Safe and efficacious for these uses for soft (hydrophilic) contact lenses.	Safety and efficacy demonstrated through previous clinical and preclinical testing submitted under K973921.
Use as Diluent for Enzymatic Cleaning Tablets: Safe and efficacious for dissolving enzymatic cleaning tablets.	No specific performance outcome detailed for this, but implied as part of overall safety and efficacy.

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

Sample Size: Not explicitly stated for the microbiological testing supporting the 10-minute disinfection claim.
Data Provenance: The document does not specify the country of origin. The study appears to be prospective as it states "a series of microbiological testing has been completed at time period ranging from 10 minutes to 240 minutes" specifically to support the new 10-minute disinfection claim. The general safety and efficacy studies for the overall cleaning, rinsing, etc., were retrospective as they were previously submitted under K973921.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. (Presumably, these would be microbiology experts if external involvement beyond internal lab expertise was required).

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The testing described is microbiological efficacy testing, not observational or diagnostic assessment requiring expert adjudication. The results are likely quantitative measurements against specific microbial reduction standards.

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:

MRMC Study: No. This is a medical device (contact lens solution), not an AI diagnostic tool that would involve human readers.

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

Standalone Performance Test: Not applicable. This is a chemical solution, not an algorithm. The "standalone" performance here refers to the solution's efficacy against microbes.

7. The Type of Ground Truth Used:

Ground Truth: Microbiological efficacy standards (e.g., specific log reduction of various microorganisms as per ISO or FDA guidelines for disinfection solutions). The document states "All results were satisfactory," implying they met predefined standards.

8. The Sample Size for the Training Set:

Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was established:

Ground Truth Establishment: Not applicable.

Summary

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510 (k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BAUSCH AND LOMB ReNu [TBD] MULTI-PURPOSE SOLUTION

Submitter Information 1.

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

Contact Person:	Paul G. Stapleton
	Director, Global Regulatory Affairs

716-338-8172 Telephone Number:

2. Device Name

Classification Name: Soft (hydrophilic) Contact Lens Solution

BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution Proprietary Name:

Predicate Device 3.

Bausch & Lomb Sensitive Eyes Multi-Purpose Solution cleared under K 973921 has been selected as the predicate device for Bausch & Lomb ReNu [TBD] Multi-Purpose Solution with the new indication of 10 minute disinfection cycle.

Description of the Device 4.

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Each plastic bottle is supplied sterile and is labeled with a lot number and expiration date.

11 11:11 11 11

Indications for Use 5.

Description of Safety and Substantial Equivalence 6.

A series clinical and preclinical, testing was performed to demonstrate the safety and efficacy of Sensitive Eyes Multi-Purpose Solution; all studies had previously been submitted under K 973921 which cleared January 12, 1998. A summary of that testing has been previously provided.

To support a claim of 10 minute disinfection cycle time, a series of microbiological testing has been completed at time period ranging from 10 minutes to 240 minutes. All results were satisfactory.

Substantial Equivalence

BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution is substantially equivalent to the predicate device. BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution in a 10 minutes disinfection cycle time is microbiologically equivalent to a 4 hour disinfection cycle time.

This product will be sold in plastic bottles as a sterile solution; each bottle will be marked STERILE and will be identified with 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 NOV

Mr. Paul G. Stapleton Director, Global Regulatory Affairs Bausch & Lomb Incorporated Global Vision Care Division 1400 North Goodman Street Rochester, NY 14603-0450

Re: K982775

Trade Name: BAUSCH & LOMB® Renu® [TBD™] Multi Purpose Solution Regulatory Class: II Product Code: 86 LPN Dated: August 5, 1998 Received: August 7, 1998

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

Indications for Use Statement

510(k) Number (if known): __

Device Name: BAUSCH & LOMB ReNu [TM TBD] Multi-Purpose Solution

Indications for Use:

BAUSCH & LOMB ReNu [TM TBD] Multi-Purpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care provider. It is also indicated for use in dissolving enzymatic cleaning tablets.

(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

r.
P

Myra Smith

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K982775

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.”