Bausch & Lomb Sensitive Eyes Multi-Purpose Solution is indicated for use in the daily cleaning, dissolving of Sensitive Eyes Enzymatic Cleaner, ReNu 1-Step or the ually cleaning, and ens Cleaning Tablets, rinsing Tablets, rinsing and storage of daily and extended wear soft (hydrophilic) contact lenses and chemical (not heat) disinfection, as recommended by your eye care practitioner.

Bausch & Lomb Sensitive Eyes Multi-Purpose Solution is indicated for use in the daily cleaning, dissolving of enzymatic cleaning tablets, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care provider.

Device Description

BAUSCH & LOMB Sensitive Eyes 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 all BAUSCH & LOMB 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 [Trademark] (alexidine dihydrochloride 4 ppm).

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

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.

AI/ML Overview

This is some information about the device BAUSCH & LOMB" SENSITIVE EYES" MULTI-PURPOSE SOLUTION. I will do my best to extract the requested information.

1. Acceptance Criteria and Reported Device Performance

The submission states that the device is "substantially equivalent" to the predicate device, BAUSCH & LOMB ReNu Multi-Purpose Solution. This implies that the acceptance criteria for the new device were that its performance should be comparable or demonstrate no clinically significant differences from the predicate device across various parameters.

Acceptance Criteria (Implied: Equivalence to Predicate)	Reported Device Performance (Summary of Findings)
Preclinical: Physical, chemical, and microbiological properties equivalent to predicate.	"The results of these studies indicate that the physical, chemical and microbiological properties of the BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution are equivalent to BAUSCH & LOMB ReNu Multi-Purpose Solution."
Preclinical: Non-toxic	"The solution is not toxic and extracts of lenses treated with the solution are not toxic when tested in laboratory animals."
Clinical: No clinically significant differences in: clinical findings, visual acuity, lens replacement, lens deposits, subject discontinuations, and lens wearing times.	"Analysis of all data from this study showed no clinically significant differences between the Test and Control Groups for clinical findings, visual acuity, lens replacement, lens deposits, discontinued subjects and lens wearing times for the Test and Control groups."

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

Test Set Sample Size: A total of 154 subjects were enrolled in the clinical study. Of these, 102 were in the Test (BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution) group and 52 were in the Control (BAUSCH & LOMB ReNu Multi-Purpose Solution) group. There were 98 completed subjects in the Test group and 51 completed subjects in the Control group.
Data Provenance: The document does not explicitly state the country of origin of the data. The study was a "three (3) month randomized, parallel, double-masked, controlled clinical study," indicating it was a prospective study.

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

The document does not provide information on specific "experts" used to establish ground truth in the traditional sense (e.g., radiologists reviewing images). The clinical study involved "seven (7) Investigators." It is assumed these investigators, who would be eye care practitioners, collected and evaluated the clinical findings that served as the basis for comparison between the two solutions. Their specific qualifications beyond being "Investigators" are not detailed.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the test set data. The study was a "double-masked" clinical study, which helps mitigate bias in assessment, but it doesn't specify a method for resolving discrepancies if they arose between investigators' observations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focused on comparing the performance of two contact lens solutions in a clinical setting with human subjects, rather than comparing human readers' diagnostic performance with and without AI assistance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable to this document.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) performance study was not done. The device is a contact lens solution, not an AI algorithm. The studies performed were a combination of preclinical (in-vitro and in-vivo lab tests) and clinical trials involving human subjects using the solution.

7. Type of Ground Truth Used

For the preclinical studies, the ground truth was established through:

Laboratory test results: Measuring physical, chemical, and microbiological properties.
Toxicology studies: In-vitro and in-vivo tests in laboratory animals to assess toxicity.

For the clinical study, the ground truth was established through:

Clinical findings: Observations made by "Investigators" (eye care practitioners) regarding various parameters like visual acuity, lens replacement, lens deposits, and subject health. Subject discontinuations and lens wearing times were also monitored. This can be considered expert clinical assessment/observation.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is not an AI/machine learning device. The preclinical tests and the clinical study are designed to evaluate the safety and effectiveness of the contact lens solution.

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

As noted in point 8, there is no "training set" in the context of an AI algorithm. The methods for establishing the "ground truth" for the overall device evaluation (preclinical and clinical) are described in point 7.

Summary

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K973921
JAN. 12, 1998

510 (k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BAUSCH & LOMB" SENSITIVE EYES" MULTI-PURPOSE SOLUTION

1. Submitter Information:

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

Contact Person:	Paul Stapleton
	Director, Regulatory Affairs

Telephone Number: (716)338-8172

2. Device Name:

Classification Name: Soft (hydrophilic) Contact Lens Solution

Proprietary Name: BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution

3. Predicate Device:

BAUSCH & LOMB ReNus Multi-Purpose Solution has been selected as the predicate device for BAUSCH & Lomb Sensitive Eyes Multi-Purpose Solution.

4. Description of the Device

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

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Indications for Use: ડ.

BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution is indicated for use in the daily cleaning, dissolving of Sensitive Eyes Enzymatic Cleaner, ReNu 1-Step or the ually cleaning, and ens Cleaning Tablets, rinsing Tablets, rinsing and storage of daily and extended wear soft (hydrophilic) contact lenses and chemical (not heat) disinfection, as recommended by your eye care practitioner.

Description of Safety and Substantial Equivalence 6.

A series of preclinical and clinical testing was performed to demonstrate the safety and effectiveness of BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution. A summary of these results from the preclinical and clinical studies is presented 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 conformance to the FDA documents entitled Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, April 1, 1995 (DRAFT) and May 1, 1997.

The results of these studies indicate that the physical, chemical and microbiological properties of the BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution are equivalent to BAUSCH & LOMB ReNu Multi-Purpose Solution.

The solution is not toxic and extracts of lenses treated with the solution are not toxic when tested in laboratory animals.

Clinical Testing

A three (3) month randomized, parallel, double-masked, controlled clinical study was designed in accordance with the Premarket Notification (510(k)) Guidance for Contact Lens Care Products of April 1, 1995. The Test Solution was BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution; the Control Solution was the predicate device, BAUSCH & LOMB ReNu Multi-Purpose Solution. The daily regimen for both solutions consisted of the standard daily rub, rinse and a four (4) hour disinfection procedures. A weekly enzymatic cleaning with ReNu 1-Step Enzymatic Cleaner Tablets occurred.

A total of 154 subjects were enrolled; of these, 102 were enrolled in the Test group and 52 in the Control group. There were 98 completed subjects in the Test group and 51 completed subjects in the Control group. There were seven (7) Investigators.

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Analysis of all data from this study showed no clinically significant differences between the Test and Control Groups for clinical findings, visual acuity, lens replacement, lens deposits, discontinued subjects and lens wearing times for the Test and Control groups.

This study has demonstrated the equivalence between BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution and BAUSCH & LOMB ReNu Multi-Purpose Solution for the care of soft (hydrophilic) contact lenses.

Substantial Equivalence

BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution is substantially equivalent to BAUSCH & LOMB ReNu Multi-Purpose Solution in that both solutions are formulated similarly with the same indications, usage and clinical experience. They differ in the preservative used in the formulation of the final product; all other aspects of manufacturing are the same. Any differences between the two products, i.e., BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution and the predicate device do not affect the use of the product.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/3/Picture/3 description: The image shows a date written in a bold, sans-serif font. The date reads "JAN 1 2 1998", indicating January 12, 1998. The month is abbreviated, and the day and year are clearly visible.

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

Re: K973921

Trade Name: BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution (preserved with alexidine dihydrochloride)

Regulatory Class: II Product Code: 86 LPN Dated: October 14, 1997 Received: October 15, 1997

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

Enclosure

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510(k) Number (if known): . K973921

Multi-Purpose Solution Device Name:_ Sensitive Eye

Indications For Use:

ﺗﺮﻛﻴﺒﺔ

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hanuel W.C. Brown, Ph.D.

Division Sign-Off)
Division of Ophthalmic Devices
(k) Number K913421

Prescription Use ......... (Per 21 CFR 801.109)

Over-The-Counter Use_ V

(Optional Format 1-2-96)

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.”