BAUSCH & LOMB® Wetting and Soaking Solution is indicated for use in disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate rigid gas permeable and hard (PMMA) contact lenses.

Device Description

BAUSCH & LOMB Wetting and Soaking Solution is a sterile conditioning solution used in the care of rigid gas permeable and hard (PMMA) contact lenses and is indicated for the disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate and hard (PMMA) contact lenses. This product is contained in a plastic bottle, and consists of a sterile, buffered solution, preserved with chlorhexidine gluconate and edetate disodium.

AI/ML Overview

The provided text describes the acceptance criteria and the studies conducted for the BAUSCH & LOMB® Wetting and Soaking Solution to demonstrate its safety and effectiveness.

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

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance
Toxicology	In-Vitro Cytotoxicity	Meets the requirements of the USP XXII Agar Diffusion Test.
	Acute Ocular Irritation	Produced no ocular irritation.
Microbiology	Preservative Effectiveness	Meets the relevant preservative efficacy requirements after 36 months at room temperature.
	Disinfection Efficacy	Meets the ISO Stand Alone Procedure for Disinfecting Products Primary Acceptance Criteria requirements after 36 months at room temperature.
Shelf Life	Expiration Dating	Established based on 36 months room temperature data.
Solution Compatibility	Lens Parameters (30 cycles with cleaner)	All physical and lens parameters were within ISO specifications for rigid corneal and scleral contact lenses. No change in cosmetic appearance.
Wetting Angle	Dynamic Contact Angle (DCA) Analysis	Equivalent behavior to the currently marketed BAUSCH & LOMB Wetting and Soaking Solution.
Substantial Equivalence	Formulation, Indications, Usage, Manufacturing	Formulated similarly, with the same indications, usage, and all aspects of manufacturing as the predicate device.

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

Toxicology (In-Vitro Cytotoxicity, Acute Ocular Irritation): The sample size for these tests is not explicitly stated, but they are described as "preclinical testing" using "laboratory animals" for the ocular irritation test, implying a controlled laboratory study. Data provenance is implied to be domestic (likely US) as it's for a US regulatory submission. The tests are retrospective in the sense that they were completed preclinical studies.
Microbiology (Preservative Effectiveness, Disinfection Efficacy): The tests were performed on "Product stored up to 36 months at room temperature." The specific number of product samples tested is not provided, but it's a prospective stability study over 36 months. Data provenance is implied to be domestic.
Solution Compatibility: "BOSTON IV (silicone acrylate), BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses and BP Flex PMMA contact lenses" were subjected to a thirty-cycle study. This implies samples of these specific lens types were used. The number of individual lenses or repetitions is not specified. Data provenance is implied to be domestic.
Wetting Angle: The study investigated "three selected RGP lens materials, BOSTON IV (silicone acrylate), BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses and BP Flex PMMA contact lenses." The number of lenses or repetitions per material is not specified. Data provenance is implied to be domestic.

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

This information is not provided in the document. The studies described are primarily analytical, microbiological, and animal-based preclinical tests, not human-reader-based evaluations that would require expert ground truth establishment in the traditional sense of medical image analysis or diagnostics.

4. Adjudication method for the test set

This information is not applicable as the studies are preclinical, analytical, and microbiological, and do not involve human interpretation or adjudication in the context of diagnostic performance.

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 type of study was not done. The submission is for a contact lens wetting and soaking solution and does not involve AI or human readers for diagnostic effectiveness.

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, and does not have standalone or human-in-the-loop performance in the context of AI.

7. The type of ground truth used

Toxicology: "Ground truth" for cytotoxicity and ocular irritation would be based on established biological and physiological responses in validated in-vitro assays (USP XXII Agar Diffusion Test) and animal models (Acute Ocular Irritation test), demonstrating the absence of harmful effects.
Microbiology: "Ground truth" for preservative effectiveness and disinfection efficacy is defined by meeting "relevant preservative efficacy requirements" and "ISO Stand Alone Procedure for Disinfecting Products Primary Acceptance Criteria requirements," respectively, which are predefined quantitative targets for microbial reduction.
Solution Compatibility: "Ground truth" is based on adherence to "ISO specifications for rigid corneal and scleral contact lenses" and subjective assessment of "cosmetic appearance" after a specified number of cleaning and soaking cycles.
Wetting Angle: "Ground truth" is established by comparing the Dynamic Contact Angle (DCA) analysis results of the modified solution to the legally marketed predicate device, aiming for equivalence.

8. The sample size for the training set

This information is not applicable as the studies are for a medical device solution and do not involve machine learning algorithms that require training sets. There is no mention of a "training set" in the document.

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

This is not applicable as there is no training set mentioned or implied in the context of this device and its studies.

Summary

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510(k) Premarket Notification BAUSCH & LOMB Wetting and Soaking Solution

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR 1 1 1998

FOR

BAUSCH & LOMB® WETTING AND SOAKING SOLUTION

1. SUBMITTER INFORMATION:

Polymer Technology, a division of Wilmington Partners, L.P. Global Vision Care 1400 N. Goodman Street Rochester, New York 14692-0450

2. CONTACT PERSON:

Address:

Telephone No .: Fax No .: E-mail Address:

Debra Ketchum Manager, Regulatory Affairs 1400 North Goodman Street Rochester, New York 14692 (716) 338-8638 (716) 338-0702 dketchum@bausch.com

3. DEVICE IDENTIFICATION:

Classification Name: Rigid Gas Permeable Contact Lens Solution BAUSCH & LOMB® Wetting and Soaking Solution Proprietary Name: Contact Lens Conditioning Solution Common Name:

4. PREDICATE DEVICE:

BAUSCH & LOMB Wetting and Soaking Solution has been selected as the predicate device for the modified BAUSCH & LOMB Wetting and Soaking Solution.

న్. DESCRIPTION OF THE DEVICE:

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6. INDICATIONS FOR USE:

BAUSCH & LOMB Wetting and Soaking Solution is indicated for use in the disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate rigid gas permeable and hard (PMMA) contact lenses.

7. DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE:

A series of preclinical testing was performed to demonstrate the safety and effectiveness of the modified BAUSCH & LOMB Wetting and Soaking Solution. A summary of these results from the preclinical studies is presented below.

Toxicology:

In-Vitro Cytotoxicity:

USP Agar Diffusion Cytotoxicity was completed in accordance with USP XXII. The test article meets the requirements of the Agar Diffusion Test.

Acute Ocular Irritation:

Acute Ocular Irritation test was performed and produced no ocular irritation.

The results of all testing demonstrated that the safety and effectiveness of the modified BAUSCH & LOMB Wetting and Soaking Solution is equivalent to the currently marketed BAUSCH & LOMB Wetting and Soaking Solution.

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

Microbiology:

Preservative Effectiveness:

Product stored up to 36 months at room temperature were tested for Preservative Effectiveness. The results of this test demonstrate that the product meets the relevant preservative efficacy requirements.

Disinfection Efficacy:

Product stored at room temperature for 36 months was tested. The results of this evaluation demonstrate that the product meets the ISO Stand Alone Procedure for Disinfecting Products Primary Acceptance Criteria requirements.

Shelf Life:

Expiration dating was established based on 36 months room temperature data.

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Solution Compatibility:

BOSTON IV (silicone acrylate), BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses and BP Flex PMMA contact lenses were subjected to a thirty cycle lens compatibility study with the modified BAUSCH & LOMB Wetting and Soaking Solution and BAUSCH & LOMB Concentrated Cleaner.

After thirty repeated cycles with BAUSCH & LOMB Concentrated Cleaner and the modified BAUSCH & LOMB Wetting and Soaking Solution, all of the physical and lens parameters tested for BOSTON IV, BOSTON ES rigid gas permeable and BP FLEX hard tinted contact lenses were within ISO specifications for rigid corneal and scleral contact lenses. There were no change in the cosmetic appearance.

Wetting Angle:

This study investigated retention of the modified BAUSCH & LOMB Wetting and Soaking Solution and the currently marketed BAUSCH & LOMB Wetting and Soaking Solution on three selected RGP lens materials, BOSTON IV (silicone acrylate), BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses and BP Flex PMMA contact lenses. Dynamic contact angle (DCA) analysis was the method chosen to measure the desorption of solution from the lens material surface. The results of the DCA testing indicate that the modified BAUSCH & LOMB Wetting and Soaking Solution and the currently marketed BAUSCH & LOMB Wetting and Soaking Solution are equivalent in their behavior.

SUBSTANTIAL EQUIVALENCE 8.

The modified BAUSCH & LOMB Wetting and Soaking Solution is substantially equivalent to the currently marketed BAUSCH & LOMB Wetting and Soaking Solution, approved July 11, 1984 under PMA P820070, Supplement 2, in that both products are formulated similarly, with the same indications, usage, and all aspects of manufacturing. The two products differ only in that one of the tonicity agents in the modified BAUSCH & LOMB Wetting and Soaking Solution has a lower concentration than found in the currently marketed 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 11 1998

Ms. Debra L.B. Ketchum Manager, Regulatory Affairs Polymer Technology 1400 N. Goodman Street Rochester, NY 14692

Re: K980133

Trade Name: BAUSCH & LOMB® Wetting and Soaking Solution Regulatory Class: II Product Code: 86 LPN Dated: January 14, 1998 Received: Tanuary 15, 1998

Dear Ms. Ketchum:

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; throughperiodic (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. Debra L.B. Ketchum

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 at (301) 443-6597.

Sincerely yours,

A. Robb Rosenthal, MD

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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Polymer Technology, a division of Wilmington Partners, L.P. 1400 North Goodman Street Rochester, NY 14692-0450

Indications for Use Statement

K980133 510(k) Number (if known):

Device Name: BAUSCH & LOMB® Wetting and Soaking 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 /

Heniel W. C. Brown, PH.D.
(Division Sign Off)

sion of Onhthalmic Devic K980133 n/k) Number

APPX1.doc

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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.”