SOLO-Care™ Brand Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and protein removal, storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate)and PMMA contact lenses as recommended by your eye care practitioner.

Device Description

SOLO-Care™ Brand Multi-Purpose Solution is a sterile aqueous solution used in the care contact lenses and is indicated for cleaning, rinsing, chemical (not heat) disinfecting and protein removal. storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate) and PMMA contact lenses as recommended by your eye care practitioner. It may also be uses as a diluent for enzymatic cleaning tablets, which are to be used in conformance to the established labeling directions of the enzymatic cleaning tablet. The solution is contains in a plastic bottle and consists of a sterile isotonic solution containing sodium chloride, polyoxyethylene polyoxypropylene block copolymer, sodium phosphate dibasic, sodium phosphate monobasic, and preserved with edetate disodium dihydrate and polyhexanide 0.0001%. Each bottle is supplied sterile and is labeled with a lot number and expiration date.

AI/ML Overview

The provided document is limited to the 510(k) Summary of Safety and Effectiveness for SOLO-Care™ Brand Multi-Purpose Solution. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. As such, it does not contain the detailed acceptance criteria and study information typically associated with performance evaluations of AI/ML-driven medical devices.

The document describes a contact lens solution, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test sets, ground truth establishment by experts, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

However, I can extract the relevant information regarding the "study" mentioned and acceptance criteria within the context of a contact lens solution:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Disinfection Efficacy	Satisfactory microbiological testing results at time periods ranging from 10 minutes to 4 hours. (Specific reduction logs or pass/fail criteria are not detailed in this summary, but are implied to be satisfactory for contact lens disinfection.)
Compatibility with PMMA Lenses	Compatibility study successfully completed.
Substantial Equivalence to Predicate Device	Demonstrated as having identical formulation and indications for use as the currently marketed SOLO-Care™ Brand MULTI-PURPOSE SOLUTION.
10-minute Disinfection Cycle Time Equivalence to 4-hour Cycle Time	Demonstrated as substantially equivalent.

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

Sample Size: Not specified. The document mentions "a series of microbiological testing" and "a compatibility study" but does not provide the number of samples or lenses used in these tests.
Data Provenance: Not explicitly stated (e.g., country of origin). However, the studies were "pre-clinical studies" and "all studies have previously been submitted under P940042, K 982168, and under K983291," indicating they were conducted as part of previous regulatory submissions. These are retrospective in the context of this submission, as they were prior submissions.

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

This information is not applicable as this is a chemical solution, not an AI/ML diagnostic device requiring expert interpretation of results for ground truth.

4. Adjudication method for the test set

This information is not applicable as this is a chemical solution, not an AI/ML diagnostic device requiring expert adjudication.

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 information is not applicable as this is a chemical solution, not an AI/ML diagnostic device involving human readers or AI assistance.

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

This information is not applicable as this is a chemical solution and does not involve an algorithm.

7. The type of ground truth used

For the microbiological testing, the "ground truth" would be established by standard microbiological methods (e.g., colony counts to determine microbial reduction). For the compatibility study, the "ground truth" would be established by observed physical or chemical integrity and performance of the PMMA lenses after exposure to the solution. These are laboratory-based scientific measurements, not expert consensus or pathology in the clinical sense.

8. The sample size for the training set

This information is not applicable as this is a chemical solution and does not involve a training set for an AI/ML algorithm.

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

This information is not applicable as this is a chemical solution and does not involve a training set for an AI/ML algorithm.

Summary

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K99/403

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR SOLO-CARE™ Brand MULTI-PURPOSE SOLUTION

Submitter Information 1.

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Steven Dowdley (Senior Regulatory Affairs Associate) Telephone No. 770-418-3897

Device Name 2. Classification Name: Proprietary Name:
Soft (hydrophilic) Contact Lens Solution SOLO-CARE™ Brand MULTI-PURPOSE SOLUTION

3. Predicate Devices

Currently marketed SOLO-Care™ Brand MULTI-PURPOSE SOLUTION was selected as the predicate devices for this submission. This product was selected because the formulation and indications for use are identical to the device proposed in this submission.

4. Description of the Devices

5. Indications for Use

SOLO-Care™ Brand Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and protein removal, storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate) and PMMA contact lenses as recommended by your eye care practitioner.

હ્ Description of Safety and Substantial Equivalence

A series of pre-clinical studies have been completed to demonstrate the safety and effectiveness of SOLO-Care Brand Multi-Purpose Solution; all studies have previously been submitted under P940042, K 982168, and under K983291. To support the claim of 10-minute disinfection, a series of microbiological testing has been completed at time perlods ranging from 10 minutes to 4 hours. A compatibility study was also successfully completed to demonstrate compatibility with PMMA lenses. All results were satisfactory.

7. Substantial Equivalence

SOLO-Care Brand Multi-Purpose Solution is substantially equivalent to the predicate device. SOLO-Care Brand Multi-Purpose Solution in a 10-minute disinfection cycle time is substantially equivalent to a 4-hour disinfection cycle time.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that form the body and wings of the bird, and two wavy lines that form the tail.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 16 1999

Mr. Steven Dowdley Senior Associate, Regulatory Affairs CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097-1556

Re: K991403 Trade Name: SOLO-Care ™ Brand Multi-Purpose Solution Regulatory Class: II Product Code: 86 LPN Dated: April 20, 1999 Received: April 22, 1999

Dear Mr. Dowdley:

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. Steven Dowdley

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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PART III. INDICATIONS FOR USE STATEMENT

This is a new 510 (k) Notification. (Number to be assigned) 510(k) Number:

Device Name: SOLO-Care ™ Brand Multi-Purpose Solution

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

or Over-the-Counter:

Nyji Smith

(Division Sign-Off) Division of Ophthalmic Devices K941403 510(k) Number_

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.”