SOLO-Care ™ Brand Multi-Purpose Solution is indicated for use In dally cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

Device Description

SOLO-Care™ Brand Multi-Purpose Solution is a sterile aqueous solution containing sodium chloride, polyoxyethylene polyoxypropylene block copolymer, sodium phosphate dibasic, sodium phosphate monobasic, and preserved with edetate disodium dihydrate 0.025% and polyhexanide 0.0001%. SOLO-Care™ Brand Multi-Purpose Solution contains multiple active ingredients in sufficient concentration to perform the function of daily cleaning, daily protein removal, rinsing, disinfecting, and storing soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the SOLO-CARE™ Brand MULTI-PURPOSE SOLUTION, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Goal	SOLO-CARE™ Device Performance/Outcome
Safety	Non-toxic	Results demonstrated non-toxicity
	Biocompatible	Results demonstrated biocompatibility
	No safety issues with use without rinse prior to insertion	No safety issues raised with SOLO-Care™ Multi-Purpose Solution used without a rinse prior to insertion.
Effectiveness (General)	Safe and effective as a multi-purpose soft (hydrophilic) contact lens solution	Results demonstrated the solution is safe and effective as a multi-purpose soft (hydrophilic) contact lens solution.
Effectiveness (Specific - Protein Removal)	Substantially equivalent to predicate device (ReNu® Multi-Purpose Solution / ReNu® 1 Step™ Enzymatic Cleaner) for removal of visible protein	Clinical results provide valid scientific evidence that SOLO-care™ Multi-Purpose Solution is substantially equivalent to ReNu® Multi-Purpose Solution / ReNu® 1 Step™ Enzymatic Cleaner for the removal of visible protein.
Substantial Equivalence	Comparable to other currently marketed soft contact lens solutions	Results demonstrate the solution is comparable to other currently marketed soft contact lens solutions.
	Substantially equivalent to predicate device across all indicated uses (daily cleaning, protein removal, rinsing, disinfecting, storing)	SOLO-Care Brand Multi-Purpose Solution is substantially equivalent to Bausch & Lomb ReNu Multi-Purpose Solution used with Bausch & Lomb ReNu 1 Step Enzymatic Cleaner in that both are indicated for use in daily cleaning, daily protein removal, rinsing, disinfecting, and storing of soft (hydrophilic) contact lenses.

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

Sample Size for Test Set: The document describes "A one month clinical evaluation" and "a series of preclinical tests." However, it does not specify the exact number of participants or samples used in either the preclinical or clinical studies.
Data Provenance: The document does not explicitly state the country of origin for the data. The submitter is located in Duluth, Georgia, USA, and the FDA review is from the USA, suggesting the studies likely occurred in the USA. The studies were conducted adhering to "current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812)" for clinical studies and "GLP regulation (21 CFR Part 58)" for preclinical studies, which are US regulations. The studies appear to be prospective as they were conducted to assess the product's safety and effectiveness.

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

The document does not provide information on the number or qualifications of experts used to establish a ground truth for the test set. For a clinical evaluation of a contact lens solution, ground truth would typically be established through patient self-assessment, clinical examinations by ophthalmologists or optometrists, and potentially laboratory analysis of lens deposits. However, these details are not provided in the given text.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

No MRMC study was done. This is a medical device (contact lens solution), not an AI-powered diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are not applicable in this context.

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

No standalone algorithm performance was done. This device is a solution, not an algorithm. Performance tests focused on the solution's properties and its effect on contact lenses and users.

7. The Type of Ground Truth Used

Based on the description:

For safety, ground truth would be based on clinical observation of adverse events and preclinical toxicology/biocompatibility testing standards.
For effectiveness (protein removal), ground truth was implicitly established by comparing the SOLO-Care™ solution's performance for "removal of visible protein" against the performance of the predicate device (ReNu® Multi-Purpose Solution / ReNu® 1 Step™ Enzymatic Cleaner). This suggests a comparative clinical outcome, likely visual assessment of protein deposits on lenses or other relevant clinical endpoints that demonstrate "removal of visible protein." The specific methodology for assessing "visible protein" is not detailed.

8. The Sample Size for the Training Set

The document does not refer to a training set in the context of an algorithm or AI. The term "training set" is not applicable to the development and testing of this type of medical device.

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

As there is no training set in the context of this device, this question is not applicable.

Summary

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K 982168

SUMMARY OF SAFETY AND EFFECTIVENESS FOR SOLO-CARE™ Brand MULTI-PURPOSE SOLUTION

1. Submitter Information

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

2. Device Name

Classification Name: Proprietary Name:

Soft (hydrophilic ) Contact Lens Solution SOLO-CARE™ Brand MULTI-PURPOSE SOLUTION

3. Predicate Devices

Bausch & Lomb ReNu® Multi-Purpose Solution and Bausch & Lomb ReNu® 1 Step Enzymatic Cleaner have been selected as the predicate devices for SOLO-Care™ Brand MULTI-PURPOSE SOLUTION. This combination of products was selected becuase when used as a system it is indicated for removing protein from soft contact lenses.

4. Description of the Devices

5. Indications for Use

SOLO-Care Brand Multi-Purpose Solution is indicated for use in daily cleaning, daily protein removal, rinsing, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by an eye care practitioner.

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Description of Safety and Substantial Equivalence 6.

A series of preclinical and clinical studies were completed to demonstrated the safety and effectiveness of SOLO-Care Brand Multi-Purpose Solution, and to establish substantial equivalence to currently marketed, predicate solutions. All testing was conducted in accordance with and in conformance to applicable device regulations. Results demonstrate the solution is non-toxic and biocompatible, and is comparable to other currently marketed soft contact lens solutions. Results from all tests demonstrate the substantial equivalence to previously FDA approved, and currently marketed predicate devices.

Preclinical Testing:

A series of preclinical tests were performed to asses the safety and effectiveness of the solution. All preclinical toxicology and microbiology tests were conducted in accordance with GLP requlation (21 CFR Part 58). Results of the testing demonstrated that SOLO-Care Brand Multi-Purpose Solution is safe and effective as a multi-purpose soft (hydrophilic) contact lenses solution.

Clinical Testing:

A one month clinical evaluation was conducted in accordance with current Good Clinical Practices and published requlations (21 CFR Parts 50, 56, 312, 812). The clinical results provide valid scientific evidence that SOLO-care™ Multi-Purpose Solution is substantially equivalent to ReNu® Multi-Purpose Solution / ReNu® 1 Step™ Enzymatic Cleaner for the removal of visible protein. There were also no safety or efficacy issues raised with SOLO-care™ Multi-Purpose Solution used without a rinse prior to insertion.

7. Substantial Equivalence

SOLO-Care Brand Multi-Purpose Solution is substantially equivalent to Bausch & Lomb ReNu Multi-Purpose Solution used with Bausch & Lomb ReNu 1 Step Enzymatic Cleaner in that both SOLO-Care Brand Multi-Purpose Solution and ReNu Multi-Purpose Solution with Bausch & Lomb ReNu 1 Step Enzymatic Cleaner are indicated for use in daily cleaning, daily protein removal, rinsing, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by your eve care practitioner.

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Image /page/2/Picture/2 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" around the perimeter. Inside the circle is a stylized image of a human figure with three wing-like shapes extending from the head, resembling a bird in flight.

NOV 17 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K982168 Trade Name: SOLO-Care ™ Brand Multi-Purpose Solution (Daily Protein Removal Claim for use with Soft Lenses) Regulatory Class: II Product Code: 86 LPN Dated: September 22, 1998 Received: September 24, 1998

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. 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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INDICATIONS FOR USE STATEMENT

Device Name:

SOLO-Care ™ Brand Multi-Purpose Solution

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ದ or Over-the-Counter: B

Erio

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K982168

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.”