SOLO-Care ™ Brand Multi-Purpose Solution Is Indicated for use in daily cleaning, ninsing, chemical (not haat) disinfecting, protein removal and storing of soft (hydrophilic) or rigld gas permeable (fluoro sillcone acrylate and sillcone acrylate) lenses as recommended by your eye care precitioner.

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, 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

This document is a 510(k) Summary for the SOLO-Care™ Brand Multi-Purpose Solution, which is a contact lens solution. It describes the device's indications for use, its substantial equivalence to a predicate device, and outlines the studies conducted to demonstrate its safety and effectiveness.

Here's the information requested, based on the provided text:

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

The document does not explicitly state acceptance criteria in a quantitative or tabular format for specific performance metrics (e.g., microbial kill rates, protein removal percentages with thresholds). Instead, it states that various studies were conducted to confirm safety and effectiveness, and that the product is shown to be "substantially equivalent" to a predicate device.

However, we can infer the intent of the acceptance criteria based on the described functions and comparative claims. The performance is reported in terms of its ability to perform these functions effectively and its compatibility.

Acceptance Criteria (Inferred from described functions and claims)	Reported Device Performance
Cleaning of soft (hydrophilic) and rigid gas permeable (RGP) contact lenses	SOLO-Care™ Brand Multi-Purpose Solution successfully performs daily cleaning.
Protein Removal for soft (hydrophilic) and RGP contact lenses	SOLO-Care™ Brand Multi-Purpose Solution successfully performs protein removal. (Also noted previous approval for daily protein removal for soft lenses under K982168).
Rinsing of soft (hydrophilic) and RGP contact lenses	SOLO-Care™ Brand Multi-Purpose Solution successfully performs rinsing.
Chemical Disinfection (not heat) of soft (hydrophilic) and RGP contact lenses	SOLO-Care™ Brand Multi-Purpose Solution successfully performs chemical disinfection.
Storing of soft (hydrophilic) and RGP contact lenses	SOLO-Care™ Brand Multi-Purpose Solution successfully performs storing.
Compatibility with rigid gas permeable (fluoro silicone acrylate and silicone acrylate) lenses under recommended care regimen	Lens solution compatibility tests indicated that SOLO-Care™ Brand Multi-Purpose Solution is compatible with RGP lenses, demonstrating equivalence to the predicate device (Boston Simplicity).
Compatibility with Focus Lens Drops	An additional compatibility study was successfully conducted to determine compatibility with Focus Lens Drops.
Safety and Effectiveness	A series of preclinical and clinical studies were conducted to assess and demonstrate the safety and effectiveness of SOLO-Care™ Brand Multi-Purpose Solution.
Substantial Equivalence to BOSTON Simplicity Multi-Action Solution	SOLO-Care™ Brand Multi-Purpose Solution is substantially equivalent for daily cleaning, rinsing, disinfecting RGP lenses.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "A series of preclinical and clinical studies have been conducted to assess and demonstrate the safety and effectiveness..." However, no specific sample sizes for clinical or preclinical test sets are provided within this document.

The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's an FDA submission, the studies would typically be prospective for clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The evaluation of contact lens solutions typically involves laboratory testing for microbial reduction, cytotoxicity, and clinical trials for safety and comfort, which are assessed by various medical professionals and technicians, but "experts" establishing ground truth in the sense of image interpretation is not directly applicable here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation where there's subjectivity and disagreement among readers. This is not directly relevant to the testing of a contact lens solution.

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 comparative effectiveness study was done, as this device is a contact lens solution, not an AI-powered diagnostic tool. Therefore, there is no effect size related to human readers improving with or without AI assistance.

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

No standalone algorithm performance study was done, as this device is a chemical solution, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a contact lens solution, "ground truth" generally refers to:

Laboratory-based measurements: e.g., microbial kill rates using standardized organisms, protein removal efficacy, cleaning efficacy using simulated soiling, lens compatibility assessments.
Clinical outcomes data: e.g., slit lamp examinations for ocular health, patient reported comfort, adverse event rates, visual acuity.
Comparison to predicate device performance benchmarks.

The document generically states "preclinical and clinical studies have been conducted to assess and demonstrate the safety and effectiveness." It implies that standard test methods applicable to contact lens solutions were used to establish the "ground truth" for these various performance parameters.

8. The sample size for the training set

This information is not provided and is not applicable in the context of a chemical contact lens solution. "Training set" refers to data used to train machine learning models, which are not involved in this device's development or evaluation.

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

This information is not provided and is not applicable for the reasons stated in point 8.

Summary

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510(k) SUMMARY - K983291

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) 770-418-3897 Telephone No.

Device Name 2.

Classification Name: Proprietary Name:

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

Predicate Devices 3.

BOSTON Simplicity Multi-action Solution (P950010, June 9, 1995) has been selected as the predicate devices for SOLO-Care™ Brand MULTI-PURPOSE SOLUTION.

Description of the Devices 4.

રું Indications for Use

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

Description of Safety and Substantial Equivalence 6.

A series of preclinical and clinical studies have been conducted to assess and demonstrate the safety and effectiveness of SOLO-Care Brand Multi-Purpose Solution for soft (hydrophilic), contact lenses (P940042, April 25, 1996). In addition, SOLO-Care Brand Multi-Purpose Solution has been approved for a daily protein removal indication for soft contact lenses under K982168. Soft contact lenses represent worst case in terms of cleaning, protein removal, rinsing, disinfecting and storing of contact lenses. In addition, lens solution compatibility tests were conducted under the recommended care regimen, compared with the predicate device (Boston Simplicity) indicating that SOLO-Care Brand Multi-Purpose Solution is compatible with rigid gas permeable (flourosilicone and silicon acrylate) lenses. An addition compatibility study was also successfully conducted to determine the compatibility of SOLO-Care Brand Multipurpose Solution when used in conjunction with Focus Lens Drops. Focus Lens Drops was previously approved for use with rigid gas permeable lenses under P860060/S02 on March 28, 1990.

7. Substantial Equivalence

SOLO-Care Brand Multi-Purpose Solution is substantially equivalent to BOSTON Simplicity Multi-Action Solution for daily cleaning, rinsing, disinfecting rigid gas permeable (fluoro silicone acrylate and silicone acrylate) lenses. In addition, SOLO-Care Brand Multi-Purpose Solution has been approved for a daily protein removal indication for soft contact lenses under K982168.

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Image /page/1/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 a stylized image of an eagle or other bird with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 1998

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

Re: K983291 Trade Name: SOLO-Care ™ Brand Multi-Purpose Solution (labeling change to allow for use with Soft and RGP Lenses) Regulatory Class: II Product Code: 86 MRC Dated: September 18, 1998 Received: September 21, 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 (OS) 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 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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INDICATIONS FOR USE STATEMENT

510(k) Number: K983291

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

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Over-the-Counter: B

$\xi$ $\Omega$

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K983291

Regulation Number and Section

§ 886.5918 Rigid gas permeable contact lens care products.

(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”