SOLO-Care ™ Hard Solution is indicated for use in daily cleaning, rinsing, chemical (not heat) disinfecting and conditioning of fluoro silicone acrylate, silicone acrylate and hard (PMMA) contact lenses as recommended by your eye care practitioner.

Device Description

SOLO-Care ™ HARD Solution is a sterile aqueous solution containing hydroxyethylicellulose, tris amino, sodium chloride, disodium edetate, poloxamer 407, polyoxyethylene polyoxpropylene block copolymer, and is preserved polyhexanide 0.0002%. SOLO-Care ™ HARD Solution contains multiple active ingredients in sufficient concentration to perform the function of daily cleaning, ninsing, disinfecting and conditioning rigid gas permeable and hard contact lenses as recommended by an 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

The provided 510(k) summary for SOLO-Care™ HARD Solution outlines various acceptance criteria and the studies conducted to demonstrate substantial equivalence to predicate devices. However, the document primarily focuses on preclinical and clinical studies for safety and effectiveness rather than providing explicit numeric acceptance criteria for each test or detailed performance metrics. It also heavily relies on the concept of "substantial equivalence" rather than specific numerical performance targets.

Here's an attempt to extract the requested information based on the provided text, with notable limitations due to the nature of the document:

Acceptance Criteria and Study Findings for SOLO-Care™ HARD Solution

Overall Goal: To demonstrate substantial equivalence to predicate devices (BOSTON Advanced Conditioning Solution, BOSTON Classic, and Boston Simplicity Solution) in terms of usage, formulation similarities, and indications for use.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Preclinical Testing
Cleaning Effectiveness	Sufficient surfactant concentration to maintain activity for cleaning and detergency.	"Results demonstrated that the surfactant concentration is formulated in SOLOCare Hard Solution at sufficiently high levels to maintain its activity for cleaning and detergency."
Contact Wetting Angle	Statistically equivalent surface wettability to predicate solution Boston Simplicity.	"Dynamic contact angle analysis indicated that the SOLO-care Hard Solution is statistically equivalent to predicate solution Boston Simplicity in terms of surface wettability of the lens."
Solution Compatibility	Lens parameters remain within ANSI/ISO reference range after 30 cycles; no change in cosmetic appearance.	"The study showed that after 30 cycles all parameters were still within the ANSI/ISO reference range for rigid gas permeable lenses for both solutions. In addition, there was no change in the cosmetic appearance of the lenses."
Stability (Chemical)	pH, osmolarity, viscosity, appearance, and active ingredients maintained for 24 months.	"Based on the data collected, the trends observed and the estimated calculations of the accelerated test samples the shelf life for SOLO-care HARD Solution is 24 months."
Stability (Microbiological)	Meet ISO/DIS 14730 Preservative Effectiveness Test requirements.	"The results demonstrate that SOLO-Care Hard meets the requirements of the ISO/DIS 14730 Preservative Effectiveness Test against the panel organisms tested."
Disinfection Efficacy	Meet ISO/CD 14729 requirements for antimicrobial effectiveness.	"The results demonstrated that the solution meets the requirements of the standard."
Toxicology	No toxic response or increase in ocular irritation.	"Results demonstrated that the solution and lenses treated with the solution did not cause a toxic response or increase ocular irritation."
Clinical Testing
Safety and Effectiveness	Non-inferiority/substantial equivalence to control solutions; no additional safety concerns.	"Analysis of all data from the studies showed no that the test and control solutions were substantially equivalent. In additional safety concerns were raised regarding the test solution." (Note: "no" likely a typo, intended as "no additional safety concerns were raised...")
Substantial Equivalence	Substantially equivalent in usage, formulation, and indications to predicate devices.	"SOLO-Care Hard Solution is substantially equivalent. to BOSTON Advanced Conditioning Solution, BOSTON Classic and Boston Simplicity Solution in terms of usage, formulation similarities, and indications for use..."

Note on "Acceptance Criteria": The document uses terms like "sufficiently high levels," "statistically equivalent," "within the ANSI/ISO reference range," "meets the requirements of the standard," and "no toxic response." These are qualitative or referential criteria rather than specific numerical thresholds presented within the text itself. The specific numerical targets for ISO standards, ANSI/ISO ranges, or statistical equivalence thresholds are not detailed.

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

Clinical Test Set Sample Size: "Overall 166 contact lens wearers were enrolled"
Data Provenance: Not explicitly stated regarding country of origin. The studies were described as "preclinical and clinical studies." Given it's a 510(k) submission to the FDA, it's highly probable the clinical studies were conducted in the USA, but this is an inference. The studies appear to be prospective clinical trials involving contact lens wearers being exposed to the test and control solutions.

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

This information is not provided in the document. The clinical studies simply state that "166 contact lens wearers were enrolled" and data was analyzed, but there's no mention of experts establishing a "ground truth" in the diagnostic sense (e.g., for a medical image or condition). The "ground truth" for a contact lens solution's safety and effectiveness would come from the observed clinical outcomes (comfort, ocular health, infection rates, etc.) of the enrolled subjects.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. Since this is a clinical trial assessing a contact lens solution, it typically involves clinical observations, subject questionnaires, and potentially eye care practitioner assessments, rather than a diagnostic adjudication process for a specific finding.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is typically relevant for diagnostic imaging devices where different readers interpret the same cases, often with and without AI assistance. This document describes preclinical and clinical studies for a contact lens solution, which does not fit the MRMC study design. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

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

Not applicable. This device is a contact lens solution, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this submission. The preclinical tests can be considered "standalone" in the sense that they assess the product's intrinsic physical, chemical, and microbiological properties.

7. The Type of Ground Truth Used

For the clinical studies, the "ground truth" was established by observed clinical outcomes and the absence of adverse events or additional safety concerns in human subjects using the solution over periods ranging from 1 to 6 months. This would include parameters like ocular health, comfort, clarity of vision, and any signs of infection or irritation, as assessed by eye care practitioners and reported by subjects. For preclinical studies, ground truth was based on established ISO standards, ANSI/ISO reference ranges, and laboratory test methodologies.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. Since SOLO-Care™ HARD Solution is a physical product (a contact lens solution) and not an AI/ML diagnostic algorithm, there is no training set in that context. The "training" for the product development would involve chemical formulation and process optimization, not data-driven machine learning training.

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

As there is no "training set" in the context of an AI/ML device, this question is not applicable. The development process would have involved iterative formulation, testing against performance requirements (as outlined in the preclinical section), and refinement based on these results.

Summary

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Brand HARD'Solution CIBANIslon Corporation

VII. I = 510(k) SUMMARY

,在此外交通的重要的意见,在此次的主要的主要。在此次的一个人的一个人的一个人的一个人的一个人

In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.

SUMMARY OF SAFETY AND EFFECTIVENESS FOR SOLO-CARE™ HARD SOLUTION

1. Submitter Information

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth. Georgia 30097 Contact Person: Steven Dowdley (Senior Requlatory Affairs Associate) Telephone No. 678-415-3897

Device Name 2.

Classification Name: Proprietary Name:

Rigid Gas Permeable Contact Lens Solution SOLO-CARE™ HARD SOLUTION

3. Predicate Devices

The predicate devices selected for this submission was BOSTON Advanced Conditioning Solution, BOSTON Classic and Boston Simplicity Solution. These products were selected because of similarities in the indication and formulation of this product and the proposed device.

4. Description of the Devices

ട. Indications for Use

SOLO-Care ™ Hard Solution is indicated for use in daily cleaning, rinsing, chemical (not heat) disinfecting and conditioning fluore acrylate, silicone acrylate and hard (PMMA) contact lenses as recommended by your eye care practitioner,

6. Description of Safety and Substantial Equivalence

A series of preclinical and clinical studies were completed the safety and effectiveness of SOLO-Care Hard 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 that the solution is non-toxic and biocompatible, and is comparable to other currently marketed contact lens solutions.

Preclinical Testing

Cleaning Effectiveness - Critical Micelle

Results demonstrated that the surfactant concentration is formulated in SOLOCare Hard Solution at sufficiently high levels to maintain its activity for cleaning and detergency.

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Contact Wetting Angle

Dynamic contact angle analysis indicated that the SOLO-care Hard Solution is statistically equivalent to predicate solution Boston Simplicity in terms of surface wettability of the lens.

Solution Compatibility

Compatibility testing of SOLO-care HARD with CAB, silicon acrylate and fluorsilicone acrylate lens materials was conducted to demonstrate compatible with various material types. The study showed that after 30 cycles all parameters were still within the ANSI/ISO reference range for rigid gas permeable lenses for both solutions. In addition, there was no change in the cosmetic appearance of the lenses.

Stability (chemical and microbiological)

Shelf life for SOLO-Care HARD Solution has been demonstrated on 3 lots of product filled in white polypropylene bottles. Chemical stability testing was conducted at 4℃, 25℃, 30℃ and 40℃ on pH, osmolarity, viscosity, appearance and active ingredients. Based on the data collected, the trends observed and the estimated calculations of the accelerated test samples the shelf life for SOLO-care HARD Solution is 24 months.

Preservative Effectiveness

Studies were performed to evaluate the preservative effectiveness of SOLOCare HARD Solution. The results demonstrate that SOLO-Care Hard meets the requirements of the ISO/DIS 14730 Preservative Effectiveness Test against the panel organisms tested.

Disinfection Efficacy

The ISO Regimen Test was performed in accordance with ISO/CD 14729 to determine the antimicrobial effectiveness of the SOLO-Care Hard regimen. The results demonstrated that the solution meets the requirements of the standard.

Toxicology Results

L929 Direct Contact Material Assay, L929 Agar Overlay Diffusion Assay, Growth Inhibition Test, and Ocular Irritation Test were conducted in accordance with and in conformance to applicable regulations. Results demonstrated that the solution and lenses treated with the solution did not cause a toxic response or increase ocular irritation.

Clinical Testing

Three clinical studies were used to evaluated SOLO-care Hard Solution. Overall 166 contact lens wearers were enrolled and were exposed to the test and control solution from a wearing period of 1 month to 6 months.

The data from the studies were examined using descriptive statistics, tests for normality, analysis of variance and/or t-tests where appropriate. Analysis of all data from the studies showed no that the test and control solutions were substantially equivalent. In additional safety concerns were raised regarding the test solution.

7. Substantial Equivalence

SOLO-Care Hard Solution is substantially equivalent.to BOSTON Advanced Conditioning Solution, BOSTON Classic and Boston Simplicity Solution in terms of usage, formulation similarities, and indications for use in daily cleaning (Boston Simplicity only), rinsing, chemical (not heat) disinfecting, storing and wetting of fluoro silicone acrylate, silicone acrylate and hard (PMMA) contact lenses as recommended by your eye care practitioner.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 5 2000

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

Re: K993949 Trade Name: SOLO-Care ™ Hard Solution (RGP multipurpose solution) Regulatory Class: II Product Code: 86 MRC Dated: October 12, 1999 Received: November 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, RAC

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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ARD Solution 3 0 3 on Concernation 1 3

PART III. INDICATIONS FOR USE STATEMENT

K993949 This is a new 510 (k) Notification. (number to be assigned) 510(k) Number:

Device Name: SOLO-Care ™ Hard Solution

Indications for Use:

motionerie to: Solution is indicated for use in daily cleaning, rinsing, chemical (not heat) disinfecting and conditioning of fluoro silicone acrylate, silicone acrylate and hard (PMMA) contact lenses as recommended by your eye care practitioner.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Or over-the-counter: 0

Lamuel W.C. Brinson, M.D.

പ്ര

Division of Ophthalmic Devices K993949 510(k) Number _

Confidential

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.”