(22 days)
For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.
Multi-Purpose Disinfecting Solution ID 90746 can be used to dissolve OPTI-ZYME® Enzymatic Cleaner.
Multi-Purpose Disinfecting Solution ID 90746 is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, TETRONIC® 1304, with edetate disodium 0.05%, POLYQUAD® (polyquaternium-1) 0.001% and AL-6289 0.0005% as preservatives.
This document describes a minor specification modification to a Multi-Purpose Disinfecting Solution. The submission focuses on demonstrating that the modified product remains substantially equivalent to the previously cleared version and meets safety guidelines. It is not an AI/ML device, so many of the requested fields are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Guidelines Met) | Reported Device Performance |
|---|---|
| FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products | Multi-Purpose Disinfecting Solution ID 90746 (minor specification) meets these guidelines. (Source: {1}) |
| Safety: Ocular hazard under normal use conditions | Based on an eight-day ocular irritation study, the product "should not present an ocular hazard to the consumer under normal use conditions." (Source: {1}) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Ocular Irritation Study: Not explicitly stated, but the study was conducted "in rabbits." {1}
- Data Provenance: The ocular irritation study was conducted on rabbits, a common animal model for ocular safety. The location/country of origin is not specified, but the submission is to the U.S. FDA, implying the study adheres to U.S. regulatory standards. The study appears to be prospective, designed specifically to evaluate the safety of the modified formulation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a chemical solution for contact lens care, not an AI/ML device involving expert interpretation of images or other data. The "ground truth" for the safety study is the observed biological response in the rabbits.
4. Adjudication Method for the Test Set
- Not Applicable. As this is not an AI/ML device, there's no adjudication in the sense of reconciling expert opinions for ground truth. The safety study involves direct observation and assessment of ocular irritation.
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
- Not Applicable. This is a chemical solution, not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a chemical solution, not an algorithm.
7. The Type of Ground Truth Used
- Biological Response/Observed Safety Outcomes: For the ocular irritation study, the ground truth is the observed physiological response in the rabbits to the application of the modified solution. This typically involves grading irritation (e.g., redness, swelling, discharge) according to established scales.
8. The Sample Size for the Training Set
- Not Applicable. This is a chemical solution, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is a chemical solution, not an AI/ML device.
§ 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.”