(164 days)
Karats Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Karats Multi-Purpose Solution is a sterile aqueous solution containing sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, edetate disodium dihydrate and preserved with polyhexanide 0.0001%.
The provided document describes the 510(k) summary for "Karats Multipurpose Solution." It details preclinical and clinical studies conducted to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Generally, acceptance criteria for medical devices like contact lens solutions are predefined benchmarks or thresholds the device must meet to be considered safe and effective. While the document mentions meeting standards and demonstrating substantial equivalence, it does not explicitly list quantitative acceptance criteria in a table format. Instead, it describes results and comparisons to a predicate device.
Based on the text, here's an attempt to infer and present the information in a table format, focusing on what was evaluated and the general outcomes:
| Metric Category | Acceptance Criteria (Inferred from study goals & FDA context) | Reported Device Performance (Karats Multipurpose Solution) |
|---|---|---|
| Lens Compatibility | No significant difference in optical and physical changes of lenses compared to control solution. | No significant difference between Karats Multi-Purpose Solution and the control solution, with respect to optical and physical changes in the measured properties of the lenses. |
| Cytotoxicity | Must be non-cytotoxic and non-irritant. | Results of the testing demonstrated that Karats Multi-Purpose Solution is non-cytotoxic and is a non-irritant. |
| Microbiological | Meets stand-alone criteria with organic load for disinfection; meets regimen test criteria (under pre-rinse/no rub regimen). | The studies demonstrated that Karats Multi-Purpose Solution meets the stand-alone criteria with organic load for disinfection and meets the regimen test criteria. |
| Clinical Safety | Equivalent safety profile (e.g., in visual acuity, symptoms, slit lamp findings) compared to predicate device. Low incidence of adverse events. | Contact lens visual acuity approximately similar (69% Karats 257 eyes, 75% SOLO-care Plus eyes having final VA same or better than baseline). Symptoms were equivalent. Slit lamp findings generally low grade ( |
§ 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.”