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Clear-It Anti-Fog Solution is indicated for use in the sterile surgical arena to eliminate condensation from endoscopic lenses, microscope lenses, goggles and other devices that are likely to fog.

Clear-It Anti-Fog is a solution whose primary ingredients are Water, Isopropyl Alcohol, Sodium Alcohol Ether Sulfate, and Ammonium Dodecylbenzene proportionally mixed balanced and packaged according to approved manufacturing processes. Clear-It Anti-Fog is terminally sterilized by gamma irradiation. The appropriate dose was established using ISO 11137 method I protocol. Quarterly dose audits are performed using the same ISO 11137 protocol. Routine production testing prior to release includes pH, cytotoxicity, efficacy, and bacterial endotoxin.

This document is a 510(k) premarket notification for the "Clear-It Anti-Fog Solution." It primarily focuses on regulatory approval and equivalence to previously marketed devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about device performance studies, sample sizes, ground truth, or expert qualifications based on the provided text.

The document indicates:

• Device Name: Clear-It Anti-Fog Solution
• Intended Use: To eliminate condensation from endoscopic lenses, microscope lenses, goggles, and other devices likely to fog in the sterile surgical arena.
• Device Description: A solution primarily composed of Water, Isopropyl Alcohol, Sodium Alcohol Ether Sulfate, and Ammonium Dodecylbenzene, terminally sterilized by gamma irradiation.

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