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The DeRoyal Industries, Inc. DeFogger is indicated for use during endoscopic, laparoscopic, gastroscopic, and arthroscopic procedures, as well as any other procedures which require the use of an endoscope device, to prevent fogging of the endoscope lens.

The DeRoyal Industries, Inc. DeFogger functions in the same manner as predicate devices in that it is intended to be used during endoscopic, laparoscopic, gastroscopic procedures, as well as any other procedures which require the use of an endoscope device to prevent fogging of the endoscope lens.

Device Design/ Materials UsedPhysical Properties: The DeRoyal Industries, Inc. DeFogger is made of materials commonly used for this purpose. The primary material components are a solution consisting of Monawet MO-70E, Isopropyl Alcohol, and Water. The solution is applied with an Adhesive-Backed X-Ray Detectable Polyurethane Foam Pad.

The provided text describes a medical device, the DeRoyal Industries, Inc. DeFogger, and its 510(k) submission for market clearance. However, the document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or any details related to AI/algorithm performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and technological characteristics. This type of submission typically relies on existing knowledge of similar devices rather than new, extensive clinical studies with specific performance metrics like those for AI/software devices.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and studies, as this information is not present in the provided text. The document confirms that the device was cleared by the FDA (K982465) based on substantial equivalence to existing devices, inferring that its performance would be similar to those already on the market.

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