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The smoke evacuation hoses are intended for the removal of smoke and particles generated from the point of surgical activity during a medical procedure that uses an electrosurgical pencil or laser for cutting and/or cauterizing. The are to be connected to a smoke evacuation unit securely on one end and the other end is to be held at the surgical site no farther than 2" from the point of lasering or cauterizing of tissue. They are a single use item, considered a bio-hazardous item after use in surgery, and must be disposed of after each case in a bio-hazardous bag (a red bag).

A plastic smooth bore corrugated tubing with polyethylene adapters. Supplied in a variety of diameters and lengths. Also supplied in Sterile and Non-Sterile.

This document is a 510(k) premarket notification for a medical device called "Koros70 Smoke Evacuation Hoses/Tubing". It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. This document does not describe an AI medical device, nor does it contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria.

Therefore, I cannot provide the requested information in the format of the bullet points and tables because the input text does not contain any details about an AI medical device or its performance studies.

The document contains information about:

• Device Type: Smoke evacuation hoses/tubing
• Manufacturer: DM Medical Inc.
• Intended Use: Removing smoke and particles from surgical sites during electrosurgical or laser procedures.
• Predicate Device: Smoke evacuation hoses/tubing manufactured by LASE, INC. (K922555).
• Performance Summary (for the non-AI device): "All smoke evacuation hoses are capable of maintaining adequate air flow to allow for adequate aspiration of smoke found at the site of surgical activity."
• Biocompatibility Testing: The materials were tested and found to be non-irritating, non-cytotoxic, and non-sensitizing.
• Sterility and Shelf Life: Gamma radiation sterilized, sterile until package opened or damaged.
• Regulatory Clearance: 510(k) clearance (K020510) for substantial equivalence to a predicate device.

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