Search Results

The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.

The Ultravision™ 5mm Trocar component also establishes a path of entry for instruments used in laparoscopic surgery.

The Ultravision™ Visual Clearing System removes surgical smoke from the visual field during laparoscopic surgery by means of electrostatic precipitation. The System consists of the Ultravision™ Generator, the Ionwand Sterile Pack, and the Ionwand 5mm Trocar. The Ionwand is connected to the energy source and is then introduced into the body cavity near the smoke generating electrosurgical device. The Ultravision™ 5mm Trocar is intended for use only with the Ultravision™ Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The Ultravision™ 5mm Trocar provides an alternative to the currently available Ultravision™ Visual Field Clearing System Ionwand™ Sterile Pack for introduction of the Ionwand. The trocar may be used with or without the Ionwand component of the system. The system is powered using a rechargeable battery or through mains power. Accessories include the rechargeable battery, battery recharging station, mains converter power supply, mains converter, power supply unit, and patient return adaptor.

This request is about a medical device called the "Ultravision™ Visual Field Clearing System," which is a surgical smoke precipitator. The provided text is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than detailed clinical performance studies or acceptance criteria for AI/ML performance.

Therefore, based on the provided document, the device does not employ Artificial Intelligence or Machine Learning, and thus, none of the requested information regarding AI/ML acceptance criteria and performance evaluation is available.

The document describes a modification to an existing mechanical device (adding a mains power option), and the safety and effectiveness are established by comparing it to a previously cleared version of the same device. The "Nonclinical Performance Data" section mentions electromagnetic compatibility and electrical safety standards, which are typical for medical devices but distinct from AI/ML performance evaluation.

Ask a specific question about this device