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Galeo coronary guide wires are indicated to facilitate the placement of balloon dilation catheters or other interventional devices with compatible guide wire lumen during an interventional procedure.

BIOTRONIK's Galeo Focus family of guide wires includes steerable coronary guide wires with various tip flexibilities and configurations that are intended to guide the placement of intravascular catheters with compatible guide wire lumens during PTCA or other therapeutic or diagnostic procedures. The Galeo Focus guide wires are identical in design and functionally equivalent to the Galeo and Galeo Hydro Guide Wires already cleared for distribution, with the guide wire consists of 3 radiopaque marker bands on the distal tip for lesion length assessment starting at 37 mm proximal to the quide wire tip. Additionally, the distal 27 mm of the quide wire are covered with a highly radiopage platinum coil. The number, dimensions and spacing of the markers on the distal tip of the Galeo Focus are the same as the legally marketed ATW Marker Wire from Cordis Corporation (#K994358, cleared 01-13-00) with the exception that the first distal marker is located 37 mm proximally from the tip versus 45 mm for Cordis' ATW.

I am sorry but this document does not contain the information you are requesting. The document focuses on the 510(k) clearance for the Galeo Focus Coronary Guide Wire, which is a medical device, not an AI/ML device. Therefore, it does not include details on acceptance criteria, study methodologies, or ground truth establishment relevant to AI/ML performance.

The document is a regulatory submission for a physical medical device and discusses its substantial equivalence to previously cleared devices, specifications of its components (like marker bands), and its indications for use. It doesn't involve any performance metrics that would typically be associated with an AI system, such as sample sizes for test/training sets, expert adjudication, or reader studies.

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