Search Results

BD Cathena™ Safety IV Catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).

BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV) catheters include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.

These devices are available with or without multi-access BD Multiguard™ Technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the cather direction.

These devices are available with or without wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Green, 16 GA (1.7 mm) = Grey). These devices are not made with natural rubber latex.

The provided document is a 510(k) summary for the BD Cathena Safety IV Catheter. It does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Instead, it describes a medical device (an IV catheter) and outlines its substantial equivalence to a predicate device based on technological characteristics and performance testing.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI device from this document. The document primarily focuses on regulatory approval for the BD Cathena Safety IV Catheter, which is a physical medical device, not an AI/ML product.

Ask a specific question about this device