(135 days)
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. These devices 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 device has entered 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 catheter hub in either direction.
These devices are available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey). These devices are not made with natural rubber latex.
The provided text does not describe an AI/ML-driven device or study. Instead, it is a 510(k) premarket notification for a medical device (BD Cathena™ Safety IV Catheter), which is an intravascular catheter. The submission outlines the device, its intended use, comparison to predicate devices, and performance tests conducted to demonstrate substantial equivalence, but it does not involve any AI/ML components or studies that would require the specific criteria requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies).
Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported device performance from the provided text in the context of an AI/ML study. The performance tests mentioned (e.g., time to visualize flashback, force to break adhesion, burst pressure, flow rate, power injection) are specific to the mechanical and functional properties of an IV catheter, not AI/ML model performance.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).