(29 days)
BD Nexiva Diffusics closed IV catheter systems are intended to be inserted into a patient's 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) when access ports not suitable for use with power injectors are removed.
BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter with side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package.
The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.
These devices have BD Instaflash needle technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. The stabilization platform and Luer connector are color coded to indicate 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).
The provided text is an FDA 510(k) summary for a medical device (BD Nexiva Diffusics Closed IV Catheter System) and does not contain information about an AI/ML-driven medical device, nor does it detail a study proving such a device meets acceptance criteria.
The document is a premarket notification to the FDA for a medical device (intravenous catheter), asserting its substantial equivalence to a legally marketed predicate device. The "performance tests" mentioned are engineering tests to ensure the physical integrity and function of the catheter after a minor design modification, not clinical studies of an AI algorithm.
Therefore, I cannot extract the requested information related to AI/ML device acceptance criteria and study details from the provided text. The questions refer to concepts like "test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "ground truth," and "training set," which are relevant to evaluating AI/ML models, but not to the type of device and submission described in the document.
§ 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).