(89 days)
BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure or administer fluids. This device 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. This device is 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 (Nexiva Diffusics) and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (Nexiva Diffusics with Max Zero) are over-the-needle, intravascular (IV) catheters. These devices have a radiopaque BD Vialon™ Catheter Material with three 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.
A BD MaxZero™ device with protective cover is provided in the unit package for BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector kit. 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 The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure.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 needle stick 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 FDA 510(k) clearance letter and summary for the BD Nexiva™ Diffusics™ Closed IV Catheter System does not contain information related to software, artificial intelligence, or diagnostic imaging. Therefore, it is impossible to describe acceptance criteria and study details related to a device using AI, ground truth, expert readers, or sample sizes for training/test sets as requested in the prompt.
The document pertains to a physical medical device (an IV catheter system) and its substantial equivalence to predicate devices, focusing on:
- Indications for Use: Changes to include "blood pressure monitoring indication" for one of the devices.
- Physical Characteristics: Materials, dimensions, sterilization, and packaging components.
- Performance Testing: Mechanical and functional tests relevant to IV catheters (frequency response, kink resistance, blood fill time, luer lock performance, packaging integrity).
There is no mention of:
- A device that uses AI.
- Any form of image analysis, signal processing, or diagnostic output that would require a "test set," "ground truth," "expert consensus," "human-in-the-loop performance," or "MRMC comparative effectiveness study."
- Specific acceptance criteria percentages for sensitivity, specificity, or similar metrics typically associated with AI/diagnostic device performance.
- Training or test data sets, data provenance, or the number/qualifications of experts for labeling or adjudication.
The questions in the prompt are designed for a different type of medical device submission, specifically those involving software as a medical device (SaMD) or AI/machine learning components for diagnostic or prognostic purposes.
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information.
§ 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).