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BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector devices are intended to be inserted into a patient's vascular system for short term use to sample blood pressure, or administer fluids. These catheters 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. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector devices are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter, and vent plug. The needle and catheter are protected by a needle cover. A MaxZero device 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 The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure.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 return along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both 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 describes specific performance tests for the BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector. However, it does not include the acceptance criteria or reported device performance for these tests in a detailed format that would allow for a direct creation of the requested table. It only states that the device "met all predetermined acceptance criteria."

Therefore, I cannot provide a table of acceptance criteria and reported device performance.

Furthermore, the document does not detail the following information regarding a hypothetical study proving the device meets acceptance criteria:

• Sample size used for the test set or the data provenance.
• Number of experts used to establish the ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
• Whether a standalone (algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with specific performance metrics and acceptance criteria for this particular device. It describes the types of tests performed (e.g., MaxZero Insertion Force, Cytotoxicity, Sensitization) and states that "the subject device met all predetermined acceptance criteria," but it doesn't quantify those criteria or the device's exact performance against them.

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