Search Results

For short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

The proposed Peripherally Inserted Catheter is a Flexible radiopaque catheter with similar technological characteristics as the predicate devices. It is available in single and multi-lumen configurations with markings along the 55cm shaft length; with extension tube(s) and suture wing for cather securement; and each lumen is differentiated by a proximally located female luer lock adaptor with valve and colored hubs that indicate lumen size.

The provided text describes a 510(k) submission for the "NMI PICC II" device, a peripherally inserted central catheter. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document outlines the device's administrative details, its intended use, and states that "Performance testing included in-vitro testing in accordance with ISO 10555-1 and ISO 10555-3; high performance testing rates and valve integrity testing; and biocompatibility evaluation in accordance with ISO 10993-1." It concludes with a determination of substantial equivalence to predicate devices based on the guidance document.

Therefore, I cannot provide the requested information from the given text. The details you've asked for (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not present in this 510(k) summary.

Ask a specific question about this device