(26 days)
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.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”