(57 days)
An intravascular catheter, inserted peripherally for long-term All intravasoalar outhors for parenteral nutrition and/or administration of drugs
Not Found
This is an FDA 510(k) clearance letter for the Vygon Nutriline Catheters, dated August 19, 2005. This document indicates the device has been found substantially equivalent to predicate devices already on the market.
It is important to note that 510(k) clearance letters typically do not contain detailed information about specific acceptance criteria or the studies used to prove those criteria were met. Instead, they confirm that the FDA has reviewed the submission and found the new device to be as safe and effective as a legally marketed predicate device. The information you are requesting is usually found in the original 510(k) submission, which is not provided in this document.
Therefore,Based on the provided document, I cannot fulfill your request for detailed information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
This document is a regulatory clearance letter, not a scientific study report.
§ 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.”