(296 days)
The Vygon LIFECATH-PICC (PUR) Catheter is intended for use in patients who require mid-long term I.V. therapy. It may be used to administer hyperalimentation, chemotherapy, pain management or intravenous fluids.
Vygon LIFECATH-PICC (PUR) Catheters & Single and Double Lumen, 3 FR, 4 FR, 4.5 FR, and 5 FR)
I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification for a medical device (Vygon Lifecath-PICC Catheters). It contains an FDA letter of substantial equivalence, an indications for use statement, and contact information.
However, the document does not contain any information about acceptance criteria for device performance, or any studies conducted to prove the device meets such criteria. It's a regulatory approval document, not a detailed performance study report. Therefore, I cannot extract the table of acceptance criteria, sample sizes, expert qualifications, or details about comparative effectiveness studies, as this information is not present.
§ 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.”