(99 days)
Premicath is a peripherally inserted central (PIC) catheter for central venous catheterization. The catheter is used for mid- to long-term infusion of TPN or intravenous medications.
Premicath is a peripherally inserted central (PIC) catheter for central venous catheterization.
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "Premicath". It discusses regulatory approval and substantial equivalence but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input.
§ 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.”