(96 days)
This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: Medications, TPN nutritional solutions, and Intravenous infusion of fluids are needed.
Not Found
I am sorry, but based on the provided document, there is no information about a study proving the device meets acceptance criteria, nor any details regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, or ground truth establishment.
The document is a letter from the FDA to Footprint Medical, Incorporated, confirming that the "Footprint Medical Polyurethane PICC Catheter" (K130507) has been found substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general information about marketing the device. The "Indications for Use" section specifies the intended patient population (neonatal and small pediatric) and applications (medications, TPN, IV fluids).
Therefore, I cannot provide the requested table or details about a study and its methodology.
§ 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.”