(62 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
The provided text is a 510(k) clearance letter from the FDA for a Peripherally Inserted Central Catheter (PICC). It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring the submission of new clinical studies with defined acceptance criteria for novel performance metrics unless specifically requested by the FDA or if the device introduces new technology or indications that raise new questions of safety and effectiveness.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided document.
§ 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.”