(14 days)
Vaxcel ™ PICC with PASV®Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, and piotics, chemotherapy, analgesics, nutitional therapy, and blood products, and blood indicated for blood specimen withdrawal.
The Vaxcel™ PICC with PASV® Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal.
The provided text is a 510(k) summary for the Vaxcel™ PICC with PASV® Valve Technology. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria, detailed study designs (such as sample sizes for test or training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance), or the type of ground truth used for a device that relies on interpretation or measurement.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study details you requested, as this information is not present in the provided document. The document primarily addresses regulatory aspects of device approval based on substantial equivalence.
§ 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.”