(96 days)
The Vygon LIFEVAC Dual Lumen PICC Catheters (4.0 Fr. and 5.0 Fr.) are intended for use in patients who require mid-long term I.V. therapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids.
Vygon Double Lumen PICC Catheter 4.0 Fr. & 5.0 Fr.
I apologize, but the provided text from the FDA 510(k) letter for the Vygon Double Lumen PICC Catheter does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
This document is a letter from the FDA confirming that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It outlines regulatory requirements and general information but does not delve into the specific details of performance studies or acceptance criteria that would typically be found in a more technical submission or a summary of safety and effectiveness.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
§ 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.”