(146 days)
The GuardianPICC™ is a sterile, disposable, single lumen catheter intended for I.V. administration. The catheter may be used for delivery of TPN nutritional solutions, antibiotics, pain medications, chemotherapy and hurritional concernis inserted peripherally and provides a mechanism for the administration of IV medications to the large central veins of the body.
The GuardianPICC™ is a sterile, disposable, single lumen catheter intended for I.V. administration.
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called GuardianPICC™ Percutaneous Central Venous Catheter. This type of document does not contain information about acceptance criteria, study details, or performance metrics of the device.
The 510(k) pathway is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than on proving new safety and effectiveness through extensive clinical trials with detailed performance metrics like those requested in your prompt.
Therefore, I cannot provide the requested information based on the given text. The document is a clearance letter, not a study report.
§ 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.”