(416 days)
The multiple-lumen catheter permits venous access to the central circulation. The Arrow antiseptic surface catheter is intended to help provide protection against catheter related infections. The catheter is not intended to be used as a treatment for existing infections nor is it indicated for longterm use.
Quad-Lumen Central Venous Catheter
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (ARROWgard Blue™ Quad-Lumen Central Venous Catheter). This document does not contain information about acceptance criteria, device performance, results of a study, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request for the specific information regarding a study and acceptance criteria based on this input. It primarily deals with the regulatory clearance process and substantial equivalence, not the detailed technical and clinical validation study results.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).