(84 days)
The Vascular Pathways RIVS system is indicated for use to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to patient size, appropriateness of the solution being infused, and duration of therapy.
The device is a single use, sterile intravascular catheter designed to provide access to veins. The device is provided with a mechanism which allows the needle to be shielded following placement of the catheter.
This document is a 510(k) summary for a medical device (Rapid Intravascular Catheter Start System) and does not contain information about acceptance criteria or a study proving device performance against such criteria.
The 510(k) summary focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance data from a specific study against acceptance criteria. The information provided is primarily administrative and descriptive of the device and its intended use.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them based on the provided text. The document refers to conformance with recognized standards (ISO 10555-1, ISO 594-1, ISO 7864, AAMI TIR 33), but does not specify the acceptance criteria or results from a study conducted by the manufacturer against these standards to demonstrate device performance.
§ 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).