(15 days)
NUOVOguard IV Catheter in sizes 14G to 26G is used to provide access into the peripheral vascular system for the administration of fluids and drugs and for withdrawal of blood. The NUOVOguard provides a passive safety tip clip to protect from the accidental needle stick injury after cannulations
Not Found
I am sorry, but based on the provided text, I cannot extract any information about acceptance criteria, study details, or device performance as requested. The document is an FDA 510(k) clearance letter for an Intravascular Catheter, which primarily focuses on the regulatory aspects of the device's market approval rather than detailed performance study results.
The document states that the device, "US SAFETY SYRINGES CO. NUOVOguard IV Catheter," is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" which describe the purpose of the device (providing access into the peripheral vascular system for fluid/drug administration and blood withdrawal, and having a passive safety tip to prevent needle stick injury). However, it does not contain the specific performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications that you are requesting.
§ 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).