(60 days)
The Polyshield and Polyguard Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.
The Polyshield and Polyguard Safety IV Catheters are over-the-needle, peripheral safety IV catheters that incorporate an active sharps prevention needle shield. The 'BC' versions also incorporate a blood control feature, and the 'Adva' versions include 'quick flash back' needle technology. The devices are available in multiple gauge sizes and lengths.
The provided text does not describe an AI medical device or a study involving AI assistance. Therefore, I cannot provide information on acceptance criteria, reported device performance, sample size for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details as requested in the prompt.
The document describes the regulatory submission for Polyguard and Polyshield Safety IV Catheters, which are traditional medical devices, not AI-powered. The submission focuses on demonstrating substantial equivalence to a predicate device (BD Insyte Autoguard BC IV Catheter) through non-clinical performance testing and biocompatibility assessments, rather than AI performance metrics.
§ 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).