(69 days)
TO FACILITATE THE PLACEMENT OF DEVICES SUCH AS GUIDEWIRES, INDWELLING CENTRAL VENOUS CATHETERS, PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS, AND MIDLINE CATHETERS INTO THE VASCULAR SYSTEM.
The subject catheter is a short term, single use introducer catheter of various gauges and lengths which is designed to split and peel away following use. It is inserted into the vascular system over a needle.
The provided text is a compilation of FDA correspondence regarding a 510(k) premarket notification for the "INTROSYTE™ Catheters." It details the device's name, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance studies, or training data.
The document is purely administrative, confirming the FDA's review and determination of substantial equivalence, which allows the submitter to market the device. It focuses on regulatory compliance rather than performance evaluation against specific metrics.
Therefore, I cannot provide the requested information from the given text.
§ 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).