(238 days)
FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)
Sterile Heparin I. V. Flush Syringe
This document is a 510(k) clearance letter from the FDA for a medical device: "Medefil's Heparin I.V. Flush Syringe". It grants permission to market the device based on its substantial equivalence to a legally marketed predicate device.
Therefore, this document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a regulatory approval document, not a scientific study report.
The request asks for specific details about acceptance criteria, device performance, study design (sample sizes, data provenance, expert involvement, adjudication), MRMC studies, standalone performance, ground truth establishment, and training set information. None of this information is present in the provided text.
To answer your request, you would need a scientific or clinical study report for the "Medefil's Heparin I.V. Flush Syringe", not this FDA clearance letter.
§ 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).