(491 days)
As described in 21 CFR section 880.5200, Cathy IV Cannula is used to administer fluids intravenously. Cathy IV Cannula may be used for writtence of propoduce intravenously. Cathy IV Califiala may be accurity of the may of procedure.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Cathy IV Cannula." It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
Unfortunately, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. It is a regulatory approval document, not a detailed technical report on device validation.
Therefore, I cannot provide the requested information based on the input text. The document confirms the device's regulatory classification, product code, and that it can be marketed, but it lacks the scientific and performance data you're asking for.
§ 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).