(130 days)
FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)
Normal Saline I. V. Flush Syringe
The provided text is a 510(k) clearance letter from the FDA for a medical device: "Normal Saline I.V. Flush Syringe." This document does not describe any acceptance criteria or a study proving the device meets those criteria.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This means the device was cleared based on its substantial equivalence to a legally marketed predicate device, rather than a study demonstrating its performance against specific acceptance criteria. The 510(k) pathway for medical device clearance often relies on demonstrating equivalence rather than conducting new clinical trials with performance metrics and acceptance criteria for novel devices.
Therefore, I cannot provide the requested information from the given text as it is not present in the document.
§ 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).