(149 days)
The ROCAP Normal Saline Flush Syringe is indicated for use to maintain patency of indwelling venous access devices.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Normal Saline IV Flush Syringe" (ROCAP Division of Sabratek Corporation). This letter grants clearance based on substantial equivalence, which means the device is considered as safe and effective as a legally marketed predicate device.
Crucially, this document is an FDA clearance letter and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
A 510(k) clearance evaluates substantial equivalence to a predicate device, not necessarily a new study proving specific performance metrics against pre-defined acceptance criteria. While the manufacturer would have submitted data to the FDA to demonstrate substantial equivalence, this specific letter does not include the details of that data or any explicit acceptance criteria.
Therefore, I cannot provide the requested information from this document. To answer your questions, one would need access to the 510(k) submission itself or other regulatory documents that detail the performance studies and acceptance criteria.
§ 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).