(88 days)
To sample blood or administer drug solutions, blood products, and other fluids intravenously. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
The subject catheter is a short term, single use, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It is inserted into the vascular system through a spittable introducer catheter.
The provided text describes a 510(k) premarket notification for an intravascular catheter (FIRST MIDCATH™ Catheter) and its substantial equivalence to a predicate device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) submission primarily focuses on:
- Device Identification: Name, common name, classification, and intended use.
- Predicate Device: Identification of the legally marketed device it claims substantial equivalence to.
- Description of Differences: States that the subject catheter differs from the predicate only in modified stylet and labeling.
- Regulatory Conclusion: The FDA's determination of substantial equivalence.
Therefore, I cannot provide the requested information, which typically would be found in a performance study report or clinical trial summary. The document explicitly states that the proposed catheter differs from the predicate only in the stylet and labeling, implying that its fundamental performance characteristics are assumed to be equivalent to the predicate without requiring new standalone performance studies.
§ 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).