(28 days)
The Celsite® System is recommended for use whenever patient therapy requires repeated I.V. Access for injection, drug therapy and/or blood sampling.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Celsite® Dual Venous Access System." It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Key information:
- Acceptance Criteria and Device Performance: The document does not contain acceptance criteria or study results demonstrating device performance against such criteria. It's an approval letter based on "substantial equivalence" to a predicate device, not a performance study report.
- Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): As this is an FDA clearance letter based on substantial equivalence, rather than a clinical trial or performance study report, none of this information is available within the provided text. The FDA determines substantial equivalence based on a comparison to predicate devices regarding indications for use, technological characteristics, and safety and effectiveness information, but the specific performance data against quantified acceptance criteria and the detailed study design elements you've asked for are typically found in the 510(k) submission itself, not the clearance letter.
Therefore, for this specific input, I must state that the requested information regarding acceptance criteria, device performance, and study details is not provided in the given FDA clearance letter.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.