(116 days)
The AngioDynamics, Inc. Morpheus® CT PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. For blood sampling, infusion, or therapy use a 4 French or larger catheter.
Not Found
I am sorry, but based on the limited information provided in the document, I cannot answer questions 1-9. This document is a letter from the FDA regarding 510(k) clearance for a medical device (AngioDynamics, Inc. 5F Dual Lumen Morpheus® CT PICC and Procedure Kit). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.
However, the document does not contain any information about:
- Acceptance criteria for device performance.
- Studies conducted to prove the device meets performance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Ground truth adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- The type of ground truth used.
- How ground truth for the training set was established.
This type of information is typically found in the 510(k) premarket notification itself, or in supporting study reports, which are not part of this FDA clearance letter.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”