(14 days)
The ANGIODYNAMICS, Inc. Morpheus™ PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, parenteral nutrition, and blood sampling.
Not Found
I apologize, but this document is a 510(k) clearance letter from the FDA to AngioDynamics, Inc. for their Morpheus PICC and Procedure Kit.
It is a regulatory document granting market clearance and does not contain any information about a clinical study, acceptance criteria, or device performance metrics as they relate to a study's results.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document indicates that the device is "substantially equivalent" to legally marketed predicate devices, meaning its safety and effectiveness are considered to be at the same level as devices already on the market, but it does not detail the specific performance metrics or studies used to demonstrate this equivalence, other than the general statement of "special 510(k) device modification" which implies some changes were made and reviewed.
§ 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.”