(28 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.
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The provided text is a 510(k) K060887 clearance letter from the FDA for the AngioDynamics, Inc. Morpheus™ CT PICC and Procedure Kit.
This document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This means the device was cleared based on its substantial equivalence to existing legally marketed predicate devices, rather than on a new, explicit clinical study demonstrating specific performance against predefined acceptance criteria for a novel AI or diagnostic algorithm. The 510(k) pathway often relies on demonstrating that a new device is as safe and effective as a predicate device, sometimes through testing that is not detailed in the final clearance letter in the way a clinical study report would be.
Therefore, I cannot fulfill your request for the specific details of a study and acceptance criteria from the provided text. The document is an FDA clearance letter, not a study report.
§ 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.”