(23 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 and blood sampling,
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device: the AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit.
This type of document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as it pertains to AI/ML device testing. It is a regulatory approval document confirming substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information based on the given input. The document confirms:
- Device Name: AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit
- Intended Use: Short or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
- Regulatory Clearance: 510(k) clearance, indicating substantial equivalence to a legally marketed predicate device.
To answer your questions, one would typically need access to the full 510(k) submission, which would include performance data if it were a novel device requiring such studies, or if it were an AI/ML powered device, which this clearly is not.
§ 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.”