(270 days)
Not Found. This document is a certification and summary for a 510(k) submission, but it does not contain the detailed information requested regarding a medical device for imaging or AI/ML.
Not Found
Analysis of Provided Information to Answer the Request
The input provided is a "PREMARKET APPROVAL NOTIFICATION CERTIFICATION AND SUMMARY" for the BioGlide Vascular Catheter, single lumen. This document does not contain any information about acceptance criteria or a study proving the device meets said criteria.
Instead, it lists potential complications associated with the use of the device and certifies that the submitter is aware of these problems. It is a general statement about potential risks, not a performance study.
Therefore, I cannot provide the requested information based on the input.
To answer your request, I would need a document describing:
- Specific performance metrics and their corresponding acceptance criteria. (e.g., "Tensile strength must be > X Newtons," "Flow rate must be > Y ml/min," "Insertion force must be
§ 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.”