(89 days)
The 1.4 Fr MAPCath Sensor Stylet is designed to be used with the NAVIGATOR Cathotors (CVCc) by indicating the position and direction of the CVC tip inside the body during the catheter insertion procedure.
The sensor stylet described in this 510(k) submission is the same product described in Bard Access Systems 510(k) (reference K935380).
I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for a medical device (1.4 Fr MAPCath sensor stylet) and focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as you've requested.
The document states:
- The device is "substantially equivalent (same product) to the 1.4 Fr sensor stylet described in Bard Access Systems submission K935380 and substantially equivalent in design, use and function to the Navion SMART-WIRE sensor described in submission K901263."
- "The sensor stylet described in this 510(k) submission is the same product described in Bard Access Systems 510(k) (reference K935380)."
This indicates that the submission relies on the prior clearances and the equivalence of the device, rather than presenting new performance study data against defined acceptance criteria.
§ 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.”