(112 days)
The NEO MAPCath sensor stylet, when used in conjunction with the NAVIGATOR locator instrument, is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.
Not Found
The provided text outlines an FDA 510(k) clearance letter for the NEO MAPCath Sensor Stylet. However, it does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.
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 indicates that the clearance was based on a demonstration of substantial equivalence to a predicate device, rather than a standalone clinical study with predefined acceptance criteria and a detailed analysis of device performance as would be required for a novel device or a Premarket Approval (PMA) application.
Therefore, I cannot provide the requested information from the provided document. The document is an FDA clearance letter, not a study report or a summary of performance data.
§ 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.”