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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.

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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.

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