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Creation of an atrial septal defect in the heart. Secondary Indications For Use: applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Toronto RF Septostomy Catheter." It is not a study report, and therefore does not contain the information required to answer the questions about acceptance criteria, device performance, study design, or ground truth establishment for a device study.

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 means the FDA granted clearance based on the device's substantial equivalence to existing, legally marketed devices, rather than on the results of a new clinical study demonstrating specific performance against predefined acceptance criteria. Clinical studies with detailed efficacy and safety endpoints are typically required for Premarket Approval (PMA) applications, not usually for 510(k) clearances which rely on substantial equivalence.

Therefore, I cannot provide the requested information from this document.

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