Search Results

The Medcomp Duo-Split Double Lumen Catheter is designed for acutehemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian or femoral vein, the internal jugular vein l the preferred site.

Not Found

The provided document is a 510(k) clearance letter for the Medcomp Duo-Split Double Lumen Catheter. This letter focuses on the regulatory aspect of device clearance based on substantial equivalence to a predicate device, rather than providing detailed information about specific performance acceptance criteria or a comprehensive study report designed to prove those criteria.

Therefore, the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not present in the provided text.

The document states: "we have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This indicates that the clearance is based on a comparison to an already approved device, rather than a de novo clinical study with predefined acceptance criteria for the new device.

The "Indications for Use" section (page 3) describes what the device is intended for (acute hemodialysis and apheresis, inserted percutaneously, ideally in the internal jugular vein), but this is not a set of performance acceptance criteria in the sense of statistical endpoints for a study.

Ask a specific question about this device