Search Results

The Paragonix SherpaPak™ Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs.

The intended organ storage time for the Paragonix SherpaPak™ Lung Preservation System is up to 8 hours.

Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

Note: Partial lungs can be transported via SherpaPak™ LPS by packaging lungs per institutional protocol and UNOS guidelines.

The Paragonix SherpaPak™ Liver Transport System is intended to be used for the static hypothermic preservation of livers during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the livers.

The intended organ storage time for the Paragonix SherpaPak™ Liver Transport System is up to 15 hours.

Donor livers exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplance with accepted clinical guidelines and in the best medical interest of the intended recipient.

Not Found

The provided text is an FDA 510(k) clearance letter for the SherpaPak™ Lung Preservation System and SherpaPak™ Liver Transport System. This document does not describe the acceptance criteria for a device performance study or the study that proves the device meets those criteria. Instead, it is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices.

The information typically provided in a device performance study, such as acceptance criteria, sample sizes, ground truth establishment, and expert qualifications, is not included in this type of FDA clearance letter. These details would be contained within the 510(k) submission itself, which is not fully provided here.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance from the given text. The document primarily focuses on regulatory approval based on substantial equivalence.

Ask a specific question about this device