(21 days)
The SherpaPak Cardiac Transport System is intended to be used for the station of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the SherpaPak Cardiac Transport System is up to 4 hours. Donor hearts 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.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the SherpaPak Cardiac Transport System. It indicates that the device has been found substantially equivalent to predicate devices for its intended use. However, the document does not contain any information about acceptance criteria for device performance, nor does it describe any study demonstrating that the device meets such criteria.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance using the provided input. The document focuses on regulatory clearance based on substantial equivalence, not on detailed performance metrics or clinical trial results.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (which may be part of a 510(k) submission but is not included in this clearance letter), a clinical study report, or a descriptive document of the device's validation.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).