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The Paragonix KIDNEYvault Portable Renal Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The Paragonix KIDNEYvault Portable Renal Perfusion System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours. Donor kidneys exceeding clinically accepted 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.

The KIDNEYvault Portable Renal Perfusion System (KIDNEYvault) device is designed to provide pulsatile perfusion of pre-chilled machine preservation solution through the kidney by means of a mechanical pump and closed fluid circuit integrated within the device and attached to the kidney. Its intended use and principle of operation are the same as the predicate device, LifePort Kidney Perfusion Transporter (K021362), while the differences in the technological characteristics from the predicate are supported by the literature, testing, and the following reference devices: SherpaPak KTS and KIDNEY Assist. To maintain the chilled temperature of the machine preservation solution, the subject KIDNEYvault utilizes the same technology as the first reference device, SherpaPak KTS; whereas certain specifications for the subject device are based on the second reference device, KIDNEY Assist-transport. The subject KIDNEYvault device consists of the following components: 1) KIDNEYvault SherpaCool Pouch and Ribbons Phase Change Material (PCM) (identical to the first reference device) to maintain temperature of the cold machine preservation solution and kidney throughout transportation. The KIDNEYvault device maintains the temperature between 4°C to 8°C throughout preservation and transportation. 2) KIDNEYvault Canister Assembly Proprietary hard shell, polycarbonate nested canister set for the packaging of the donor kidney within cold machine preservation solution and circulation of preservation solution through kidney vasculature. The Canister Assembly incorporates a closed fluid pathway and connections to the donor kidney that draws cold machine preservation solution from the Inner Canister and circulates it through the renal artery of the kidney and exits through the renal vein or ureter back into the Inner Canister. 3) KIDNEYvault Shipper Outer transport shipper which comprises a protective and insulative package. The KIDNEYvault Shipper is a rigid, molded expanded polystyrene (EPS) insulative container into which the KIDNEYvault SherpaCool and KIDNEYvault Canister Assembly are placed. The maintenance of temperature of the donor kidney between 4°C to 8°C is assisted by the EPS insulation of the Shipper, providing insulation from the exterior environment to the interior components and KIDNEYvault SherpaCool. The KIDNEYvault Shipper incorporates a peristaltic pump used to circulate the machine preservation solution through the kidney vascular system. The pump is a peristaltic pump that circulates chilled machine preservation solution (drawn from the Inner Canister) into the renal artery, through the kidney vasculature, and exiting back into the Inner Canister through the renal vein or ureter. The KIDNEYvault Shipper includes a datalogger (connected to a temperature probe and pressure sensor) which records and displays the temperature of the machine preservation solution surrounding the donor kidney and the perfusion pressure within the fluid pathway. 4) KIDNEYvault Cannula The cannula connects to the renal artery of the kidney and the fluid circuit of the KIDNEYvault. There are multiple sizes of round cannulas and oval cannulas for different kidney anatomies.

BAROguard™ 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 BAROguard™ 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 BAROguard™ by packaging lungs per institutional protocol and UNOS guidelines.

The subject BAROguard device results from modifications made to the cleared LUNGguard (previously named, SherpaPak Lung Preservation System) cleared under K192869. The subject BAROguard device consists of the following components: 1) BAROguard SherpaCool Pouches Phase Change Material (PCM) pouches (identical to the predicate) to maintain temperature of the cold preservation solution and lung throughout transportation. The BAROguard device maintains the temperature between 4°C to 8°C identical to the predicate with the use SherpaCool pouches throughout preservation and transportation. 2) BAROguard Lung Containment Assembly Nested lung containment bags for the packaging of donor lungs and preservation solution. BAROquard Lung Containment Assembly includes pneumatic connections to the donor lung in the inner-most bag, a pneumatic connection to the BAROguard Shipper Airway Pressure Management System, endotracheal connectors to connect the trachea of the donor lungs to the BAROguard Lung Containment Assembly, and tools for the secure attachment of the endotracheal connectors and closure of the BAROguard nested lung containment bags. 3) BAROquard Shipper- Outer transport shipper which comprises a protective and insulative package. The BAROguard Shipper is a rigid, molded expanded polystyrene (EPS) insulative container and into which the SherpaCool pouches and donor lung within the BAROguard Lung Containment Assembly are placed. The maintenance of temperature of the donor lung between 4°C to 8°C is assisted by the EPS insulation of the BAROguard Shipper, providing insulation from the exterior environment to the interior components and BAROguard SherpaCool. The BAROguard Shipper incorporates an Airway Pressure Management System. The Airway Pressure Management System maintains the donor lung airway pressure when connected to the BAROguard Lung Containment Assembly. The BAROquard Shipper includes an off-the-shelf datalogger (connected to a temperature probe and airway pressure sensor) which monitors and displays the temperature of the solution surrounding the donor lungs and the airway pressure of the donor lungs. Although the BAROguard is based on the predicate LUNGguard design, it also includes two new design elements: . Incorporation of a sterile Lung Containment Assembly instead of use of offthe-shelf bags in K192869. . Incorporation of an Airway Pressure Management System to maintain donor lung airway pressure during preservation and transportation.

The Paragonix SherpaPak™ Pediatric Liver Transport System is intended to be used for the static hypothermic preservation of pediatric donor livers or partial adult livers intended for pediatric recipients 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™ Pediatric 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 transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

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The SherpaPak™ Pancreas Transport System is intended to be used for the static hypothermic preservation of pancreas organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The SherpaPak™ Pancreas Transport System can maintain the donor organ storage temperature between 4º C and 8º C up to 21 hours.

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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.

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SherpaPak Cardiac Transport System: The SherpaPak Cardiac Transport System is intended to be used for the static hypothermic preservation 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. SherpaPak Kidney Transport System: The SherpaPak Kidney Transport System is intended to be used for the static hypothermic preservation of kidney organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The SherpaPak Kidney Transport System can maintain the donor organ storage temperature between 4 C and 8 C through 24 hours.

The SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System result from modifications made to the cleared Sherpa Pak Cardiac Transport System and Sherpa Pak Kidney Transport System most recently cleared under K133432 and K133694, respectively. The principle of operation of the modified devices is identical to that of the cleared devices, namely, cold static storage and transportation of donor hearts (Cardiac version) or donor kidneys (Kidney version), using cleared preservation solutions specific to the organ type being transported. Further, the modified designs have the same indications for use and utilize the same technology as the predicate devices. The subject SherpaPak design (cardiac and kidney) like its predecessor, consists of 1) outer transport shipper which contains within it various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell assembly (i.e. Sherpa Canister/Sherpa Shell) which provides a double, rigid barrier shipper in which the heart/kidney is immersed and suspended in a cold storage solution cleared for use in storing and transporting donor hearts/kidneys, and 3) a data logger that monitors and displays the temperature of the cold storage solution in which the heart/kidney is stored during transport.

The Sherpa Pak Kidney Transport System is intended to be used for the static hypothermic preservation of kidney organs during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with these organs. The Sherpa Pak Kidney Transport System can maintain the donor organ storage temperature between 4℃ and 8℃ through 24 hours.

The Paragonix Sherpa Pak Kidney Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor organs to recipients for transplantation. The Sherpa Pak System consists of 1) an shipper which contains various non-ice based outer temperature controlled packaging elements, 2) an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container in which the kidney is immersed and suspended in a Cold Storage Fluid cleared for use in storing and transporting donor organs and 3) a temperature display and timer to monitor temperature and elapsed time of transport, respectively. The device is identical to the cleared Sherpa Pak Kidney Transport System in all respects. The purpose for this change is to allow the Paragonix Sherpa Pak Kidney Transport System to be distributed with any FDA-cleared, commercially-available preservation solution, as a Convenience Kit.

The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation 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 Sherpa Pak 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.

The Paragonix Sherpa Pak Cardiac Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor hearts to recipients for transplantation. The Sherpa Pak System consists of 1) an outer shipper which contains various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container in which the heart is immersed and suspended in a Cold Storage Fluid cleared for use in storing and transporting donor organs and 3) a temperature display and timer to monitor temperature and elapsed time of transport, respectively. The device is identical to the cleared Sherpa Pak Cardiac Transport System in all respects.

The Sherpa Pak Kidney Transport System is intended to be used for the static hypothermic preservation of kidney organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The Sherpa Pak Kidney Transport System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours.

The Paragonix Sherpa Pak Kidney Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor kidney organs to recipients for transplantation. The Sherpa Pak Kidney Transport System consists of 1) an outer shipper which contains various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container in which the donor kidney is immersed and suspended in a Cold Storage Fluid cleared for use in storing and transporting donor organs and 3) a temperature display and timer to monitor temperature and elapsed time of transport, respectively. The device is identical to the cleared Sherpa Pak Cardiac Transport System with the exception of the indications for use specific to donor organs, and removal of a connector in the canister component.

The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation 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 Sherpa Pak 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.

The Paragonix Sherpa Pak Cardiac Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor hearts to recipients for transplantation. The Sherpa Pak System consists of 1) an outer shipper which contains various non-ice based temperature controlled packaging elements. 2) an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container in which the heart is immersed and suspended in a Cold Storage Fluid cleared for use in storing and transporting donor hearts and 3) a temperature display and timer to monitor temperature and elapsed time of transport. respectively. The changes made to the currently cleared device are labeling changes only. The device subject to this notification is identical to that cleared under K123326.