(306 days)
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:
- 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.
- 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. - 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. - 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.
The provided document is a 510(k) summary for the Paragonix KIDNEYvault Portable Renal Perfusion System (K234060). It describes the device, its intended use, and its comparison to predicate and reference devices, as well as a summary of bench testing. However, it does not contain specific acceptance criteria, reported device performance metrics in relation to those criteria, or details of a study explicitly proving the device meets acceptance criteria in a quantifiable manner (e.g., sensitivity, specificity, accuracy for a diagnostic device).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (LifePort Perfusion Kidney Transporter, K021362) and reference devices (SherpaPak Kidney Transport System, K180194; KIDNEY ASSIST-transport, K211333) through a comparison of technological characteristics and a summary of bench testing. The bench testing verifies that the device meets specifications, but these specifications are not explicitly laid out as acceptance criteria with numerical performance targets in the context of a clinical study or performance evaluation in the provided text.
Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format requested. It discusses "specifications" met by various components during verification and validation, but these are not framed as quantifiable acceptance criteria with numerical results in a performance table.
The key performance claims related to the intended use are:
- Temperature Maintenance: "The Paragonix KIDNEYvault Portable Renal Perfusion System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours."
- Pulsatile Perfusion: The device provides "pulsatile hypothermic machine perfusion of kidneys."
The bench testing "demonstrates the ability of the KIDNEYvault device to maintain hypothermic preservation and pulsatile perfusion under varying environmental and transportation conditions of the donor kidney beyond the intended organ storage time of 24 hours." This is a general statement of meeting specifications rather than reporting specific performance metrics against defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document summarizes bench testing, not clinical studies with "test sets" in the context of diagnostic or interventional effectiveness. The provenance mentioned in the "Summary of Literature" is "relevant publications" from a "literature search" and does not refer to data provenance for a specific test set used in the device evaluation.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This information is typically relevant for diagnostic AI/ML device evaluations where expert consensus is used to establish ground truth for image interpretation or disease classification. This document describes a medical device for organ preservation and transport, which does not involve such a process.
4. Adjudication Method
Not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is relevant for diagnostic devices involving human readers. The KIDNEYvault is an organ preservation and transport system.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a mechanical system with integrated datalogger and pump, not a standalone algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI/ML or diagnostic devices (e.g., pathology, outcomes data) is not directly relevant here. The evaluation focuses on the mechanical and thermodynamic performance of the system. The "ground truth" for verifying its function would be measured physical parameters (temperature, pressure, flow) under controlled conditions and comparison against engineering specifications. The conclusion section mentions "verification/validated" and "supported by the reference devices," suggesting that physical and operational characteristics were assessed against predetermined engineering and functional requirements derived from predicate devices and standards.
8. Sample Size for the Training Set
Not applicable. The device is not an AI/ML or diagnostic algorithm that undergoes a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
In summary, the provided FDA 510(k) document is a summary for a mechanical device used in organ preservation and transportation. It focuses on demonstrating substantial equivalence through a comparison of technological characteristics and basic bench testing (biocompatibility, electrical safety, mechanical verification of components, and performance validation). It does not detail specific acceptance criteria or performance metrics in the way a diagnostic or AI/ML device submission would, nor does it refer to clinical studies with test sets, expert-driven ground truth, or MRMC studies.
§ 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).