(33 days)
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 provided document describes the Paragonix Sherpa Pak Kidney Transport System (K143054), which is a device for the static hypothermic preservation of kidney organs during transportation.
Based on the document, here's a breakdown of the acceptance criteria and the study that demonstrates the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain donor organ storage temperature between 4°C and 8°C through 24 hours. | "Thermal qualification demonstrated the ability of the Sherpa Pak Kidney Transport System to maintain the required temperature through 24 hours." (Page 6) |
| Provide a transport system robust enough to protect the donor organ during transport. | "Specifically, testing to demonstrate that the Sherpa Pak Kidney Transport System provided a transport system robust enough to protect the donor organ during transport... was included." (Page 6) |
| Meet design specifications, perform as intended, and be safe for its intended use. | "Descriptive information and laboratory bench testing were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use. Additional biocompatibility testing was not necessary as there were no material changes from the device cleared under K133694." (Page 6) |
| Biocompatibility for direct and indirect organ contact materials. | "Direct and indirect organ contact materials have been tested for biocompatibility." (Page 8) |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Descriptive information and laboratory bench testing were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use." (Page 6).
- Sample Size for Test Set: The exact sample size for the "laboratory bench testing" is not explicitly stated in the provided document. It refers generally to "testing".
- Data Provenance: The testing appears to be prospective bench testing conducted in a laboratory setting by the manufacturer, Paragonix Technologies, Inc. No information regarding country of origin of the data is provided, but the submission is to the US FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document describes bench testing, which typically does not involve human expert adjudication of results in the same way clinical studies do. The ground truth for temperature maintenance and robustness would be established directly through measurements and engineering assessments, not expert consensus on interpretations. Therefore, this question is not applicable in the context of the testing performed as described.
4. Adjudication Method for the Test Set:
Not applicable. The testing described (thermal qualification, robustness testing) uses objective measurements and engineering standards, not human adjudication of a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a kidney transport system and not an AI-powered diagnostic or interpretive device that would be used by human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for the acceptance criteria is based on objective physical measurements and engineering standards for temperature stability and physical robustness. For example, for temperature maintenance, the ground truth is simply whether the measured temperature stayed within 4°C and 8°C for 24 hours. For robustness, the ground truth would be determined by the intactness of the system and its ability to continue functioning after simulated transport conditions.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of its development and validation.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As explained above, this is a physical device, not an AI/machine learning system.
Key takeaway regarding the study:
The submission for K143054 is a "Special 510(k)" for a modification to the previously cleared Sherpa Pak Kidney Transport System (K133694). The primary change is to allow the system to be distributed as a "Convenience Kit" with any FDA-cleared preservation solution. The document explicitly states: "The design, indications for use, principles of operation, technological characteristics, and packaging of the Sherpa Pak Kidney Transport System are exactly the same as the previously cleared Sherpa Pak Kidney Transport System (K133694)... As a result, no further testing is required." (Page 11).
Therefore, the study proving the device meets the acceptance criteria was primarily done for the original K133694 device. For K143054, the claim is substantial equivalence based on no material change to the device itself and its components/functionality, meaning the prior testing's results are considered applicable. The current submission relies on the prior approval and the concept of a "Convenience Kit" not requiring new testing for the combination of already-cleared components.
§ 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).