(171 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 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.
Acceptance Criteria and Device Performance for Paragonix Sherpa Pak Kidney Transport System
Here's a breakdown of the acceptance criteria and the study details for the Paragonix Sherpa Pak Kidney Transport System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Characteristic | K133694 Acceptance Criteria (Indications for Use) | Reported Device Performance (Functional Testing/Substantial Equivalence) |
|---|---|---|
| Intended Use | Organ storage and preservation for transplantation. | "The design, intended use, principles of operation, and technological characteristics of the Sherpa Pak Kidney Transport System are substantially equivalent to the previously cleared Sherpa Pak Cardiac Transport System (K123326). The intended use of the subject device is the same as all the cited predicates..." "testing conducted to demonstrate that the subject device performs as intended and is substantially equivalent to the predicate devices in terms of its ability to safely store and transport a donor organ at a clinically acceptable temperature range to a recipient for transplantation." |
| Storage Temperature | Maintain donor organ storage temperature between 4°C and 8°C. | "Specifically, testing to demonstrate that the Sherpa Pak Kidney Transport System provides a transport system robust enough to protect the donor organ during transport and maintain temperature throughout the duration of transport..." "Device can maintain 4° C to 8° C through 24 hours" (stated in the "Intended storage time" table, implying it meets this in testing). |
| Storage Duration | Through 24 hours. | "Device can maintain 4° C to 8° C through 24 hours" (stated in the "Intended storage time" table, implying it meets this in testing). |
| Organ Type | Kidney organs. | "The Sherpa Pak Kidney Transport System is intended to be used for the static hypothermic preservation of kidney organs..." This is part of the device's specific indication, thus the device is designed and tested for this. |
| Preservation Method | Static hypothermic preservation. | "The Sherpa Pak Kidney Transport System is intended to be used for the static hypothermic preservation..." "Mode of Operation: Static cold ischemic storage." |
| Safety and Performance | Safe, consistent method for cold ischemic storage and transport of donor kidney organs. No explicit criteria, but expected. | "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 K123326." "Substantial equivalence is based upon descriptive characteristics of the various cited predicate devices and upon the testing conducted to demonstrate that the subject device performs as intended and is substantially equivalent to the predicate devices in terms of its ability to safely store and transport a donor organ at a clinically acceptable temperature range to a recipient for transplantation." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a "test set" in the context of clinical data for algorithmic performance. The testing described is laboratory bench testing and refers to a "descriptive information and laboratory bench testing" approach to demonstrate the device meets design specifications and perform as intended.
There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a test set, as clinical data for performance assessment (e.g., organ viability post-transport) is not described as being part of the submission for determining substantial equivalence regarding its temperature maintenance capabilities. The focus is on the physical and functional characteristics of the transport system itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a medical device for organ transport, not an AI/diagnostic software. No "ground truth" established by experts in the context of diagnostic accuracy is mentioned.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method for a test set, as the testing described focuses on bench-top performance of the device's physical functions.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance. It describes a medical device for organ transport.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for organ transport, not an algorithm.
7. The type of ground truth used
The "ground truth" can be inferred from the stated performance goals:
- Temperature Maintenance: The ability to consistently maintain the temperature of a simulated/actual organ (or the internal environment of the device) between 4°C and 8°C for 24 hours. The ground truth would be the actual measured temperature by calibrated sensors.
- Physical Protection/Robustness: The ability to protect the donor organ during transport. The ground truth would be the structural integrity of the device and its contents after simulated transport conditions.
- Biocompatibility: The materials being non-toxic and compatible with the organ. The ground truth would rely on established biocompatibility testing standards and results from a predicate device.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI model.
Summary of the Study that Proves Acceptance Criteria:
The key study information provided is:
- Type of Study: Descriptive information and laboratory bench testing.
- Purpose: To demonstrate that the device meets its design specifications, performs as intended, and is safe for its intended use.
- Specific Tests: Testing was conducted to demonstrate the system's robustness to protect the donor organ during transport and its ability to maintain the specified temperature range (4°C to 8°C) for the duration of transport (24 hours).
- Biocompatibility: No new biocompatibility testing was deemed necessary because there were no material changes from the previously cleared Sherpa Pak Cardiac Transport System (K123326), implying the previous device's biocompatibility data was leveraged.
- Basis for Equivalence: Substantial equivalence was based on these descriptive characteristics and testing, comparing the Sherpa Pak Kidney Transport System to its predicate, the Sherpa Pak Cardiac Transport System (K123326), as well as other predicate devices for context (Avid Medical Custom Procedure Tray and CoStorSol Cold Storage Solution).
§ 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).