(29 days)
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.
Here's an analysis of the provided text regarding the Paragonix Sherpa Pak Cardiac Transport System, focusing on acceptance criteria and the supporting study information:
It's important to note that this document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for a novel device with specific acceptance criteria in the same way a PMA (Premarket Approval) submission would.
Key takeaway from the document: The applicant is seeking to distribute the existing Sherpa Pak Cardiac Transport System (K133432) as a "Convenience Kit" with any FDA-cleared, commercially-available preservation solution. The core device itself (the transport system) has no design changes. Therefore, the document largely refers to the prior clearance (K133432) for performance data.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a Special 510(k) for a "Convenience Kit" that involves no design changes to the core device, the acceptance criteria are not presented in a classic statistical hypothesis testing format for a performance study. Instead, the "acceptance criteria" are implied by the demonstration that the modified device (the kit) performs identically to the predicate device in terms of temperature maintenance and organ protection, and that the combination with other cleared solutions is safe and effective.
| Acceptance Criteria (Implied) | Reported Device Performance (from prior clearance K133432, referenced by the current submission) |
|---|---|
| Maintain required temperature range for static hypothermic preservation of hearts. (Specific temperature range not stated, but implied to be appropriate for organ preservation). | "Thermal qualification demonstrated the ability of the Sherpa Pak Cardiac Transport System to maintain the required temperature through 12 hours." (Found in "Functional Testing" section on page 6). The intended organ storage time is stated as "up to 4 hours." The 12-hour thermal qualification exceeds the stated intended use storage time, providing a safety margin. |
| Provide a robust transport system to protect the donor organ during transport. | "Testing to demonstrate that the Sherpa Pak Cardiac Transport System provided a transport system robust enough to protect the donor organ during transport..." (Found in "Functional Testing" section on page 6). Details of "robustness" testing (e.g., shock, vibration) are not explicitly described in this summary but were presumably part of K133432. The device description mentions "an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container." |
| Biocompatibility of direct and indirect heart contact materials. | "Direct and indirect heart contact materials have been tested for biocompatibility." (Found in "Device Characteristic Comparison" table on page 7, under "Biocompatibility"). |
| Sterilization effectiveness for relevant components. | "Sherpa Pak, Sherpa Pak Shell, and Heart connector are sterilized by gamma irradiation." (Found in "Device Characteristic Comparison" table on page 7, under "Sterilization"). |
| Compatibility with FDA-cleared preservation solutions. | The entire premise of this Special 510(k) is to demonstrate that using the device with any FDA-cleared, commercially-available preservation solution (e.g., Celsior, Custodiol HTK) does not change its substantial equivalence, classifying it as a "Convenience Kit." The comparison tables show that these solutions are themselves cleared for organ storage and preservation. The core transport system, which maintains temperature and provides physical protection, is unchanged. Therefore, the combination is deemed safe and effective based on the prior clearance of its components. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a sample size for a new test set in this Special 510(k). The functional testing described ("Thermal qualification" and "robustness") refers to tests performed for the original K133432 clearance. The details of those tests, including sample sizes, are not provided in this summary.
- Data Provenance: Not explicitly stated as retrospective or prospective, nor does it mention a country of origin. This type of engineering bench testing is typically prospective, conducted in a lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable in the context of this device. The "ground truth" for this device's performance relates to physical parameters like temperature maintenance and structural integrity, which are established through engineering tests, not expert interpretation of medical images or clinical outcomes. Clinical efficacy would be evaluated in PAI (Premarket Approval Inspection) rather then 510K.
4. Adjudication Method for the Test Set
Not applicable. This device's performance is measured objectively against engineering specifications (e.g., temperature range, structural robustness), not requiring expert adjudication in the way medical image analysis or clinical endpoint determination might.
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 medical device for organ transport, not an AI-powered diagnostic or assistive technology involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the Sherpa Pak Cardiac Transport System is based on engineering specifications and physical measurements. This includes:
- Temperature measurements in controlled environments (thermal qualification).
- Mechanical testing (implied by "robustness" testing).
- Biocompatibility testing against established standards.
- Sterilization validation.
8. The sample size for the training set
Not applicable. This device does not utilize machine learning or AI, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for it.
§ 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).