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510(k) Data Aggregation
(29 days)
Sherpa Pak Cardiac Transport System
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.
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(108 days)
SHERPA PAK CARDIAC TRANSPORT SYSTEM
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.
The provided document is a 510(k) premarket notification for a medical device called the "Paragonix Sherpa Pak Cardiac Transport System." It describes a device intended for the cold ischemic storage and transport of donor hearts.
The key finding from the document is that the submission is for a labeling change only. The device itself has not changed and is identical to a previously cleared device (K123326). Therefore, the substantial equivalence determination is based on the prior clearance and the fact that the labeling change does not alter the device's intended use or technological characteristics.
This means the current document does not contain a new study proving the device meets new acceptance criteria, as the device itself hasn't changed. The original device's performance data and acceptance criteria would be in the K123326 submission, which is not provided here.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
Since this is a labeling change and the device is identical to the cleared predicate (K123326), no new acceptance criteria or performance data are presented in this document. The document states:
- "The device subject to this notification is identical to that cleared under K123326." {1}
- "The testing performed in support of the original 510(k) continues to be supportive of the modified device." {1}
- "The design, intended use, principles of operation, and technological characteristics of the Sherpa Pak Cardiac Transport System are substantially equivalent to the previously cleared Sherpa Pak Cardiac Transport System. The labeling change does not alter the device's intended use. There were no changes to the device itself and it is identical to the device cleared under K123326." {1}
The stated "Intended Use" and "Indications for Use" from the document are:
| Acceptance Criteria (from "Indications for Use") | Reported Device Performance (from "Functional Testing" and "Summary of Substantial Equivalence") |
|---|---|
| Intended Use: Organ storage and preservation for transplantation. | Met by substantial equivalence to K123326. Device design, intended use, principles of operation, and technological characteristics are identical. |
| Indications for Use: |
- Static hypothermic preservation of hearts during transportation and eventual transplantation.
- Use with cold storage solutions indicated for the heart.
- Intended organ storage time: up to 4 hours.
- Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon. | Met by substantial equivalence to K123326. The device did not change, only the labeling. The original testing for K123326 supports these indications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this submission. This 510(k) is for a labeling change, not a new performance study. The document explicitly states: "Functional Testing: The premarket notification was submitted for a labeling change to the device. The device did not change in any respect otherwise. The testing performed in support of the original 510(k) continues to be supportive of the modified device." {1}
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As noted above, no new performance study was conducted for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new performance study was conducted.
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 physical transport system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical transport system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new performance study was conducted. Performance for the device would likely be assessed through engineering testing (e.g., temperature stability, integrity) and potentially clinical outcomes data from the original K123326 submission, but this information is not in the provided document.
8. The sample size for the training set
Not applicable. This device is a physical transport system and does not involve AI or machine learning that would require a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is relevant for this type of device.
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(103 days)
SHERPA PAK CARDIAC TRANSPORT SYSTEM
The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts, up to 4 hours, during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart.
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.
Here's a breakdown of the acceptance criteria and study information for the Paragonix Sherpa Pak Cardiac Transport System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" for the device's performance in a table format. Instead, it describes general design specifications and functional testing outcomes.
| Characteristic | Acceptance Criteria (Implied / Desired Outcome) | Reported Device Performance |
|---|---|---|
| Protection during Transport (Robustness) | Device should be robust enough to protect the heart during transport. | Testing demonstrated the Sherpa Pak System provided a transport system robust enough to protect the heart during transport. |
| Temperature Maintenance | Device should maintain temperature throughout the duration of transport. | Testing demonstrated the Sherpa Pak System maintained temperature throughout the duration of transport. |
| Biocompatibility | Direct and indirect heart contact materials must be biocompatible (non-toxic, non-sensitizing, etc.). | Biocompatibility testing including cytotoxicity, systemic toxicity, genotoxicity, sensitization, and intracutaneous testing was performed. Direct and indirect heart contact materials have been tested for biocompatibility. (Implied: results were acceptable, as the device was cleared). |
| Intended Use Period | Static hypothermic preservation of hearts up to 4 hours. | The Sherpa Pak Cardiac Transport System is intended to be used for static hypothermic preservation of hearts, up to 4 hours. The marketing clearance implies that the device demonstrated it can achieve this. |
| UNOS Policy 5 Compliance | Conformity to UNOS Policy 5 for organ storage and preservation. | The device's "Meets UNOS Policy 5" characteristic is listed as "Yes" in the comparison table. |
| Sterilization | Specific components (Sherpa Pak, Sherpa Pak Shell, Heart connector) should be sterilized. Other parts non-sterile. | Sherpa Pak, Sherpa Pak Shell, and Heart connector are sterilized by gamma irradiation. All other components are non-sterile. (This is a design characteristic that was met, rather than a performance outcome in the same way as temperature). |
| Single Use/Reuse | Entire system is single use/patient only. | The entire system is single use/patient only. (This is a design characteristic that was met, rather than a performance outcome in the same way as temperature). |
| Overall Performance | Performs as intended and is safe for its intended use, substantially equivalent to predicate devices. | The testing conducted demonstrated 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 heart at a clinically acceptable temperature range to a recipient for transplantation. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Descriptive information, laboratory bench testing, and biocompatibility testing were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use."
- Sample Size: The document does not specify any sample sizes for the functional or biocompatibility testing conducted. It refers to "testing" generically.
- Data Provenance: The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned. The testing described appears to be internal lab testing rather than clinical study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: This information is not provided. The "ground truth" for this device's performance primarily relates to objective physical parameters (temperature stability, structural integrity, biocompatibility) rather than expert interpretation of images or clinical outcomes.
- Qualifications of Experts: This information is not provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: This information is not provided. Given the nature of the tests (bench testing, biocompatibility), there is no indication of an adjudication process typically associated with subjective assessments or clinical outcomes.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or mentioned. This type of study is typically relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a transport system, not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
- Yes, a standalone performance study was done in the sense that the "Functional Testing" described ("testing to demonstrate that the Sherpa Pak System provided a transport system robust enough to protect the heart during transport and maintained temperature throughout the duration of transport") and "biocompatibility testing" were evaluations of the device itself, independent of human interaction during the test. There is no "algorithm" in the conventional AI sense for this device.
7. Type of Ground Truth Used:
The ground truth used was based on objective measurements and laboratory standards:
- Functional Testing: Measuring whether the device maintained temperature, its structural integrity under stress (robustness), and protection of the "heart" (simulated or actual, not specified but likely simulated for bench testing).
- Biocompatibility Testing: Adherence to established standards for cytotoxicity, systemic toxicity, genotoxicity, sensitization, and intracutaneous reactivity.
- UNOS Policy 5: Assessed against a defined policy standard.
8. Sample Size for the Training Set:
This device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established:
As there is no AI/machine learning algorithm with a training set for this device, how ground truth for a training set was established is not applicable.
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