Search Results

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:

1. 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.
2. 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.
3. 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.
4. 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.

Ask a specific question about this device

BAROguard™ is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs.

The intended organ storage time for BAROguard™ is up to 8 hours.

Donor lungs 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.

Note: Partial lungs can be transported via BAROguard™ by packaging lungs per institutional protocol and UNOS guidelines.

The subject BAROguard device results from modifications made to the cleared LUNGguard (previously named, SherpaPak Lung Preservation System) cleared under K192869. The subject BAROguard device consists of the following components:

1. BAROguard SherpaCool Pouches Phase Change Material (PCM) pouches (identical to the predicate) to maintain temperature of the cold preservation solution and lung throughout transportation. The BAROguard device maintains the temperature between 4°C to 8°C identical to the predicate with the use SherpaCool pouches throughout preservation and transportation.
2. BAROguard Lung Containment Assembly Nested lung containment bags for the packaging of donor lungs and preservation solution. BAROquard Lung Containment Assembly includes pneumatic connections to the donor lung in the inner-most bag, a pneumatic connection to the BAROguard Shipper Airway Pressure Management System, endotracheal connectors to connect the trachea of the donor lungs to the BAROguard Lung Containment Assembly, and tools for the secure attachment of the endotracheal connectors and closure of the BAROguard nested lung containment bags.
3. BAROquard Shipper- Outer transport shipper which comprises a protective and insulative package. The BAROguard Shipper is a rigid, molded expanded polystyrene (EPS) insulative container and into which the SherpaCool pouches and donor lung within the BAROguard Lung Containment Assembly are placed. The maintenance of temperature of the donor lung between 4°C to 8°C is assisted by the EPS insulation of the BAROguard Shipper, providing insulation from the exterior environment to the interior components and BAROguard SherpaCool.

The BAROguard Shipper incorporates an Airway Pressure Management System. The Airway Pressure Management System maintains the donor lung airway pressure when connected to the BAROguard Lung Containment Assembly.

The BAROquard Shipper includes an off-the-shelf datalogger (connected to a temperature probe and airway pressure sensor) which monitors and displays the temperature of the solution surrounding the donor lungs and the airway pressure of the donor lungs.

Although the BAROguard is based on the predicate LUNGguard design, it also includes two new design elements:
. Incorporation of a sterile Lung Containment Assembly instead of use of offthe-shelf bags in K192869.
. Incorporation of an Airway Pressure Management System to maintain donor lung airway pressure during preservation and transportation.

The provided text describes the BAROguard device, intended for static hypothermic preservation of lungs during transportation for transplantation. The acceptance criteria and supporting studies are detailed, particularly in comparison to a predicate device (Paragonix LUNGguard, K192869) and a reference device (Auto CPAP System, K211155).

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes various bench testing and validation studies for the device's components and overall function (biocompatibility, electrical safety, thermal/airway pressure, shipper durability, component verification, sterile packaging, filter validation).

• Sample sizes for these tests are not explicitly stated in the provided text. For example, while it mentions "Validation demonstrates the ability of the BAROguard device," it doesn't quantify how many devices or trials were part of that validation.
• Data provenance: The studies are described as functional testing and verification/validation studies, implying laboratory or engineering testing. There is no mention of human clinical data, animal studies, country of origin of data, or whether it was retrospective or prospective. The testing focuses on the physical and functional characteristics of the device itself.

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)

This information is not provided in the document. The studies are described as engineering-focused verification and validation, not clinical trials requiring expert consensus on ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. As the testing focuses on objective functional performance rather than subjective interpretation, an adjudication method, as typically used in clinical studies with human assessors, would not apply here.

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

There is no mention of an MRMC comparative effectiveness study in the provided text. The device is for organ preservation and transport, not for interpretation or diagnosis by human "readers" or involving AI assistance in that context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to the BAROguard device, as it is a medical device for organ preservation and transport, not an algorithm, or AI diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance criteria appears to be based on established engineering specifications, recognized international standards (e.g., ISO, IEC), and clinical guidelines related to organ preservation (e.g., maintaining specific temperature and pressure ranges, sterility, biocompatibility). For example, temperature maintenance is verified against the 4°C to 8°C range; airway pressure is verified against 12-15 cmH2O. These are objective, measurable parameters rather than subjective interpretations or clinical outcomes in the traditional sense of a diagnostic device.

8. The sample size for the training set

This question is not applicable. The BAROguard device is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This question is not applicable for the same reason as above.

Ask a specific question about this device

The Paragonix SherpaPak™ Pediatric Liver Transport System is intended to be used for the static hypothermic preservation of pediatric donor livers or partial adult livers intended for pediatric recipients during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the livers. The intended organ storage time for the Paragonix SherpaPak™ Pediatric Liver Transport System is up to 15 hours.

Donor livers 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.

Not Found

This document is a 510(k) premarket notification for the Paragonix SherpaPak Pediatric Liver Transport System. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, as it is a notice of substantial equivalence rather than a detailed performance study report.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Ask a specific question about this device

The SherpaPak™ Pancreas Transport System is intended to be used for the static hypothermic preservation of pancreas organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The SherpaPak™ Pancreas Transport System can maintain the donor organ storage temperature between 4º C and 8º C up to 21 hours.

Not Found

This looks like a 510(k) clearance letter for the Paragonix SherpaPak Pancreas Transport System. As such, the information you've requested about acceptance criteria and study details (like sample size, number of experts, ground truth, etc.) is typically not found directly within the clearance letter itself.

A 510(k) clearance is about demonstrating substantial equivalence to a predicate device, not necessarily extensive clinical performance studies like those required for a PMA (Premarket Approval). The FDA reviews the provided data (which might include bench testing, engineering reports, and sometimes limited clinical data or literature reviews) to determine if the new device is as safe and effective as a legally marketed predicate device.

Therefore, based solely on the provided text, I cannot extract the specific details you've asked for. The document primarily outlines the FDA's regulatory decision and standard disclaimers.

However, I can tell you the stated "Indications for Use" which implicitly sets the performance envelope for the device:

• Intended Use: Static hypothermic preservation of pancreas organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ.
• Performance Claim: The SherpaPak™ Pancreas Transport System can maintain the donor organ storage temperature between 4º C and 8º C up to 21 hours.

To get the detailed information you're looking for (acceptance criteria, study design, sample sizes, ground truth establishment, etc.), you would typically need to refer to:

• The original 510(k) submission document: This is a comprehensive package submitted by the manufacturer to the FDA. It contains all the bench testing, performance data, and other information used to support the substantial equivalence claim. This is usually not publicly available in full detail.
• Any associated clinical trial publications: If the manufacturer performed any studies (even limited ones for 510(k), or more extensive ones for other regulatory purposes or marketing), they might be published in scientific journals.
• The manufacturer's official documentation: User manuals, technical specifications, and marketing materials might provide some of this performance data.

In summary, the provided FDA letter does not contain the detailed study information you're seeking. It confirms the clearance of the device and its intended use and a key performance parameter (temperature range and duration).

Ask a specific question about this device

The SherpaPak Cardiac Transport System is intended to be used for the station 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 SherpaPak 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.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the SherpaPak Cardiac Transport System. It indicates that the device has been found substantially equivalent to predicate devices for its intended use. However, the document does not contain any information about acceptance criteria for device performance, nor does it describe any study demonstrating that the device meets such criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance using the provided input. The document focuses on regulatory clearance based on substantial equivalence, not on detailed performance metrics or clinical trial results.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (which may be part of a 510(k) submission but is not included in this clearance letter), a clinical study report, or a descriptive document of the device's validation.

Ask a specific question about this device

SherpaPak Cardiac Transport System: The SherpaPak 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 SherpaPak 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.

SherpaPak Kidney Transport System: The SherpaPak 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 SherpaPak Kidney Transport System can maintain the donor organ storage temperature between 4 C and 8 C through 24 hours.

The SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System result from modifications made to the cleared Sherpa Pak Cardiac Transport System and Sherpa Pak Kidney Transport System most recently cleared under K133432 and K133694, respectively. The principle of operation of the modified devices is identical to that of the cleared devices, namely, cold static storage and transportation of donor hearts (Cardiac version) or donor kidneys (Kidney version), using cleared preservation solutions specific to the organ type being transported. Further, the modified designs have the same indications for use and utilize the same technology as the predicate devices.

The subject SherpaPak design (cardiac and kidney) like its predecessor, consists of 1) outer transport shipper which contains within it various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell assembly (i.e. Sherpa Canister/Sherpa Shell) which provides a double, rigid barrier shipper in which the heart/kidney is immersed and suspended in a cold storage solution cleared for use in storing and transporting donor hearts/kidneys, and 3) a data logger that monitors and displays the temperature of the cold storage solution in which the heart/kidney is stored during transport.

The provided document (K180194 510(k) Summary for SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System) does not pertain to an AI/ML medical device. It describes a medical device designed for the static hypothermic preservation and transport of donor hearts and kidneys.

Therefore, the document does not contain any information regarding:

• Acceptance criteria for an AI/ML device.
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for AI/ML test sets or training sets.
• Data provenance for AI/ML models.
• Number of experts or their qualifications for establishing ground truth for AI/ML models.
• Adjudication methods for AI/ML test sets.
• MRMC comparative effectiveness studies for AI/ML.
• Standalone performance of an AI/ML algorithm.
• Types of ground truth for AI/ML models.
• How ground truth for AI/ML training sets was established.

The document focuses on the functional testing performed on the modified SherpaPak systems to demonstrate their equivalence to predicate devices, including:

• Biocompatibility testing of new materials.
• Electrical Safety and EMC testing.
• Transportation testing (ASTM D4169-09).
• Thermal qualification to maintain specified temperature ranges (4°C - 8°C for up to 4 hours for cardiac, and 24 hours for kidney).
• Helium leak testing for seal integrity.

The "acceptance criteria" and "device performance" in this context are related to the physical and functional aspects of the transport system, particularly its ability to maintain organ temperature during transport and ensure sterility, rather than an AI/ML model's diagnostic or predictive performance.

The thermal qualification section implicitly describes a key performance characteristic and implied acceptance criteria:

• Acceptance Criteria (Implied from Thermal Qualification): Maintain donor organ storage temperature between 4°C and 8°C for:
  • Cardiac Transport System: up to 4 hours
  • Kidney Transport System: up to 24 hours (as stated in the Indications for Use and the predicate device description)
• Reported Device Performance: "This test was performed to demonstrate the system could meet this specification." (This implies successful demonstration, but quantitative results are not explicitly provided in the summary, only the duration the system "can maintain" the temperature in comparison to the predicate). The "Storage Temperature Duration" characteristic in the comparison table states that the Modified SherpaPak Cardiac/Kidney Transport System "Device can maintain 4°C to 8°C through 44 hours," which exceeds the 24-hour requirement for kidneys and 4-hour requirement for hearts, and also exceeds the predicate's 36-hour duration.

Since the request specifically asks for information relevant to an AI/ML device, and this document describes a physical transport system, I cannot fulfill the request as phrased based on the provided text.

Ask a specific question about this device

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:

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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

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).

Ask a specific question about this device

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:

• 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.

Ask a specific question about this device