Search Results

Date Cleared

2014-11-25

(33 days)

Product Code

KDN,CLA

Regulation Number

Type

Special

Panel

Sherpa Pak Cardiac Transport System

Reference & Predicate Devices

K133694,K944866,K091245,K091656,K043461

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

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K Number

K143074

Device Name

Manufacturer

Date Cleared

2014-11-25

(29 days)

Product Code

MSB

Regulation Number

Type

Special

Panel

Reference & Predicate Devices

K133432,K991594,K032794

Intended Use

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.

Device Description

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.

AI/ML Overview

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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K Number

K133694

Device Name

SHERPA PAK TRANSPORTER

Manufacturer

Date Cleared

2014-05-23

(171 days)

Product Code

KDN

Regulation Number

Type

Traditional

Panel

SHERPA PAK CARDIAC TRANSPORT SYSTEM

Reference & Predicate Devices

K123326,K091245

Intended Use

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.

Device Description

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.

AI/ML Overview

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).

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K Number

K133432

Device Name

Manufacturer

Date Cleared

2014-02-21

(108 days)

Product Code

MSB

Regulation Number

Type

Traditional

Panel

SHERPA PAK CARDIAC TRANSPORT SYSTEM

Reference & Predicate Devices

K123326,K991594

Intended Use

The intended organ storage time for the Sherpa Pak Cardiac Transport System is up to 4 hours.

Device Description

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.

AI/ML Overview

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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K Number

K123326

Device Name

Manufacturer

Date Cleared

2013-02-06

(103 days)

Product Code

MSB

Regulation Number

Type

Traditional

Panel