(29 days)
The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart.
The intended organ storage time for the Sherpa Pak Cardiac Transport System is up to 4 hours.
Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.
The Paragonix Sherpa Pak Cardiac Transport System is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor hearts to recipients for transplantation. The Sherpa Pak System consists of 1) an outer shipper which contains various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container in which the heart is immersed and suspended in a Cold Storage Fluid cleared for use in storing and transporting donor organs and 3) a temperature display and timer to monitor temperature and elapsed time of transport, respectively. The device is identical to the cleared Sherpa Pak Cardiac Transport System in all respects.
Here's an analysis of the provided text regarding the Paragonix Sherpa Pak Cardiac Transport System, focusing on acceptance criteria and the supporting study information:
It's important to note that this document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for a novel device with specific acceptance criteria in the same way a PMA (Premarket Approval) submission would.
Key takeaway from the document: The applicant is seeking to distribute the existing Sherpa Pak Cardiac Transport System (K133432) as a "Convenience Kit" with any FDA-cleared, commercially-available preservation solution. The core device itself (the transport system) has no design changes. Therefore, the document largely refers to the prior clearance (K133432) for performance data.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a Special 510(k) for a "Convenience Kit" that involves no design changes to the core device, the acceptance criteria are not presented in a classic statistical hypothesis testing format for a performance study. Instead, the "acceptance criteria" are implied by the demonstration that the modified device (the kit) performs identically to the predicate device in terms of temperature maintenance and organ protection, and that the combination with other cleared solutions is safe and effective.
| Acceptance Criteria (Implied) | Reported Device Performance (from prior clearance K133432, referenced by the current submission) |
|---|---|
| Maintain required temperature range for static hypothermic preservation of hearts. (Specific temperature range not stated, but implied to be appropriate for organ preservation). | "Thermal qualification demonstrated the ability of the Sherpa Pak Cardiac Transport System to maintain the required temperature through 12 hours." (Found in "Functional Testing" section on page 6). The intended organ storage time is stated as "up to 4 hours." The 12-hour thermal qualification exceeds the stated intended use storage time, providing a safety margin. |
| Provide a robust transport system to protect the donor organ during transport. | "Testing to demonstrate that the Sherpa Pak Cardiac Transport System provided a transport system robust enough to protect the donor organ during transport..." (Found in "Functional Testing" section on page 6). Details of "robustness" testing (e.g., shock, vibration) are not explicitly described in this summary but were presumably part of K133432. The device description mentions "an inner and outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, rigid barrier container." |
| Biocompatibility of direct and indirect heart contact materials. | "Direct and indirect heart contact materials have been tested for biocompatibility." (Found in "Device Characteristic Comparison" table on page 7, under "Biocompatibility"). |
| Sterilization effectiveness for relevant components. | "Sherpa Pak, Sherpa Pak Shell, and Heart connector are sterilized by gamma irradiation." (Found in "Device Characteristic Comparison" table on page 7, under "Sterilization"). |
| Compatibility with FDA-cleared preservation solutions. | The entire premise of this Special 510(k) is to demonstrate that using the device with any FDA-cleared, commercially-available preservation solution (e.g., Celsior, Custodiol HTK) does not change its substantial equivalence, classifying it as a "Convenience Kit." The comparison tables show that these solutions are themselves cleared for organ storage and preservation. The core transport system, which maintains temperature and provides physical protection, is unchanged. Therefore, the combination is deemed safe and effective based on the prior clearance of its components. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a sample size for a new test set in this Special 510(k). The functional testing described ("Thermal qualification" and "robustness") refers to tests performed for the original K133432 clearance. The details of those tests, including sample sizes, are not provided in this summary.
- Data Provenance: Not explicitly stated as retrospective or prospective, nor does it mention a country of origin. This type of engineering bench testing is typically prospective, conducted in a lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable in the context of this device. The "ground truth" for this device's performance relates to physical parameters like temperature maintenance and structural integrity, which are established through engineering tests, not expert interpretation of medical images or clinical outcomes. Clinical efficacy would be evaluated in PAI (Premarket Approval Inspection) rather then 510K.
4. Adjudication Method for the Test Set
Not applicable. This device's performance is measured objectively against engineering specifications (e.g., temperature range, structural robustness), not requiring expert adjudication in the way medical image analysis or clinical endpoint determination might.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical device for organ transport, not an AI-powered diagnostic or assistive technology involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the Sherpa Pak Cardiac Transport System is based on engineering specifications and physical measurements. This includes:
- Temperature measurements in controlled environments (thermal qualification).
- Mechanical testing (implied by "robustness" testing).
- Biocompatibility testing against established standards.
- Sterilization validation.
8. The sample size for the training set
Not applicable. This device does not utilize machine learning or AI, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for it.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2014
Paragonix Technologies, Inc. % Mason Diamond Regulatory Consultant Texel Fortis, LLC 150 Levinberg Lane Wayne, NJ 07470
Re: K143074
Trade/Device Name: Sherpa Pak Cardiac Transport System Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion And Transport System And Accessories Regulatory Class: Class II Product Code: MSB. Dated: November 10, 2014 Received: November 13, 2014
Dear Mason Diamond.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
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found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin Fisher Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 7.0
Indications for Use Statement
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Indications for Use
510(k) Number (if known): K143074
Device Name: Paragonix Sherpa Pak Cardiac Transport System
Indications For 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."
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Section 8
510(k) Summary
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Paragonix Sherpa Pak Cardiac Transport System
Premarket Notification: Special 510(k)
510(k) Summary
Paragonix Sherpa Pak Cardiac Transport System Kit
| Submitter: | Paragonix Technologies, Inc.c/o Vaughn & Associates639 Granite StreetBraintree, MA 02184 |
|---|---|
| Contact Person: | Mason W. Diamond, DDSTexel Fortis, LLC150 Levinberg LaneWayne, NJ 07470Phone: 508-333-0108Fax: 973-305-0213masonwd@aol.com |
| Date Prepared: | October 24, 2014 |
| Trade Name: | Paragonix Sherpa Cardiac Kidney Transport System |
| Classification Name: | System and Accessories, Isolated Heart, Transport andPreservation |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | MSB |
| Predicate Devices: | Sherpa Pak Cardiac Transport System (ParagonixTechnologies, Inc) - K133432Celsior Cold Storage Solution (SangStat Medical Corp) -K991594Custodiol HTK (Dr Franz Köhler Chemie GmbH) – K032794 |
| Device Description: | The Paragonix Sherpa Pak Cardiac Transport System is adevice intended to provide a safe, consistent method for coldischemic storage and transport of donor hearts to recipientsfor transplantation. The Sherpa Pak System consists of 1) anouter shipper which contains various non-ice basedtemperature controlled packaging elements, 2) an inner andouter hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell)which provides a double, rigid barrier container in which theheart is immersed and suspended in a Cold Storage Fluidcleared for use in storing and transporting donor organs and3) a temperature display and timer to monitor temperatureand elapsed time of transport, respectively. The device isidentical to the cleared Sherpa Pak Cardiac Transport Systemin all respects. |
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| Submitter: | Paragonix Technologies, Inc. |
|---|---|
| Paragonix Sherpa Pak Cardiac Transport SystemPremarket Notification: Special 510(k) | |
| The purpose for this change it to allow the Paragonix SherpaPak Cardiac Transport System to be distributed with anyFDA-cleared, commercially-available preservation solution, asa Convenience Kit. | |
| Intended Use: | Organ storage and preservation for transplantation. |
| Indications for Use: | The Sherpa Pak Cardiac Transport System is intended to beused for the static hypothermic preservation of hearts duringtransportation and eventual transplantation into a recipientusing cold storage solutions indicated for use with the heart. |
| The intended organ storage time for the Sherpa Pak CardiacTransport System is up to 4 hours. | |
| Donor hearts exceeding clinically accepted static hypothermicpreservation times should be evaluated by the transplantsurgeon to determine transplantability in accordance withaccepted clinical guidelines and in the best medical interest ofthe intended recipient. | |
| Functional Testing: | Descriptive information and laboratory bench testing wereprovided to demonstrate the device meets its designspecifications, performs as intended, and is safe for itsintended use. |
| Specifically, testing to demonstrate that the Sherpa PakCardiac Transport System provided a transport system robustenough to protect the donor organ during transport andmaintained temperature throughout the duration of transportwas included. Thermal qualification demonstrated the abilityof the Sherpa Pak Cardiac Transport System to maintain therequired temperature through 12 hours. |
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Premarket Notification: Special 510(k)
Device Characteristic Comparison
| Characteristic | Proposed Sherpa Pak CardiacTransport System[Modification] | Sherpa Pak CardiacTransport System - K133432 | Celsior - K991594 | Custodiol HTK-K032794 |
|---|---|---|---|---|
| Intended Use | Organ storage and preservationfor transplantation. | Organ storage and preservationfor transplantation. | Organ storage and preservationfor transplantation. | Organ storage and preservationfor transplantation. |
| Indications forUse | "The Sherpa Pak CardiacTransport System is intendedto be used for the statichypothermic preservation ofhearts during transportationand eventual transplantationinto a recipient using coldstorage solutions indicated foruse with the heart.The intended organ storagetime for the Sherpa PakCardiac Transport System isup to 4 hours.Donor hearts exceedingclinically accepted statichypothermic preservation timesshould be evaluated by thetransplant surgeon todetermine transplantability inaccordance with acceptedclinical guidelines and in thebest medical interest of theintended recipient." | "The Sherpa Pak CardiacTransport System is intendedto be used for the statichypothermic preservation ofhearts during transportationand eventual transplantationinto a recipient using coldstorage solutions indicated foruse with the heart.The intended organ storagetime for the Sherpa PakCardiac Transport System isup to 4 hours.Donor hearts exceedingclinically accepted statichypothermic preservation timesshould be evaluated by thetransplant surgeon todetermine transplantability inaccordance with acceptedclinical guidelines and in thebest medical interest of theintended recipient." | "Celsior is intended for flushingand cold storage of a heart at thetime of its removal from a donorin preparation for storage,transportation, and eventualtransplantation into a recipient." | "Custodiol HTK Solution isindicated for perfusion andflushing donor kidneys, livers,and hearts prior to removal fromthe donor or immediately afterremoval from the donor. Thesolution is left in the organvasculature during hypothermicstorage and transportation (notfor continuous perfusion) to therecipient." |
| RegulationNumber | 878.5880 | 878.5880 | 878.5880 | 878.5880 |
| Product Code | MSB | MSB | MSB | MSB |
| DeviceClassificationName | Device Classification Name -System & Accessories, IsolatedHeart, Transport & Preservation | Device Classification Name -System & Accessories, IsolatedHeart, Transport & Preservation | Device Classification Name -System & Accessories, IsolatedHeart, Transport & Preservation | Device Classification Name -Isolated kidney perfusion andtransport system andaccessories |
| Mode ofOperation | Static cold ischemic storage | Static cold ischemic storage | Static cold ischemic storage | Static cold ischemic storage |
| Characteristic | Proposed Sherpa Pak CardiacTransport System[Modification] | Sherpa Pak CardiacTransport System - K133432 | Celsior - K991594 | Custodiol HTK-K032794 |
| Meets UNOSPolicy 51 | Yes | Yes | Yes | Yes |
| Organ container | Two rigid airtight containers oneof which contains the coldstorage solution in which theheart is immersed. | Two rigid airtight containers oneof which contains the coldstorage solution in which theheart is immersed. | None. Solution is used by organprocurement centers but requiresan organ container such as thatused in the proposed SherpaPak Transporter System or theAvid custom procedure tray tub. | None. Solution is used by organprocurement centers but requiresan organ container such as thatused in the proposed SherpaPak Transporter System or theAvid custom procedure tray tub. |
| Cooling | Temperature preconditionedstorage solution andtemperature controlledpackaging includingpreconditioned phase changematerial cold packs, PIRinsulating panels, andExpandable Polystyrene panels | Temperature preconditionedstorage solution andtemperature controlledpackaging includingpreconditioned phase changematerial cold packs, PIRinsulating panels, andExpandable Polystyrene panels | Temperature preconditioned.Relies on transport system fortype of cooling and maintenanceof temperature. | Temperature preconditioned.Relies on transport system fortype of cooling and maintenanceof temperature. |
| Systemcomponents | Image: System componentsOuter plastic corrugated container (top and base with wheels) | Image: System componentsOuter plastic corrugated container (top and base with wheels) | Plastic bag with cold storagesolution to be used incombination with some type oforgan transport container (e.g.,such as the Avid customprocedure kit and off-the-shelfcooler). | Plastic bag with cold storagesolution to be used incombination with some type oforgan transport container (e.g.,such as the Avid customprocedure kit and off-the-shelfcooler). |
| Characteristic | Proposed Sherpa Pak CardiacTransport System[Modification] | Sherpa Pak CardiacTransport System - K133432 | Celsior - K991594 | Custodiol HTK–K032794 |
| PCM Cold Pack Panels EPS panels Sherpa Pak and Sherpa Pak Shell without connector Temperature data logger Timer Plastic bags with cold storage solution to be used in combination with the Sherpa Pak Kidney Transporter System [supplied in a separate package]. | PCM Cold Pack Panels EPS panels Sherpa Pak and Sherpa Pak Shell without connector Temperature data logger Timer | |||
| SingleUse/Reuse | Entire system is single use/patient only. | Entire system is single use/patient only. | Single use/patient only. | Single use/patient only. |
| Sterilization | Sherpa Pak, Sherpa Pak Shell, and Heart connector are sterilized by gamma irradiation. All other components are non-sterile. | Sherpa Pak, Sherpa Pak Shell, and Heart connector are sterilized by gamma irradiation. All other components are non-sterile. | Sterilized. | Sterilized. |
| Biocompatibility | Direct and indirect heart contact materials have been tested for biocompatibility. | Direct and indirect heart contact materials have been tested for biocompatibility. | Yes. | Yes. |
| Intendedstorage time | Up to 4 hours (clinical standard is 4-6 hours) | Up to 4 hours (clinical standard is 4-6 hours) | No time within indication statement | No time within indication statement |
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Submitter:
Paragonix Technologies, Inc.
Paragonix Sherpa Pak Cardiac Transport System
Premarket Notification: Special 510(k)
1 http://www.optn.transplant.hrsa.gov
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Submitter:
Paragonix Technologies, Inc.
Paragonix Sherpa Pak Cardiac Transport System
Premarket Notification: Special 510(k)
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Paragonix Sherpa Pak Cardiac Transport
Submitter: System Paragonix Technologies, Inc. 510(k)
Premarket Notification: Special
Summary of Design
Changes:
The design, indications for use, principles of operation, technological characteristics, and packaging of the Sherpa Pak Cardiac Transport System are exactly the same as the previously cleared Sherpa Pak Cardiac Transport System (K133432). Sherpa Pak Cardiac Transport System is intended to be used with any preservation solution that is cleared by the FDA for use with hearts, and, therefore, the combined kitting of the Paragonix Sherpa Pak Cardiac Transport System and any FDA-Cleared preservation solution (i.e., Celsior, Custodiol HTK, etc.) falls within the current scope of use for the aforementioned devices. The purpose for this change is to allow the Paragonix Sherpa Pak Cardiac Transport System to be distributed with any FDA-cleared, commercially-available donor heart cold storage preservation solution, as a Convenience Kit. According to the FDA "Convenience Kits Interim Regulatory Guidance" (May 20, 1997), the Sherpa Pak Cardiac Transport System falls within the definition of a Convenience Kit. As a result, no further testing is required.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).