(33 days)
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:
| 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.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. 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: K143054
Trade/Device Name: Sherpa Pak Kidney Transport System Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion And Transport System And Accessories Regulatory Class: Class II Product Code: KDN. PIN Dated: November 7, 2014 Received: November 10, 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
{1}------------------------------------------------
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,
Benjamin R. Fisher -A
Benjamin Fisher Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Section 7.0
Indications for Use Statement
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K143054
Device Name: Paragonix Sherpa Pak Kidney Transport System
Indications For 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."
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
{4}------------------------------------------------
Section 8
510(k) Summary
{5}------------------------------------------------
Premarket Notification: Special 510(k)
510(k) Summary
Paragonix Sherpa Pak Transport System Kit
K143054
- Submitter: Paragonix Technologies, Inc. c/o Vaughn & Associates 639 Granite Street Braintree, MA 02184 Contact Person: Mason W. Diamond, DDS Texel Fortis. LLC 150 Levinberg Lane Wayne, NJ 07470 Phone: 508-333-0108 Fax: 973-305-0213 masonwd@aol.com Date Prepared: November 7, 2014 Trade Name: Paragonix Sherpa Pak Kidney Transport System Classification Name: Isolated kidney perfusion and transport system and accessories Regulation Number: 21 CFR 876.5880 Product Codes: Classification - KDN Subsequent - PIN Sherpa Pak Kidney Transport System (Paragonix Predicate Devices: Technologies, Inc) - K133694 Belzer UW Cold Storage Solution (DuPont Merk Pharmaceutical Company) - K944866 CoStorSol (Preservation Solutions Inc) - K091245 SPS-1 (Organ Recovery Systems, Inc) - K091656 Custodiol HTK Solution (Dr Franz Köhler Chemie GmbH) -K043461 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
{6}------------------------------------------------
| Submitter:Paragonix Technologies, Inc. | Paragonix Sherpa Pak Kidney Transport SystemPremarket Notification: Special 510(k) | |||
|---|---|---|---|---|
| and elapsed time of transport, respectively. The device isidentical to the cleared Sherpa Pak Kidney Transport Systemin all respects. | ||||
| The purpose for this change is to allow the Paragonix SherpaPak Kidney Transport System to be distributed with any FDA-cleared, commercially-available preservation solution, as aConvenience Kit. | ||||
| Intended Use: | Organ storage and preservation for transplantation. | |||
| Indications for Use: | The Sherpa Pak Kidney Transport System is intended to beused for the static hypothermic preservation of kidney organsduring transportation and eventual transplantation into arecipient, using cold storage solutions indicated for use withthese organs. | |||
| The Sherpa Pak Kidney Transport System can maintain thedonor organ storage temperature between 4℃ and 8℃through 24 hours. | ||||
| 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. Additional biocompatibility testing was notnecessary as there were no material changes from the devicecleared under K133694. | |||
| Specifically, testing to demonstrate that the Sherpa PakKidney 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 Kidney Transport System to maintain therequired temperature through 24 hours. |
{7}------------------------------------------------
Premarket Notification: Special 510(k)
Device Characteristic Comparison
| Characteristic | Proposed Sherpa PakKidney TransportSystemK143054 | Sherpa Pak KidneyTransport System -K133694 | BelzerUW ColdStorageSolution -K944866 | CoStorSol ColdStorageSolutionK091245 | SPS-1 -K091656 | CustodiolHTKSolution -K043461 |
|---|---|---|---|---|---|---|
| Intended Use | Organ storage andpreservation fortransplantation. | Organ storage andpreservation fortransplantation. | Organ storage andpreservation fortransplantation. | Organ storage andpreservation fortransplantation. | Organ storage andpreservation fortransplantation. | Organ storage andpreservation fortransplantation. |
| Indications forUse | "The Sherpa PakKidney Transport isintended to be used forthe static hypothermicpreservation of kidneyorgans duringtransportation andeventualtransplantation into arecipient, using coldstorage solutionsindicated for use withthese organs.The Sherpa Pak KidneyTransport can maintainthe donor organstorage temperaturebetween 4°C and 8°Cthrough 24 hours." | "The Sherpa PakKidney Transport isintended to be used forthe static hypothermicpreservation of kidneyorgans duringtransportation andeventualtransplantation into arecipient, using coldstorage solutionsindicated for use withthese organs.The Sherpa Pak KidneyTransport can maintainthe donor organstorage temperaturebetween 4°C and 8°Cthrough 24 hours." | "Belzer UW Cold StorageSolution is intended forthe flushing and coldstorage of kidney, liverand pancreas organs atthe time of organ removalfrom the donor inpreparation for storage,transportation andeventual transplantationinto a recipient." | "CoStorSol® is intendedfor the flushing and coldstorage of kidney, liverand pancreas organs atthe time of organremoval from the donorin preparation forstorage, transportationand eventualtransplantation into arecipient." | "SPS-1 is intended for theflushing and cold storageof kidney, liver andpancreas organs at thetime of organ removal fromthe donor in preparation forstorage, transportation andeventual transplantationinto a recipient." | "Custodiol HTK Solution isindicated for perfusion andflushing donor kidneys, liver,pancreas and heart prior toremoval from the donor orimmediately after removalfrom the donor. The solutionis left in the organvasculature duringhypothermic storage andeventual transplantation (notfor continuous perfusion) tothe recipient." |
| RegulationNumber | 878.5880 | 878.5880 | 878.5880 | 878.5880 | 878.5880 | 878.5880 |
| Product Code | KDN and PIN | KDN | KDL | KDN | KDN | KDL and MSB |
| DeviceClassificationName | Device ClassificationName - Isolated kidneyperfusion and transportsystem and accessories | Device ClassificationName - Isolated kidneyperfusion and transportsystem and accessories | Device ClassificationName - Set, perfusion,kidney, disposable | Device ClassificationName - Isolated kidneyperfusion and transportsystem and accessories | Device ClassificationName - Isolated kidneyperfusion and transportsystem and accessories | Device Classification Name -Isolated kidney perfusion andtransport system andaccessories |
| Mode ofOperation | Static cold ischemicstorage | Static cold ischemicstorage | Static cold ischemicstorage | Static cold ischemicstorage | Static cold ischemicstorage | Static cold ischemic storage |
| Meets UNOSPolicy 5¹ | Yes | Yes | Yes | Yes | Yes | Yes |
| Characteristic | Proposed Sherpa PakKidney TransportSystemK143054 | Sherpa Pak KidneyTransport System -K133694 | BelzerUW ColdStorageSolution - | CoStorSol ColdStorageSolution | SPS-1 -K091656 | CustodiolHTKSolution -K043461 |
| K944866 | K091245 | |||||
| Organ container | Two rigid airtightcontainers one of whichcontains the coldstorage solution in whichthe organ is immersed. | Two rigid airtightcontainers one of whichcontains the coldstorage solution in whichthe organ is immersed. | None. Solution is usedby organ procurementcenters but requires anorgan container such asthat used in the proposedSherpa Pak TransporterSystem or the Avidcustom procedure traytub. | None. Solution is usedby organ procurementcenters but requires anorgan container such asthat used in theproposed Sherpa PakTransporter System orthe Avid customprocedure tray tub. | None. Solution is used byorgan procurement centersbut requires an organcontainer such as thatused in the proposedSherpa Pak TransporterSystem or the Avid customprocedure tray tub. | None. Solution is used byorgan procurement centersbut requires an organcontainer such as that usedin the proposed Sherpa PakTransporter System or theAvid custom procedure traytub. |
| Cooling | Temperaturepreconditioned storagesolution andtemperature controlledpackaging includingpreconditioned phasechange material coldpacks, PIR insulatingpanels, and ExpandablePolystyrene panels | Temperaturepreconditioned storagesolution andtemperature controlledpackaging includingpreconditioned phasechange material coldpacks, PIR insulatingpanels, and ExpandablePolystyrene panels | Temperaturepreconditioned. Relies ontransport system for typeof cooling andmaintenance oftemperature | Temperaturepreconditioned. Relieson transport system fortype of cooling andmaintenance oftemperature. | Temperaturepreconditioned. Relies ontransport system for type ofcooling and maintenanceof temperature. | Temperature preconditioned.Relies on transport systemfor type of cooling andmaintenance of temperature. |
| Systemcomponents | Outer plasticcorrugatedcontainer (topand base with | Outer plasticcorrugatedcontainer (topand base with | Plastic baq with coldstorage solution to beused in combination withsome type of organtransport container (e.g.,such as the Avid customprocedure kit and off-the-shelf cooler). | Plastic baq with coldstorage solution to beused in combination withsome type of organtransport container (e.g.,such as the Avid customprocedure kit and off-the-shelf cooler). | Plastic bag with coldstorage solution to be usedin combination with sometype of organ transportcontainer (e.g., such as theAvid custom procedure kitand off-the-shelf cooler). | Plastic bag with cold storagesolution to be used incombination with some typeof organ transport container(e.g., such as the Avidcustom procedure kit and off-the-shelf cooler). |
| wheels)PIR insulatingpanels | wheels)PIR insulatingpanels | |||||
| Characteristic | Proposed Sherpa PakKidney TransportSystemK143054 | Sherpa Pak KidneyTransport System -K133694 | BelzerUW ColdStorageSolution -K944866 | CoStorSol ColdStorageSolution -K091245 | SPS-1 -K091656 | CustodiolHTKSolution -K043461 |
| 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 | |||||
| Single Use/Reuse | Entire system is single use/patient only. | Entire system is single use/patient only. | Single use/patient only. | Single use/patient only. | Single use/patient only. | Single use/patient only. |
| Sterilization | Sherpa Pak and Sherpa Pak Shell are sterilized by gamma irradiation. All other components are non-sterile. | Sherpa Pak and Sherpa Pak Shell are sterilized by gamma irradiation. All other components are non-sterile. | Sterilized. | Sterilized. | Sterilized. | Sterilized. |
| Characteristic | Proposed Sherpa PakKidney TransportSystemK143054 | Sherpa Pak KidneyTransport System -K133694 | BelzerUW ColdStorageSolution -K944866 | CoStorSol ColdStorageSolutionlK091245 | SPS-1 -K091656 | CustodiolHTKSolution -K043461 |
| Biocompatibility | Direct and indirect organcontact materials havebeen tested forbiocompatibility. | Direct and indirect organcontact materials havebeen tested forbiocompatibility. | Yes. | Yes. | Yes. | Yes. |
| Intended storagetime | Device can maintain 4°C to 8°C through 24hours | Device can maintain 4°C to 8°C through 24hours | No time within indicationstatement | No time within indicationstatement | No time within indicationstatement | No time within indicationstatement |
1 http://www.optn.transplant.hrsa.gov
{8}------------------------------------------------
Submitter:
Paragonix Technologies, Inc.
Paragonix Sherpa Pak Kidney Transport System
Premarket Notification: Special 510(k)
{9}------------------------------------------------
Submitter:
Paragonix Technologies, Inc.
Paragonix Sherpa Pak Kidney Transport System
Premarket Notification: Special 510(k)
{10}------------------------------------------------
Submitter:
Paragonix Sherpa Pak Kidney Transport System
Paragonix Technologies, Inc.
Premarket Notification: Special 510(k)
{11}------------------------------------------------
Summary of Design Changes:
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). Sherpa Pak Kidney Transport System is intended to be used with any preservation solution that is cleared by the FDA for use with kidneys, and, therefore, the combined kitting of the Paragonix Sherpa Pak Kidney Transport System and any FDA-Cleared preservation solution (i.e., Belzer UW, CoStorSol, SPS-1, 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 Kidney Transport System to be distributed with any FDA-cleared, commerciallyavailable preservation solution, as a Convenience Kit. According to the FDA "Convenience Kits Interim Regulatory Guidance" (May 20, 1997), the Sherpa Pak Kidney Transport System falls within the definition of a Convenience Kit under the generic heading of a "Kidney Perfusion 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).