Sherpa Pak Kidney Transport System

K143054 · Paragonix Technologies, Inc. · KDN · Nov 25, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K143054
• Device Name: Sherpa Pak Kidney Transport System
• Applicant: Paragonix Technologies, Inc.
• Product Code: KDN · Gastroenterology, Urology
• Decision Date: Nov 25, 2014
• Decision: SESK
• Submission Type: Special
• Regulation: 21 CFR 876.5880
• Device Class: Class 2

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.

Device Story

Device provides static cold ischemic storage/transport for donor kidneys; consists of outer shipper, inner/outer hard shell containers (Sherpa Pak/Shell), and temperature display/timer. Kidney is immersed/suspended in FDA-cleared cold storage fluid within rigid barrier. System maintains 4°C-8°C for 24 hours using phase change material cold packs, PIR insulating panels, and EPS panels. Used by organ procurement personnel; provides consistent thermal environment during transit. Output (temperature/time) allows monitoring of storage conditions; ensures organ viability for transplantation. Distributed as convenience kit with FDA-cleared preservation solutions.

Clinical Evidence

Bench testing only. Thermal qualification demonstrated ability to maintain 4°C-8°C for 24 hours. No material changes from predicate K133694; no new biocompatibility testing required.

Technological Characteristics

Static cold ischemic storage system. Components: outer corrugated plastic container, PIR insulating panels, PCM cold pack panels, EPS panels, hard shell containers. Sterilization: gamma irradiation for Sherpa Pak/Shell; other components non-sterile. Single-use. Integrated temperature display and timer.

Indications for Use

Indicated for static hypothermic preservation of kidney organs during transport and transplantation into a recipient, maintaining storage temperatures between 4°C and 8°C for up to 24 hours.

Regulatory Classification

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.

Predicate Devices

• Sherpa Pak Kidney Transport System (K133694)

Reference Devices

• Belzer UW Cold Storage Solution (K944866)
• CoStorSol (K091245)
• SPS-1 (K091656)
• Custodiol HTK Solution (K043461)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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Section 7.0

Indications for Use Statement

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#### 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

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Section 8

#### 510(k) Summary

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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: [phone] Fax: [phone] [e-mail] 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

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| Submitter:<br>Paragonix Technologies, Inc. | Paragonix Sherpa Pak Kidney Transport System<br>Premarket Notification: Special 510(k) | | | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | and elapsed time of transport, respectively. The device is<br>identical to the cleared Sherpa Pak Kidney Transport System<br>in all respects. | | | |
| | The purpose for this change is to allow the Paragonix Sherpa<br>Pak Kidney Transport System to be distributed with any FDA-<br>cleared, commercially-available preservation solution, as a<br>Convenience Kit. | | | |
| Intended Use: | Organ storage and preservation for transplantation. | | | |
| Indications for Use: | The Sherpa Pak Kidney Transport System is intended to be<br>used for the static hypothermic preservation of kidney organs<br>during transportation and eventual transplantation into a<br>recipient, using cold storage solutions indicated for use with<br>these organs. | | | |
| | The Sherpa Pak Kidney Transport System can maintain the<br>donor organ storage temperature between 4℃ and 8℃<br>through 24 hours. | | | |
| Functional Testing: | Descriptive information and laboratory bench testing were<br>provided to demonstrate the device meets its design<br>specifications, performs as intended, and is safe for its<br>intended use. Additional biocompatibility testing was not<br>necessary as there were no material changes from the device<br>cleared under K133694. | | | |
| | Specifically, testing to demonstrate that the Sherpa Pak<br>Kidney Transport System provided a transport system robust<br>enough to protect the donor organ during transport and<br>maintained temperature throughout the duration of transport<br>was included. Thermal qualification demonstrated the ability<br>of the Sherpa Pak Kidney Transport System to maintain the<br>required temperature through 24 hours. | | | |

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Premarket Notification: Special 510(k)

### Device Characteristic Comparison

| Characteristic | Proposed Sherpa Pak<br>Kidney Transport<br>System<br>K143054 | Sherpa Pak Kidney<br>Transport System -<br>K133694 | Belzer<br>UW Cold<br>Storage<br>Solution -<br>K944866 | CoStorS<br>ol Cold<br>Storage<br>Solution<br>K091245 | SPS-1 -<br>K091656 | Custodiol<br>HTK<br>Solution -<br>K043461 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Organ storage and<br>preservation for<br>transplantation. | Organ storage and<br>preservation for<br>transplantation. | Organ storage and<br>preservation for<br>transplantation. | Organ storage and<br>preservation for<br>transplantation. | Organ storage and<br>preservation for<br>transplantation. | Organ storage and<br>preservation for<br>transplantation. |
| Indications for<br>Use | "The Sherpa Pak<br>Kidney Transport is<br>intended to be used for<br>the static hypothermic<br>preservation of kidney<br>organs during<br>transportation and<br>eventual<br>transplantation into a<br>recipient, using cold<br>storage solutions<br>indicated for use with<br>these organs.<br>The Sherpa Pak Kidney<br>Transport can maintain<br>the donor organ<br>storage temperature<br>between 4°C and 8°C<br>through 24 hours." | "The Sherpa Pak<br>Kidney Transport is<br>intended to be used for<br>the static hypothermic<br>preservation of kidney<br>organs during<br>transportation and<br>eventual<br>transplantation into a<br>recipient, using cold<br>storage solutions<br>indicated for use with<br>these organs.<br>The Sherpa Pak Kidney<br>Transport can maintain<br>the donor organ<br>storage temperature<br>between 4°C and 8°C<br>through 24 hours." | "Belzer UW Cold Storage<br>Solution is intended for<br>the flushing and cold<br>storage of kidney, liver<br>and pancreas organs at<br>the time of organ removal<br>from the donor in<br>preparation for storage,<br>transportation and<br>eventual transplantation<br>into a recipient." | "CoStorSol® is intended<br>for the flushing and cold<br>storage of kidney, liver<br>and pancreas organs at<br>the time of organ<br>removal from the donor<br>in preparation for<br>storage, transportation<br>and eventual<br>transplantation into a<br>recipient." | "SPS-1 is intended for the<br>flushing and cold storage<br>of kidney, liver and<br>pancreas organs at the<br>time of organ removal from<br>the donor in preparation for<br>storage, transportation and<br>eventual transplantation<br>into a recipient." | "Custodiol HTK Solution is<br>indicated for perfusion and<br>flushing donor kidneys, liver,<br>pancreas and heart prior to<br>removal from the donor or<br>immediately after removal<br>from the donor. The solution<br>is left in the organ<br>vasculature during<br>hypothermic storage and<br>eventual transplantation (not<br>for continuous perfusion) to<br>the recipient." |
| Regulation<br>Number | 878.5880 | 878.5880 | 878.5880 | 878.5880 | 878.5880 | 878.5880 |
| Product Code | KDN and PIN | KDN | KDL | KDN | KDN | KDL and MSB |
| Device<br>Classification<br>Name | Device Classification<br>Name - Isolated kidney<br>perfusion and transport<br>system and accessories | Device Classification<br>Name - Isolated kidney<br>perfusion and transport<br>system and accessories | Device Classification<br>Name - Set, perfusion,<br>kidney, disposable | Device Classification<br>Name - Isolated kidney<br>perfusion and transport<br>system and accessories | Device Classification<br>Name - Isolated kidney<br>perfusion and transport<br>system and accessories | Device Classification Name -<br>Isolated kidney perfusion and<br>transport system and<br>accessories |
| Mode of<br>Operation | Static cold ischemic<br>storage | Static cold ischemic<br>storage | Static cold ischemic<br>storage | Static cold ischemic<br>storage | Static cold ischemic<br>storage | Static cold ischemic storage |
| Meets UNOS<br>Policy 5¹ | Yes | Yes | Yes | Yes | Yes | Yes |
| Characteristic | Proposed Sherpa Pak<br>Kidney Transport<br>System<br>K143054 | Sherpa Pak Kidney<br>Transport System -<br>K133694 | Belzer<br>UW Cold<br>Storage<br>Solution - | CoStorS<br>ol Cold<br>Storage<br>Solution | SPS-1 -<br>K091656 | Custodiol<br>HTK<br>Solution -<br>K043461 |
| | | | K944866 | K091245 | | |
| Organ container | Two rigid airtight<br>containers one of which<br>contains the cold<br>storage solution in which<br>the organ is immersed. | Two rigid airtight<br>containers one of which<br>contains the cold<br>storage solution in which<br>the organ is immersed. | None. Solution is used<br>by organ procurement<br>centers but requires an<br>organ container such as<br>that used in the proposed<br>Sherpa Pak Transporter<br>System or the Avid<br>custom procedure tray<br>tub. | None. Solution is used<br>by organ procurement<br>centers but requires an<br>organ container such as<br>that used in the<br>proposed Sherpa Pak<br>Transporter System or<br>the Avid custom<br>procedure tray tub. | None. Solution is used by<br>organ procurement centers<br>but requires an organ<br>container such as that<br>used in the proposed<br>Sherpa Pak Transporter<br>System or the Avid custom<br>procedure tray tub. | None. Solution is used by<br>organ procurement centers<br>but requires an organ<br>container such as that used<br>in the proposed Sherpa Pak<br>Transporter System or the<br>Avid custom procedure tray<br>tub. |
| Cooling | Temperature<br>preconditioned storage<br>solution and<br>temperature controlled<br>packaging including<br>preconditioned phase<br>change material cold<br>packs, PIR insulating<br>panels, and Expandable<br>Polystyrene panels | Temperature<br>preconditioned storage<br>solution and<br>temperature controlled<br>packaging including<br>preconditioned phase<br>change material cold<br>packs, PIR insulating<br>panels, and Expandable<br>Polystyrene panels | Temperature<br>preconditioned. Relies on<br>transport system for type<br>of cooling and<br>maintenance of<br>temperature | Temperature<br>preconditioned. Relies<br>on transport system for<br>type of cooling and<br>maintenance of<br>temperature. | Temperature<br>preconditioned. Relies on<br>transport system for type of<br>cooling and maintenance<br>of temperature. | Temperature preconditioned.<br>Relies on transport system<br>for type of cooling and<br>maintenance of temperature. |
| System<br>components | Outer plastic<br>corrugated<br>container (top<br>and base with | Outer plastic<br>corrugated<br>container (top<br>and base with | Plastic baq with cold<br>storage solution to be<br>used in combination with<br>some type of organ<br>transport container (e.g.,<br>such as the Avid custom<br>procedure kit and off-the-<br>shelf cooler). | Plastic baq with cold<br>storage solution to be<br>used in combination with<br>some type of organ<br>transport container (e.g.,<br>such as the Avid custom<br>procedure kit and off-<br>the-shelf cooler). | Plastic bag with cold<br>storage solution to be used<br>in combination with some<br>type of organ transport<br>container (e.g., such as the<br>Avid custom procedure kit<br>and off-the-shelf cooler). | Plastic bag with cold storage<br>solution to be used in<br>combination with some type<br>of organ transport container<br>(e.g., such as the Avid<br>custom procedure kit and off-<br>the-shelf cooler). |
| | wheels)<br>PIR insulating<br>panels | wheels)<br>PIR insulating<br>panels | | | | |
| Characteristic | Proposed Sherpa Pak<br>Kidney Transport<br>System<br>K143054 | Sherpa Pak Kidney<br>Transport System -<br>K133694 | Belzer<br>UW Cold<br>Storage<br>Solution -<br>K944866 | CoStorS<br>ol Cold<br>Storage<br>Solution -<br>K091245 | SPS-1 -<br>K091656 | Custodiol<br>HTK<br>Solution -<br>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 Pak<br>Kidney Transport<br>System<br>K143054 | Sherpa Pak Kidney<br>Transport System -<br>K133694 | Belzer<br>UW Cold<br>Storage<br>Solution -<br>K944866 | CoStorS<br>ol Cold<br>Storage<br>Solution<br>l<br>K091245 | SPS-1 -<br>K091656 | Custodiol<br>HTK<br>Solution -<br>K043461 |
| Biocompatibility | Direct and indirect organ<br>contact materials have<br>been tested for<br>biocompatibility. | Direct and indirect organ<br>contact materials have<br>been tested for<br>biocompatibility. | Yes. | Yes. | Yes. | Yes. |
| Intended storage<br>time | Device can maintain 4°<br>C to 8°C through 24<br>hours | Device can maintain 4°<br>C to 8°C through 24<br>hours | No time within indication<br>statement | No time within indication<br>statement | No time within indication<br>statement | No time within indication<br>statement |

¹ http://www.optn.transplant.hrsa.gov

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### Submitter:

Paragonix Technologies, Inc.

# Paragonix Sherpa Pak Kidney Transport System

Premarket Notification: Special 510(k)

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Submitter:

Paragonix Technologies, Inc.

Paragonix Sherpa Pak Kidney Transport System

Premarket Notification: Special 510(k)

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### Submitter:

# Paragonix Sherpa Pak Kidney Transport System

Paragonix Technologies, Inc.

Premarket Notification: Special 510(k)

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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.