Sherpa Pak Cardiac Transport System

K143074 · Paragonix Technologies, Inc. · MSB · Nov 25, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K143074
• Device Name: Sherpa Pak Cardiac Transport System
• Applicant: Paragonix Technologies, Inc.
• Product Code: MSB · 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 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 Story

System provides static cold ischemic storage for donor hearts during transport. Components include outer shipper, double rigid hard shell container (Sherpa Pak/Shell), temperature display, and timer. Heart is immersed and suspended in FDA-cleared cold storage solution. Used by transplant teams during organ procurement and transport. Device maintains hypothermic environment via preconditioned phase change material cold packs and insulating panels. Output includes temperature and elapsed time monitoring. Benefits include consistent, safe transport environment for donor hearts, potentially improving preservation quality before transplantation.

Clinical Evidence

Bench testing only. Thermal qualification demonstrated ability to maintain required temperature for 12 hours. Biocompatibility testing performed on heart-contact materials.

Technological Characteristics

Static cold ischemic storage system. Components: outer shipper, rigid hard shell containers, phase change material cold packs, PIR/EPS insulation, temperature display, timer. Materials: Gamma-irradiated plastic components. Connectivity: None (standalone).

Indications for Use

Indicated for static hypothermic preservation of donor hearts during transport for transplantation in recipients. Intended for use with FDA-cleared cold storage solutions. Storage time up to 4 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 Cardiac Transport System (K133432)
• Celsior Cold Storage Solution (K991594)
• Custodiol HTK (K032794)

Submission Summary (Full Text)

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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 [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,

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.<br>c/o Vaughn & Associates<br>639 Granite Street<br>Braintree, MA 02184 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mason W. Diamond, DDS<br>Texel Fortis, LLC<br>150 Levinberg Lane<br>Wayne, NJ 07470<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | October 24, 2014 |
| Trade Name: | Paragonix Sherpa Cardiac Kidney Transport System |
| Classification Name: | System and Accessories, Isolated Heart, Transport and<br>Preservation |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | MSB |
| Predicate Devices: | Sherpa Pak Cardiac Transport System (Paragonix<br>Technologies, Inc) - K133432<br>Celsior Cold Storage Solution (SangStat Medical Corp) -<br>K991594<br>Custodiol HTK (Dr Franz Köhler Chemie GmbH) – K032794 |
| Device Description: | The Paragonix Sherpa Pak Cardiac Transport System is a<br>device intended to provide a safe, consistent method for cold<br>ischemic storage and transport of donor hearts to recipients<br>for transplantation. The Sherpa Pak System consists of 1) an<br>outer shipper which contains various non-ice based<br>temperature controlled packaging elements, 2) an inner and<br>outer hard shell container (i.e. Sherpa Pak/Sherpa Pak Shell)<br>which provides a double, rigid barrier container in which the<br>heart is immersed and suspended in a Cold Storage Fluid<br>cleared for use in storing and transporting donor organs and<br>3) a temperature display and timer to monitor temperature<br>and elapsed time of transport, respectively. The device is<br>identical to the cleared Sherpa Pak Cardiac Transport System<br>in all respects. |

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| Submitter: | Paragonix Technologies, Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Paragonix Sherpa Pak Cardiac Transport System<br>Premarket Notification: Special 510(k) |
| | The purpose for this change it to allow the Paragonix Sherpa<br>Pak Cardiac Transport System to be distributed with any<br>FDA-cleared, commercially-available preservation solution, as<br>a Convenience Kit. |
| Intended Use: | Organ storage and preservation for transplantation. |
| Indications for Use: | The Sherpa Pak Cardiac Transport System is intended to be<br>used for the static hypothermic preservation of hearts during<br>transportation and eventual transplantation into a recipient<br>using cold storage solutions indicated for use with the heart. |
| | The intended organ storage time for the Sherpa Pak Cardiac<br>Transport System is up to 4 hours. |
| | Donor hearts exceeding clinically accepted static hypothermic<br>preservation times should be evaluated by the transplant<br>surgeon to determine transplantability in accordance with<br>accepted clinical guidelines and in the best medical interest of<br>the intended recipient. |
| 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. |
| | Specifically, testing to demonstrate that the Sherpa Pak<br>Cardiac 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 Cardiac Transport System to maintain the<br>required temperature through 12 hours. |

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Premarket Notification: Special 510(k)

# Device Characteristic Comparison

| Characteristic | Proposed Sherpa Pak Cardiac<br>Transport System<br>[Modification] | Sherpa Pak Cardiac<br>Transport System - K133432 | Celsior - K991594 | Custodiol HTK-<br>K032794 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Organ storage and preservation<br>for transplantation. | Organ storage and preservation<br>for transplantation. | Organ storage and preservation<br>for transplantation. | Organ storage and preservation<br>for transplantation. |
| Indications for<br>Use | "The Sherpa Pak Cardiac<br>Transport System is intended<br>to be used for the static<br>hypothermic preservation of<br>hearts during transportation<br>and eventual transplantation<br>into a recipient using cold<br>storage solutions indicated for<br>use with the heart.<br>The intended organ storage<br>time for the Sherpa Pak<br>Cardiac Transport System is<br>up to 4 hours.<br>Donor hearts exceeding<br>clinically accepted static<br>hypothermic preservation times<br>should be evaluated by the<br>transplant surgeon to<br>determine transplantability in<br>accordance with accepted<br>clinical guidelines and in the<br>best medical interest of the<br>intended recipient." | "The Sherpa Pak Cardiac<br>Transport System is intended<br>to be used for the static<br>hypothermic preservation of<br>hearts during transportation<br>and eventual transplantation<br>into a recipient using cold<br>storage solutions indicated for<br>use with the heart.<br>The intended organ storage<br>time for the Sherpa Pak<br>Cardiac Transport System is<br>up to 4 hours.<br>Donor hearts exceeding<br>clinically accepted static<br>hypothermic preservation times<br>should be evaluated by the<br>transplant surgeon to<br>determine transplantability in<br>accordance with accepted<br>clinical guidelines and in the<br>best medical interest of the<br>intended recipient." | "Celsior is intended for flushing<br>and cold storage of a heart at the<br>time of its removal from a donor<br>in preparation for storage,<br>transportation, and eventual<br>transplantation into a recipient." | "Custodiol HTK Solution is<br>indicated for perfusion and<br>flushing donor kidneys, livers,<br>and hearts prior to removal from<br>the donor or immediately after<br>removal from the donor. The<br>solution is left in the organ<br>vasculature during hypothermic<br>storage and transportation (not<br>for continuous perfusion) to the<br>recipient." |
| Regulation<br>Number | 878.5880 | 878.5880 | 878.5880 | 878.5880 |
| Product Code | MSB | MSB | MSB | MSB |
| Device<br>Classification<br>Name | Device Classification Name -<br>System & Accessories, Isolated<br>Heart, Transport & Preservation | Device Classification Name -<br>System & Accessories, Isolated<br>Heart, Transport & Preservation | Device Classification Name -<br>System & Accessories, Isolated<br>Heart, Transport & Preservation | Device Classification Name -<br>Isolated kidney perfusion and<br>transport system and<br>accessories |
| Mode of<br>Operation | Static cold ischemic storage | Static cold ischemic storage | Static cold ischemic storage | Static cold ischemic storage |
| Characteristic | Proposed Sherpa Pak Cardiac<br>Transport System<br>[Modification] | Sherpa Pak Cardiac<br>Transport System - K133432 | Celsior - K991594 | Custodiol HTK-<br>K032794 |
| Meets UNOS<br>Policy 51 | Yes | Yes | Yes | Yes |
| Organ container | Two rigid airtight containers one<br>of which contains the cold<br>storage solution in which the<br>heart is immersed. | Two rigid airtight containers one<br>of which contains the cold<br>storage solution in which the<br>heart is immersed. | None. Solution is used by organ<br>procurement centers but requires<br>an organ container such as that<br>used in the proposed Sherpa<br>Pak Transporter System or the<br>Avid custom procedure tray tub. | None. Solution is used by organ<br>procurement centers but requires<br>an organ container such as that<br>used in the proposed Sherpa<br>Pak Transporter System or the<br>Avid custom procedure tray tub. |
| Cooling | Temperature preconditioned<br>storage solution and<br>temperature controlled<br>packaging including<br>preconditioned phase change<br>material cold packs, PIR<br>insulating panels, and<br>Expandable Polystyrene panels | Temperature preconditioned<br>storage solution and<br>temperature controlled<br>packaging including<br>preconditioned phase change<br>material cold packs, PIR<br>insulating panels, and<br>Expandable Polystyrene panels | Temperature preconditioned.<br>Relies on transport system for<br>type of cooling and maintenance<br>of temperature. | Temperature preconditioned.<br>Relies on transport system for<br>type of cooling and maintenance<br>of temperature. |
| System<br>components | Image: System components<br>Outer plastic corrugated container (top and base with wheels) | Image: System components<br>Outer plastic corrugated container (top and base with wheels) | Plastic bag with cold storage<br>solution to be used in<br>combination with some type of<br>organ transport container (e.g.,<br>such as the Avid custom<br>procedure kit and off-the-shelf<br>cooler). | Plastic bag with cold storage<br>solution to be used in<br>combination with some type of<br>organ transport container (e.g.,<br>such as the Avid custom<br>procedure kit and off-the-shelf<br>cooler). |
| Characteristic | Proposed Sherpa Pak Cardiac<br>Transport System<br>[Modification] | Sherpa Pak Cardiac<br>Transport System - K133432 | Celsior - K991594 | Custodiol HTK–<br>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 | | |
| Single<br>Use/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. |
| Intended<br>storage 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.