SHERPA PAK CARDIAC TRANSPORT SYSTEM

K123326 · Paragonix Technologies, Inc. · MSB · Feb 6, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K123326
• Device Name: SHERPA PAK CARDIAC TRANSPORT SYSTEM
• Applicant: Paragonix Technologies, Inc.
• Product Code: MSB · Gastroenterology, Urology
• Decision Date: Feb 6, 2013
• Decision: SESE
• Submission Type: Traditional
• 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, up to 4 hours, during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart.

Device Story

Device provides cold ischemic storage and transport for donor hearts. System components: outer shipper with non-ice temperature-controlled packaging (phase change material, PIR insulating panels, EPS panels); inner/outer hard shell container (Sherpa Pak/Sherpa Pak Shell) for heart immersion/suspension in cold storage fluid; integrated temperature display and timer. Used by organ procurement personnel during transport to transplant centers. Heart is placed in rigid barrier container with cold storage solution; system maintains hypothermic environment. Output: visual temperature and elapsed time monitoring. Benefit: consistent, robust thermal protection for donor heart during transit, reducing risk of temperature excursions.

Clinical Evidence

Bench testing only. Testing demonstrated device robustness, ability to protect the heart during transport, and maintenance of temperature throughout the 4-hour duration. Biocompatibility testing included cytotoxicity, systemic toxicity, genotoxicity, sensitization, and intracutaneous testing.

Technological Characteristics

System includes outer shipper with PIR insulating panels, EPS panels, and phase change material (PCM) cold packs. Inner/outer hard shell containers (Sherpa Pak/Sherpa Pak Shell) provide rigid barrier. Components (Sherpa Pak, Shell, heart connector) sterilized by gamma irradiation. Integrated electronic temperature display and timer. Static hypothermic storage principle.

Indications for Use

Indicated for static hypothermic preservation of donor hearts for up to 4 hours during transport prior to transplantation into a recipient, using compatible cold storage solutions.

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

• Lifeport Kidney Transport System (K021362)
• Avid Custom Procedure Tray [Class I 510(k) Exempt]
• Celsior Cold Flush Storage and Transport Solution for Hearts (K991594)

Submission Summary (Full Text)

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## 510(k) Summary Paragonix Sherpa Pak Cardiac Transport System

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FEB 0 6 2013

| Submitter: | Paragonix Technologies, Inc.<br>Fifth Floor<br>2 Canal Street<br>Cambridge, MA 02141<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leo Basta<br>NorthStar Biomedical Associates<br>755 Westminster St., Unit 120<br>Providence, RI, 02903<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | October 24, 2012 |
| Trade Name: | Paragonix Sherpa Pak Cardiac Transport System |
| Classification Name: | System & Accessories, Isolated Heart, Transport &<br>Preservation |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | MSB |
| Predicate Devices: | Lifeport Kidney Transport System (K021362) |
| | Avid Custom Procedure Tray [Class I 510(k) Exempt] |
| | Celsior Cold Flush Storage and Transport Solution for Hearts<br>(K991594) |
| 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 for<br>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) |

FDA Response
Rev. A

:

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which provides a double, rigid barrier container in which the heart is immersed and suspended in a Cold Storage Fluid cleared for use in storing and transporting donor hearts and 3) a temperature display and timer to monitor temperature and elapsed time of transport, respectively.

Organ storage and preservation for transplantation.

The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts, up to 4 hours, during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart.

Descriptive information, laboratory bench testing, and biocompatibility testing were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use. Specifically, testing to demonstrate that the Sherpa Pak System provided a transport system robust enough to protect the heart during transport and maintained temperature throughout the duration of transport, was included. In addition, biocompatibility testing including cytotoxicity, systemic toxicity, genotoxicity, sensitization, and intracutaneous testing was performed.

Functional Testing:

Indications for Use:

Intended Use:

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| Characteristic | Device Characteristic Comparison | | | Characteristic | Organ container | Cooling | System components | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed Sherpa Pak Cardiac<br>Transport System Device<br>[current 510(k)] | Celsior Cold Storage<br>Solution - K991594 | Lifeport<br>Kidney<br>Transporter<br>K021362 | Avid Medical<br>Custom<br>Procedure Tray<br>Class I 510(k)<br>Exempt | Transport System Device<br>[current 510(k)] | Two rigid airtight containers one of<br>which contains the cold storage solution<br>in which the heart is immersed. | Preconditioned storage solution and<br>temperature controlled packaging<br>including preconditioned phase change<br>material cold packs, PIR insulating<br>panels, and Expandable Polystyrene<br>panels | Outer plastic corrugated<br>container (top and base with<br>wheels)<br>PIR insulating panels<br>PCM Cold Pack Panels<br>EPS panels<br>Sherpa Pak and Sherpa Pak<br>Shell with heart connector<br>Temperature data logger<br>Timer |
| Intended Use | Organ storage and preservation for<br>transplantation. | Organ storage and preservation for<br>transplantation. | Organ storage and preservation<br>for transplantation. | Organ storage and preservation<br>for transplantation | Solution - K991594 | None. Solution is used by organ<br>procurement centers in various<br>containers or bags. | Preconditioned. Relies on transport<br>system for type of cooling and<br>maintenance of temperature | 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). |
| Indications for<br>Use | "The Sherpa Pak Cardiac Transport<br>System is intended to be used for the<br>static hypothermic preservation of<br>hearts, up to 4 hours, during<br>transportation and eventual<br>transplantation into a recipient, using<br>cold storage solutions indicated for use<br>with the heart." | "Celsior is intended for flushing and<br>cold storage of a heart at the time of<br>its removal from a donor in<br>preparation for storage,<br>transportation, and eventual<br>transplantation into a recipient." | "LifePortTM, Kidney Perfusion<br>Transporter (KTR) is intended to<br>be used for the continuous<br>hypothermic machine perfusion<br>of kidneys for the preservation,<br>transportation and eventual<br>transplantation into a recipient." | Specific indication statement is<br>unknown. However, the Avid<br>procedure tray is sold to an<br>organ procurement center, Avid<br>NEOB0005-03, for heart<br>packaging with Celsior Cold<br>Storage Solution for<br>transportation to recipient for<br>transplantation. | Lifeport<br>Kidney<br>Transporter -<br>K021362 | Cassette well with top. | Preconditioned storage solution,<br>ice and water. Case has<br>insulated cover. | Ice container<br>Cassette<br>Insulating cover<br>Infusion pump<br>Cannula<br>Control panel<br>Batteries<br>Pressure sensor<br>Organ cradle |
| Regulation<br>Number<br>Product Code | 878.5880<br>MSB | 878.5880<br>MSB | 878.5880<br>KDN | 876.4800<br>KDD | Avid Medical<br>Custom<br>Procedure Tray<br>- Class I 510(k)<br>Exempt | Plastic tub with lid and bags. | Preconditioned storage solution<br>ice and water. Requires use of<br>commercial cooler (e.g., igloo<br>style). | 64 oz. tub with lid<br>Polyethylene bags<br>Procedure wrap<br>Twill tape<br><br>Once heart is packaged, kit is<br>stored on ice in a standard<br>cooler. |
| Device<br>Classification<br>Name | Device Classification Name – System &<br>Accessories, Isolated Heart, Transport<br>& Preservation | Device Classification Name – System<br>& Accessories, Isolated Heart,<br>Transport & Preservation | System, Perfusion, Kidney | Kit, surgical instrument,<br>disposable. | FDA Response | | | |
| Mode of<br>Operation | Static cold ischemic storage | Static cold ischemic storage | Cold ischemic perfusion storage | Static cold ischemic storage | | | | |
| Meets UNOS<br>Policy 5¹ | Yes | Yes | Yes | Yes | | | | |

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| Characteristic | Proposed Sherpa Pak Cardiac<br>Transport System Device<br>(current 510(k)) | Celsior Cold Storage<br>Solution-K991594 | Liteport<br>Kidney<br>Transporter<br>K021362 | Avid Medical<br>Custom<br>Procedure Tray<br>Class I 510(k)<br>Exempt |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Single Use/Reuse | Entire system is single use/patient only. | Single use/patient only. | Some components are single<br>use/patient only; others are<br>reusable. | Single use/patient only.<br>Commercial cooler may be<br>reused. |
| Sterilization | Sherpa Pak, Sherpa Pak Shell, and Heart<br>connector are sterilized by gamma<br>irradiation. All other components are<br>non-sterile. | Sterilized. | Disposable accessories are EO<br>sterilized; other components are<br>non-sterile. | EO sterilized. |
| Biocompatibility | Direct and indirect heart contact<br>materials have been tested for<br>biocompatibility. | Yes. | Kidney contact materials have<br>been tested for biocompatibility. | Unknown. |
| Intended storage<br>time | Up to 4 hours (clinical standard is 4-6<br>hours) | Unspecified. | Unspecified | Unspecified |

K123326
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Summary of Substantial Equivalence:

The design, intended use, principles of operation, and technological characteristics of the Sherpa Pak Cardiac Transport System are substantially equivalent to those of the predicate devices cited above. Substantial equivalence is based upon descriptive characteristics of the various cited predicate devices and upon the testing conducted to demonstrate that the subject device performs as intended and is substantially equivalent to the predicate devices in terms of its ability to safely store and transport a donor heart at a clinically acceptable temperature range to a recipient for transplantation.

FDA Response Rev. A

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 6, 2013

Paragonix Technologies, Inc. % Mr. Leo Basta Owner NorthStar Biomedical Associates 755 Westminister Street Unit 120 PROVIDENCE RI 02903

Re: K123326

Trade/Device Name: Paragonix Sherpa Pak Cardiac Transport System Regulation Number: 21 CFR§ 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: MSB Dated: December 17, 2012 Received: December 20, 2012

Dear Mr. Basta:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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.

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Page 2 - Mr. Leo Basta

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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert P.Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE

510(k) Number (if known): K123326

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, up to 4 hours, during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart.

Prescription Use: ____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The Counter Use:

(Per 21 CFR 801 Subpart D) ...................................................................................................................................................

(Per 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Bvaluation (ODE)

Page 1 of 1

Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number

FDA Response Res. A