SHERPA PAK TRANSPORTER

K133694 · Paragonix Technologies, Inc. · KDN · May 23, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133694
• Device Name: SHERPA PAK TRANSPORTER
• Applicant: Paragonix Technologies, Inc.
• Product Code: KDN · Gastroenterology, Urology
• Decision Date: May 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5880
• Device Class: Class 2

Indications for Use

Organ storage and preservation for transplantation.

Device Story

The Paragonix Sherpa Pak Kidney Transport System provides a controlled environment for donor kidney transport. The system comprises an outer shipper with non-ice temperature-controlled elements, an inner/outer hard shell container (Sherpa Pak/Sherpa Pak Shell) for organ immersion in cold storage fluid, and a temperature display/timer. The device is used by medical personnel during organ procurement and transport to maintain hypothermic conditions (4°C–8°C) for up to 24 hours. By providing a rigid, temperature-monitored barrier, the system protects the donor organ from physical trauma and thermal fluctuations, potentially improving organ viability for transplantation.

Clinical Evidence

Bench testing only. Testing demonstrated the system maintains donor organ storage temperature between 4°C and 8°C for 24 hours and provides a robust transport environment to protect the organ. No clinical data was required or provided.

Technological Characteristics

Static cold ischemic storage system. Components include an outer shipper, hard shell container (Sherpa Pak/Sherpa Pak Shell), and temperature display/timer. Materials are identical to K123326; direct/indirect contact materials are biocompatibility tested. Sterilization of Sherpa Pak and Shell via gamma irradiation; other components non-sterile. Single-use.

Indications for Use

Indicated for static hypothermic preservation of kidney organs during transport and eventual transplantation into a recipient using compatible cold storage solutions. Maintains organ storage temperature 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 Cardiac Transport System (K123326)
• Avid Medical Custom Procedure Tray (Class I exempt)
• CoStorSol (K091245)

Submission Summary (Full Text)

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# MAY 2 3 2014

#### . 510(k) Summary Paragonix Sherpa Pak Kidney Transport System

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| Submitter: | Paragonix Technologies, Inc.<br>c/o Vaughn & Associates<br>639 Granite Street<br>Braintree, MA02184 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leo Basta<br>NorthStar Biomedical Associates<br>93 Benefit Street<br>Providence, RI, 02904<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | December 23, 2013 |
| Trade Name: | Paragonix Sherpa Pak Kidney Transport System |
| Classification Name: | Isolated kidney perfusion<br>and transport system and accessories |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | KDN |
| Predicate Devices: | Sherpa Pak Cardiac Transport System, 21 CFR 876.5880 -<br>Paragonix Technologies, Inc., K123326, Product Code MSB |
| | Avid Medical Custom Procedure Tray, 21 CFR 878.4800 -<br>Avid Medical, Class I exempt, Product Code KDD |
| | CoStorSol, 21 CFR 876.5880. Preservation Solutions Inc. -<br>K091245, Product Code KDN |
| Device Description: | The Paragonix Sherpa Pak Kidney Transport System is a<br>device intended to provide a safe, consistent method for cold<br>ischemic storage and transport of donor kidney organs to<br>recipients for transplantation. The Sherpa Pak Kidney<br>Transport System consists of 1) an outer shipper which<br>contains various non-ice based temperature controlled<br>packaging elements, 2) an inner and outer hard shell container<br>(i.e. Sherpa Pak/Sherpa Pak Shell) which provides a double, |
| | rigid barrier container in which the donor kidney is immersed<br>and suspended in a Cold Storage Fluid cleared for use in<br>storing and transporting donor organs and 3) a temperature<br>display and timer to monitor temperature and elapsed time of<br>transport, respectively. The device is identical to the cleared<br>Sherpa Pak Cardiac Transport System with the exception of<br>the indications for use specific to donor organs, and removal<br>of a connector in the canister component. |
| 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>this organ. |
| | The Sherpa Pak Kidney Transport System can maintain the<br>donor organ storage temperature between 4°C and 8°C<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 K123326. |
| | Specifically, testing to demonstrate that the Sherpa Pak<br>Kidney Transport System provides a transport system robust<br>enough to protect the donor organ during transport and<br>maintain temperature throughout the duration of transport, was<br> |

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Paragonix Kidney 510(k) Rev. B

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Paragonix Kidney 510(k)
Rev. B

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K133694
Page 3 of 6

| Device Characteristic | Proposed Sherpa Pak Kidney<br>Transport System<br>[current 510(k)] | Proposed Sherpa Pak Cardiac<br>Transport System Device -<br>K123326 | CoStorSol Cold<br>Storage Solution -<br>K091245 | Avid Medical<br>Custom<br>Procedure Tray<br>- Class 1 510(k)<br>Exempt |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Organ storage and preservation for<br>transplantation. | Organ storage and preservation for<br>transplantation. | Organ storage and preservation for<br>transplantation. | Organ storage and preservation<br>for transplantation |
| Indications for<br>Use | "The Sherpa Pak Kidney Transport<br>System is intended to be used for the<br>static hypothermic preservation of<br>kidney organs during transportation<br>and eventual transplantation into a<br>recipient using cold storage solutions<br>indicated for use with this organ.<br><br>The Sherpa Pak Kidney Transport<br>System can maintain the donor organ<br>storage temperature between 4°C and<br>8°C through 24 hours." | "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<br>use with the heart." | "CoStorSol® is intended for the<br>flushing and cold storage of kidney,<br>liver and pancreas organs at the time<br>of organ removal from the donor in<br>preparation for storage, transportation<br>and eventual transplantation into a<br>recipient." | Specific indication statement is<br>unknown. However, the Avid<br>procedure tray is sold to organ<br>procurement centers, for organ<br>packaging with Cold Storage<br>Solutions for transportation to<br>recipient for transplantation. |
| Regulation<br>Number | 878.5880 | 878.5880 | 878.5880 | 878.4800 |
| Product Code | KDN | MSB | KDN | KDD |
| Device<br>Classification<br>Name | Device Classification Name – Isolated<br>kidney perfusion and transport system<br>and accessories | Device Classification Name – System<br>& Accessories, Isolated Heart,<br>Transport & Preservation | Device Classification Name –<br>Isolated kidney perfusion and<br>transport system and accessories | Kit, surgical instrument,<br>disposable. |
| Mode of<br>Operation | Static cold ischemic storage | Static cold ischemic storage | Static cold ischemic storage | Static cold ischemic storage |
| Meets UNOS<br>Policy 5¹ | Yes | Yes | Yes | Yes |

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' http://www.optn.transplant.hrsa.gov
Paragonix Kidney 510(k)
Rev. B

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K133694
Page 5 of 6

| Characteristic | Proposed Sherpa Pak Kidney<br>Transport System<br>[current 510(k)] | Proposed Sherpa Pak Cardiac<br>Transport System Device –<br>K123326 | CoStorSol Cold<br>Storage Solution –<br>K091245 | Avid Medical<br>Custom<br>Procedure Tray<br>- Class I 510(k) Exempt |
|--------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------|
| 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.<br>Commercial cooler may be reused. |
| Sterilization | Sherpa Pak and Sherpa Pak Shell are<br>sterilized by gamma irradiation. All<br>other components are non-sterile. | Sherpa Pak, Sherpa Pak Shell, and<br>Heart connector are sterilized by<br>gamma irradiation. All other<br>components are non-sterile. | Sterilized. | EO sterilized. |
| Biocompatibility | Direct and indirect organ contact<br>materials have been tested for<br>biocompatibility. | Direct and indirect heart contact<br>materials have been tested for<br>biocompatibility. | Yes. | Unknown. |
| Intended storage<br>time | Device can maintain 4° C to 8° C<br>through 24 hours | Currently indicated for up to 4 hours.<br>Device testing demonstrates<br>maintenance of 4° C to 8° C range<br>through 12 hours. | No time within indication statement | Unspecified |

Paragonix Kidney 510(k)
Rev. B

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### Summary of Substantial Equivalence:

The design, intended use, principles of operation, and technological characteristics of the Sherpa Pak Kidney Transport System are substantially equivalent to the previously cleared Sherpa Pak Cardiac Transport System (K123326). The intended use of the subject device is the same as all the cited predicates and the labeled indications for use is similar for each device. 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 organ at a clinically acceptable temperature range to a recipient for transplantation.

Paragonix Kidney 510(k) Rev. B

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Public Health Service

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

May 23, 2014 '

Paragonix Technologies, Inc. % Leo L. Basta Owner NorthStar Biomedical Associates 93 Benefit Street Providence, RI 02904

Re: K133694

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Trade/Device Name: Paragonix Sherpa Pak Kidney Transport System Regulation Number: 21 CFR§ 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDN Dated: May 15, 2014 Received: May 16, 2014

Dear Leo L. 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, 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 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.

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Page 2 - Leo L. Basta

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/7/Picture/7 description: The image shows the name "Herbert P. Lerner - S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and easy to read. The text appears to be a signature or a title.

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): K133694

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 this organ.

The Sherpa Pak Kidney Transport System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours.

Prescription Use: ____________________________________________________________________________________________________________________________________________________________ Over-The Counter Use: (Per 21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D) ...................................................................................................................................................

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/8/Picture/10 description: The image shows the name "Herbert P. Lerner" in bold, black font at the top. Below the name is the date and time "2014.05.23 07:10:27 -04'00'" also in bold, black font. The text appears to be a timestamp or record of some kind.

Paragonix Kidney 510(k) Rev. B