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.

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 kidney organs to recipients for transplantation. The Sherpa Pak Kidney Transport System consists of 1) an outer shipper which contains various non-ice based 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 donor 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 Cardiac Transport System with the exception of the indications for use specific to donor organs, and removal of a connector in the canister component.

AI/ML Overview

Acceptance Criteria and Device Performance for Paragonix Sherpa Pak Kidney Transport System

Here's a breakdown of the acceptance criteria and the study details for the Paragonix Sherpa Pak Kidney Transport System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device Characteristic	K133694 Acceptance Criteria (Indications for Use)	Reported Device Performance (Functional Testing/Substantial Equivalence)
Intended Use	Organ storage and preservation for transplantation.	"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..." "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."
Storage Temperature	Maintain donor organ storage temperature between 4°C and 8°C.	"Specifically, testing to demonstrate that the Sherpa Pak Kidney Transport System provides a transport system robust enough to protect the donor organ during transport and maintain temperature throughout the duration of transport..." "Device can maintain 4° C to 8° C through 24 hours" (stated in the "Intended storage time" table, implying it meets this in testing).
Storage Duration	Through 24 hours.	"Device can maintain 4° C to 8° C through 24 hours" (stated in the "Intended storage time" table, implying it meets this in testing).
Organ Type	Kidney organs.	"The Sherpa Pak Kidney Transport System is intended to be used for the static hypothermic preservation of kidney organs..." This is part of the device's specific indication, thus the device is designed and tested for this.
Preservation Method	Static hypothermic preservation.	"The Sherpa Pak Kidney Transport System is intended to be used for the static hypothermic preservation..." "Mode of Operation: Static cold ischemic storage."
Safety and Performance	Safe, consistent method for cold ischemic storage and transport of donor kidney organs. No explicit criteria, but expected.	"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 K123326." "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."

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a sample size for a "test set" in the context of clinical data for algorithmic performance. The testing described is laboratory bench testing and refers to a "descriptive information and laboratory bench testing" approach to demonstrate the device meets design specifications and perform as intended.

There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a test set, as clinical data for performance assessment (e.g., organ viability post-transport) is not described as being part of the submission for determining substantial equivalence regarding its temperature maintenance capabilities. The focus is on the physical and functional characteristics of the transport system itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This device is a medical device for organ transport, not an AI/diagnostic software. No "ground truth" established by experts in the context of diagnostic accuracy is mentioned.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method for a test set, as the testing described focuses on bench-top performance of the device's physical functions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance. It describes a medical device for organ transport.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device for organ transport, not an algorithm.

7. The type of ground truth used

The "ground truth" can be inferred from the stated performance goals:

Temperature Maintenance: The ability to consistently maintain the temperature of a simulated/actual organ (or the internal environment of the device) between 4°C and 8°C for 24 hours. The ground truth would be the actual measured temperature by calibrated sensors.
Physical Protection/Robustness: The ability to protect the donor organ during transport. The ground truth would be the structural integrity of the device and its contents after simulated transport conditions.
Biocompatibility: The materials being non-toxic and compatible with the organ. The ground truth would rely on established biocompatibility testing standards and results from a predicate device.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a medical device, not an AI model.

Summary of the Study that Proves Acceptance Criteria:

The key study information provided is:

Type of Study: Descriptive information and laboratory bench testing.
Purpose: To demonstrate that the device meets its design specifications, performs as intended, and is safe for its intended use.
Specific Tests: Testing was conducted to demonstrate the system's robustness to protect the donor organ during transport and its ability to maintain the specified temperature range (4°C to 8°C) for the duration of transport (24 hours).
Biocompatibility: No new biocompatibility testing was deemed necessary because there were no material changes from the previously cleared Sherpa Pak Cardiac Transport System (K123326), implying the previous device's biocompatibility data was leveraged.
Basis for Equivalence: Substantial equivalence was based on these descriptive characteristics and testing, comparing the Sherpa Pak Kidney Transport System to its predicate, the Sherpa Pak Cardiac Transport System (K123326), as well as other predicate devices for context (Avid Medical Custom Procedure Tray and CoStorSol Cold Storage Solution).

Summary

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MAY 2 3 2014

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

Submitter:	Paragonix Technologies, Inc.c/o Vaughn & Associates639 Granite StreetBraintree, MA02184
Contact Person:	Leo BastaNorthStar Biomedical Associates93 Benefit StreetProvidence, RI, 02904Phone: 617.834.9866lbasta@northstarbiomedical.com
Date Prepared:	December 23, 2013
Trade Name:	Paragonix Sherpa Pak Kidney Transport System
Classification Name:	Isolated kidney perfusionand transport system and accessories
Regulation Number:	21 CFR 876.5880
Product Code:	KDN
Predicate Devices:	Sherpa Pak Cardiac Transport System, 21 CFR 876.5880 -Paragonix Technologies, Inc., K123326, Product Code MSB
	Avid Medical Custom Procedure Tray, 21 CFR 878.4800 -Avid Medical, Class I exempt, Product Code KDD
	CoStorSol, 21 CFR 876.5880. Preservation Solutions Inc. -K091245, Product Code KDN
Device Description:	The Paragonix Sherpa Pak Kidney Transport System is adevice intended to provide a safe, consistent method for coldischemic storage and transport of donor kidney organs torecipients for transplantation. The Sherpa Pak KidneyTransport System consists of 1) an outer shipper whichcontains various non-ice based temperature controlledpackaging 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 donor kidney is immersedand suspended in a Cold Storage Fluid cleared for use instoring and transporting donor organs and 3) a temperaturedisplay and timer to monitor temperature and elapsed time oftransport, respectively. The device is identical to the clearedSherpa Pak Cardiac Transport System with the exception ofthe indications for use specific to donor organs, and removalof 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 beused for the static hypothermic preservation of kidney organsduring transportation and eventual transplantation into arecipient using cold storage solutions indicated for use withthis organ.
	The Sherpa Pak Kidney Transport System can maintain thedonor organ storage temperature between 4°C and 8°Cthrough 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 K123326.
	Specifically, testing to demonstrate that the Sherpa PakKidney Transport System provides a transport system robustenough to protect the donor organ during transport andmaintain temperature throughout the duration of transport, was

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 KidneyTransport System[current 510(k)]	Proposed Sherpa Pak CardiacTransport System Device -K123326	CoStorSol ColdStorage Solution -K091245	Avid MedicalCustomProcedure Tray- Class 1 510(k)Exempt
Intended Use	Organ storage and preservation fortransplantation.	Organ storage and preservation fortransplantation.	Organ storage and preservation fortransplantation.	Organ storage and preservationfor transplantation
Indications forUse	"The Sherpa Pak Kidney TransportSystem is intended to be used for thestatic hypothermic preservation ofkidney organs during transportationand eventual transplantation into arecipient using cold storage solutionsindicated for use with this organ.The Sherpa Pak Kidney TransportSystem can maintain the donor organstorage temperature between 4°C and8°C through 24 hours."	"The Sherpa Pak Cardiac TransportSystem is intended to be used for thestatic hypothermic preservation ofhearts, up to 4 hours, duringtransportation and eventualtransplantation into a recipient, usingcold storage solutions indicated foruse with the heart."	"CoStorSol® is intended for theflushing and cold storage of kidney,liver and pancreas organs at the timeof organ removal from the donor inpreparation for storage, transportationand eventual transplantation into arecipient."	Specific indication statement isunknown. However, the Avidprocedure tray is sold to organprocurement centers, for organpackaging with Cold StorageSolutions for transportation torecipient for transplantation.
RegulationNumber	878.5880	878.5880	878.5880	878.4800
Product Code	KDN	MSB	KDN	KDD
DeviceClassificationName	Device Classification Name – Isolatedkidney perfusion and transport systemand accessories	Device Classification Name – System& Accessories, Isolated Heart,Transport & Preservation	Device Classification Name –Isolated kidney perfusion andtransport system and accessories	Kit, surgical instrument,disposable.
Mode ofOperation	Static cold ischemic storage	Static cold ischemic storage	Static cold ischemic storage	Static cold ischemic storage
Meets UNOSPolicy 5¹	Yes	Yes	Yes	Yes

' 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 KidneyTransport System[current 510(k)]	Proposed Sherpa Pak CardiacTransport System Device –K123326	CoStorSol ColdStorage Solution –K091245	Avid MedicalCustomProcedure Tray- 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.Commercial cooler may be reused.
Sterilization	Sherpa Pak and Sherpa Pak Shell aresterilized by gamma irradiation. Allother components are non-sterile.	Sherpa Pak, Sherpa Pak Shell, andHeart connector are sterilized bygamma irradiation. All othercomponents are non-sterile.	Sterilized.	EO sterilized.
Biocompatibility	Direct and indirect organ contactmaterials have been tested forbiocompatibility.	Direct and indirect heart contactmaterials have been tested forbiocompatibility.	Yes.	Unknown.
Intended storagetime	Device can maintain 4° C to 8° Cthrough 24 hours	Currently indicated for up to 4 hours.Device testing demonstratesmaintenance of 4° C to 8° C rangethrough 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

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 (800) 638-2041 or (301) 796-7100 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 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) ...................................................................................................................................................

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Paragonix Kidney 510(k) Rev. B

Regulation Number and Section

§ 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).