The Paragonix KIDNEYvault Portable Renal Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ.

The Paragonix KIDNEYvault Portable Renal Perfusion System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours.

Donor kidneys exceeding clinically accepted 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 Description

The KIDNEYvault Portable Renal Perfusion System (KIDNEYvault) device is designed to provide pulsatile perfusion of pre-chilled machine preservation solution through the kidney by means of a mechanical pump and closed fluid circuit integrated within the device and attached to the kidney. Its intended use and principle of operation are the same as the predicate device, LifePort Kidney Perfusion Transporter (K021362), while the differences in the technological characteristics from the predicate are supported by the literature, testing, and the following reference devices: SherpaPak KTS and KIDNEY Assist. To maintain the chilled temperature of the machine preservation solution, the subject KIDNEYvault utilizes the same technology as the first reference device, SherpaPak KTS; whereas certain specifications for the subject device are based on the second reference device, KIDNEY Assist-transport.

The subject KIDNEYvault device consists of the following components:

KIDNEYvault SherpaCool Pouch and Ribbons Phase Change Material (PCM) (identical to the first reference device) to maintain temperature of the cold machine preservation solution and kidney throughout transportation. The KIDNEYvault device maintains the temperature between 4°C to 8°C throughout preservation and transportation.
KIDNEYvault Canister Assembly Proprietary hard shell, polycarbonate nested canister set for the packaging of the donor kidney within cold machine preservation solution and circulation of preservation solution through kidney vasculature.
The Canister Assembly incorporates a closed fluid pathway and connections to the donor kidney that draws cold machine preservation solution from the Inner Canister and circulates it through the renal artery of the kidney and exits through the renal vein or ureter back into the Inner Canister.
KIDNEYvault Shipper Outer transport shipper which comprises a protective and insulative package. The KIDNEYvault Shipper is a rigid, molded expanded polystyrene (EPS) insulative container into which the KIDNEYvault SherpaCool and KIDNEYvault Canister Assembly are placed. The maintenance of temperature of the donor kidney between 4°C to 8°C is assisted by the EPS insulation of the Shipper, providing insulation from the exterior environment to the interior components and KIDNEYvault SherpaCool.
The KIDNEYvault Shipper incorporates a peristaltic pump used to circulate the machine preservation solution through the kidney vascular system. The pump is a peristaltic pump that circulates chilled machine preservation solution (drawn from the Inner Canister) into the renal artery, through the kidney vasculature, and exiting back into the Inner Canister through the renal vein or ureter.
The KIDNEYvault Shipper includes a datalogger (connected to a temperature probe and pressure sensor) which records and displays the temperature of the machine preservation solution surrounding the donor kidney and the perfusion pressure within the fluid pathway.
KIDNEYvault Cannula The cannula connects to the renal artery of the kidney and the fluid circuit of the KIDNEYvault. There are multiple sizes of round cannulas and oval cannulas for different kidney anatomies.

AI/ML Overview

The provided document is a 510(k) summary for the Paragonix KIDNEYvault Portable Renal Perfusion System (K234060). It describes the device, its intended use, and its comparison to predicate and reference devices, as well as a summary of bench testing. However, it does not contain specific acceptance criteria, reported device performance metrics in relation to those criteria, or details of a study explicitly proving the device meets acceptance criteria in a quantifiable manner (e.g., sensitivity, specificity, accuracy for a diagnostic device).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (LifePort Perfusion Kidney Transporter, K021362) and reference devices (SherpaPak Kidney Transport System, K180194; KIDNEY ASSIST-transport, K211333) through a comparison of technological characteristics and a summary of bench testing. The bench testing verifies that the device meets specifications, but these specifications are not explicitly laid out as acceptance criteria with numerical performance targets in the context of a clinical study or performance evaluation in the provided text.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format requested. It discusses "specifications" met by various components during verification and validation, but these are not framed as quantifiable acceptance criteria with numerical results in a performance table.

The key performance claims related to the intended use are:

Temperature Maintenance: "The Paragonix KIDNEYvault Portable Renal Perfusion System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours."
Pulsatile Perfusion: The device provides "pulsatile hypothermic machine perfusion of kidneys."

The bench testing "demonstrates the ability of the KIDNEYvault device to maintain hypothermic preservation and pulsatile perfusion under varying environmental and transportation conditions of the donor kidney beyond the intended organ storage time of 24 hours." This is a general statement of meeting specifications rather than reporting specific performance metrics against defined acceptance criteria.

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

Not applicable. The document summarizes bench testing, not clinical studies with "test sets" in the context of diagnostic or interventional effectiveness. The provenance mentioned in the "Summary of Literature" is "relevant publications" from a "literature search" and does not refer to data provenance for a specific test set used in the device evaluation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This information is typically relevant for diagnostic AI/ML device evaluations where expert consensus is used to establish ground truth for image interpretation or disease classification. This document describes a medical device for organ preservation and transport, which does not involve such a process.

4. Adjudication Method

Not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is relevant for diagnostic devices involving human readers. The KIDNEYvault is an organ preservation and transport system.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a mechanical system with integrated datalogger and pump, not a standalone algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI/ML or diagnostic devices (e.g., pathology, outcomes data) is not directly relevant here. The evaluation focuses on the mechanical and thermodynamic performance of the system. The "ground truth" for verifying its function would be measured physical parameters (temperature, pressure, flow) under controlled conditions and comparison against engineering specifications. The conclusion section mentions "verification/validated" and "supported by the reference devices," suggesting that physical and operational characteristics were assessed against predetermined engineering and functional requirements derived from predicate devices and standards.

8. Sample Size for the Training Set

Not applicable. The device is not an AI/ML or diagnostic algorithm that undergoes a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reasons as point 8.

In summary, the provided FDA 510(k) document is a summary for a mechanical device used in organ preservation and transportation. It focuses on demonstrating substantial equivalence through a comparison of technological characteristics and basic bench testing (biocompatibility, electrical safety, mechanical verification of components, and performance validation). It does not detail specific acceptance criteria or performance metrics in the way a diagnostic or AI/ML device submission would, nor does it refer to clinical studies with test sets, expert-driven ground truth, or MRMC studies.

Summary

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October 23, 2024

Paragonix Technologies, Inc. Lucas Churchill Chief Innovation Officer 950 Winter Street, North Waltham, MA 02451

Re: K234060

Trade/Device Name: KIDNEYvault Portable Renal Perfusion System Regulation Number: 21 CFR§ 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDN Dated: October 21, 2024 Received: October 21, 2024

Dear Lucas Churchill:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Maura Rooney -S

Maura Rooney Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K234060

Device Name

KIDNEYvault Portable Renal Perfusion System

Indications for Use (Describe)

The Paragonix KIDNEYvault Portable Renal Perfusion System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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PARAGONIX®	510k SummaryParagonix Technologies' KidneyVault Device (K234060)
Submitter:	Paragonix Technologies Inc.950 Winter St, NorthWaltham, MA 02451
Contact Person:	Lucas ChurchillParagonix Technologies, Inc.950 Winter St, NorthWaltham, MA 02451617.306.7219 (phone)lucas@paragonixtechnologies.com
Date Prepared:	August 14, 2024
Trade Name:	KIDNEYvault Portable Renal Perfusion System
Classification Name:	Isolated kidney perfusion and transport system andaccessories
Classification:	Class II
Regulation Number:	21 CFR § 876.5880
Product Code:	KDN
Predicate Device:	LifePort Perfusion Kidney Transporter (K021362)
Reference Devices:	SherpaPak Kidney Transport System (SherpaPak KTSK180194)
	KIDNEY ASSIST - transport (K211333)

Device Description:

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following reference devices: SherpaPak KTS and KIDNEY Assist. To maintain the chilled temperature of the machine preservation solution, the subject KIDNE Yvault utilizes the same technology as the first reference device, SherpaPak KTS; whereas certain specifications for the subject device are based on the second reference device, KIDNEY Assist-transport.

The subject KIDNEYvault device consists of the following components:

1. KIDNEYvault SherpaCool Pouch and Ribbons Phase Change Material (PCM) (identical to the first reference device) to maintain temperature of the cold machine preservation solution and kidney throughout transportation. The KIDNEYvault device maintains the temperature between 4°C to 8°C throughout preservation and transportation.
1. KIDNEYvault Canister Assembly Proprietary hard shell, polycarbonate nested canister set for the packaging of the donor kidney within cold machine preservation solution and circulation of preservation solution through kidney vasculature.

The Canister Assembly incorporates a closed fluid pathway and connections to the donor kidney that draws cold machine preservation solution from the Inner Canister and circulates it through the renal artery of the kidney and exits through the renal vein or ureter back into the Inner Canister.

1. KIDNEYvault Shipper Outer transport shipper which comprises a protective and insulative package. The KIDNEYvault Shipper is a rigid, molded expanded polystyrene (EPS) insulative container into which the KIDNEYvault SherpaCool and KIDNEYvault Canister Assembly are placed. The maintenance of temperature of the donor kidney between 4°C to 8°C is assisted by the EPS insulation of the Shipper, providing insulation from the exterior environment to the interior components and KIDNEYvault SherpaCool.
  The KIDNEYvault Shipper incorporates a peristaltic pump used to circulate the machine preservation solution through the kidney vascular system. The pump is a peristaltic pump that circulates chilled machine preservation solution (drawn from the Inner Canister) into the renal

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k Summa

Paragonix Technologies' KidneyVault Device (K234060)

artery, through the kidney vasculature, and exiting back into the Inner Canister through the renal vein or ureter.

The KIDNEYvault Shipper includes a datalogger (connected to a temperature probe and pressure sensor) which records and displays the temperature of the machine preservation solution surrounding the donor kidney and the perfusion pressure within the fluid pathway.

1. KIDNEYvault Cannula The cannula connects to the renal artery of the kidney and the fluid circuit of the KIDNEYvault. There are multiple sizes of round cannulas and oval cannulas for different kidney anatomies.

Intended Use:

Donor kidney preservation and transportation

Indications for Use:

The Paragonix KIDNEYvault Portable Renal Perfusion System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours.

Technological Comparison with Predicate and Reference Devices

The following table compares the Paragonix KIDNEYvault device with the predicate and reference devices.

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510k Summary

Table 1. Substantial Equivalence Comparison Table
Characteristic	Subject Device	Predicate Device	First Reference Device	Second Reference Device
	KIDNEYvault	LifePort Perfusion KidneyTransporter (K021362)	SherpaPak Kidney TransportSystem (K180194)	KIDNEY ASSIST-transport(K211333)
Intended Use	Kidney preservation andtransportation.	Kidney preservation andtransportation.	Kidney preservation andtransportation.	Kidney preservation andtransportation.
Indicationsfor Use	The Paragonix KIDNEYvaultPortable Renal Perfusion System isintended to be used for the pulsatilehypothermic machine perfusion ofkidneys for the preservation,transportation and eventualtransplantation into a recipient usingcold storage solutions indicated foruse with this organ.The Paragonix KIDNEYvaultPortable Renal Perfusion Systemcan maintain the donor organstorage temperature between 4°Cand 8°C through 24 hours.Donor kidneys exceeding clinicallyaccepted hypothermic preservationtimes should be evaluated by thetransplant surgeon to determinetransplantability in accordance withaccepted clinical guidelines and inthe best medical interest of theintended recipient.	LifePort Kidney PerfusionTransporter (KTR) is intended to beused for the continuous hypothermicmachine perfusion of kidneys for thepreservation, transportation andeventual transplantation into arecipient.	The SherpaPak KidneyTransport System is intended tobe used for the statichypothermic preservation ofkidney organs duringtransportation and eventualtransplantation into a recipientusing cold storage solutionsindicated for use with this organ.The SherpaPak KidneyTransport System can maintainthe donor organ storagetemperature between 4°C and8°C through 24 hours.	The KIDNEY ASSIST-transportis intended to be used for thepulsatile hypothermicoxygenated machine perfusion ofkidneys for the preservation,transport and eventualtransplantation into a recipient.
RegulationNumber	876.5880	876.5880	876.5880	876.5880
Product Code	KDN	KDN	KDN	KDN
DeviceClassificationName	Isolated kidney perfusion andtransport system and accessories.	Isolated kidney perfusion andtransport system and accessories.	Isolated kidney perfusion andtransport system andaccessories.	Isolated kidney perfusion andtransport system andaccessories.
Table 1. Substantial Equivalence Comparison Table
Characteristic	Subject Device	Predicate Device	First Reference Device	Second Reference Device
	KIDNEYvault	LifePort Perfusion KidneyTransporter (K021362)	SherpaPak Kidney TransportSystem (K180194)	KIDNEY ASSIST-transport(K211333)
OperatingPrinciple	Hypothermic machine perfusionstorage and transportation (i.e.,HMP) of donor kidneys.	Hypothermic machine perfusionstorage and transportation (i.e.,HMP) of donor kidneys.	Static hypothermic storage (i.e.,Static Cold Storage) of donorkidneys.	Oxygenated hypothermicmachine perfusion storage andtransportation (i.e., HMP) ofdonor kidneys.
IntendedOrganStorage Time	Up to 24 hours.	Not expressly limited.	Through 24 hours.	Up to 24 hours.
Single Use	Entire system is single-use/single-patient only.	Organ contacting components aredisposable. Reusable componentsfor perfusion.	Entire system is single-use/single-patient only.	Organ contacting componentsare disposable. Reusablecomponents for perfusion.
Meets UNOSPolicy 161	Yes	Yes	Yes	Yes
Shipper	Outer molded EPS Shippingcontainer with wheels, extendinghandle, integrated mechanicalperfusion pump, and integrateddatalogger	Reusable transport system withincorporated mechanical perfusionpump and data display	Outer molded EPS Shippingcontainer with wheels, extendinghandle, and integrateddatalogger	Reusable transport system withincorporated mechanicalperfusion pump and data display
OrganContainer	Two single use, rigid, fluid-tightcanisters; the inner of whichcontains the cold machinepreservation solution in which thekidney is immersed. Organcontainer provides closed loopcircuit for machine preservation ofdonor kidney.	Two single use, rigid containers,inner of which contains the coldmachine preservation solution inwhich the kidney is immersed.Organ container provides closedloop circuit for machine preservationof donor kidney.	Two single use, rigid, fluid-tightcanisters: the inner of whichcontains the cold storagesolution in which the kidney isimmersed.	Two single use, rigid containers.Inner container holds donorkidney and is submerged in theouter container containing coldmachine preservation solution.Organ container provides closedloop circuit for machinepreservation of donor kidney.
PreservationTemperatureRegulation	4°-8° C using SherpaCool phasechange material (PCM) cold packs.	0.5°-8° C using a mixture of ice andwater.	4°-8° C using SherpaCool phasechange material (PCM) coldpacks.	2°-10° C using crushed ice.
Table 1. Substantial Equivalence Comparison Table
Characteristic	Subject Device	Predicate Device	First Reference Device	Second Reference Device
	KIDNEYvault	LifePort Perfusion KidneyTransporter (K021362)	SherpaPak Kidney TransportSystem (K180194)	KIDNEY ASSIST-transport(K211333)
Cannula	Various sizes and configurations toaccommodate renal arteries ofvarious diameters, kidneys withmultiple renal arteries, and renalarteries with an aortic patch.	Various sizes and configurations toaccommodate renal arteries ofvarious diameters, kidneys withmultiple renal arteries, and renalarteries with an aortic patch.	N/A	Various sizes and configurationsto accommodate renal arteries ofvarious diameters, kidneys withmultiple renal arteries, and renalarteries with an aortic patch.
MechanicalPerfusionPump	Peristaltic; Pulsatile perfusion; FixedSpeed. On/Off controls. Flowthrough donor kidney regulated byperfusion pressure. Not userconfigurable.	Peristaltic; Pulsatile perfusion. Flowthrough donor kidney regulated byperfusion pressure set by user.	N/A	Centrifugal; Pulsatile oxygenatedperfusion. Flow through donorkidney regulated by perfusionpressure set by user.
PreservationSolutionCapacity	1-2 Liters of hypothermic machineperfusion solution.	1 Liter of hypothermic machineperfusion solution.	4 Liters of hypothermic solution.	1 Liter of hypothermic machineperfusion solution.
Power	Alkaline batteries power dataloggerand mechanical perfusion pump.	AC/DC; Portable with Li-ion Battery.	Alkaline batteries powerdatalogger.	AC/DC; Portable with Li-ionBattery.
PerfusionPressureLimit	65mmHg	65mmHg	N/A	70mmHg
OperatingPerfusionPressure	0-50mmHg	10-65mmHg	N/A	0-50mmHg
PerfusionPressureRegulation	Mechanically Controlled	Software Controlled	N/A	Software Controlled
PreservationFluid	An FDA-cleared hypothermicmachine perfusion solution for donorkidneys.	An FDA-cleared hypothermicmachine perfusion solution fordonor kidneys.	An FDA-cleared hypothermicmachine perfusion solution for donor kidneys	An FDA-cleared hypothermicmachine perfusion solution fordonor kidneys.
Renal FlowOperatingRangeMeasurement	0 mL/min to 150 mL/min	0 mL/min to 200 mL/min	N/A	0 mL/min to 250 mL/min
Dimensions	20.25" L x 16" W x 18.5" H	24" L x 14.5" W x 14" H	20.25" L x 16" W x 18.5" H	23.6" L x 15.3" W x 13.4" H
Table 1. Substantial Equivalence Comparison Table
Characteristic	Subject Device	Predicate Device	First Reference Device	Second Reference Device
	KIDNEYvault	LifePort Perfusion KidneyTransporter (K021362)	SherpaPak Kidney TransportSystem (K180194)	KIDNEY ASSIST-transport(K211333)
Air BubblePrevention	Kidney is completely submerged in1-2 Liters of hypothermic machineperfusion solution with air removedfrom closed nested canisters.Mechanical bubble trap eliminatesair from perfusion circuit.	1 liter of hypothermic machineperfusion solution with room airabove preservation solution in non-sealed disposable fluid circuit.Perfusion circuit is primed toremove air.	Kidney is completely submergedin up to 4 Liters of hypothermicpreservation solution with airremoved from inner canister.	1 liter of hypothermic machineperfusion solution with room airabove preservation solution innon-sealed disposable fluidcircuit. Perfusion circuit isprimed to remove air.
Recordingand Display	Temperature and pressure displayintegrated in device.Bluetooth Low Energy EnabledDatalogger with optionaldownloadable mobile app.	Flow, temperature, pressure, andrenal resistance display integratedin device.	Temperature display integratedin device.Bluetooth Low Energy EnabledDatalogger with optionaldownloadable mobile app.	Flow, temperature, pressure, andrenal resistance displayintegrated in device.

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510k Summary

1 http://www.optn.transplant.hrsa.gov

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510k Summary

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510k Summary

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Summary of Literature

A literature search was conducted to analyze available clinical data on perfusion parameters for hypothermic machine perfusion and further assess available clinical literature for any evidence of limitations or specific parameters based on the type of donor kidneys (pediatric, extended criteria, etc.). All of the relevant publications reported perfusion pressures and flow rates within the subject device's specified pressure operating range. None clearly defined differential perfusion pressure or flow rate targets based on donor type.

Summary of Bench Testing:

. Biocompatibility testing in accordance with
- o ISO 10993-1: 2018 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process.
Electrical Safety and EMC testing in accordance with the following ● standards:
- o IEC 60601-1:2005, AMD1:2012, AMD2:2020: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety & Essential Performance Testing
- IEC 60601-1-2:2020 (ed. 4.1), Medical Electrical Equipment Part 1 o 2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests
- IEC 60601-1-6:2010, AMD1:2013, AMD2:2020: Medical Electrical o Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
- O IEC 62366-1:2015, AMD1:2020: Medical Devices - Part 1: Application of Usability Engineering to Medical Devices
- FCC 47CFR Part 15.247:09: Radiated spurious emissions O verification for a pre-certified radio continuous compliant when it incorporated into a host device
KIDNEYvault Shipper Verification ●
- Verification demonstrates the KIDNEYvault Shipper meets O specifications beyond the intended organ storage time of 24 hours following exposure to worst-case shipping and handling.
KIDNEYvault Canister Assembly Verification ●
- Verification demonstrates the KIDNEYvault Canister Assembly meets o specifications following exposure to sterilization and accelerated aging simulating real-time aging.

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510k Summary

Paragonix Technologies' KidneyVault Device (K234060)

KIDNEYvault Cannula Assembly Verification
- Verification demonstrates the KIDNEYvault Cannula meets o specifications following exposure to sterilization and accelerated aging simulating real-time aging.
- KIDNEYvault Sterile Barrier Validation
  - · Verification demonstrates the ability of the KIDNEYvault sterile barrier system to maintain sterility following exposure to sterilization and accelerated aging simulating real-time aging.
- KIDNEYvault Performance Validation ●
  - Validation demonstrates the ability of the KIDNEYvault device to о maintain hypothermic preservation and pulsatile perfusion under varying environmental and transportation conditions of the donor kidney beyond the intended organ storage time of 24 hours.

Conclusion

By design, the subject device is substantially equivalent to the predicate device based on equivalent intended use and principles of operation for pulsatile hypothermic machine perfusion within the donor kidney. The differences in the technological characteristics between the subject and predicate devices, as explained, verified/validated, and supported by the reference devices, do not lead to a different question of safety or effectiveness. The subject device is therefore substantially equivalent to the predicate device.

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).

Maura Rooney -S

Indications for Use

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Device Description:

k Summa

Intended Use:

Indications for Use:

Technological Comparison with Predicate and Reference Devices

510k Summary

510k Summary

510k Summary

510k Summary

Summary of Literature

Summary of Bench Testing:

510k Summary

Conclusion

§ 876.5880 Isolated kidney perfusion and transport system and accessories.

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