(306 days)
Not Found
No
The description focuses on mechanical components, temperature control, and basic data logging (temperature and pressure). There is no mention of AI/ML algorithms for analysis, prediction, or control.
No.
The device is intended for the preservation and transportation of kidneys for eventual transplantation, not for direct therapeutic treatment of a patient.
No
The device is designed for the preservation and transportation of kidneys for transplantation, not for diagnosing medical conditions. While it monitors temperature and pressure, this is for organ preservation, not patient diagnosis.
No
The device description clearly outlines multiple hardware components including a mechanical pump, fluid circuit, canisters, shipper, phase change material, and a datalogger with temperature and pressure sensors. The performance studies also include testing related to electrical safety, EMC, and mechanical verification of these hardware components.
Based on the provided information, the Paragonix KIDNEYvault Portable Renal Perfusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the preservation, transportation, and eventual transplantation of kidneys. This is a process related to organ viability and preparation for surgical implantation, not for diagnosing a condition or disease in a patient using a sample from the body.
- Device Description: The device is a mechanical system designed to perfuse and maintain the temperature of a donor organ outside of the body. It involves a pump, fluid circuit, temperature control, and monitoring of physical parameters (temperature and pressure). It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device performing any tests or analyses on the kidney or any associated fluids to diagnose a condition or provide information about the health status of the organ in a diagnostic sense. The monitoring of temperature and pressure is for maintaining the organ's viability during transport, not for diagnostic purposes.
- Predicate and Reference Devices: The predicate and reference devices mentioned (LifePort Kidney Perfusion Transporter, SherpaPak Kidney Transport System, KIDNEY ASSIST - transport) are also systems designed for organ preservation and transport, not for in vitro diagnostic testing.
In summary, the Paragonix KIDNEYvault is a medical device used for the preservation and transport of a donor organ, which is a therapeutic and logistical function, not a diagnostic one.
N/A
Intended Use / Indications for Use
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.
Product codes
KDN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidneys / renal artery / renal vein / ureter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
transplant surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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:
- 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 1-2: 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 Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
- 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 verification for a pre-certified radio continuous compliant when it incorporated into a host device
- KIDNEYvault Shipper Verification: Verification demonstrates the KIDNEYvault Shipper meets 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 specifications following exposure to sterilization and accelerated aging simulating real-time aging.
- KIDNEYvault Cannula Assembly Verification: Verification demonstrates the KIDNEYvault Cannula meets 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LifePort Perfusion Kidney Transporter (K021362)
Reference Device(s)
SherpaPak Kidney Transport System (SherpaPak KTS K180194), KIDNEY ASSIST - transport (K211333)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.
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).
1
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.
2
3
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
3
Indications for Use
Submission Number (if known)
Device Name
KIDNEYvault Portable Renal Perfusion System
Indications for Use (Describe)
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.
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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4
| PARAGONIX® | 510k Summary
Paragonix Technologies' KidneyVault Device (K234060) |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Paragonix Technologies Inc.
950 Winter St, North
Waltham, MA 02451 |
| Contact Person: | Lucas Churchill
Paragonix Technologies, Inc.
950 Winter St, North
Waltham, MA 02451
617.306.7219 (phone)
lucas@paragonixtechnologies.com |
| Date Prepared: | August 14, 2024 |
| Trade Name: | KIDNEYvault Portable Renal Perfusion System |
| Classification Name: | Isolated kidney perfusion and transport system and
accessories |
| 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 KTS
K180194) |
| | KIDNEY ASSIST - transport (K211333) |
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
5
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:
-
- 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
- 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.
6
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.
-
- 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 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.
Technological Comparison with Predicate and Reference Devices
The following table compares the Paragonix KIDNEYvault device with the predicate and reference devices.
7
510k Summary
| Table 1. Substantial Equivalence Comparison Table | ||||
|---|---|---|---|---|
| Characteristic | Subject Device | Predicate Device | First Reference Device | Second Reference Device |
| KIDNEYvault | LifePort Perfusion Kidney | |||
| Transporter (K021362) | SherpaPak Kidney Transport | |||
| System (K180194) | KIDNEY ASSIST-transport | |||
| (K211333) | ||||
| Intended Use | Kidney preservation and | |||
| transportation. | Kidney preservation and | |||
| transportation. | Kidney preservation and | |||
| transportation. | Kidney preservation and | |||
| transportation. | ||||
| Indications | ||||
| for Use | 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. | LifePort Kidney Perfusion | |||
| Transporter (KTR) is intended to be | ||||
| used for the continuous hypothermic | ||||
| machine perfusion of kidneys for the | ||||
| preservation, transportation and | ||||
| eventual transplantation into a | ||||
| recipient. | The SherpaPak 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 SherpaPak Kidney | ||||
| Transport System can maintain | ||||
| the donor organ storage | ||||
| temperature between 4°C and | ||||
| 8°C through 24 hours. | The KIDNEY ASSIST-transport | |||
| is intended to be used for the | ||||
| pulsatile hypothermic | ||||
| oxygenated machine perfusion of | ||||
| kidneys for the preservation, | ||||
| transport and eventual | ||||
| transplantation into a recipient. | ||||
| Regulation | ||||
| Number | 876.5880 | 876.5880 | 876.5880 | 876.5880 |
| Product Code | KDN | KDN | KDN | KDN |
| Device | ||||
| Classification | ||||
| Name | Isolated kidney perfusion and | |||
| transport system and accessories. | Isolated kidney perfusion and | |||
| transport system and accessories. | Isolated kidney perfusion and | |||
| transport system and | ||||
| accessories. | Isolated kidney perfusion and | |||
| transport system and | ||||
| accessories. | ||||
| Table 1. Substantial Equivalence Comparison Table | ||||
| Characteristic | Subject Device | Predicate Device | First Reference Device | Second Reference Device |
| KIDNEYvault | LifePort Perfusion Kidney | |||
| Transporter (K021362) | SherpaPak Kidney Transport | |||
| System (K180194) | KIDNEY ASSIST-transport | |||
| (K211333) | ||||
| Operating | ||||
| Principle | Hypothermic machine perfusion | |||
| storage and transportation (i.e., | ||||
| HMP) of donor kidneys. | Hypothermic machine perfusion | |||
| storage and transportation (i.e., | ||||
| HMP) of donor kidneys. | Static hypothermic storage (i.e., | |||
| Static Cold Storage) of donor | ||||
| kidneys. | Oxygenated hypothermic | |||
| machine perfusion storage and | ||||
| transportation (i.e., HMP) of | ||||
| donor kidneys. | ||||
| Intended | ||||
| Organ | ||||
| Storage 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 are | |||
| disposable. Reusable components | ||||
| for perfusion. | Entire system is single- | |||
| use/single-patient only. | Organ contacting components | |||
| are disposable. Reusable | ||||
| components for perfusion. | ||||
| Meets UNOS | ||||
| Policy 161 | Yes | Yes | Yes | Yes |
| Shipper | Outer molded EPS Shipping | |||
| container with wheels, extending | ||||
| handle, integrated mechanical | ||||
| perfusion pump, and integrated | ||||
| datalogger | Reusable transport system with | |||
| incorporated mechanical perfusion | ||||
| pump and data display | Outer molded EPS Shipping | |||
| container with wheels, extending | ||||
| handle, and integrated | ||||
| datalogger | Reusable transport system with | |||
| incorporated mechanical | ||||
| perfusion pump and data display | ||||
| Organ | ||||
| Container | Two single use, rigid, fluid-tight | |||
| canisters; the inner of which | ||||
| contains the cold machine | ||||
| preservation solution in which the | ||||
| kidney is immersed. Organ | ||||
| container provides closed loop | ||||
| circuit for machine preservation of | ||||
| donor kidney. | Two single use, rigid containers, | |||
| inner of which contains the cold | ||||
| machine preservation solution in | ||||
| which the kidney is immersed. | ||||
| Organ container provides closed | ||||
| loop circuit for machine preservation | ||||
| of donor kidney. | Two single use, rigid, fluid-tight | |||
| canisters: the inner of which | ||||
| contains the cold storage | ||||
| solution in which the kidney is | ||||
| immersed. | Two single use, rigid containers. | |||
| Inner container holds donor | ||||
| kidney and is submerged in the | ||||
| outer container containing cold | ||||
| machine preservation solution. | ||||
| Organ container provides closed | ||||
| loop circuit for machine | ||||
| preservation of donor kidney. | ||||
| Preservation | ||||
| Temperature | ||||
| Regulation | 4°-8° C using SherpaCool phase | |||
| change material (PCM) cold packs. | 0.5°-8° C using a mixture of ice and | |||
| water. | 4°-8° C using SherpaCool phase | |||
| change material (PCM) cold | ||||
| packs. | 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 Kidney | |||
| Transporter (K021362) | SherpaPak Kidney Transport | |||
| System (K180194) | KIDNEY ASSIST-transport | |||
| (K211333) | ||||
| Cannula | Various sizes and configurations to | |||
| accommodate renal arteries of | ||||
| various diameters, kidneys with | ||||
| multiple renal arteries, and renal | ||||
| arteries with an aortic patch. | Various sizes and configurations to | |||
| accommodate renal arteries of | ||||
| various diameters, kidneys with | ||||
| multiple renal arteries, and renal | ||||
| arteries with an aortic patch. | N/A | Various sizes and configurations | ||
| to accommodate renal arteries of | ||||
| various diameters, kidneys with | ||||
| multiple renal arteries, and renal | ||||
| arteries with an aortic patch. | ||||
| Mechanical | ||||
| Perfusion | ||||
| Pump | Peristaltic; Pulsatile perfusion; Fixed | |||
| Speed. On/Off controls. Flow | ||||
| through donor kidney regulated by | ||||
| perfusion pressure. Not user | ||||
| configurable. | Peristaltic; Pulsatile perfusion. Flow | |||
| through donor kidney regulated by | ||||
| perfusion pressure set by user. | N/A | Centrifugal; Pulsatile oxygenated | ||
| perfusion. Flow through donor | ||||
| kidney regulated by perfusion | ||||
| pressure set by user. | ||||
| Preservation | ||||
| Solution | ||||
| Capacity | 1-2 Liters of hypothermic machine | |||
| perfusion solution. | 1 Liter of hypothermic machine | |||
| perfusion solution. | 4 Liters of hypothermic solution. | 1 Liter of hypothermic machine | ||
| perfusion solution. | ||||
| Power | Alkaline batteries power datalogger | |||
| and mechanical perfusion pump. | AC/DC; Portable with Li-ion Battery. | Alkaline batteries power | ||
| datalogger. | AC/DC; Portable with Li-ion | |||
| Battery. | ||||
| Perfusion | ||||
| Pressure | ||||
| Limit | 65mmHg | 65mmHg | N/A | 70mmHg |
| Operating | ||||
| Perfusion | ||||
| Pressure | 0-50mmHg | 10-65mmHg | N/A | 0-50mmHg |
| Perfusion | ||||
| Pressure | ||||
| Regulation | Mechanically Controlled | Software Controlled | N/A | Software Controlled |
| Preservation | ||||
| Fluid | An FDA-cleared hypothermic | |||
| machine perfusion solution for donor | ||||
| kidneys. | An FDA-cleared hypothermic | |||
| machine perfusion solution for | ||||
| donor kidneys. | An FDA-cleared hypothermic | |||
| machine perfusion solution for donor kidneys | An FDA-cleared hypothermic | |||
| machine perfusion solution for | ||||
| donor kidneys. | ||||
| Renal Flow | ||||
| Operating | ||||
| Range | ||||
| Measurement | 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 Kidney | |||
| Transporter (K021362) | SherpaPak Kidney Transport | |||
| System (K180194) | KIDNEY ASSIST-transport | |||
| (K211333) | ||||
| Air Bubble | ||||
| Prevention | Kidney is completely submerged in | |||
| 1-2 Liters of hypothermic machine | ||||
| perfusion solution with air removed | ||||
| from closed nested canisters. | ||||
| Mechanical bubble trap eliminates | ||||
| air from perfusion circuit. | 1 liter of hypothermic machine | |||
| perfusion solution with room air | ||||
| above preservation solution in non- | ||||
| sealed disposable fluid circuit. | ||||
| Perfusion circuit is primed to | ||||
| remove air. | Kidney is completely submerged | |||
| in up to 4 Liters of hypothermic | ||||
| preservation solution with air | ||||
| removed from inner canister. | 1 liter of hypothermic machine | |||
| perfusion solution with room air | ||||
| above preservation solution in | ||||
| non-sealed disposable fluid | ||||
| circuit. Perfusion circuit is | ||||
| primed to remove air. | ||||
| Recording | ||||
| and Display | Temperature and pressure display | |||
| integrated in device. | ||||
| Bluetooth Low Energy Enabled | ||||
| Datalogger with optional | ||||
| downloadable mobile app. | Flow, temperature, pressure, and | |||
| renal resistance display integrated | ||||
| in device. | Temperature display integrated | |||
| in device. | ||||
| Bluetooth Low Energy Enabled | ||||
| Datalogger with optional | ||||
| downloadable mobile app. | Flow, temperature, pressure, and | |||
| renal resistance display | ||||
| integrated in device. |
8
510k Summary
1 http://www.optn.transplant.hrsa.gov
9
510k Summary
10
510k Summary
11
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.
12
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.