KIDNEY ASSIST-transport

K211333 · Xvivo Perfusion AB · KDN · Jan 20, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K211333
• Device Name: KIDNEY ASSIST-transport
• Applicant: Xvivo Perfusion AB
• Product Code: KDN · Gastroenterology, Urology
• Decision Date: Jan 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5880
• Device Class: Class 2

Indications for Use

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.

Device Story

Portable pump system for hypothermic pulsatile perfusion of donor kidneys; maintains organ viability during transport from donor to recipient. System comprises reusable control unit and single-use disposable perfusion set (reservoir, kidney holder, cannula, oxygenator, pump head, pressure sensor, tubing). Operates via centrifugal pump driven by electromotor; provides pressure-controlled perfusion using University of Wisconsin Machine Perfusion Solution (UW-MP). Cooling achieved via passive ice-filled enclosure; oxygenation provided by hollow fiber membrane oxygenator using medical oxygen. Device monitors and displays perfusion parameters (pressure, flow, resistance, temperature) via integrated firmware. Used by transplant clinicians; supports up to 24-hour application period. Benefits include improved preservation, reduced post-operative complications, and lower rejection rates compared to non-oxygenated cold storage.

Clinical Evidence

Investigator-initiated clinical study (paired design) compared oxygenated (HMPO2) vs. non-oxygenated (HMP) perfusion in 212 recipients (106 per arm). Donors aged 50+ (38% female, 62% male). Primary endpoints: kidney function and graft survival at 1 year. Results: HMPO2 significantly improved outcomes, reduced severe post-operative complications, and demonstrated 44% fewer rejections compared to standard HMP.

Technological Characteristics

Portable thermo-isolated enclosure; centrifugal pump; 4x 11.1V Li-ion batteries or auxiliary power. Materials validated per ISO 10993. Sterilization via Ethylene Oxide (ISO 11135). Connectivity: numerical display of perfusion parameters. Software: IEC 62304 Class B, major level of concern. Dimensions: 600mm x 390mm x 340mm; Weight: 25.3 kg.

Indications for Use

Indicated for pulsatile hypothermic oxygenated machine perfusion of donor kidneys to facilitate preservation and transport prior to transplantation in recipients.

Regulatory Classification

Identification

An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.

Predicate Devices

• Waves (K111521)

Submission Summary (Full Text)

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January 20, 2022

Organ Assist Products B.V. % Kathleen Johnson President (Regulatory Affairs Consultant) Medical Device Approvals, Inc. 104 E. Harrison Ave. Fairfield, Iowa 52556

Re: K211333

Trade/Device Name: KIDNEY ASSIST-transport Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: Class II Product Code: KDN Dated: December 20, 2021 Received: December 20, 2021

Dear Kathleen Johnson:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-reporting-

mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Gema Gonzalez Acting 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

510(k) Number (if known) K211333

Device Name KIDNEY ASSIST-transport

Indications for Use (Describe)

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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

## Submitter of 510(k)

| Owner's name:<br>Address: | Organ Assist Products B.V. (an affiliation of XVIVO Perfusion AB)<br>Bornholmstraat 84,<br>9723AZ Groningen<br>The Netherlands |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Arjan van der Plaats |
| Title: | Chief Technology Officer |
| Phone: | [phone] |
| E-mail: | [e-mail] |
| Official Correspondent: | Kathleen Johnson |
| Title: | Regulatory Affairs Consultant |
| Phone: | 610-527-0585 |

[e-mail] E-mail:

April 30, 2021

Date Prepared:

# Device Name

| Trade/proprietary name: | KIDNEY ASSIST-transport |
|-------------------------|-----------------------------------------------------------------------------------|
| Common/usual name: | Transportable kidney perfusion system |
| Classification name: | Isolated kidney perfusion and transport system and accessories (21 CFR §876.5880) |
| Product code: | KDN |
| Regulatory Class: | Class II |

# Device Description

The KIDNEY ASSIST-transport system of Organ Assist Products B.V. is a portable pump system that continuously allows hypothermic pulsatile perfusion of donor kidneys with oxygenated preservation solution during transport from donor to recipient in transplantation procedures. The system consists of the reusable KIDNEY ASSISTtransport device and a disposable KIDNEY ASSIST-transport perfusion set. The characteristics of the KIDNEY ASSIST-transport are:

- Pulsatile oxygenated hypothermic machine perfusion of donor kidneys ●
- Transportable hypothermic machine perfusion technique
- Hypothermic preservation and reconditioning device
- Improved preservation compared to cold storage in DBD, ECD and DCD
- Easy to install disposable perfusion set

The KIDNEY ASSIST-transport device is a thermo isolated enclosure wherein the kidneys are cooled passively by ice and a separate compartment holding the electronics, batteries and a dedicated medical oxygen cylinder. The device has sufficient battery power, holds enough oxygen and ice for an application period of 24 hours of hypothermic oxygenated perfusion. Pulsatile perfusion is generated by a rotary pump driven by an electromotor and is pressure controlled. User-friendly firmware allows the user to change perfusion parameters. Settings and results of the perfusion measurements are numerically displayed on the top of the enclosure. The single-use disposable KIDNEY ASSIST-transport perfusion set contains an easy to install preassembled perfusion cartridge for use in combination with the KIDNEY ASSIST-transport device. The purpose of the KIDNEY ASSIST-transport Perfusion Set is to perfuse human organs to be transplanted with an approved pump perfusion solution. Its set contains a reservoir, kidney holder, cannula, oxygenator, pump head, pressure sensor and compatible tubing. Pulsatile perfusion is maintained by the centrifugal pump head, pulsating the perfusion

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solution from the reservoir through the oxygenator to the kidney holder in the reservoir. Oxygenation is performed by the hollow fiber membrane oxygenator which facilitates the gas exchange with the perfusion solution. All kidneys will be perfused with University of Wisconsin Machine Perfusion Solution (UW-MP).

KIDNEY ASSIST-transport allows transportable machine perfusion to bridge the timespan between procurement and transplantation of kidneys.

#### Application period

The 'KIDNEY ASSIST-transport' is a portable pump system that continuously allows hypothermic pulsatile perfusion of donor kidneys with oxygenated preservation solution during transport from donor to recipient in transplantation procedures for a period up to 24 hours.

#### Indications for Use

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.

# Legally Marketed Predicate Device (K111521)

The KIDNEY ASSIST-transport (KAt) has been shown to be substantially equivalent to the legally marketed predicate device:

Trade/proprietary name: Waves (Waters Medical Systems LLC)

Common name: Renal Preservation Systems Classification name: Isolated kidney perfusion and transport system and accessories (21 CFR §876.5880) Product code: KDN Regulatory Class: Class II 510(k) number: K111521

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# Substantial equivalence summary

The KIDNEY ASSIST-transport can be considered substantial equivalent to the legally marketed predicate device (K111521, Waves system manufactured by Waters Medical Systems LLC).

| | Subject device: KIDNEY ASSIST-transport<br>Image: KIDNEY ASSIST-transport | Predicate device: Waves<br>Image: Waves |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Organ Assist Products b.v. | Waters Medical Systems LLC |
| Registration | FDA 510(k): pending as per this submission | FDA 510(k): K111521 |
| Intended use | The KIDNEY ASSIST-transport is intended to be used for<br>the pulsatile hypothermic oxygenated machine perfusion<br>of kidneys for the preservation, transport and eventual<br>transplantation into a recipient. | The Waves device is intended to be used for the<br>pulsatile hypothermic machine perfusion of kidneys for<br>the preservation, transport and eventual<br>transplantation into a recipient. |
| Configuration | Device in combination with sterile disposable set. | Device in combination with sterile disposable set. |
| Sterilization | Ethylene Oxide (ISO 11135) | Ethylene Oxide (ISO 11135) |
| Materials | Validated against ISO 10993 | Validated against ISO 10993 |
| Perfusion pump | Centrifugal pump | Displacement pump |
| Perfusion mode | Pulsatile | Pulsatile |
| Perfusion<br>control | Pressure control, automated control features | Pressure control, automated control features |
| Software | Validated Embedded software and user interface (watch<br>dog safety) | Validated Embedded software and user interface<br>(watch dog safety) |
| Coolant | Crushed ice (6 L) | Crushed ice and water (5 L) |
| Power source | Battery 4x 11.1 V Li-ion<br>or auxiliary power | Battery 4x 11.1 V Li-ion<br>or auxiliary power |
| Perfusion rates | Pressure: 0-50 mmHg<br>Flow: 0-250 mL/min<br>Temp: 2°C -10°C | Pressure: 0-100 mmHg<br>Flow: 0-250 mL/min<br>Temp: 3°C-10°C |
| Duration | Up to 24 hours | Up to 24 hours with extra ice filling |
| Perfusate | Hypothermic machine perfusion solution | Hypothermic machine perfusion solution |
| Oxygenation | Medical oxygen<br>100 mL/min gas flow<br>Hollow fibre oxygenator | Air or other gas mixtures<br>Up to 1.5-2 L/min gas flow<br>Silicone membrane oxygenator |
| Dimensions | 23.6″x15.3″x13.4″<br>600mm x 390mm x 340mm | 25.5″x16.25″x13.25″<br>(648 mm x 413 mm x 337 mm) |
| Weight | 55.8 lbs (25.3 kg) | 57 lbs (26 kg) |
| Storage<br>conditions | T: 5 - 40°C<br>H: 5 - 85 %RH | T: 0°C tot 40°C<br>H: 0-95% |

A detailed comparison overview is presented below

#### Intended use

Both KIDNEY ASSIST-transport and the predicate device (K111521) are intended to be used for the pulsatile hypothermic machine perfusion of kidneys for the preservation, transport, and eventual transplantation into a recipient. Both systems oxygenate the cold perfusion that is perfused through the kidney; however, this is not included in the Intended Use statement of WAVES. For KIDNEY ASSIST-transport, the oxygenation intention is included for clarification.

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### Principle of Operation

Principle of operation is equivalent. Both KIDNEY ASSIST-transport and the predicate device (K111521) consist of a pump unit and a single-use disposable perfusion set/cassette. UW-MP solution is pumped through the kidney while being cooled passively by ice and oxygenated through an oxygenator. Perfusion parameters (pressure, flow, resistance and temperature) are continuously monitored, displayed and stored, safeguarded by an alarm system. The systems incorporate embedded software for user interface and safety and control mechanisms.

#### Confiquration characteristics

Both KIDNEY ASSIST-transport and the predicate device (K111521) are comprised of reusable control/pump unit in combination with a single-use sterile perfusion set/cassette.

### Perfusion Characteristics

Both KIDNEY ASSIST-transport and the predicate device (K111521) provide pressure-controlled pulsatile perfusion to the kidney. Perfusion characteristics on pressure are similar. The predicate device (K111521) WAVES allows a higher user-set pressure than the KIDNEY ASSIST-transport (100 mmHg vs 50 mmHg). In most clinical trials a mean pressure of 25 mmHg is used and demonstrated safety and efficacy of the technology. Therefore, the 50-mmHg limit in the KIDNEY ASSIST-transport does not induce new safety and effectiveness questions.

In addition, the predicate device (K111521) uses a displacement pump, where the KIDNEY ASSIST-transport incorporates a centrifugal pump to provide perfusion to the kidney. Since the perfusion parameters (pulsatile pressure and flow) are similar, this has no influence on the perfusion reaching the kidney. In principle, the centrifugal pump is considered a safer alternative for the displacement pump with respect to pressure build as it is an open pump system. Application period of both devices is 24 hours.

#### Cooling characteristics

Both KIDNEY ASSIST-transport and the predicate device (K111521) provides cooling by melting ice that is added to the insulated device.

#### Power source characteristics

Power source is identical in both systems: 4 Li-ion batteries, or auxiliary power supply can be used. The WAVES batteries are automatically charged while the device is on auxiliary power.

For the KIDNEY ASSIST-transport, the batteries must be charged using an external charger. As this means that less electrical power is needed inside the device, this situation is considered safer.

### Oxygenation characteristics

Both KIDNEY ASSIST-transport and the predicate device (K111521) incorporate oxygenation of the cold perfusion solution that is pumped through the kidney. Both systems actively oxygenated the solution by means of an oxygenator that is part of the sterile single-use perfusion set/cassette. The oxygenator is part of the preassembled single-use sterile perfusion set.

Both systems use oxygen to oxygenate, where the WAVES also allows other gas mixtures.

# Performance Data

# Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on KIDNEY ASSIST-transport. The system complies with the IEC 60601-1:2012 Edition 3.1, ANSI/AAMI ES60601-1:2005/(R)2012 standards for safety and the IEC 60601-1-2:2007 + AC:2010 standard for EMC.

# Software

The KIDNEY ASSIST-transport contains software that shows compliance with IEC 62304:2006. The software for this device is classified as IEC 62304 Class B software and is considered as a "major" level of concern in the US.

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#### Biocompatibility testing

The biocompatibility evaluation for the KIDNEY ASSIST-transport was conducted and shows compliance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process."

#### Human factors and usability

The usability evaluation is conducted on the KIDNEY ASSIST-transport. The system complies with the IEC 62366:2008 application of usability engineering to medical devices and ANSI/AAMI HE75 human factors engineering - design of medical devices.

#### Sterility

The sterility evaluation is conducted on the KIDNEY ASSIST-transport Perfusion set. The system complies with the ISO 11135:2014 for Ethylene Oxide sterilization of health-care products (SAL 10°) and ISO 10993-7:2008 for Ethylene oxide sterilization residuals.

#### Packaging and shelf life

Packaging for the sterile components complies with ISO 11607:2019 packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.

Shelf life for the sterile components complies with ASTM F 1980-16:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

#### Bench testing

Performance testing -Bench include tests on functional performance, transport and storage validation and usability validation for the complete system.

#### Investigator Initiated Clinical Data

The published data of an investigator-initiated clinical study supports the claimed Performance and benefit of the KIDNEY ASSIST-transport. The KIDNEY ASSIST-transport provides safe hypothermic machine perfusion of kidneys, while adding beneficial oxygen during perfusion.

In detail, the objective of the investigator-initiated clinical study was to investigate the effects of oxygenation in HMP (hypothermic machine perfusion). Following standard organ procurement, kidney pairs (donors aged 50 or older, 38 % Female and 62 % Male) were cannulated and connected to the KIDNEY ASSIST-transport and perfused with UW-MP solution. Kidney pairs were randomly assigned to oxygenated (HMPQ2) or nonoxygenated (HMP) perfusion in a paired design. In total 106 recipients were present in each study arm and followed one year post transplantation. Baseline characteristics were similar in both groups (HMPO) : Age 60 years on average, 35 % Female, 65 % Male; HMP: Age 61 years on average, 37 % Female, 63 % Male). No data on ethnicity or race were reported.

The study results show that the addition of oxygen to HMP improves the outcomes compared to standard nonoxygenated HMP on kidney function and graft survival at 1 year after transplantation. HMPO2 significantly reduces the number of severe post-operative complications (including (S)AE) and even leads to a drastic 44% fewer rejections of the kidney after transplantation.

#### Conclusion

Based on the intended use, indications for use, principle of operall technological characteristics the KIDNEY ASSIST-transport has been shown to be substantially equivalent to the predicate device (K111521). Results of validation (including performance data) did not raise any questions on safety and effectiveness. It is concluded that the KIDNEY ASSIST-transport has been shown to be substantially equivalent to the legally marketed predicate device (K111521).

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