Perfadex Plus

K170826 · Xvivo Perfusion AB · KDN · Jun 22, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K170826
• Device Name: Perfadex Plus
• Applicant: Xvivo Perfusion AB
• Product Code: KDN · Gastroenterology, Urology
• Decision Date: Jun 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5880
• Device Class: Class 2

Indications for Use

Perfadex Plus is indicated for the flushing, static cold storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Device Story

Perfadex Plus is a pre-buffered, extracellular solution containing dextran 40 and calcium; used for rapid cooling, perfusion, and static cold storage of isolated donor lungs. It replaces the predicate Perfadex, which required manual buffering with THAM and manual calcium supplementation at the clinic. The device is supplied in an 'Ecobag' featuring a 'Click System' connector for sterile connection, replacing the traditional spike port. It is used by transplant clinicians in a clinical or surgical setting to preserve donor lungs during transport. By providing a ready-to-use, pre-buffered, and calcium-supplemented solution, it simplifies preparation, reduces potential for manual errors, and maintains physiological electrolyte balance, ultimately supporting lung viability for transplantation.

Clinical Evidence

Clinical evidence derived from a federally mandated registry (UNOS) and a clinical trial. Comparison of Perfadex supplemented with THAM and calcium ions (PTHCa) versus Perfadex without calcium. Results demonstrate substantial equivalence in patient survival outcomes, indicating that supplementation with THAM and calcium does not increase patient risk.

Technological Characteristics

Pre-buffered, extracellular solution containing dextran 40 and calcium. Packaged in an 'Ecobag' with a 'Click System' connector. Sterile barrier maintenance tested per ISO 11607. Mechanical testing includes pressure, leakage, drop resistance, penetration, tensile strength, and flow testing. Stability testing covers pH, calcium, osmolality, dextran, glucose, and particulate analysis.

Indications for Use

Indicated for flushing, static cold storage, and transport of isolated donor lungs prior to transplantation.

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

• Perfadex with THAM (K091989)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 22, 2018

XVIVO Perfusion AB % Kathleen Johnson President Medical Device Approvals, Inc. P.O. Box 421 Fairfield, Iowa 52556

Re: K170826

Trade/Device Name: Perfadex Plus Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: Class II Product Code: KDN Dated: May 24, 2018 Received: May 25, 2018

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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### Page 2 - Kathleen Johnson

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Carolyn Y. Neuland -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K170826

Device Name Perfadex Plus

Indications for Use (Describe)

Perfadex Plus is indicated for the flushing, static cold storage and transportation of isolated lungs after removal from the donor in preparation for 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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## Section 7. 510(k) SUMMARY

| DATE: | June 22, 2018 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | XVIVO Perfusion AB<br>Mässans gata 10<br>SE-41251 Göteborg<br>Sweden<br><br>Contact: Kathleen Johnson<br>Regulatory Affairs Consultant<br>610-527-0585<br>[e-mail] |
| REGULATION NAME: | Isolated kidney perfusion and transport system and accessories |
| COMMON OR<br>USUAL NAME: | Perfadex Plus® |
| REGULATION<br>NUMBER | 21 CFR §876.5880 |
| CLASSIFICATION: | Class II |
| PRODUCT CODE | KDN |
| PREDICATE DEVICE: | Perfadex® with THAM K091989 |
| DESCRIPTION: | Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40<br>containing calcium used for rapid cooling, perfusion and storage of lungs in<br>connection with transplantation. |
| INDICATIONS FOR USE: | Perfadex Plus is indicated for the flushing, static cold storage and<br>transportation of isolated lungs after removal from the donor in<br>preparation for eventual transplantation into a recipient. |
| SUBSTANTIAL<br>EQUIVALENCE: | Perfadex® Plus is substantially equivalent to the predicate Perfadex®<br>with THAM cleared under K091989. The devices have the same<br>intended use.<br><br>The differences between Perfadex® Plus and the predicate device<br>Perfadex® with THAM (K091989) are the following:<br><ul><li>The subject device Perfadex® Plus, is buffered with<br/>Tromethamine (THAM) and does not require buffering prior<br/>use, while the predicate device Perfadex with THAM<br/>(K091989) has a slightly acidic pH and requires buffering prior<br/>use. The predicate device is supplied with a sterile 50 ml glass<br/>bottle containing THAM.</li><li>The subject device Perfadex® Plus contains calcium to further<br/>mimic extracellular plasma concentration of electrolytes<br/>while the predicate device (K091989) does not contain<br/>calcium which is therefore often added at the clinics prior to<br/>use.</li><li>Perfadex and Perfadex Plus both are packaged in the Ecobag<br/>however the Perfadex Plus Ecobag utilizes the "Click System"</li></ul> |

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instead of a spike port. The connection to the bag is made with a connector that "clicks" onto the port rather than by inserting a spike into the rubber stopper as in the Perfadex Ecobag. Complete information on the "Click System" can be found in the Device Description.

- Package testing to ensure maintenance of the sterile barrier has been performed according to ISO 11607. The bags have been tested by the manufacturer for bag welding, port system welding, tube welding, and fill volume.
#### NONCLINICAL TESTING:

Nonclinical testing including biological safety including:

- · Cytotoxicity
- Intracutaneous Irritation
- · Sensitization
- · Hemolysis
- · Material Mediated Pyrogenicity
- · Leachables

As well as Stability Studies including: •pH •Calcium

-
- •Osmolality
- •Dextran
- •Glucose
- ·Particulate analysis

Additionally, mechanical testing on the new bag and port system includes:

- · Pressure and Leakage testing
- · Resistance to dropping
- · Penetration testing
- · Tensile strength testing
- · Flow testing

has shown the changes to the product do not produce any new safety or effectiveness issues.

- CLINICAL DATA: Using a statistically powered sample size with p-values obtained from a federally mandated registry [UNOS] and from a clinical trial, Clinical data on Perfadex® supplemented at point of use with THAM and calcium ions (PTHCa) shows it is substantially equivalent in survival to Perfadex not supplemented with Calcium. Therefore, we can conclude that supplementation with THAM and Calcium does not add any additional risk to patients receiving a lung transplant.
- CONCLUSION: The non-clinical testing conducted as well as clinical data and realworld evidence with the proposed device demonstrate that the proposed device does not raise any new issues of safety and effectiveness and is substantially equivalent to the predicate device.