Perfadex Plus

{0} FDA U.S. FOOD & DRUG ADMINISTRATION July 23, 2026 Xvivo Perfusion AB Petra Rosen Regulatory Affairs Manager Entreprenörsstråket 10 Mölndal, SE-431 53 Sweden Re: K261644 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: July 21, 2026 Received: July 22, 2026 Dear Petra Rosen: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261644 - Petra Rosen Page 2 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). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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 Rule"). 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-devices/device-advice-comprehensive-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-devices/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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K261644 - Petra Rosen Page 3 assistance/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, # Gema Gonzalez -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 | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K261644; K261644/S | | Please provide the device trade name(s). | | ? | | Perfadex Plus | | | | Please provide your Indications for Use below. | | ? | | 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. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} Page 1 of 2 | 510(k) #: K261644 | 510(k) Summary | Prepared on: 2026-07-23 | | --- | --- | --- | | Contact Details | | 21 CFR 807.92(a)(1) | | Applicant Name | XVIVO Perfusion AB | | | Applicant Address | Entreprenörsstråket 10 Mölndal SE-431 53 Sweden | | | Applicant Contact Telephone | +46730259244 | | | Applicant Contact | Ms. Petra Rosen | | | Applicant Contact Email | petra.rosen@xvivogroup.com | | | Device Name | | 21 CFR 807.92(a)(2) | | Device Trade Name | Perfadex Plus | | | Common Name | Isolated kidney perfusion and transport system and accessories | | | Classification Name | System, Perfusion, Kidney | | | Regulation Number | 876.5880 | | | Product Code(s) | KDN, N/A | | | Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) | | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | K170826 | Perfadex Plus | KDN | | Device Description Summary | | 21 CFR 807.92(a)(4) | | Perfadex® Plus is a sterile, single-use organ preservation solution indicated for the flushing, cold static storage, and transportation of isolated donor lungs prior to transplantation. The product is supplied in flexible sterile containers for use in professional healthcare settings. | | | | During organ procurement, the solution is used to flush the donor lung and provide hypothermic preservation prior to implantation. Perfadex® Plus functions as an extracellular preservation solution intended for ex vivo use during the transplantation process. The device does not contain software or electrical components and operates through its solution-based preservation properties. | | | | Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) | | 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. | | | | Indications for Use Comparison | | 21 CFR 807.92(a)(5) | | Perfadex Plus has the same indications for use as the predicate device, Perfadex Plus (K170826). | | | | Technological Comparison | | 21 CFR 807.92(a)(6) | | Perfadex Plus has the same technological characteristics as the predicate device, Perfadex Plus (K170826). It is a sterile, ready-to-use extracellular low-potassium dextran lung preservation solution supplied in sterile flexible Ecobag containers (1000 mL and 3000 mL). The | | | {5} Page 2 of 2 device is terminally sterilized by moist heat and functions through its solution composition during flushing and cold static preservation of donor lungs. The formulation, chemical composition, sterilization method, packaging configuration, and principle of operation are unchanged from the predicate device. The differences are limited to labeling updates expanding the preservation temperature range from 2–8 °C to 2–10 °C and extending the labeled shelf life from 12 months to 18 months. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) No new bench or animal testing was required to support the labeling change increasing the upper preservation temperature limit from 8 °C to 10 °C. The modification does not alter the intended use, formulation, technological characteristics, sterilization method, packaging configuration, or performance specifications. Therefore, no additional nonclinical performance testing was necessary. The extension of labeled shelf life from 12 months to 18 months is supported by stability data generated using established and previously validated methods. Stability testing demonstrates continued compliance with product specifications throughout the proposed 18-month shelf life. Collectively, the supporting stability data demonstrate that the modified storage temperature and extended shelf life maintain compliance with established product specifications. The device continues to meet all performance requirements and remains safe and effective for its intended use. No new clinical investigations were conducted for this submission. To support the labeling change increasing the upper preservation temperature limit to 10 °C, published clinical literature was reviewed. This approach was previously discussed with FDA in December 2025 (refer to Attachment B04). The identified studies, including prospective and retrospective clinical analyses of lung transplantation procedures, demonstrated comparable safety and performance outcomes at preservation temperatures up to 10 °C. Baseline demographic and clinical characteristics were comparable between the 10 °C and control cohorts. Across the reviewed studies, median recipient age ranged from 57 to 64 years in the 10 °C cohorts and from 49 to 64 years in the control cohorts. Female recipients comprised 43% to 54% of the 10 °C cohorts and 27% to 43% of the control cohorts. Demographic information regarding race or ethnicity was not reported in the reviewed literature. Overall, the available clinical evidence supports the safety and effectiveness of Perfadex Plus at the revised temperature range. Based on the available nonclinical and clinical evidence, including published literature supporting the revised preservation temperature, Perfadex Plus is as substantially equivalent to the legally marketed predicate device. The labeling modification increasing the upper preservation temperature limit to 10 °C does not adversely affect device safety or performance and supports a determination of substantial equivalence.