Product Classification

• Device: normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
• Definition: To preserve donor lungs prior to transplantation
• Physical State: The device may consists of a portable enclosure with electronics and hardcore that control the ventilation and perfusion of the donor organ, disposable components that complete the ventilation and perfusion circuits, and a preservation solution used to perfuse the organ.
• Technical Method: The device perfuses and ventilates the donor lungs prior to transplantation
• Target Area: Donor lungs
• Review Panel: Gastroenterology/Urology
• Product Code: QBA
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Document

• Utilizing Animal Studies to Evaluate Organ Preservation Devices: Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible