Product Classification

• Device: normothermic preservation system for transplantation of initially unacceptable donor lungs
• Definition: Preservation of donor lungs for transplantation.
• Physical State: Device consists of a system made up of several components, such as an oxygenator, ventilator, thermal control unit, flow pumps, as well as dedicated disposable sets, cannulation accessories, organ chamber and preservation solution.
• Technical Method: Device actively perfuses the donor lung with a preservation solution, while also ventilating and oxygenating it, and while maintaining it in near-physiologic temperatures, so that it may be preserved and assessed for transplantation.
• Target Area: Donor lungs
• Review Panel: Gastroenterology/Urology
• Product Code: PHO
• 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?: Yes

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