OrganOx metra System
by Organox Limited United States PMA
PMA P200035 Product code QQK
Overview
The OrganOx metra System is a normothermic machine perfusion system designed to preserve donor livers in a functioning state prior to transplantation. It maintains liver grafts from donors after brain death (DBD) or donors after circulatory death (DCD) ≤40 years old, with ≤20 minutes of warm ischemic time and macrosteatosis ≤15%, in a near-physiologic, normothermic environment. The device is intended to sustain viability for up to 12 hours during transport or evaluation.
The system is supplied as a transportable device and is approved under FDA_PMA (PMA Number: P200035). It is intended for single-use per liver graft and requires sterile handling, as specified in the regulatory submission. No MRI safety or reusable components are indicated in the documentation. Storage and operational conditions align with standard perfusion system protocols, adhering to the approved preservation parameters.
Regulatory status
Recall ongoing. 1 ongoing FDA recall. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP200035 | Date9 Dec 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
-
- Ongoing Z-0501-2025
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
Specification
- Generic Name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- PMA Number
- FDA Product Code
- QQK
- Device Class
- Class III
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- APPR Approved
Other devices from Organox Limited
Questions
What types of donor livers is the OrganOx metra System approved to preserve, and what are the key criteria for eligibility?
The OrganOx metra System is approved for preserving donor livers from donors after brain death (DBD) or donors after circulatory death (DCD), provided the donor is ≤40 years old and has ≤20 minutes of warm ischemic time (defined as the time from when the donor’s systolic blood pressure drops below 50 mmHg). Additionally, the liver must have macrosteatosis of ≤15%. The system maintains the graft in a near-physiologic, normothermic state for up to 12 hours, ensuring viability during transport or evaluation.
Is the OrganOx metra System intended for reuse, or is it designed for single-use per liver graft?
The OrganOx metra System is explicitly designed for single-use per liver graft. This is due to the requirement for sterile handling, as outlined in the regulatory submission, to maintain the integrity and safety of the preserved liver during perfusion.
How does the OrganOx metra System differ from traditional cold storage methods for liver preservation?
Unlike traditional cold storage methods, the OrganOx metra System preserves donor livers in a **normothermic** (body-temperature) environment, allowing the liver to function metabolically during preservation. This contrasts with cold storage, which halts metabolic activity to slow cellular damage. The system is designed to sustain viability for up to 12 hours, offering a more physiologic approach to liver graft preservation before transplantation.
What storage and operational conditions should be followed when using the OrganOx metra System?
The OrganOx metra System adheres to standard perfusion system protocols for storage and operation, as specified in its regulatory submission. While exact conditions aren’t detailed, the system is designed for transportability and must be handled in a manner that maintains the sterile environment required for single-use per liver graft. Operational parameters align with the approved preservation protocols to ensure the liver remains viable in a near-physiologic state.
Can the OrganOx metra System be used with livers that have higher macrosteatosis levels, or is it limited to ≤15%?
The OrganOx metra System is **only approved for livers with macrosteatosis of ≤15%**. This criterion is explicitly stated in the approved indication, meaning it is not intended for use with livers exhibiting higher levels of fat infiltration, regardless of other factors like donor age or ischemic time.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA PMA P200035