Identity
- Trade Name
- Organ Care System (OCS) Liver FDA PMA
- Generic Name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation FDA PMA
Identifiers
- PMA Number
- P200031 FDA PMA
- FDA Product Code
- QQK FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Organ Care System Liver is a normothermic machine perfusion system (Device Class III) designed for the preservation and ex-vivo assessment of liver allografts. It maintains near-physiologic, normothermic conditions to monitor hemodynamics and metabolic function, enabling evaluation of donor livers from donors after brain death (DBD) or circulatory death (DCD) with specific criteria: ≤55 years old, ≤30 minutes of warm ischemic time, and macrosteatosis ≤15%. This system supports resuscitation and functional assessment prior to transplantation, ensuring suitability for potential recipients.
The device is supplied as a portable extracorporeal system and is intended for single-use in a clinical setting. It requires FDA_PMA authorization (PMA P200031) and is regulated under the QQK product code. No sterility or MRI safety information is specified in the data. Storage and handling instructions are not detailed beyond standard medical device protocols. The system is manufactured by TransMedics, Inc., based in Andover, MA.
Frequently asked questions
What types of donor livers can be assessed using the Organ Care System Liver, and what specific criteria must they meet?
The Organ Care System Liver is designed to assess liver allografts from donors after brain death (DBD) or donors after circulatory death (DCD). To qualify, the donor must be ≤55 years old, have ≤30 minutes of warm ischemic time, and exhibit macrosteatosis of ≤15%. This system helps evaluate the liver’s hemodynamics and metabolic function in near-physiologic, normothermic conditions before transplantation.
Is the Organ Care System Liver intended for reuse, or is it meant for single-use in a clinical setting?
The Organ Care System Liver is explicitly supplied as a single-use device for clinical settings. It is not designed for reuse, ensuring sterility and safety for each procedure.
How is the Organ Care System Liver different from traditional liver preservation methods?
Unlike traditional cold storage methods, the Organ Care System Liver maintains the liver in a normothermic (body-temperature) state during perfusion. This allows for real-time monitoring of hemodynamics and metabolic function, enabling functional assessment of the liver’s viability before transplantation—unlike static cold preservation, which does not provide this level of evaluation.
What regulatory pathway was followed for the approval of the Organ Care System Liver, and what does this mean for its use?
The Organ Care System Liver received FDA approval through a Premarket Approval (PMA) application (PMA P200031), which is the highest regulatory standard for Class III medical devices. This means the device has undergone rigorous clinical evaluation to demonstrate its safety and effectiveness for its intended use—preservation and ex-vivo assessment of donor livers under specific criteria.
Does the Organ Care System Liver come with specific storage or handling instructions beyond standard medical device protocols?
The provided data does not specify any unique storage or handling instructions beyond general medical device protocols. Clinicians should follow standard practices for maintaining the device’s integrity until use, though no details on temperature, humidity, or shelf life are included.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - Transmedics, TransMedics® Organ Care SystemTM (OCS) Liver System, PDF TransMedics® Organ Care System(OCSTM) OCSTM LiverUserGuide, PDF TransMedics® Organ Care System™ (OCS™) Liver System (b)(4)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P200031 | Class III | Active |
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Manufacturer
- Manufacturer
- TransMedics, Inc
- FDA Applicant
- TransMedics, Inc.
Sources (1)
- FDA PMA P200031 23 fields · synced Sep 20, 2026