| Device |
hypothermic machine perfusion system and accessories for orthotopic liver transplant |
| Definition |
A hypothermic machine perfusion system and accessories for orthotopic liver transplant is a device that performs oxygenated perfusion of liver grafts at sub-physiological temperatures until it is transplanted into a recipient patient. This generic type of device may also include perfusion sets, oxygenators, and other components of the perfusion circuit. |
| Physical State |
Device consists of a system made up of several components, such as an oxygenator, thermal control unit, a flow pump, as well as dedicated disposable sets, cannulation accessories, and organ chamber. Bile salts are included with the device. |
| Technical Method |
Device actively perfuses the donor liver with a preservation solution, while also oxygenating it, collecting bile and maintaining it in hypothermic temperatures, so that it may be preserved and assessed for transplantation. |
| Target Area |
Donor livers |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | SGY |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.5881
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
