| Device |
pediatric ventricular assist device |
| Regulation Description |
Ventricular bypass (assist) device. |
| Definition |
A ventricular assist device (VAD) assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body. |
| Physical State |
Ventricular assist devices may come in many shapes (depending on pulsatile or continuous flow, and mechanism of function) and sizes (depending on size of the patient). They utilize different functions to achieve replacement of the primary function of the ventricle. Generally, the pump itself has both plastic and metal components. Cannulae/catheters attaching to the ventricles and/or arteries are made of plastic. In addition to the pump, the system also generally has a driver where the pump function (speed, pressure, etc.) can be monitored and controlled. |
| Technical Method |
Uses mechanical means to replace function of the left and/or right ventricles. For left ventricular support, blood is pumped from the left ventricle to the aortic arch. For right ventricular support, blood is pumped from the right ventricle to the pulmonary arteries. |
| Target Area |
Heart; Cardiovascular System |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | PCK |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
HDE - Humanitarian Device Exemption
|
|---|
| Regulation Number |
870.3545
|
|---|
| Device Class |
HDE
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
