| Device |
interventional cardiovascular implant simulation software device |
| Regulation Description |
Interventional cardiovascular implant simulation software device. |
| Definition |
An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment. |
| Physical State |
Software device |
| Technical Method |
The device performs simulation by combining a predefined device model with a patient-specific model of the patient anatomy. |
| Target Area |
Left atrial appendage |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QQI |
|---|
| Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.1405
|
|---|
| 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? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
