| Device |
table mounted miniaturized electromechanical surgical system |
| Definition |
A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical device’s miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms |
| Physical State |
The device is compact robot which operated via a surgeon console. The electromechanical system has an shoulder, elbow, wrist configuration, which mimics human motion at the shoulder and elbow level but only rotates at the wrist. The console is open format and allows the surgeon to sit at the necessary height to comfortable control and monitor the device. |
| Technical Method |
Is a table mounted, teleoperated device with two arms which can grasp, retract, and dissect tissue. The device is suspended above the patient and positioned intra-abdominally to mobilize tissue. |
| Target Area |
Intra-abdominal, colon |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | SAB |
|---|
| Premarket Review |
General Surgery Devices
(DHT4A)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4962
|
|---|
| 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
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
