| Device |
high intensity focused ultrasound system for peripheral neural tissue ablation |
| Definition |
A high intensity focused ultrasound system for peripheral neural tissue ablation is a device that transmits ultrasound energy to produce thermal lesions in a defined, targeted volume of peripheral nervous tissue through acoustic coupling. |
| Physical State |
The device includes an energy control unit and transducer hardware to generate and deliver ultrasound energy to the target and software to plan and control the location and parameters for energy delivery. The device may also include accessories to facilitate positioning. |
| Technical Method |
The device delivers energy to an anatomical target to cause thermal ablation without piercing the skin. |
| Target Area |
Peripheral Neural Tissue |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | SGN |
|---|
| Premarket Review |
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.4420
|
|---|
| 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 |
