| Device |
water-induced thermotherapy system, benign prostatic hyperplasia |
| Regulation Description |
Endoscopic electrosurgical unit and accessories. |
| Definition |
Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia |
| Physical State |
The device consists primarily of a water heating unit and an applicator. The applicator is a catheter-like device inserted into the urethra. The dilation balloon and the heat conductive area of the applicator are positioned in the prostatic urethra. |
| Technical Method |
The prostate is heated by means of hot water passed through an applicator and dilated by a balloon. Radio frequency energy is applied to the prostate using electrodes. Conductive heating and dilation of the prostatic urethra produces relief of symptoms of BPH. |
| Target Area |
Prostate |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OEK |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.4300
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Guidance Document
|
| Third Party Review |
Not Third Party Eligible |
