| Device |
implanted tibial electrical urinary continence device |
| Definition |
An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of overactive bladder related symptoms of urge urinary incontinence, urinary urgency, urinary frequency and nocturia. |
| Physical State |
The device includes an implanted battery less neurostimulator, an external power source (may be wearable) which gets connected to the implanted component to supply power and a software interface for the clinicians to set-up and monitor the stimulation parameters. |
| Technical Method |
The implanted neurostimulator, powered by an external (non-implanted) power source, sends electrical pulses to the tibial nerve in proximity to the ankle to treat urge urinary incontinence, urinary urgency and/or urinary frequency related symptoms. |
| Target Area |
Tibial nerve in proximity to the ankle. |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | QXM |
|---|
| Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.5305
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
