| Device |
powered fecal management system |
| Definition |
A powered fecal management system is a device that uses powered components to partially or fully divert and contain fecal waste away from a bed-ridden patient. This classification includes accessories such as filters, conduits for fecal waste transfer, and receptacles for fecal waste containment. |
| Physical State |
Patient Receptacle that enters the anus/rectum, stool/feces receptacle for containment, tube from patient to fecal containment receptacle, mechanical and electrical hub that powers the diversion of fecal waste towards the containment receptacle. |
| Technical Method |
Device is placed in patient rectum with a tube that extends from patient to some waste collection container. Functions of the powered hub may generate functions such as suction or irrigation to divert fecal waste that enters tube and towards a feces containment receptacle. |
| Target Area |
Anus, Rectum |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | SJB |
|---|
| Premarket Review |
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.5230
|
|---|
| 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 |
|
|
