# K181643: SmartBag (SmartPouch)

- Pathway: 510(k) (Traditional)
- Applicant: 11 Health Technologies Limited
- Decided: Nov 16, 2018 after 147 days
- Product code: EXB (Collector, Ostomy)
- Device class: 1
- Regulation: 21 CFR 876.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K813269 (1981). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140938: Ostom-I Alert, 11 Health and Technologies, LLC (2014) Summary page 4.
- K150457: AlfaSight 9000 Thermographic System, Alfa Thermodiagnostics, Inc. (2015) Summary page 4.

## Indications for use
SmartBag is intended for use inside and out of hospitals for any patient with a diversionary urinary or fecal stoma. It works in conjunction with 11 Health’s care management platform known as Alfred. The SmartBag system uses integrated sensors to continuously monitor bag filling and drainage, providing cumulative output data to the patient and clinical team. The system also monitors skin condition, the occurrence of leaks and visual condition of the stoma. SmartBag's intended use is to help ostomates acclimate to their lifestyle. It works in conjunction with 11 Health's care management platform known as Alfred, designed for patients and medical professionals. The SmartBag system (including the wafer and Hub), offers a continuous ostomy monitoring system, tracks the estimated volumetric filling of the bag and visual condition of the stoma using integrated sensor technology. The SmartBag Sytem is for adult use only. (22 years and above)

Source page: https://510kreport.com/device/K181643
Methodology: https://510kreport.com/methodology