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510(k) Data Aggregation
K Number
K181643Device Name
SmartBag (SmartPouch)
Manufacturer
11 Health Technologies Limited
Date Cleared
2018-11-16
(147 days)
Product Code
EXB, EZQ, EZS, LHQ
Regulation Number
876.5900Why did this record match?
Applicant Name (Manufacturer) :
11 Health Technologies Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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)
Device Description
The SmartBag with integrated thermistors and capacitive sensors can be used in place of a traditional ostomy bag. It notifies patients or medical professionals of any potential leaks around the peristomal skin as well as giving an estimate of the output volume within the bag.
Alfred software is a companion software suite for SmartBag. It consists of Alfred mobile app and Alfred hospital app. Alfred mobile app is a companion application for mobile phone. The application provides SmartBag user easy access to bag status, hydration tracking and restroom search functionalities. The SmartBag could operate without Alfred mobile app.
The sensors in the bag and the wafer will be able to transmit data to the hub via NFC protocol communication. The data from the hub will be transmitted to the cloud via LTE-M data transfer via secure MQTT protocol and then this data can be downloaded to web supported devices – such as an iPhone.
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