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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?
Product Code :
EXB
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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K Number
K140938Device Name
OSTOM-I ALERT
Manufacturer
11 HEALTH AND TECHNOLOGIES LLC
Date Cleared
2014-10-10
(182 days)
Product Code
EXB, EZQ, EZS
Regulation Number
876.5900Why did this record match?
Product Code :
EXB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OSTOM-i™ Alert is intended to be used as an accessory to any ostomy bag by monitoring the filling of the bag which information is sent via Bluetooth to a tablet computer to warn healthcare personnel when a patient's bag is close to being full. The Tablet computer automatically captures the data as to the volume and timing of output for each patient.
The OSTOM-i™ Alert is indicated for all patient populations.
The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn patient when ostomy bag is close to being full. The sensor-based OSTOM-i™ Alert is intended to be used by the hospital environment.
The OSTOM-i™ Alert is indicated for all patient populations.
Device Description
The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn the health care provider when their patients' bags are close to being full, or to the patient in the post-hospital setting.
The flex sensor changes its resistance according to curvature and converts resistance into mls, thereby detecting the progressive filling of the bag. This information is relayed to the tablet generating an additional report on bag status versus the visual one now available.
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