Automated Actuator Active Bag Ventilator

 

 

The main design goal was to choose components known and available in Puerto Rico and the USA to expedite the prototype's manufacturing, testing, validation, and eventual FDA approval.

The mechanical design intends to safely ventilate a COVID-19 patient by automatically actuating a manual resuscitator. The A³B is compatible with existing manual resuscitators.

• Designed with industrial automation components mostly used in the life-science industry. 
• Monitor critical parameters of operations in order not to cause harm to patients.

• The A³B is classified as a Class II Medical Device with no requirement for clinical testing.
• The ventilators and the resuscitators are already approved and included in the FDA Emergency Use Authorization (EUA). 
• A 510(k) requires a demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicated.  
• The A³B submittal strategy is based on demonstrating that our ventilator is equivalent to MIT's approved E-Vent design ventilators such as the Spiro Wave and the Spanish OxyGen versions.