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510(k) Data Aggregation
K Number
K131877Device Name
SAVE II, SAVE II BASIC
Manufacturer
AUTOMEDX INC.
Date Cleared
2014-03-21
(269 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
AUTOMEDX INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SA Ve II™ series are intended to provide short-term ventilatory support to adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). The SAVe 11™ series are appropriate for adults that weigh at least 45 kg. It is intended to be used in pre-hospital, field hospitals, and transport environments.
Device Description
The SAVe II™ and SAVe II™ Basic ventilators are battery powered compressors to deliver automated, controlled positive pressure breaths with ambient air for up to 10 hours. It is designed to augment the capabilities of first responders by supplementing Bag Valve Mask (BVM) manual ventilation delivery with an automated solution that can be rapidly deployed by minimally skilled providers in environments where compressed oxygen is unavailable or ill-advised.
To support use in emergency situations, the SA Ve II™ is portable and easy to carry. Rapid initial setup is enabled by default ventilator settings based on adult patient's height, ranging from 4'6'' to 6'6" weighing at least 45 kg, organized in a circular-shaped graphic. To mitigate the risk of patient injury, airway pressure is monitored and users are alerted to potentially dangerous low and high pressure situations. Immediate patient injury due to high pressure is avoided by a pressure cut-off that triggers an exhalation if inspiratory pressure exceeds device settings. Rapid troubleshooting is enabled by visual alarm indicators located together at the bottom of the unit that identifies the most likely cause of the triggered alarm.
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K Number
K071221Device Name
SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12
Manufacturer
AUTOMEDX INC.
Date Cleared
2007-09-06
(127 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
AUTOMEDX INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SAVe is intended for use on adults that need ventilatory support. Specifically, the SAVe is intended to provide short term ventilatory support for individuals during CPR or when positive-pressure ventilation is required to manage acute respiratory failure. The SAVe device is appropriate for individuals that weigh at least 45 kilograms. It is intended to be used in field hospitals, transport and prehospital environments.
Device Description
The SAVe is a time cycled ventilator that delivers a set tidal volume. If, at any point, an upper threshold pressure is reached, the device immediately triggers the exhale mode. The SAVe consists of an internal pump (blower), rechargeable sealed lead acid battery, circuit board, manifold, face plate, EMI shielded upper and lower enclosure, air intake port with debris filter, patient port, pressure port, supplemental air / oxygen port, electric port for recharging and / or running, charger / power supply, patient circuit, pressure tubing, oxygen tubing and an activation switch. The device has audio and visual alarms that trigger for low pressure, disconnect, blockage, low battery, high temperature or internal failure. The device not only alarms for stacked breaths but also cuts off the pump until adequate pressure has been released before triggering the next breath. The SAVe comes in three distinct models. Each has a set tidal volume and respiratory rate. Model 550x10 delivers 550 mL of air 10 times per minute. Model 600x10 delivers 600 mL of air 10 times per minute and Model 600x12 delivers 600 mL of air 12 times per minute.
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