(88 days)
The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator with pressure monitoring port is disposable medical device intended for use on patients requiring temporary augmentation of ventilation, with or without supplemental oxygen delivery, during episode of acute ventilatory failure or insufficiency, who, because of their weight or other factors, require monitoring of peak inspiratory pressure.
The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator provides a means of temporary ventilation until the patient either regains the ability to spontaneously ventilate, or until other life sustaining measures may be implemented. Resuscitators may also be used as a "back-up" ventilation system in the event of mechanical ventilator failure, or may be used to hyper oxygenate or hyperventilate a patient prior to endotracheal tube suctioning or endotracheal intubation. The pressure monitoring port component of the device permits the monitoring of peak inspiratory pressures in those patients where PIP is a concern.
The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator is a disposable, single patient use, medical device which temporarily augments ventilation in patients during ventilatory insufficiency or ventilatory failure. As is the case with the device in the original submission, this modified resuscitator may be used in the hospital, in physician office, outpatient care facilities, extended care facility, home, emergency medical services and patient transport. The only difference between the original device and this modified version is the presence of a pressure monitoring port located on the non-rebreathing valve component of the finished device assembly.
This document does not contain an AI/ML device. It describes a manual resuscitator. Therefore, the requested information about acceptance criteria for an AI/ML device and the study proving it meets those criteria cannot be extracted.
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SMDA
510(k) Summary
1.0 Date
November 21, 1996
FEB 2 1 1997
1964719
2.0 Submitter
Hudson Respiratory Care, Inc. 27711 Diaz Road Temecula, California 92590
3.0 Contact Person
Arden P. Morley Director, Regulatory Affairs and Product Evaluation
4.0 Telephone
(909) 676-5611, ext. 1247
5.0 Proprietary Device Name
Lifesaver Single Patient Use Manual Resuscitator
6.0 Classification Name
Ventilator, emergency, manual (resuscitator)
7.0 Common Name
Resuscitation Bag or Resuscitator
8.0 Predicate Device
Infant/Pediatric Resuscitation Circuit Vital Signs, Inc. K911465
9.0 Device Description
The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator is a disposable, single patient use, medical device which temporarily augments ventilation in patients during ventilatory insufficiency or ventilatory failure. As is the case with the device in the original submission, this modified resuscitator may be used in the hospital, in physician office, outpatient care facilities, extended care facility, home, emergency medical services and patient transport. The only difference between the original device and this modified version is the presence of a pressure monitoring port located on the non-rebreathing valve component of the finished device assembly.
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10.0 Intended Use
The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator with pressure monitoring port is disposable medical device intended for use on patients requiring temporary augmentation of ventilation, with or without supplemental oxygen delivery, during episode of acute ventilatory failure or insufficiency, who, because of their weight or other factors, require monitoring of peak inspiratory pressure.
The Hudson RCI Lifesaver Single Patient Use Manual Resuscitator provides a means of temporary ventilation until the patient either regains the ability to spontaneously ventilate, or until other life sustaining measures may be implemented. Resuscitators may also be used as a "back-up" ventilation system in the event of mechanical ventilator failure, or may be used to hyper oxygenate or hyperventilate a patient prior to endotracheal tube suctioning or endotracheal intubation. The pressure monitoring port component of the device permits the monitoring of peak inspiratory pressures in those patients where PIP is a concern.
11.0 Patient Population
The Hudson RCI Lifesaver Single Patient Use Manual Resuscitators may be used on a varying population from neonates to adults. The modified component with the pressure monitoring port will initially be offered on neonate and child versions of the product line. However, the pressure monitoring port may be offered as an option on adult models in the future.
12.0 Comparison of Technological Characteristics
Hudson RCI Lifesaver Single Patient Use Manual Resuscitators with pressure monitoring port are substantially equivalent to the predicate device in design and function.
Both products use a duck-bill valve in their non-rebreathing valve assemblies, and both devices have a pressure monitoring port located prior to the duck-bill valve. Both devices attach the non-rebreathing valve directly onto the ventilation bag, offer three different size resuscitators, and provide oxygen reservoir systems.
Testing of the modified non-rebreathing valve component against the predicate devices similar component to determine the capability of the pressure monitoring port to provide access for measuring peak inspiratory pressures at various settings for ventilatory rates, tidal volumes, compliance and resistance, demonstrated only a slight discrepancy between the two devices. The Hudson RCI pressure monitoring port provided pressure differentials between readings taken at the valve versus readings taken proximal to the patient ranging from 0-3 cm HzO, while the predicate device provided pressure differential readings of 0-5 cm H2O. This difference is not considered to be clinically significant.
13.0 Conclusion
Both the Hudson RCI pressure monitoring port and the predicate device pressure monitoring port are able to provide peak inspiratory pressure measurements. Test results have demonstrated that the Hudson RCI modified component is substantially equivalent in safety and effectiveness to the legally marketed predicate device with respect to its intended use.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).