(90 days)
The NeoForce ISPIRA Resuscitation System is a manually operated, gas powered resuscitator intended for controlled and accurate pulmonary resuscitation and emergency respiratory support of pediatric and adult patients with a body weight of more than 22 lbs (10 kg.) in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via face mask, laryngeal mask or endotracheal tube.
The device is also intended to provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via face mask, laryngeal mask or endotracheal tube.
This is a prescription device.
The ISPIRA Resuscitation System is intended to deliver a consistent tidal volume rescue breath of oxygen or blended gas to a pediatric or adult patient. Peak Inspiratory Pressure and flow are set by the user. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated. In addition to resuscitation the device also provides CPAP capability.
The provided text is a 510(k) summary for the ISPIRA Resuscitation System, which is a regulatory document submitted to the FDA. It does not include a description of a clinical study with acceptance criteria, sample sizes, expert involvement, or any of the detailed information requested regarding device performance.
The document focuses on the device description, intended use, and its substantial equivalence to predicate devices, which is typical for a 510(k) submission. It establishes that the device is an emergency resuscitation device with CPAP capability, manually operated, and gas-powered for pediatric and adult patients (>10kg).
Therefore, I cannot provide the requested information about acceptance criteria, study details, or performance metrics because those details are not present in the provided text. The submission itself is the "study" in a regulatory sense, proving substantial equivalence rather than a clinical performance study against specific acceptance criteria.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator 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).