(268 days)
The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities:
- Assist/Control and SIMV with either Volume, Pressure Regulated Volume . Control (PRVC)
- CPAP with Pressure Support and CPAP / Pressure Support Volume Guaranteed (VG) ●
- Adaptive Bi-Level for either NIV or invasive ventilation and Adaptive Bi-Level Volume ● Guaranteed [VG]
The iVent101 ventilator is suitable for use in institution, home and portable settings
The iVent101 is a compact, portable, microprocessor-controlled ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. Internal flow and pressure are read through low/pressure sensors. Clinical data [Tidal Volume, Rate, PIP, FiO2, Peak Flow, Inspiratory Time, I:E Minute Volume) are presented on machine screen. All the operator actions are performed on the LCD touch-screen on the front panel, allowing rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes. The iVent101 can use external AC or DC power supply and contains an integrated battery. The iVent101 is equipped with two configurations, which differs in the patient circuit type that connects to the machine. One configuration is to be used with a standard one limb patient circuit, and the second configuration is to be used with a standard dual limb patient circuit. The two configurations are incorporating the same infrastructure and can be easily replaced by the user.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for the iVent101 portable ventilator, which focuses on demonstrating substantial equivalence to a predicate device. It describes the device, its intended use, and the types of non-clinical tests performed (e.g., risk analysis, software validation, performance testing). Crucially, the document explicitly states:
"The subject of this premarket submission, the iVent101, did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods, as no such study was conducted or reported in this submission.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).