(318 days)
The e500 Ventilator is intended to provide continuous (ET tube) or noncontinuous (mask) ventilatory support and monitoring for infant, peditric and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only.
The intended environments include hospital, hospitaltype and intra- hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities suc h as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.
The Newport e500 Wave Ventilator is a self-contained, electrically powered microprocessor controlled ventilator. Performance characteristics and clinical features support infant/pediatric (=20mL) through adult patients.
Front panel controls allow trained operators to select between a number of operational modes, pressure support and volume or pressure control. A comprehensive alarm system is built-in to alert the user to violations of preset safety limits. When fully charged, the internal battery provides an average of 1.5 hours of power.
The alarms associated with the e500 meet or exceed standards of critical care ventilators and have been developed in compliance with ISO9703-1, ISO9703-2 and EN475. The alarms of the e500 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).
The provided text describes a 510(k) submission for the Newport e500 Wave Ventilator, asserting its substantial equivalence to predicate devices. However, it does not explicitly detail acceptance criteria or a specific study proving the device meets those criteria in a format that lends itself to direct extraction for the requested table and analytical points.
Instead, the document focuses on regulatory compliance, outlining the device's characteristics, intended use, and comparison to predicate devices, along with the results of non-clinical tests demonstrating adherence to various standards. It concludes that the device has "functionally proven to be safe" and "meets its stated performance specifications."
Therefore, I cannot directly populate the requested table or provide detailed responses to points 1-9 as a specific "study" with set acceptance criteria, sample sizes, and ground truth establishment is not presented in the provided text.
The closest information available is:
- Acceptance Criteria (implied): Conformance to various domestic and international standards (IEC601-1, CISPR 11, EN60601-1-2, EN 794-1, ISO9703-1&2, ASTM F 1100-90, MIL-STD461D, MIL-STD810E) and the "FDA Reviewer Guidance for Ventilators" and "Reviewer Guidance for Premarket Computer Controlled Medical Devices Undergoing 510(k) Review." The device must also be "safe" and "effective" as the predicate devices.
- Reported Device Performance: "The Newport e500 Wave Ventilator meets all applicable device specification requirements for performance testing" and "functionally proven to be safe. The device meets its stated performance specifications."
Without a dedicated study section detailing performance against specific, quantifiable acceptance criteria, the other points (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) cannot be extracted from this document. The document primarily focuses on regulatory approval through substantial equivalence and compliance with established standards, rather than presenting a performance study against novel acceptance criteria.
§ 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).