(385 days)
The Puritan Bennett 980 Series Ventilator System is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3kg (0.66lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively to patients who require the following types of ventilator support
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Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trachectorny tube) or non-invasively (via mask or nasal prongs)
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Assist/Control, SIMV, or Spontaneous modes of ventilation
The Puritan Bennett 980 Series Ventilator System is a dual-microprocessor-based, touch-screen controlled; critical care ventilator intended to provide continuous ventilation for neonate to adult patients who require either invasive ventilation or non-invasive ventilation. It can be used in hospitals and institutions and for intra -hospital transport applications with access to the appropriate services.
The ventilator system offers features for patient comfort while delivering sensitive, precise breaths to critically ill patients. The product ventilates Neonatal, Pediatric, and Adult patients with predicted body weights from 0.3 kg, and with tidal volumes for mandatory volume-controlled breaths from 2 mL to 2500 mL.
The following options are being made to the Subject Device:
- Initial release -
- Integrated Nebulizer option ●
- High Flow Oxygen Therapy (HFO2T) option ●
- NIV+ Software option ●
- New Monitored Parameter Porive ●
- Modification to previously cleared feature -
- Updated IE Sync Algorithm
This document is an FDA 510(k) Premarket Notification for the Puritan Bennett 980 Series Ventilator System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, none of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, or training set details can be extracted from the provided text. The document states that "Clinical evidence was not necessary to show substantial equivalence," and the non-clinical evidence focuses on verification and validation against standards and software/system tests, not a performance study as would be expected for a new or modified algorithm with performance metrics.
§ 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).