(298 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 hospitals (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support, delivered invasively or non-invasively, to patients who require the following types of ventilator support:
- . Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs)
- Assist/ Control, SIMV or Spontaneous modes of ventilation o
The Puritan Bennett 980 Series Ventilator System is a dual-microprocessor-based, touchscreen 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 that improve patient comfort while delivering sensitive, precise breaths to critically ill patients of any age. 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 ventilator is designed to help clinicians improve ventilation outcomes and quality of care for patients, and can be customized with advanced technology focused on supporting patient ventilator synchrony. A full suite of software options, safety features and accessories to fit a variety of patient needs, from infant to adult are available. Software options assist clinicians in assessing the best treatment approach for their patients at any given time by amplifying the patient's own spontaneous effort to breathe.
This document is a 510(k) summary for the Puritan Bennett™ 980 Series Ventilator System. It details the device, its intended use, comparison to predicate devices, and performance testing. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the format specified.
The document states:
- No clinical testing was necessary to show substantial equivalence.
- "Verification and validation activities were conducted to establish the performance characteristics of the Puritan Bennett 980 Ventilator System. All testing demonstrated that the Puritan Bennett 980 Ventilator System met required design verification criteria and has acceptable performance when used in accordance with its labeling..."
This indicates that the "performance testing" section, including Reliability, Human Factors and Usability, Labeling validation, Breathing System, Alarms, Controls Design Verification, Software Verification, Hardware Safety Compliance, Electromagnetic Compliance Testing, Electrical Verification, Mechanical Subsystems, Environmental Testing, Packaging Verification, and Biocompatibility Risk Analysis, cumulatively demonstrates the device's acceptable performance and substantial equivalence to predicate devices based on design verification criteria.
However, the document does not present:
- A table of explicit acceptance criteria and reported device performance.
- Sample sizes used for a "test set" in the context of classification or diagnostic performance, nor its provenance.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, or how human readers' performance improved with AI assistance (as this is a ventilator, not an AI diagnostic device).
- A standalone (algorithm-only) performance study.
- The type of ground truth used in the sense of a diagnostic outcome (e.g., pathology, outcomes data).
- Sample size for a "training set."
- How ground truth for a "training set" was established.
Therefore, the requested information, specifically regarding acceptance criteria and a study proving the device meets those specified acceptance criteria in the context of diagnostic performance or AI model evaluation, is not present in the provided text. The document focuses on engineering verification and validation testing to establish substantial equivalence for a medical ventilator.
§ 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).