(108 days)
The Model 731EMV+ (EMV+) is indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers.
The Uni-Vent ® Model 731EMV+ is a portable, microprocessor controlled, electrically or pneumatically powered intensive care ventilator designed to use either oxygen (02) from a 55 psig source or ambient air using an internal compressor power to deliver a positive pressure breaths. The unit can be electrically powered from an externating current source, external direct current (DC) source or the internal DC battery. An intuitive point-turn-and click interface allows the operator to set and monitor ventilation in all operating environments. A series of alarms alert the user operator to all conditions that affect the ventilator's operation and/or performance and provide context sensitive help relevant to the alarm condition. Ambient air is filtered using a particulate filter or when the operating environment requires either a bacterial/viral or chemical/biologic (NATO No: 4240-01-361-1319) filter. The unit is contained in an impact resistant polycarbonate case which protects of the controls from damage and inadvertent manipulation.
The Uni-Vent ® Model 731EMV+ internal pulse oximeter connects to the patient using noninvasive sensors to monitor oxygen saturation and pulse rate. Pulse oximeter specific alarms and instructions are presented to the operator through the user interface. Isolated DC power is provided to the pulse oximeter.
The provided text is a 510(k) summary for a continuous ventilator, the Uni-Vent® Model 731EMV+. It focuses on describing the device, its intended use, and establishing substantial equivalence to predicate devices.
This document does not contain information regarding:
- Acceptance criteria for device performance.
- Results of a study proving the device meets acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance for testing.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used (e.g., pathology, outcomes data).
- How ground truth for a training set was established.
Therefore, I cannot provide the requested table and information based directly on the given text.
The document is a regulatory submission for premarket notification (510(k)) and primarily addresses:
- Device Description: A portable, microprocessor-controlled intensive care ventilator.
- Intended Use: For infant through adult patients (≥5 kg) with acute or chronic respiratory failure or during resuscitation, in various environments (hospitals, transport, austere environments), to be used by skilled care providers, EMS personnel, and first responders under direction.
- Substantial Equivalence: It claims substantial equivalence to two predicate devices:
To find the information you're looking for, one would typically need to consult a detailed design validation report, clinical study report, or a comprehensive test report, which are separate from this 510(k) summary document. These documents would outline the specific performance tests conducted, the acceptance criteria for those tests, "and the results showing that criteria were met."
§ 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).