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The Model 731EMV (EMV) is indicated for use in the management of adolescent and adult patients weighing ≥30 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 external alternating 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.

This 510(k) summary describes a medical device, specifically a continuous ventilator, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found for AI/ML-driven devices.

The document focuses on:

• Device Description: The Uni-Vent® Model 731EMV is a portable, microprocessor-controlled intensive care ventilator. It uses oxygen or ambient air, can be electrically powered, and has an intuitive interface. It also includes a noninvasive pulse oximeter.
• Intended Use: For adolescent and adult patients (≥30 kg) with acute or chronic respiratory failure, or during resuscitation. It's for use in hospitals, outside hospitals, during transport, and in austere environments. It can operate with a third-party filter in chemical/biological toxin environments but not explosive ones. Intended users are skilled care providers, EMS personnel, and first responders under direction.
• Substantial Equivalence: The device is deemed substantially equivalent to several predicate devices, including other Impact Uni-Vent models, a Masimo pulse oximeter, Versamed SmartVent, and Vela Bird Products.
• Regulatory Information: Classification as Class II, Product Codes CBK and DQA.

Therefore, the requested information regarding acceptance criteria and performance study results cannot be extracted from the provided text. This type of detail is more common in submissions for AI/ML devices where specific performance metrics are critical for regulatory clearance. For devices like this ventilator, substantial equivalence to existing devices often forms the primary basis for clearance, along with adherence to relevant performance standards (which are not detailed here).

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