(231 days)
The InspirationTM Ventilator System is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.
The Inspiration™ Ventilator System is housed in a metallic enclosure, comprising clear anodized aluminum with painted finish and is mounted on a mobile stand. User controls and display screen are located on the front face of the Ventilator. Display and controls operation is described in the Ventilator Settings and Controls section of the User Manual (See Section 14 of this Submission). Ventilation parameters are programmed by the operator, using the function and navigation keys plus the Push & Turn control device on the Ventilator front panel, in conjunction with selectable display screens. The programmed data from the User Interface is processed by the main microprocessor and stored in ventilator non-volatile memory. The microprocessor uses the stored data in the control of breath delivery. Oxygen and air supply connections are located on the back of the Ventilator. The patient breathing circuit connection is located below the front face of the unit, together with a pneumatic outlet for driving an optional accessory jet nebulizer. The Ventilator stand serves to support the main Ventilator unit, breathing circuit tubing and accessory equipment, facilitating connection to the Ventilator. The Inspirations Ventilator System incorporates three communications interfaces, namely, a Nurse Call interface, an RS-232 and an Ethernet interface. The Nurse Call interface comprises normally open and normally closed relay contacts (changeover switch) acting simultaneously with an alarm condition. Both the RS232 and Ethernet interfaces enable the same data transmission to receiving terminals such as nurse and physician workstations and PC equipment. The Inspiration ... Ventilator System consists of two major systems, the pneumatic system and the electrical/electronic system, which combine under software control to deliver respiratory support at operator-determined parameters. The pneumatic system, under microprocessor control, supplies air and oxygen to the patient system, external to the device. The electricallelectronic system inputs and supervises one of three alternative power sources to the unit and provides electronic control of the ventilator's pneumatic system components. The Inspiration™ Ventilator System can operate with a range of standard ventilator accessories, such as breathing circuits, nebulizer and humidifier.
I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves the device meets acceptance criteria, or any of the detailed study parameters you've requested.
The document is a 510(k) summary for the "Inspiration™ Ventilator System" from eVent Medical Ltd. It covers:
- Company Information: Manufacturer, contact person.
- Device Name: Proprietary, common, and classification.
- Equivalent Devices: Predicate devices used for substantial equivalence comparison.
- Device Description: Physical layout, user interface, communication interfaces.
- Intended Use: Broad patient range (infant to adult), clinical conditions, environment of use (hospital, intra-hospital transport).
- Technological Characteristics: How it provides ventilation (pressure/volume-based), power sources, integral compressor, available ventilation modes.
- Certification Statement: Affirmation of truthfulness and accuracy of submitted data.
- FDA Clearance Letter: Official letter from the FDA stating substantial equivalence and allowing marketing.
- Indications for Use Statement: Formal statement of the device's intended use.
This document focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results. Such detailed study information would typically be found in a separate section of a 510(k) submission, often within performance testing reports, which are not included in this summary.
§ 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).