(127 days)
The Infinity Acute Care System Workstations Critical Care consist of monitoring and control displays and additional therapy units. They are intended to be used as integrated, networked, and configurable workstations to provide critical care specific therapy. The Infinity Acute Care System Workstations Critical Care are intended to be used by qualified and trained medical personnel.
The Infinity C Series Medical Cockpits, consisting of the C500 and the C700, are monitoring and control displays for the Infinity Acute Care System (IACS). Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings. The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.
The Evita V500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of adult, pediatric and neonatal patients. Evita V500 offers mandatory ventilation modes and ventilation modes for spontaneous breathing support and airway monitoring. The Evita V500 ventilation unit is used with Infinity C Series Dräger Medical Cockpits. The Evita V500 ventilation unit is intended for use in different medical care areas.
Evita V500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.
The Infinity Acute Care System Workstation Critical Care provides critical-care specific functionality. It is made up of the Infinity Medical Cockpit C500 and the ventilation unit Evita Infinity V500. The optional gas supply unit GS500 can be added. The ventilation unit provides critical-care specific ventilation and monitoring data of ventilation parameters. The Infinity Medical Cockpit is the control and display unit witch runs a ventilation application. The patient monitoring data are displayed on the Infinity Medical Cockpit, which is also used to control ventilation settings including alarms. The optional gas supply unit provides compressed air to the ventilation unit in case of central gas failure or in house transport.
This document is a 510(k) summary for the Dräger Infinity Acute Care System Workstation Critical Care. It does not contain the detailed information required to describe acceptance criteria and a study that proves the device meets those criteria, as typically found in a clinical study report or validation protocol.
The document primarily focuses on:
- Device Description: What the device is and its components (Infinity Medical Cockpit and Evita Infinity V500 ventilator).
- Operating Modes/Features: Detailed list of ventilation modes (VC, PC, Spn, and special modes).
- Regulatory Information: Applicant details, date of submission, device name, and the FDA's 510(k) clearance letter (K093633).
- Standards Compliance: A list of performance testing standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-12, IEC 60601-1-6, IEC 60601-1-8, EN ISO 14971, EN ISO 17664) and the FDA Guidance for Ventilators: 1995.
- Indications for Use: The intended purpose and patient population for the device.
Therefore, I cannot provide the requested information from the provided document.
The document states that "Performance was tested in compliance with following standards," and lists various IEC and ISO standards, along with the FDA Guidance for Ventilators: 1995. However, it does not include:
- A table of specific acceptance criteria and reported device performance values. The standards listed usually define general safety and essential performance requirements, but the specific, quantitative acceptance criteria for this particular device are not detailed here, nor are the actual performance results (e.g., measured accuracy of a parameter, response time, etc.).
- Details of any specific studies conducted to demonstrate clinical performance or effectiveness. This document is a regulatory submission for substantial equivalence based on technical standards and predicate devices, not a report of a clinical efficacy or performance study. As such, it lacks information on:
- Sample sizes (for test sets or training sets)
- Data provenance
- Number and qualifications of experts for ground truth
- Adjudication methods
- MRMC comparative effectiveness study results or effect sizes
- Standalone algorithm performance
- Type of ground truth used
- How ground truth was established for any training data.
In summary, the provided text describes regulatory compliance through adherence to standards but does not detail the specific performance acceptance criteria or the study data that would demonstrate the device meets those criteria in a quantitative sense.
§ 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).