(29 days)
The Infinity MultiView WorkStation, Infinity Network and Remote Display are intended for use as a central monitoring device, communications network, and remote display for Draeger patient monitoring systems and recorders.
The Infinity Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
The Infinity Gateway Suite (K014213/K030657) is a server-based software application that provides a connection to the Infinity Network and the hospital network infrastructure for the data exchange of select clinical and administrative information. The Infinity Gateway complies with healthcare information protocols to support data sets of many different sources, including medical devices, hospital information systems, clinical information systems, and laboratory systems.
Infinity Gateway includes a suite of software products to support the unique needs of hospitals, and provide a complete range of options for information connectivity:
- . Server Software
- . Interface Software Options
- Developers Tools .
- Remote View Applications 해
- . Pager Interface
The primary modification included in the VF4 software release of the Infinity Gateway Suite is the visual display of alarms on WinView and WebViewer.
I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, or any studies conducted on the Infinity Gateway Suite. The document is a 510(k) summary and FDA clearance letter, which describes the device, its intended use, and indicates that verification and validation testing was performed to establish equivalence to previous versions, but does not provide details of such testing or specific performance metrics.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.