(72 days)
The Infinity MultiView WorkStation, Infinity Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems and recorders.
Use of the Infinity MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:
- Heart rate .
- ECG Arrhythmia Analysis .
- Arterial oxygen saturation .
- Pulse rate .
- ST segment analysis .
Infinity Telemetry Pacer Fusion
Infinity MultiView Telemetry with VF6 software supports the new pacer detection mode, Fusion. The Pacer Fusion mode has increased sensitivity to psuedofusion paced beats, sometimes known as fused beats.
Infinity Symphony
The MultiView WorkStation with VF6 supports the new web-based browser application, Infinity Symphony, for enhanced full disclosure review. Infinity Symphony provides users with retrospective reviews of stored continuous and episodic patient information -- continuous physiologic waveforms and other stored data over an extended period of time -- to provide review, analysis, and documentation of the patient's condition.
The provided text is related to a 510(k) summary for a medical device called "Infinity MultiView Workstation and Telemetry" manufactured by Draeger Medical Systems, Inc. However, it does not contain any information about acceptance criteria, device performance, sample sizes used for testing, expert qualifications, adjudication methods, details of comparative effectiveness studies, standalone performance, type of ground truth used, or details about the training set.
The document primarily describes:
- The device name and classification.
- The submitter's information.
- A brief description of the device's features (Pacer Fusion mode, Infinity Symphony web-based browser application).
- The intended use of the device as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems, measuring vital signs like heart rate, ECG arrhythmia analysis, arterial oxygen saturation, pulse rate, and ST segment analysis.
- A statement regarding substantial equivalence, noting that "Verification and validation testing performed indicates that the modifications implemented are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)." It explicitly states "Assessment of clinical performance data for equivalence: Not applicable".
- The FDA's letter of clearance stating that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested table and study details as that information is not present in the provided text.
§ 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.