(275 days)
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The INFINITY TeleSmart is a patient-worn transceiver (PWT) that is derived from miniaturization of the INFINITY ALPHA patient monitor. This new device performs telemetry monitoring of ambulatory and non-ambulatory patients, using the same algorithms that are incorporated in the INFINITY ALPHA.
The provided text is a truncated 510(k) summary for the "Infinity TeleSmart Telemetry System." It does not contain the necessary information to answer your request regarding acceptance criteria, device performance, and study details. The document explicitly states:
- "Assessment of non-clinical performance data for equivalence: Refer to section 10"
- "Assessment of clinical performance data for equivalence: Was not generated for this submission"
Without access to "section 10" and with the statement that clinical performance data was not generated, I cannot extract the specific details you've asked for. The summary primarily focuses on identifying the device, its classification, and predicate devices, along with indicating that it uses the same algorithms as a previously cleared device.
§ 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.