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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.
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510(k) SUMMARY as required per 807.92(c)
- Submitter's Name and Address:
Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810
FEB 1 6 2007
Charles C. Morganson, Jr., Manager Regulatory Affairs Tel: (978) 379-8309 Fax: (978) 379-8333
Date submission was prepared:
Contact Person:
May 17, 2006
- Trade Name, Common Name and Classification Name:
A. Trade Name:
Infinity TeleSmart Telemetry System
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classification Number | Class | Regulation Number |
|---|---|---|---|
| Detector and Alarm | 74DSI | II | 21 CFR 870.1025 |
| Monitor, Physiological,Patient (with ArrhythmiaDetector or Alarms | 74MHX | II | 21 CFR 870.1025 |
| Cardiac Monitor | 74DRT | II | 21 CFR 870.2300 |
| ST Segment Monitor withAlarm | 74MLD | II | 21 CFR 870.1025 |
| Pulse Oximeter | 74DQA | II | 21 CFR 870.2700 |
| Pulse Rate Monitor | 74BWS | II | 21 CFR 870.2300 |
| System, Network andCommunication,Physiological Monitors | 74MSX | II | 21 CFR 870.2300 |
| Radiofrequency PhysiologicalSignal Transmitter andReceiver | 74DRG | II | 21 CFR 870.2910 |
- Predicate Device Identification:
Infinity MultiView Workstation Telemetry K024108
K051658 Infinity Alpha
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4. Device Description:
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.
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- Comparison to Predicate Device:
The Infinity TeleSmart Telemetry System is substantially equivalent to the Infinity MultiView Workstation Telemetry cleared for market under 510(k) K024108 and Infinity Alpha, 510(k) K051658.
- 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
8 Biocompatibility:
Not applicable
9.Sterilization:
Not applicable
- Standards and Guidance's:
Refer to section 10
§ 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.