← Product Code [MHX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX) · K061379 # INFINITY TELESMART TELEMETRY SYSTEM (K061379) _Draeger Medical Systems, Inc. · MHX · Feb 16, 2007 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K061379 ## Device Facts - **Applicant:** Draeger Medical Systems, Inc. - **Product Code:** [MHX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX.md) - **Decision Date:** Feb 16, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1025 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use 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. ## Device Story Patient-worn transceiver (PWT) for ambulatory/non-ambulatory telemetry monitoring; miniaturized version of Infinity Alpha monitor. Inputs: physiological signals (ECG, SpO2, pulse rate). Processing: utilizes same algorithms as Infinity Alpha for arrhythmia and ST segment detection. Output: physiological data and alarms transmitted to central monitoring station. Used in clinical settings; operated by healthcare professionals. Benefits: enables continuous patient monitoring while allowing mobility. ## Clinical Evidence No clinical data generated for this submission; equivalence established via non-clinical performance data and comparison to predicate devices. ## Technological Characteristics Patient-worn transceiver (PWT); miniaturized form factor; utilizes same algorithms as Infinity Alpha; wireless physiological signal transmission; Class II device. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Infinity MultiView Workstation Telemetry ([K024108](/device/K024108.md)) - Infinity Alpha ([K051658](/device/K051658.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ g lofr 661399 510(k) SUMMARY as required per 807.92(c) 1. 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 2. 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 Arrhythmia
Detector or Alarms | 74MHX | II | 21 CFR 870.1025 | | Cardiac Monitor | 74DRT | II | 21 CFR 870.2300 | | ST Segment Monitor with
Alarm | 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 and
Communication,
Physiological Monitors | 74MSX | II | 21 CFR 870.2300 | | Radiofrequency Physiological
Signal Transmitter and
Receiver | 74DRG | II | 21 CFR 870.2910 | 3. Predicate Device Identification: Infinity MultiView Workstation Telemetry K024108 K051658 Infinity Alpha {1}------------------------------------------------ ## 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. 2 of 2 5. 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. 6. Assessment of non-clinical performance data for equivalence: Refer to section 10 7. Assessment of clinical performance data for equivalence: Was not generated for this submission 8 Biocompatibility: Not applicable 9.Sterilization: Not applicable 10. Standards and Guidance's: Refer to section 10 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K061379](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K061379) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com