Who is the manufacturer of INFINITY TELESMART TELEMETRY SYSTEM?

Draeger Medical Systems, Inc. filed the 510(k) submission for INFINITY TELESMART TELEMETRY SYSTEM (K061379).

What is the FDA product code for INFINITY TELESMART TELEMETRY SYSTEM?

MHX. It is classified under 21 CFR 870.1025 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for INFINITY TELESMART TELEMETRY SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for INFINITY TELESMART TELEMETRY SYSTEM?

Infinity MultiView Workstation Telemetry (K024108); Infinity Alpha (K051658).

Who can help prepare an FDA 510(k) submission like INFINITY TELESMART TELEMETRY SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

INFINITY TELESMART TELEMETRY SYSTEM

K061379 · Draeger Medical Systems, Inc. · MHX · Feb 16, 2007 · Cardiovascular

Device Facts

Record ID	K061379
Device Name	INFINITY TELESMART TELEMETRY SYSTEM
Applicant	Draeger Medical Systems, Inc.
Product Code	MHX · Cardiovascular
Decision Date	Feb 16, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1025
Device Class	Class 2

Intended 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.

Indications for Use

Indicated for ambulatory and non-ambulatory patients requiring physiological telemetry monitoring, including arrhythmia detection, ST segment monitoring, pulse oximetry, and pulse rate monitoring.

Regulatory Classification

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)
Infinity Alpha (K051658)

Related Devices

K121480 — ARIATELE TELEMETRY TRANSMITTER (96281) · Spacelabs Healthcare · Jun 6, 2012
K132320 — INTELLIVUE CL RESPIRATION POD · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Mar 26, 2014
K122253 — PROCARE MONITOR B20 · Ge Medical Systems China Co., Ltd. · Mar 22, 2013
K200859 — Infinity M300 · Draeger Medical Systems, Inc. · Aug 28, 2020
K051658 — INFINITY ALPHA · Draeger Medical Systems, Inc. · Nov 16, 2005

Submission Summary (Full Text)

{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