INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM

K060223 · Draeger Medical Systems, Inc. · MHX · Apr 12, 2006 · Cardiovascular

Device Facts

• Record ID: K060223
• Device Name: INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
• Applicant: Draeger Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Apr 12, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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. The Infinity MultiView WorkStation (MVWS) Telemetry System is intended to measure and produce visual and audible alarms for one or more physiological parameters. This device is intended for use in an environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

Device Story

Infinity MultiView WorkStation and Telemetry system functions as central monitoring, network, and remote display for Draeger patient monitoring systems. System inputs include continuous physiologic waveforms and episodic patient data. New features include 'Pacer Fusion' mode for increased sensitivity to pseudofusion/fused paced beats and 'Infinity Symphony' web-based application for retrospective review of stored data. Operated by healthcare professionals in clinical environments to provide visual/audible alarms for physiological parameters. Output allows clinicians to perform analysis, review, and documentation of patient condition, supporting clinical decision-making regarding patient status.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical verification and validation testing.

Technological Characteristics

Central monitoring workstation and telemetry system. Connectivity: Networked. Software: VF6 version supporting web-based browser application. Standards: IEC 60601-1.

Indications for Use

Indicated for adult and pediatric patients in clinical settings under professional care (physicians, nurses, technicians) requiring measurement and alarm monitoring for heart rate, ECG arrhythmia, arterial oxygen saturation, pulse rate, and ST segment analysis.

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.

Submission Summary (Full Text)

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K060223
P1/2

### APR 1 2 2006

# 510(k) SUMMARY

as required per 807.92(c)

Submitter's Name and Address: Draeger Medical Systems, Inc. 16 Electionics Avenue Danvers, MA 01923

Contact Person:

Karen Iorio, Director OA/RA Ph: [phone] Fax: [phone]

Date submission was prepared:

January 25, 2006

Device Name:

Detector and Alarm, Arrhythmia

Classification Name: MHX

Regulation Number: 21 CFR 870.1025

2

Class:

Common Name:

Legally Marketed Device Identification:

Infinity MultiView Workstation and Telemetry

#### Device Description:

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.

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#### Intended Use:

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.

060223 , 2/2

The Infinity MultiView WorkStation (MVWS) Telemetry System is intended to measure and produce visual and audible alarms for one or more physiological parameters

This device is intended for use in an environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

Substantial Equivalence:

Assessment of non-clinical performance data for equivalence:

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).

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidance: IEC 60601-1

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2006

Draeger Medical Systems, Inc. c/o Mr. Thomas M. McIntosh Regulatory Submission Manager 16 Electronics Avenue Danvers, MA 01923

Re: K060223

Trade Name: Infinity MultiView WorkStation and Telemetry Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: March 21, 2006 Received: March 22, 2006

Dear Mr. McIntosh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 – Mr. Thomas M. McIntosh

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Dr lass Intactions and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Far 007); its eller (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product taxilation some to begin marketing your device as described in your Section 510(k) Premarket notification. The FDA finding of substantial equivalence of your device to a legally premance notification "ceresults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmar for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 060223

510(k) Number (if known):_

Device Name: Infinity MultiView WorkStation and Telemetry

Indications for Use

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 .

Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummana

510(k) Number

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