ENSEMBLE CENTRAL STATION MONITOR

K970358 · Mennen Medical, Inc. · DSI · Feb 11, 1998 · Cardiovascular

Device Facts

• Record ID: K970358
• Device Name: ENSEMBLE CENTRAL STATION MONITOR
• Applicant: Mennen Medical, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Feb 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

ENSEMBLE includes the essential features of a central station monitor for up to 12 patients. It can display vital signs information collected from bedside patient monitoring devices such as: ECG/Heart Rate, Arrhythmia (basic and extended alarms), ST Segment, Respiration, Temperature, Invasive Blood Pressure, Noninvasive Blood Pressure, Pulse Oximetry, and End Tidal carbon-dioxide. The ENSEMBLE may be used in system application in many different clinical specialties within the hospital.

Device Story

ENSEMBLE is a hospital-based, multi-patient central station display terminal. It functions as a component of a physiological monitoring system, receiving vital signs, waveforms, and alarm data from bedside devices (e.g., HORIZON XL, 219 TELEMETRY) via an Ethernet network. It displays data for up to 12 patients simultaneously, including patient name, location, vital sign values, alarm limits, waveforms, and alarm status. The device does not perform primary alarm determination; this occurs at the bedside. However, it provides remote interaction capabilities, allowing clinicians to adjust bedside alarm/parameter settings and initiate recordings or printouts. Operated via mouse, keyboard, touchscreen, trackball, or light pen by hospital staff. It centralizes patient data to facilitate clinical monitoring and decision-making, improving patient oversight.

Clinical Evidence

Bench testing only. The device complies with AAMI/ANSI ES11 (Safe Current Limits), AAMI/ANSI EC13 (Cardiac Monitors), and UL-544 standards. No clinical data provided.

Technological Characteristics

Software-driven central station display terminal. Ethernet connectivity for data acquisition from bedside monitors. Supports mouse, keyboard, touchscreen, trackball, and light pen inputs. Complies with UL 544, ANSI Safe Current Limits, and FDA MDS-201-0004. Non-implantable, non-life-sustaining. No drug/biological components.

Indications for Use

Indicated for hospital-based physiological monitoring of up to 12 patients simultaneously. Displays vital signs including ECG/Heart Rate, Arrhythmia, ST Segment, Respiration, Temperature, Invasive/Noninvasive Blood Pressure, Pulse Oximetry, and End Tidal CO2. For prescription use only.

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

• MENNEN MEDICAL COMPREHENSIVE CENTRAL STATION (K892066)
• HEWLETT-PACKARD M2360A WAVEVUE CENTRAL MONITOR (K921014)

Submission Summary (Full Text)

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K970358

FEB 11 1998

# MENNEN MEDICAL LTD.

Kiryat Weizmann Science Park
P.O.B. 102
Rehovot 76100 Israel
Tel: [phone]
Fax: [phone]

**Date:** 10 November 1997
**To:** Food and Drug Administration
Center for Devices and Radiological Health Document Control Center (HFZ-401)
1390 Piccard Drive
Rockville MD 20850
**Attn.:** Document Control Clerk
**From:** Kenneth Raichman
Director of Regulatory Affairs
**Topic:** 510(k) Summary
**ENSEMBLE Central Station Monitor**
**Safety and Effectiveness**

## Product Name

**Proprietary:** ENSEMBLE
**Common:** Physiological Monitoring System, Central Station Display Terminal

## Establishment Registration Number and Address

**Registration Number** 9611022
**Mennen Medical LTD.**
Alan Schwebel, Ph.D.
**President**
Kiryat Weizmann Science Park
Rehovot 76100 Israel
Tel: [phone]

## Classification (Section 513)

**Classification:** Class III
**Panel:** Anesthesiology and Respiratory/Cardiology

## Performance Standards

None Established.

## Voluntary Standards

AAMI/ANSI ES11 Safe Current Limits for Electromedical Devices
AAMI/ANSI EC13, Cardiac Monitors, Heart Rate Meters and Alarms
UL-544

## Predicate Devices

MENNEN MEDICAL COMPREHENSIVE CENTRAL STATION (K892066).
HEWLETT-PACKARD M2360A WAVEVUE CENTRAL MONITOR (K921014).

## Date Prepared

10 November 1997

127

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Food and Drug Administration
10 November 1997
510(k) Summary, ENSEMBLE Safety & Effectiveness
Page 2 of 7.

# Device Description

ENSEMBLE is hospital based, multi-patient, multi-parameter display terminal. As such, it is a component in a physiological patient vital signs monitoring system.

A system consists of any of the several possible combinations of the following components:

## Bedside Devices

HORIZON XL patient monitor, and/or

219 TELEMETRY RECEIVER/TRANSMITTER with NS-7,

(K911616, and K895395, respectively)

## Ethernet™ Communication Network

Documentation Peripherals (Chart Recorders and Laser Printers), and

ENSEMBLE Central Station Monitor.

ENSEMBLE acquires patient vital signs, waveforms and alarm indications from Mennen Medical HORIZON XL and 219 TELEMETRY systems. All processing and alarm determination is made in these “bedside devices”, using proprietary algorithms and software contained therein. Processed information is communicated from the bedside devices to one or more ENSEMBLE Central Station Monitors by the Mennen Medical ENSEMBLE system Ethernet™ network. If documentation is requested, information is transmitted to the appropriate Documentation Peripheral, using the same network.

Although ENSEMBLE does not make alarm determinations, it does provide users with a remote interaction capability, allowing users to make changes to both parameter and alarm settings in the remote bedside devices. Similarly, ENSEMBLE users have a remote interactive capability to initiate recordings or printing of patient information and waveforms.

Vital signs and waveform information from up to 12 patients are displayed simultaneously on an ENSEMBLE Central Station Monitor. Information from each individual patient is presented in a separate portion of the display. Each patient display area includes: Patient Name, Assigned Location (room), Primary Vital Sign Name, Value & Alarm Limits (nominally Heart Rate), Primary Waveform (nominally ECG), Secondary Vital Sign Numeric Data, Alarm Status Messages, and a dedicated “soft key” for recording waveforms. Software configurations allow more than one waveform or parameter to be displayed for each patient.

Primary operation of the ENSEMBLE is accomplished by a desktop mouse. A standard computer keyboard is used for manual entry of alphanumeric information. An optional touchscreen is available for users who prefer to use a touchscreen. Alternative “desktop devices”, such as trackball and light pen, are also available as options. For large installations, with several ENSEMBLEs intended for a single user, the system may be configured to enable one keyboard and one mouse to control up to eight individual ENSEMBLE computers.

ENSEMBLE is a reusable, software driven, central station display terminal, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, or life sustaining device; nor is it implantable and therefore sterility is not a consideration. ENSEMBLE complies with UL 544, ANSI Safe Current Limits for Electromedical Apparatus, and FDA MDS-201-0004 voluntary standards. ENSEMBLE is not a kit, does not contain any drug or biological products and is for prescription use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 11 1998

Allen Schwebel, Ph.D.
Mennen Medical Ltd.
Kiryat Weizmann Science Park
P.O.B. 102
Rehovot 76100
ISRAEL

Re: K970358
Ensemble Central Station Monitor
Regulatory Class: III (three)
Product Code: 74 DSI
Dated: November 10, 1997
Received: November 13, 1997

Dear Dr. Schwebel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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970358
10 November 1997
Page 3 of 7.

Food and Drug Administration
510(k) Summary, ENSEMBLE Safety & Effectiveness

## Indications for Use:

ENSEMBLE includes the essential features of a central station monitor for up to 12 patients. It can display vital signs information collected from bedside patient monitoring devices such as: ECG/Heart Rate, Arrhythmia (basic and extended alarms), ST Segment, Respiration, Temperature, Invasive Blood Pressure, Noninvasive Blood Pressure, Pulse Oximetry, and End Tidal carbon-dioxide. The ENSEMBLE may be used in system application in many different clinical specialties within the hospital.

_________________________
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number **K970358**

*Prescription: ☑*