MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR

• K Number: K982697
• Device Name: MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR
• Manufacturer: MENNEN MEDICAL, INC.
• Date Cleared: 1998-08-12 ( 9 days)
• Product Code: DSI
• Regulation Number: 870.1025

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 Description

The Ensemble Central Station is able to display the signals that are transmitted to it by the patient monitor to which it is connected via the communication network.

Predicate Devices

K974510, K911616

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a central station monitor that displays vital signs from connected bedside devices. There is no mention of AI, ML, image processing, or any performance studies typically associated with AI/ML algorithms.

Therapeutic

No

The device is a central station monitor that displays vital signs information collected from bedside patient monitoring devices. It is for monitoring and display purposes, not for treating or providing therapy to a patient.

Diagnostic

Yes

The device displays vital signs information collected from bedside patient monitoring devices, which is used for patient assessment and monitoring, a key aspect of diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Central Station" which receives signals from "bedside patient monitoring devices" via a "communication network." This implies a hardware component (the central station itself) that is distinct from the software displaying the information. While the software is a critical part of the system, the description does not indicate it is only software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use describes the device as a central station monitor that displays vital signs information collected from bedside patient monitoring devices. This involves monitoring physiological parameters of a patient in vivo (within the living body), not analyzing samples in vitro (outside the living body).
• Device Description: The description reinforces that it displays signals transmitted from patient monitors, further indicating its role in patient monitoring rather than laboratory analysis of samples.
• Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in samples
  • Providing information for diagnosis, monitoring, or screening based on sample analysis

The device functions as a central hub for displaying patient vital signs data, which is a core function of patient monitoring systems, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

74 DSI

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

within the hospital

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K974510, K911616

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

AUG / 2 1998

510(k) Summary

Product Name

Proprietary: Common:

ENSEMBLE 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
Classification Number	74 DSI
Panel:	Anesthesiology and Respiratory/Cardiology

Substantial Equivalency Information:

The following tables summarize data on the Mennen Medical ENVOY (K974510) and the Mennen Medical Medical HORIZON XL (K911616 ) Patient monitors. The Ensemble Central Station is able to display the signals that are transmitted to it by the patient monitor to which it is connected via the communication network.

| Displayed
Parameters | Mennen Medical
ENVOY
Patient Monitor | Mennen Medical
HORIZON XL
Patient Monitor | Equivalency
Statement |
|-------------------------|--------------------------------------------|-------------------------------------------------|-------------------------------------------------------------------|
| ECG | 8 waveforms
display | 3 waveforms
display | Ensemble does not
analyze waveforms; it
only displays them. |
| Heart Rate | numerical | numerical | No difference |
| Invasive BP | waveform/numerical | waveform/numerical | No difference |
| Noninvasive BP | numerical | numerical | No difference |
| Pulse Oximetry | waveform/numerical | waveform/numerical | No difference |
| Respiration | numerical | numerical | No difference |
| Temperature | numerical | numerical | No difference |

1

| Alarm Indications: | Mennen Medical
ENVOY
Patient Monitor | Mennen Medical
HORIZON XL
Patient Monitor | Equivalency Statement |
|----------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------------|-----------------------|
| Arrhythmia | Yes | Yes | No difference |
| Heart Rate | Yes | Yes | No difference |
| Invasive BP | Yes | Yes | No difference |
| Noninvasive BP | Yes | Yes | No difference |
| Pulse Oximetry | Yes | Yes | No difference |
| Respiration | Yes | Yes | No difference |
| Temperature | Yes | Yes | No difference |
| Graded according to
Severity: audio, visual | Yes | Yes | No difference |
| Technical Alarms
(INOPS) | Yes | Yes | No difference |
| Resetting/Suspending
Alarms - silence tone,
automatic reactivate
after set interval | Yes | Yes | No difference |
| Auxiliary Functions | Mennen Medical
ENVOY
Patient Monitor | Mennen Medical
HORIZON XL
Patient Monitor | Equivalency Statement |
| Change ECG Lead
Selection | Yes | Yes | No difference |
| Display of Arrhythmia
Information | Yes | Yes | No difference |
| Change BP Range/Scale | Yes | Yes | No difference |
| Data Review: Trends | Yes | Yes | No difference |
| Data Review: Tabular | Yes | Yes | No difference |

2

Substantial Equivalency

Mennen Medical deems the operation of the Ensemble opposite the Mennen Medical Envoy patient monitor to be substantially equivalent to the operation of the Ensemble opposite the Mennen Medical Horizon XL patient monitor.

Mennen Medical considers all information in this submittal to be confidential.

Please contact the undersigned either by telephone: [phone], Fax: [phone] or E-mail: [e-mail]

Sincerely,

Ken Kaichman Director of Regulatory Affairs MENNEN MEDICAL LTD.

3

Public Health Service

Image /page/3/Picture/2 description: The image shows a partial view of a logo or emblem, specifically the symbol associated with the U.S. Department of Health & Human Services (HHS). The symbol features a stylized representation of a human figure, with three distinct wave-like lines forming the body. The text "DEPARTMENT OF HEALTH & HO" is visible, indicating the emblem is likely part of the department's official seal or branding.

AUG | 2 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kenneth Raichman Mennen Medical Ltd. Kiryat Weizmann Science Park P.O.B. 102 Rehovot 76100 ISRAEL

K982697 Re : Ensemble Central Station Monitor with Envoy Patient Monitor Regulatory Class: III (three) Product Code: 74 DSI Dated: July 30, 1998 Received: August 3, 1998

Dear Mr. Raichman:

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 leqally 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). 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.

4

Page 2 - Mr. Kenneth Raichman

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/dsma/dsmamain.html".

Sincerely yours,

Sincerely yours,

Thomas J. Callahon

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

Enclosure

5

Image /page/5/Picture/1 description: The image shows the logo and contact information for Mennen Medical LTD. The logo features a stylized letter 'm' inside a circle, followed by the text 'mennenmedical'. Below the logo is the phrase 'Partners In Patient Care' inside a rectangular box. The contact information includes the address 'Kiryat Weizmann Science Park P.O.B. 102 Rehovot 76100 Israel' and the telephone and fax numbers 'Tel: [phone]' and 'Fax: [phone]'.

Special 510(k): K982697 - Modification to the Ensemble Central Station

Ensemble Central Station monitor with Envoy Patient monitor

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.

(Signature)

Kenneth Raichman Director of Regulatory Affairs Mennen Medical Ltd.

Date: August 10, 1998

Mok Kame

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number __

PRESCRIPTION USE ✓