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.

AI/ML Overview

The document provided is a 510(k) premarket notification for the Mennen Medical ENSEMBLE Physiological Monitoring System, Central Station Display Terminal. It establishes substantial equivalence by comparing the new device to existing predicate devices (Mennen Medical ENVOY and HORIZON XL Patient monitors). This type of submission generally does not include performance studies with detailed acceptance criteria, sample sizes for test/training sets, expert adjudication, or MRMC comparative effectiveness studies in the same way a de novo or PMA submission might for novel AI/ML devices.

The information primarily focuses on demonstrating that the new Central Station performs similarly to previous versions in terms of displaying physiological parameters and alarm indications. The "equivalency statement" column acts as the "reported device performance" in this context, asserting that the new device performs identically or similarly in its function.

Given the nature of the document, many of your requested fields are not directly applicable or are not explicitly stated.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly that the ENSEMBLE Physiological Monitoring System, Central Station Display Terminal, when connected to the Mennen Medical ENVOY patient monitor, performs equivalently to when it is connected to the Mennen Medical HORIZON XL patient monitor across various functionalities.

Acceptance Criteria (Implicit from Predicate Comparison)	Reported Device Performance (Equivalency Statement)
Displayed Parameters:
ECG display of waveforms	"Ensemble does not analyze waveforms; it only displays them." (Equivalent functionality across both predicates, as the central station's role is display only)
Heart Rate numerical display	"No difference" (Equivalent to both predicates)
Invasive BP waveform/numerical display	"No difference" (Equivalent to both predicates)
Noninvasive BP numerical display	"No difference" (Equivalent to both predicates)
Pulse Oximetry waveform/numerical display	"No difference" (Equivalent to both predicates)
Respiration numerical display	"No difference" (Equivalent to both predicates)
Temperature numerical display	"No difference" (Equivalent to both predicates)
Alarm Indications:
Arrhythmia alarms	"No difference" (Equivalent to both predicates)
Heart Rate alarms	"No difference" (Equivalent to both predicates)
Invasive BP alarms	"No difference" (Equivalent to both predicates)
Noninvasive BP alarms	"No difference" (Equivalent to both predicates)
Pulse Oximetry alarms	"No difference" (Equivalent to both predicates)
Respiration alarms	"No difference" (Equivalent to both predicates)
Temperature alarms	"No difference" (Equivalent to both predicates)
Graded alarms (audio, visual)	"No difference" (Equivalent to both predicates)
Technical Alarms (INOPS)	"No difference" (Equivalent to both predicates)
Resetting/Suspending Alarms with automatic reactivation	"No difference" (Equivalent to both predicates)
Auxiliary Functions:
Change ECG Lead Selection	"No difference" (Equivalent to both predicates)
Display of Arrhythmia Information	"No difference" (Equivalent to both predicates)
Change BP Range/Scale	"No difference" (Equivalent to both predicates)
Data Review: Trends	"No difference" (Equivalent to both predicates)
Data Review: Tabular	"No difference" (Equivalent to both predicates)

Study Information:

Sample size used for the test set and the data provenance: Not explicitly stated. This type of submission relies on demonstrating functional equivalence through comparison to legally marketed predicate devices, rather than a clinical trial with a specific test set of patients or data. The "test" here is the comparison of features, not a performance evaluation on clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., from expert annotations or pathology) is not discussed in this device's 510(k) submission.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a central station display system, not an AI/ML diagnostic or assistive tool, and thus MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's function is to display data from patient monitors; it does not contain a standalone algorithm for diagnosis or interpretation.
The type of ground truth used: Not explicitly defined in terms of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission is implicitly the established and legally marketed functionality of the predicate devices. The claim is that the new configuration (ENSEMBLE with ENVOY) performs equivalently to the existing configuration (ENSEMBLE with HORIZON XL), where the existing configuration's performance is the reference.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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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: 972-8-938-3030

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.

DisplayedParameters	Mennen MedicalENVOYPatient Monitor	Mennen MedicalHORIZON XLPatient Monitor	EquivalencyStatement
ECG	8 waveformsdisplay	3 waveformsdisplay	Ensemble does notanalyze waveforms; itonly 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

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Alarm Indications:	Mennen MedicalENVOYPatient Monitor	Mennen MedicalHORIZON XLPatient 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 toSeverity: audio, visual	Yes	Yes	No difference
Technical Alarms(INOPS)	Yes	Yes	No difference
Resetting/SuspendingAlarms - silence tone,automatic reactivateafter set interval	Yes	Yes	No difference
Auxiliary Functions	Mennen MedicalENVOYPatient Monitor	Mennen MedicalHORIZON XLPatient Monitor	Equivalency Statement
Change ECG LeadSelection	Yes	Yes	No difference
Display of ArrhythmiaInformation	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

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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: 972-8-938-3030, Fax: 972-8-940-6519 or E-mail: kenr@mmi.co.il

Sincerely,

Ken Kaichman Director of Regulatory Affairs MENNEN MEDICAL LTD.

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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.

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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

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

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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: 972-8-9383030' and 'Fax: 972-8-9406519'.

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

Ensemble Central Station monitor with Envoy Patient monitor

Indications for Use:

(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 ✓

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.