(377 days)
No
The description explicitly states that "All processing and alarm determination is made in these 'bedside devices', using proprietary algorithms and software contained therein." The central station monitor (ENSEMBLE) is primarily a display and remote interaction terminal, not performing the core processing or decision-making. There is no mention of AI or ML in the document.
No
The device is described as a "central station monitor" and a "display terminal" that acquires and displays vital signs and waveforms. It specifically states: "As such it is not a life supporting, or life sustaining device." It facilitates monitoring but does not provide therapy or treatment.
No
The ENSEMBLE device is described as a "multi-patient, multi-parameter display terminal" that acquires vital signs, waveforms, and alarm indications from "bedside devices" where "all processing and alarm determination is made." It displays information and allows remote interaction with bedside devices but does not perform diagnostic functions itself.
No
The device description explicitly states that ENSEMBLE is a "display terminal" and a "component in a physiological patient vital signs monitoring system." It also mentions the use of a desktop mouse, standard computer keyboard, optional touchscreen, and other "desktop devices" as primary operation methods, indicating the presence of hardware.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ENSEMBLE's Function: The description clearly states that ENSEMBLE is a central station monitor that displays vital signs information collected from bedside patient monitoring devices. It processes and displays physiological data (ECG, blood pressure, temperature, etc.) obtained directly from the patient, not from specimens taken from the patient.
- No Specimen Handling: There is no mention of ENSEMBLE handling or analyzing any biological specimens.
Therefore, ENSEMBLE falls under the category of a physiological patient monitoring system, not an In Vitro Diagnostic device.
N/A
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
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 be 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,
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
hospital based / hospital environment
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
97035-8
FEB 11 1998
Image /page/0/Picture/2 description: The image shows the logo for Mennen Medical. The logo consists of a stylized lowercase "m" inside of a black circle, followed by the words "mennenmedical" in a sans-serif font. The word "mennen" is in bold, while "medical" is in regular font.
1992-2
MENNEN MEDICAL LTD. Kirvat Weizmann Science Park P.O.B. 102
Rehovot 76100 Israel Tel: 972-8-938-3030 Fax: 972-8-940-6519
10 November 1997 Date:
-
Food and Drug Administration To: Center for Devices and Radiological Health Document Control Center (HFZ-401) 1390 Piccard Drive Rockville MD 20850
Document Control Clerk Attn.: -
Kenneth Raichman From: Director of Regulatory Affairs
510(k) Summary Topic: 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: 972-8-938-3030
Classification (Section 513)
Classification: 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
Class III
Predicate Devices
MENNEN MEDICAL COMPREHENSIVE CENTRAL STATION (K892066). HEWLETT-PACKARD M2360A WAVEVUE CENTRAL MONITOR (K921014).
Date Prepared
10 November 1997
1
Food and Drug Administration
Page 2 of 7.
510(k) Summary, ENSEMBLE Safety & Effectiveness
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 be 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,
2
Image /page/2/Picture/2 description: The image shows a stylized emblem or logo. It features a graphic of a bird-like figure with three curved lines representing its body or wings. The emblem also includes text, with the letters 'DEPA' visible at the bottom and partial text around the top edge, including 'HUMAN' and 'USA'.
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
K970358 Re: Ensemble Central Station Monitor Requlatory Class: ... III (tbree) Product Code: 74 DSI Dated: November 10, 1997 November 13, 1997 Received:
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 requlations 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.
3
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 requlation (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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Food and Drug Administration
510(k) Summary, ENSEMBLE Safety & Effectiveness
10 November 1997
97035
Page 3 of 7.
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.
Mr. Pugh
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _ 29703
Prescription