(504 days)
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No
The document describes a standard multiparameter physiological patient monitoring system and does not mention any AI or ML capabilities.
No
The device is described as a "multiparameter physiological patient monitoring system" intended for "monitoring and recording patient information." Its functions are listed as displaying waveforms, vital signs, alarms, and status messages. There is no mention of it treating or preventing disease, only observing patient conditions.
No
The device is a multiparameter monitoring system designed to display physiological data and vital signs. While it can indicate brain activity, it explicitly states that the EEG module "is not a replacement for a comprehensive multi-channel... EEG diagnosis by a neurology specialist" and its primary purpose is "to determine the need for more detailed EEG recordings." This indicates it's for monitoring and flagging potential issues rather than making a diagnosis.
No
The device description explicitly states that the Envoy consists of a "main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules." This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the Envoy device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Envoy is a patient monitoring system that directly measures physiological parameters from the patient (ECG, blood pressure, temperature, pulse oximetry, respiration, EtCO2, and EEG). It does not analyze samples like blood, urine, or tissue.
- The intended use and device description clearly state it's a multiparameter physiological patient monitoring system. Its purpose is to monitor and record vital signs and waveforms from the patient in real-time.
- There is no mention of analyzing biological samples or performing tests on specimens.
Therefore, the Envoy falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Envoy is intended for use as a multiparameter physiological patient monitoring system for the monitoring and recording of patient information or any in-hospital application that requires patient monitoring. The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, eTCO2 and EEG.
Functions include display of multiparameter waveforms, vital signs, alarm & status messages. This effectively allows the Envoy to monitor a wide-range of adult, pediatric, and neonatal patient conditions, in many different areas of the hospital.
The Envoy EEG module can monitor up to 4 differential EEG channels and display processed trend and real-time EEG waveforms. EEG monitoring is continuous and in real time. The Envoy EEG module does not have derived parameters such as Aspect BIS or other derived parameters. The Envoy EEG module can be used as an indicator of brain damage or cerebral activity. The EEG module is commonly used to monitor the cerebral activity of patients who have suffered serious head injury or to evaluate the state of consciousness of a patient.
The primary purpose of the EEG module is to determine the need for more detailed EEG recordings. The EEG module is not a replacement for a comprehensive multi-channel (16 to 36 or more) EEG diagnosis by a neurology specialist. Since four channels are displayed simultaneously, qualitative assessments can be made regarding right and left hemispheric activity.
The Envoy is intended for use as a multiparameter monitoring system.
The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, EtCO2 and EEG.
This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multiparameter waveforms, vital signs, alarm & status messages.
The Mennen Medical Envoy is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring of intended clinical applications:
- Critical Care Patients
- Cardiac Step-down/Telemetry Units
- Emergency Departments
- Intra-operative (Anesthesia) Monitoring
- Post Anesthesia Care
Product codes (comma separated list FDA assigned to the subject device)
OMC
Device Description
The Envoy consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules monitor the patient's vital signs. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays.
The Envoy vital signs modules acquire vital signs data from the patient; the modules display the patient waveforms, vital signs information, and alarms indications on the Envoy display unit.
The Envoy is not a life supporting, nor life-sustaining device; nor is it implantable; therefore sterility is not a consideration. The Envoy is not a kit and does not contain any drug or biological products.
The EEG module of the Envoy monitor consists of the following main parts/components:
- 5 lead input cable
- Four channel differential amplifier
- Processing and Storage circuit block (P&SB)
The P&SB of the EEG module is identical to the Mennen Medical P&S Boards located in the other Envoy input modules. The P&SB consists of a communications processor and memory, and performs local data storage and protocol translation from low-level protocol to high level protocol. The Envoy can display between one and four EEG channels on and the user can control the sensitivity and the frequency response of the EEG waveforms. Both sensitivity and filters are common to all four channels. The top displayed EBG channel is stored in Overview for up to 72 hours.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult, pediatric, and neonatal patient conditions (for the overall Envoy system).
The EEG module is not intended for use on infants.
Intended User / Care Setting
Qualified medical personnel only.
In-hospital application.
Clinical applications: Critical Care Patients, Cardiac Step-down/Telemetry Units, Emergency Departments, Intra-operative (Anesthesia) Monitoring, Post Anesthesia Care.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Envoy EEG module has been subject to extensive safety and performance testing. Final testing for the system included various performance tests designed to ensure that the device meets all functional requirements and performance specifications. Safety testing and EMC testing were performed by an independent testing laboratory to ensure that the device complies to applicable industry and safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
ENVOY Patient Monitor: 510(k) for new BEG module
Image /page/0/Picture/3 description: The image shows the logo for "mennenmedical". The logo consists of a stylized lowercase "m" inside of a circle. The word "mennenmedical" is written in a stylized font below the circle.
MAY 1 0 2004
Mennen Medical Ltd., 4 Hayarden Street, Yavne 81228 PO Box 102, Rehovot 76100 Israel
Tel.: +972-8-9323333 Fax: +972-8-9328510
Date: 14 March, 2004
Topic: 510(k) Safety and Effectiveness Summary as per 21 CFR Section 807,92(c) Envoy Patient Monitor - new EEG module:
- To: Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville MD, 20850
Attn.: Document Control Clerk
From: Asher Kassel, Director of Regulatory Affairs
Establishment Name, Registration Number and Address:
| Name: | Mennen Medical Ltd. |
|---|---|
| Registration Number | 9611022 |
| Operator Number: | 9011766 |
| Address: | 4 Hayarden Street, Yavne, 81228, Israel |
| Postal Address: | PO Box 102, |
| Rehovot, 76100, Israel | |
| Tel: | +972-8-9323333 |
| Fax: | +972-8-9328510 |
| Contact person: | Asher Kassel, Director of Regulatory Affairs |
| Product Name: | Proprietary: ENVOY |
| Common: | Physiological Patient Monitor |
| Mennen Medical Part Number: | 550-010-000 (full system) |
| 554-000-010 (CPU only) | |
| New Envoy EEG module | P/N: 551-138-000 |
Page 1 of 6
1
ENVOY Patient Monitor: 510(k) for new EEG module
FDA Classification of Envoy Patient Monitor:
Arrhythmia Detector and Alarm Classification Name: 21 CFR 870.1025 Classification Number: Class III Classification: 74 DSI Product Code:
FDA Classification of new Envoy EEG module:
| Classification Name: | Electroencephalograph |
|---|---|
| Classification Number: | 21 CFR 882.1400 |
| Classification: | Class II |
| Product Code: | OMC |
Performance Standards:
None promulgated
Voluntary Standards:
*IEC 60601-1 : General Requirements for Safety for Medical Electrical Systems - part 1, (1988); Amendment 1 - 1991-11; Amendment 2 - 1995-03
*IEC 60601-1-2:
General Requirements for Safety Collateral Standard: Electromagnetic compatibility - Requirements and tests.
*IEC 60601-2-26:
Particular Requirements for the safety of electroencephalographs
Predicate Device:
EEG module of the Mennen Medical Horizon 2000 patient monitor (K910945)
2
Food and Drug Administration ENVOY Patient Monitor: 510(k) for new EEG module
Intended Use and Device Description of the Envoy Patient Monitor:
The Envoy is intended for use as a multiparameter physiological patient monitoring system for the monitoring and recording of patient information or any in-hospital application that requires patient monitoring. The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, eTCO2 and EEG.
Functions include display of multiparameter waveforms, vital signs, alarm & status messages. This effectively allows the Envoy to monitor a wide-range of adult, pediatric, and neonatal patient conditions, in many different areas of the hospital.
The Envoy consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules monitor the patient's vital signs. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays.
The Envoy vital signs modules acquire vital signs data from the patient; the modules display the patient waveforms, vital signs information, and alarms indications on the Envoy display unit.
The Envoy is not a life supporting, nor life-sustaining device; nor is it implantable; therefore sterility is not a consideration. The Envoy is not a kit and does not contain any drug or biological products.
Intended Use and Functional Description and of the Envoy EEG module:
The Envoy EEG module can monitor up to 4 differential EEG channels and display processed trend and real-time EEG waveforms. EEG monitoring is continuous and in real time. The Envoy EEG module does not have derived parameters such as Aspect BIS or other derived parameters. The Envoy EEG module can be used as an indicator of brain damage or cerebral activity. The EEG module is commonly used to monitor the cerebral activity of patients who have suffered serious head injury or to evaluate the state of consciousness of a patient.
The EEG module of the Envoy patient monitor is not sold as a stand-alone EEG device, but as part of a multiparameter physiological patient monitoring system (Envoy). In Chapter 1 of the Envoy Operating Manual, the following Prescription Notice appears: "Federal United States law restricts the sale and use of this instrument to qualified medical personnel only."
The primary purpose of the EEG module is to determine the need for more detailed EEG recordings. The EEG module is not a replacement for a comprehensive multi-channel (16 to 36 or more) EEG diagnosis by a neurology specialist. Since four channels are displayed simultaneously, qualitative assessments can be made regarding right and left hemispheric activity.
Note: The EEG module is not Intended for use on infants.
3
ENVOY Patient Monitor: 510(k) for new EEG modulo
The EEG module of the Envoy monitor consists of the following main parts/components:
- 5 lead input cable
- Four channel differential amplifier �
- Processing and Storage circuit block (P&SB) ●
The P&SB of the EEG module is identical to the Mennen Medical P&S Boards located in the other Envoy input modules. The P&SB consists of a communications processor and memory, and performs local data storage and protocol translation from low-level protocol to high level protocol. The Envoy can display between one and four EEG channels on and the user can control the sensitivity and the frequency response of the EEG waveforms. Both sensitivity and filters are common to all four channels. The top displayed EBG channel is stored in Overview for up to 72 hours.
Summary of the technological characteristics of the new Envoy EEG module (incorporating Mennen Medical proprietary technology):
| Envoy EEG module | |
|---|---|
| Part Number: | 551-138-000 |
| Module size: | Single slot |
| Height: 10.0cm (4.0 in) | |
| Width: 4.0 cm (1.6 in) | |
| Depth: 14.0 cm (5.5 in) |
| Monitored Parameters
and Features | Mennen Medical Envoy
EEG module |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Part/Option Number | 551-138-000 |
| EEG channels | 4 differential channels |
| Gain Selection/
Sensitivity Control | Selects one of 10 possible gains:
10, 20, 50, 70, 100, 200, $\mu$ Volt/cm and
$\frac{1}{2}$ ,1, 2, 4 mVolt/cm |
| Common Mode Rejection Ratio | 100 dB at 50/60 Hz (5 K $\Omega$ imbalance) |
| Frequency Response selection | 0.5 Hz to 75 Hz (-3db) |
| Noise |