(504 days)
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. The EEG module is not intended for use on infants. 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. Intended clinical applications: Critical Care Patients, Cardiac Step-down/Telemetry Units, Emergency Departments, Intra-operative (Anesthesia) Monitoring, Post Anesthesia Care.
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.
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). 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 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.
The Envoy Patient Monitor with the new EEG module was determined to be substantially equivalent to the predicate device (EEG module of the Mennen Medical Horizon 2000 patient monitor (K910945)) through performance testing and comparison of technological characteristics.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Monitored Parameters and Features" table and the "Displayed Parameters" table, alongside the claim of compliance with relevant IEC standards. The "Reported Device Performance" is directly listed within these tables.
| Parameter/Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional & Electrical | ||
| EEG channels | 4 differential channels | 4 differential channels |
| Gain Selection/Sensitivity Control | Selects 1 of 10 possible gains (10 $\mu$V/cm - 4 mVolt/cm, 0.5 $\mu$Volt/mm - 70 $\mu$Volt/mm) | 10, 20, 50, 70, 100, 200, $\mu$Volt/cm and $\frac{1}{2}$, 1, 2, 4 mVolt/cm; |
| 0.5, 1, 2, 3, 5, 7, 10, 15, 20, 30, 50, 70 $\mu$Volt/mm or mVolt/cm | ||
| Common Mode Rejection Ratio | 100 dB at 50/60 Hz (5 K $\Omega$ imbalance) | 100 dB at 50/60 Hz (5 K $\Omega$ imbalance) |
| Frequency Response selection | 0.5 Hz to 75 Hz (-3db) | 0.5 Hz to 75 Hz (-3db) |
| Noise |
§ 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).