(105 days)
K 040183
No
The document describes the use of "proprietary algorithms and software" and "software and/or hardware technology developed by vendors" for signal processing and analysis, but does not mention AI or ML. The BIS index is described as a "complex technology" and a "processed parameter," but not specifically as an AI/ML output.
No
This device is a patient monitor, which measures and displays physiological parameters. While the information it provides can aid in clinical decision-making, the device itself does not directly treat or prevent a disease or condition. Its function is to monitor, not to therapeutically intervene.
No
The device is described as a "physiological patient monitor" that measures and presents vital signs. While it monitors the "state of the brain by data acquisition of EEG signals" and provides a "BIS Index" as an "aid in monitoring the effects of certain anesthetic agents," its primary function is monitoring, not diagnosing a specific condition or disease. The BIS index is explicitly stated as "intended for use only as an adjunct to clinical judgment and training," supporting its role as monitoring data rather than a definitive diagnostic tool.
No
The device description explicitly states that the Envoy is a multiparameter physiological patient monitor consisting of a main processing unit, a mountable color monitor, and a module rack housing various plug-in vital signs modules. It also mentions vital signs modules that acquire data from the patient and interface with transducers, indicating significant hardware components beyond just software.
Based on the provided text, the ENVOY Monitor itself is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. The ENVOY Monitor directly monitors physiological signals from the patient's body (ECG, blood pressure, respiration, etc.). It does not analyze blood, urine, tissue, or other samples collected from the patient.
- The intended use describes direct patient monitoring. The intended use clearly states it's for "monitoring vital signs of critically ill adult and pediatric patients in the hospital environment." This is in vivo monitoring, not in vitro.
- The device description details sensors and direct patient connections. The description talks about "electrically isolated patient input connections" and acquiring "vital signs data from the patient."
While the BIS module processes EEG signals, which are electrical signals from the brain, this is still considered direct physiological monitoring of the patient, not the analysis of a sample taken from the patient.
Therefore, the ENVOY Monitor, including the BIS module as described, falls under the category of a physiological patient monitor, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, CO, Pulse Oximetry and EtCO2. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The Mennen Medical Envoy BIS module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.
The BIS Index, a processed parameter may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
-
The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training.
-
In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.
Product codes (comma separated list FDA assigned to the subject device)
OLW, OMC, OLT, MHX, ORT
Device Description
The Envoy is a multiparameter physiological patient monitor, capable of monitoring:
- ECG/Heart Rate .
- Invasive blood pressure .
- Non-invasive blood pressure ●
- Respiration ●
- Pulse oximetry
- Two temperature channels ●
- Cardiac output ●
- EtCo2 .
- Spirometry ●
- EEG ●
- BIS module (new subject of this application) .
The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. 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, and display their waveforms and alarms indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time.
The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. The SpO2, Non-Invasive Blood Pressure, ExCO2 and Spirometry modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA.
Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, waveform, Vital Sign Numeric Value, Alarm Status Message.
Operation of the Envoy is accomplished by interaction with front panel controls on the main processor unit. A quick-knob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a ` menu keyboard menu is displayed.
The Envoy is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, nor life sustaining device; nor is it implantable and therefore sterility is not a consideration.
The Envoy complies with (amongst others) the following voluntary standards:
- IEC 60601-1: Medical Electrical Equipment General Requirements for Safety .
- IEC 60601-1-2: General Requirements for Safety. Collateral standard: Electromagnetic . compatibility - Requirements and tests.
- IEC 60601-2-27: Medical Electrical Equipment Part 2: Particular Requirements for the . Safety of Electrocardiographic Monitoring Equipment.
- IEC 60601-2-30: Requirements for Automatic Cycling Indirect Blood Pressure . monitoring.
- AAMI/ANSI SP-10/A I: Electronic or Automated Sphygmomanometers .
- IEC 60601-2-34: Requirements for Invasive Blood Pressure monitoring. .
- AAMVANSI ES1: Safe Current Limits for Electromedical Apparatus, and .
- AAMI/ANSI EC13: Cardiac Monitors, Heart Rate Meters and Alarms. .
The Envoy is not a kit and does not contain any drug or biological products. The BIS module of the Envoy patient monitor is not sold as a stand alone 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"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EEG signals
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care.
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
At the system level, SW Validation of the performance of the Envoy with 550-OPT-400 as compared to the Spacelab with BIS module, was carried out in accordance with the test plan described in the Mennen Medical Validation Test Procedure for the Envoy BIS module.
The SW Test Description for the Envoy with BIS - 550-OPT-400 was derived from the SW Test Description for the Envoy, with the necessary addition of the BIS measurements
Final testing for the Envoy BIS module included performance tests designed to ensure that the device meets all functional requirements and performance specifications, in accordance with the requirements of the Final Test Procedure for the Envoy BIS module. Electrical Safety testing and BMC testing were performed by an independent testing laboratory (Standard Institute of Israel SII) to ensure that the device complies to applicable industry and safety standards.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Envoy BIS module has been subject to extensive performance testing to ensure that: 1. The acquisition and display of the patient data and waveforms by the Envoy with BIS - 550-OPT-400 are equivalent to the predicate device Spacelab with BIS module.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K 040183
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).
Not Found
§ 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
CCT 2 2 2007
| Name: | Mennen Medical Ltd. |
|---|---|
| Registration Number: | 9611022 |
| Operator Number: | 9069173 |
| 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: | Ifat Oren, Regulatory Affairs |
Traditional 510(k): Device Modification - Envoy Patient Monitor Terminology
Envoy = Subject of this 510(k). The Envoy Patient Monitor is a modified device, a system identical to of the Envoy Patient Monitor with the addition of BISx module.
SPACELAB MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS - The predicate device. The SpaceLab monitor was cleared for marketing by the FDA (K060900)
Intended Use of the Envoy Patient Monitor
The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, CO, Pulse Oximetry and EtCO2. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
Indications for use - BIS Module
The Mennen Medical Envoy BIS module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.
The BIS Index, a processed parameter may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
- The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training.
1
-
- In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.
*The Intended Use of the Envoy monitor as indicated above are same as the Indications For Use.
- In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.
Device Description - Envoy Patient Monitor with BIS module
The Envoy is a multiparameter physiological patient monitor, capable of monitoring:
- ECG/Heart Rate .
- Invasive blood pressure .
- Non-invasive blood pressure ●
- Respiration ●
- Pulse oximetry
- Two temperature channels ●
- Cardiac output ●
- EtCo2 .
- Spirometry ●
- EEG ●
- BIS module (new subject of this application) .
The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. 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, and display their waveforms and alarms indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time.
The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. The SpO2, Non-Invasive Blood Pressure, ExCO2 and Spirometry modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA.
2
Food and Drug Administration Device Modification - Envoy Patient Monitor 510(k) for addition of BIS module
Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, waveform, Vital Sign Numeric Value, Alarm Status Message.
Operation of the Envoy is accomplished by interaction with front panel controls on the main processor unit. A quick-knob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a ` menu keyboard menu is displayed.
The Envoy is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, nor life sustaining device; nor is it implantable and therefore sterility is not a consideration.
The Envoy complies with (amongst others) the following voluntary standards:
- IEC 60601-1: Medical Electrical Equipment General Requirements for Safety .
- IEC 60601-1-2: General Requirements for Safety. Collateral standard: Electromagnetic . compatibility - Requirements and tests.
- IEC 60601-2-27: Medical Electrical Equipment Part 2: Particular Requirements for the . Safety of Electrocardiographic Monitoring Equipment.
- IEC 60601-2-30: Requirements for Automatic Cycling Indirect Blood Pressure . monitoring.
- AAMI/ANSI SP-10/A I: Electronic or Automated Sphygmomanometers .
- IEC 60601-2-34: Requirements for Invasive Blood Pressure monitoring. .
- AAMVANSI ES1: Safe Current Limits for Electromedical Apparatus, and .
- AAMI/ANSI EC13: Cardiac Monitors, Heart Rate Meters and Alarms. .
The Envoy is not a kit and does not contain any drug or biological products. The BIS module of the Envoy patient monitor is not sold as a stand alone 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"
Functional description of the new Envoy BIS Module:
3
(Interface to Aspect BISx device cleared in K 040183)
The BIS Module is used to monitor dual channel EEG waveform and the BIS index, used to estimate the level of conciseness of patient under anesthesia, or patients in the ICU that may be with limited conciseness.
The BIS index together with several quality parameters are displayed and stored by the Envoy monitor.
| Parameter | Range | Description |
|---|---|---|
| BIS | 0 - 99 | Bispectral Index: The measure of consciousness of a |
| patient, (0 = no brain activity), (100 = fully conscious). | ||
| EMG | 30 - 55 dB | Electromyography: The absolute power of muscle |
| activity and artifacts in the 70 - 110 Hz range. Value is in | ||
| dB with respect to 0.0001 µV2. | ||
| SQI | 0 - 100 % | Signal Quality Index: The percentage of good epochs |
| and suppressed epochs in the last 120 epochs collected | ||
| that could be used in the Bispectral Index calculation. | ||
| SR | 0 - 100 % | Suppression Ratio: The percentage of epochs in the |
| past 63 seconds In which the EEG signal is considered | ||
| suppressed | ||
| BC | 0-30 | Burst Count: The number of EEG bursts in the last |
| minute. An EEG burst is a momentary period of EEG | ||
| activity among isoelectric or flat EEG. Blanked if SR is less | ||
| than 5. Activated by connection of an Extend sensor. | ||
| SEF | 0.5 - 30 Hz | Spectral Edge Frequency: The frequency at which 95% |
| of the total power lies below it and 5% lies above it. |
The parameters displayed and stored by the Envoy monitor are the following:
To get these parameters we use Aspect sensor and BISx unit attached to the Envoy BIS module with an interface cable produced by Aspect.
The BISx Is a product of Aspect and is sold to Mennen Medical under OEM agreement.
The BIS sensors, that consist of a set of 4 electrodes, attached to the patients forehead, are Aspect products and will be sold to end users by Aspect directly and not by Mennen Medical.
The function of the Envoy BIS module and Envoy display and storage capabilities is to display the BIS parameter and the quality parameters. To provide alarm limits for the BIS index and provide visual and audible alarms in case of the BIS index being out of the preset range, or in cases that the quality parameters are in such range that they limit the reliability of the BIS Index.
The decision on artifacts and limited rellability are provided to the Envoy BIS module by the BISx. Those can not be set by Mennen Medical Envoy monitor. The clinical BIS alarm limits are set by the user, on the Envoy monitor.
4
The Description of the BIS measurement system is described below:
- The BIS sensor (Made and sold by Aspect) is attached to the patients forehead. (See attached
Aspect document: "The BIS"" Family of Sensors") 1. - BISx (Figure 1 OEM by Aspect) is receiving, amplifying and digitizing the EEG brain signals. It 2. analyses the EEG and creates the BIS index and the quality parameters and sends them to the BIS module by RS232 protocol
- Envoy BIS Module receives the BISx output and transfers it to the Envoy bedside computer for 3. display and storage.
-
- BIS Display and storage: BIS is displayed as a number. EMG and SQI are displayed as vertical bars, and SR and BC as numbers in the BIS display area.
- Clinical and technical alarm messages are displayed in the BIS display area. 5.
- Continuous graphic trend of the BIS inclex and quality parameters are also available on the screen 6. under the label CRG.
-
- The real time EEG signal is continuously displayed on the monitor screen.
- In edition, the Envoy provides long term storage and display of the BIS index and its related 8. parameters as numeric Charts and graphic Trends.
Image /page/4/Picture/10 description: The image shows a black and white photo of an electrical device with a cord. The device has a circular shape with a lighter-colored center and darker edges. The cord is coiled on either side of the device. The cord appears to be thick and insulated.
Figure 1: BISx™ device
Substantial Equivalence Discussion
Comparison of the Envoy BIS Module with the predicated device Spacelab Bispectral Index (BISx) analysis module 91482
Page 5 of 14
5
Comparison of the indication for use
Spacelab Indication for Use
The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482
is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.
The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482
may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
Mennen Indication for use
The Mennen Medical Envoy BIS module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.
The Mennen Medical BIS module may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
Conclusion
The indication for use of Mennen Medical BIS module and of the predicated device, has the same wording. The only difference between the two is the module and company name.
| | Spacelab Bispectral Index
(BISx) Analysis | Envoy BIS Module |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Part Number | Module 91482 | 551-147-000 |
| 510K | K060900 | |
| Features | | |
| Display format:
Single zone | BIS Numeric and BIS Trend | BIS numeric + one EEG +
EMG vertical bar + EMG
vertical bar + SR, BC
numeric |
| | Spacelab Bispectral Index
(BISx) Analysis | Envoy BIS Module |
| Single zone
Waveform + trend | | BIS numeric + Two EEG +
EMG vertical bar + EMG
vertical bar + SR, BC
numeric + Trend of BIS
and EMG |
| Dual zone | N/A | BIS numeric + Two EEG +
EMG vertical bar + EMG
vertical bar + SR, BC
numeric |
| Three zone | BIS + EMG trends +one EEG | BIS numeric + Two EEG +
EMG vertical bar + EMG
vertical bar + SR, BC
numeric + Trend of BIS
and EMG |
| Four zone | N/A | BIS numeric + Two EEG +
EMG vertical bar + EMG
vertical bar + SR, BC,
numeric + Trend of BIS
and EMG + Trend of any
two other parameters |
| Waveform + Trend | N/A | EEG waveform and BIS +
EMG graphic trend |
| Wave scale | +/- 2, 5, 10, 20, 50, 100, 200,
400 μV | 5, 10, 25, 50, 100 µV/cm |
| EEG sweep speed | 12.5, 25, 50 mm/sec | 6.25, 12.5, 25 mm/sec |
| BIS Task window | BIS, EEG waveform, EMG, SQI,
SR, SEF, MF, Alarm limits | BIS, EEG waveform,
EMG, SQI, SR, BC,
Alarm limits,
Alarm messages |
| Data Storage | 24 hours of:
BIS,
Spectral Edge Frequency (SEF),
Median Power Frequency (MF)
Electromyography strength
(EMG)
Signal Quality Index (SQI)
Suppression Ratio (SR) | EEG waveform - 45 days
3 month of:
BIS,
Spectral Edge Frequency
(SEF),
Electromyography strength
(EMG)
Signal Quality Index (SQI) |
| | Spacelab Bispectral Index
(BISx) Analysis | Envoy BIS Module |
| | Burst Count (BC) | Suppression Ratio (SR) |
| | | Burst Count (BC) |
| | | |
| Electrode
Impedance testing | Manual or Auto by BISx | Auto on connection of
sensor and Manual any
time |
| Patient
compatibility | Adult and pediatric | Same |
| Input Specification | Set By BISx | Set By BISx |
| Number of channels | Two | Same |
| Sweep speed | 15, 30, 50 mm/second | 6.25, 12.5, 25 mm/second |
| EEG Input signal | +/- 1 µV to +/-400 µV | Same |
| EEG Bandwidth | 0.25 to 100 Hz | Same |
| EMG bandwidth | 70 to 110 Hz | Same |
| DC offset | +/- 300 mV | Same |
| Input Impedance | >50 MΩ | Same |
| Input Capacitance | 110dB | Same |
| Input Noise |