(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 | < 0.4 $\mu$V rms, 0.5 to 30Hz; < 2.5 $\mu$V rms, 30 to 70Hz | < 0.4 $\mu$V rms, 0.5 to 30Hz; < 2.5 $\mu$V rms, 30 to 70Hz |
| Input Range | 1.0 mV p-p full scale | 1.0 mV p-p full scale |
| Input impedance | 0.5 M Ohm | 0.5 M Ohm |
| Input Resolution | 70 nV p-p minimum | 70 nV p-p minimum |
| Linearity | +2% | +2% |
| DC input offset | + 320 mV maximum | + 320 mV maximum |
| Bias Current | Less than 7 nA per input | Less than 7 nA per input |
| Low filter (High pass) | 0.5 - 1.5 Hz | 0.5 - 1.5 Hz |
| High filter (Low pass) | 15 - 35 - 50 - 70 Hz | 15 - 35 - 50 - 70 Hz |
| Sampling rate | at least 600 Hz per channel | at least 600 Hz per channel |
| Anti-Aliasing Filter | EEG stopband 77 - 80 Hz dB | EEG stopband 77 - 80 Hz dB |
| Maximum sensitivity | 0.5 $\mu$Volt/mm | 0.5 $\mu$Volt/mm |
| Defibrillation Protection | 400 Joule | 400 Joule |
| Protection against electrical shock | Type BF Applied part | Type BF Applied part |
| Electro-surgery | EEG waveform returns to normal within 5 seconds from cessation of ESU operation | EEG waveform returns to normal within 5 seconds from cessation of ESU operation |
| Display & User Interface | ||
| Displayed EEG waveforms | 4 channels | 4 channels |
| Channel selection | Yes - 1 to 4 channels | Yes - 1 to 4 channels |
| Waveform Selection | A-B; B-C; C-D; D-E | A-B; B-C; C-D; D-E |
| EEG Cable | 5 Leads (4 differential channels), labeled A, B, C, D, E | 5 Leads (4 differential channels). Leads marked as A, B, C. D and E. |
| Error Message | Cable out | Cable out |
| Compliance with Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26 | Compliance with applicable industry and safety standards (implied by statement that "Safety testing and EMC testing were performed by an independent testing laboratory...") |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document refers to "various performance tests" and "extensive safety and performance testing" but does not specify the sample size for these tests.
- Data Provenance: Not explicitly stated, but given that the manufacturer is Mennen Medical Ltd. in Israel, it is likely that parts of the testing were conducted there. The document mentions "Safety testing and EMC testing were performed by an independent testing laboratory," but the location of this laboratory or the origin of the data is not provided. It's unclear if the testing involved real patient data (prospective or retrospective) or simulations/phantoms.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The testing described focuses on technical performance specifications rather than clinical accuracy determined by experts.
4. Adjudication Method for the Test Set
- This information is not provided in the document. The testing described appears to be objective measurements against technical specifications rather than interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device through technical specifications and performance testing, not on comparing reader performance with or without AI assistance. The EEG module itself does not perform AI-driven interpretation requiring human-in-the-loop studies.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone study of the device's technical performance was done. The document states, "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." This describes the algorithm/device-only performance against its design specs. The EEG module described is a data acquisition and display device, not an AI-driven interpretive algorithm in the modern sense.
7. The Type of Ground Truth Used
- The "ground truth" for the performance testing described appears to be technical specifications and established engineering standards (e.g., precise voltage measurements, frequency response curves, noise levels, impedance measurements). For the safety and EMC testing, the ground truth was compliance with IEC standards (60601-1, 60601-1-2, 60601-2-26). There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the device's functional performance.
8. The Sample Size for the Training Set
- Not applicable / Not provided. The Envoy EEG module is described as a physiological patient monitor module that converts analog EEG signals into digital data for display. It does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense for algorithm development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not provided. As mentioned above, a "training set" doesn't appear to be relevant for this type of device.
{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
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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 slotHeight: 10.0cm (4.0 in)Width: 4.0 cm (1.6 in)Depth: 14.0 cm (5.5 in) |
| Monitored Parametersand Features | Mennen Medical EnvoyEEG 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 | < 0.4 $\mu$ V rms, 0.5 to 30Hz< 2.5 $\mu$ V rms, 30 to 70Hz |
| Input Range | 1.0 mV p-p full scale |
| Input impedance | 0.5 M Ohm |
| Input Resolution | 70 nV p-p minimum |
| Linearity | +2% |
| DC input offset + | + 320 mV maximum |
| Bias Current: | Less than 7 nA per input (each electrode may be connected tomore than one input) |
{4}------------------------------------------------
ENVOY Patient Monitor: 510(k) for new EEG module
| Monitored Parameters | Mennen Medical Envoy |
|---|---|
| and Features | EEG module |
| Low filter (High pass) | 0.5 - 1.5 Hz |
| High filter (Low pass) | 15 - 35 - 50 - 70 Hz |
| Sampling rate: | at least 600 Hz por channel |
| Anti-Aliasing Filter: | EEG stopband 77 - 80 Hz dB |
| Maximum sensitivity: | 0.5 $ \mu $ Volt/mm |
| Sensitivity control: | 1 - 2 - 3 - 5 - 7 - 10 - 15 - 20 - 30 - 50 - 70 $ \mu $ Volt/mm ormVolt/cm |
| Defibrillation Protection | 400 Joule |
| Degree of protection againstelectrical shock | Type BF Applied part |
| Electro-surgery | EEG waveform returns to normal within 5 seconds fromcessation of ESU operation |
| DisplayedParameters | Mennen Medical EnvoyEEG module |
|---|---|
| EEG waveforms | 4 channels |
| DisplayFunctions | Mennen Medical EnvoyEEG module |
| Channel selection | Yes - 1 to 4 channels |
| Mennen Medical EnvoyEEG module | |
|---|---|
| Waveform Selection | A-B; B-C; C-D; D-E |
| EEG Cable | 5 Leads (4 differential channels).Leads marked as A, B, C. D and E. |
| Error Message | Cable out |
{5}------------------------------------------------
ENVOY Patient Monitor: 510(k) for new EEG module
Conclusion of comparison of technological characteristics:
We consider the Envoy EEG module to be substantially equivalent to the EEG module of the Mennen Medical Horizon 2000 patient monitor (K910945) and we submit that the differences between the two modules do not raise any now issues of safety and offectiveness
Testing
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.
Signature:
A. Hass.el
Asher Kassel, Director of Regulatory Affairs, Mennen Medical Ltd.
Tel: +972-8-9323311 (direct) Fax: +972-8-9328510 E-mail: asher@mmi.co.il
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Asher Kassel Director of Regulatory Affairs Mennen Medical Ltd. P.O. Box 102 Rehovot, 76100, Israel
Re: K024245
Trade/Device Name: Envoy Patient Monitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMC Dated (Date on orig SE ltr): April 18, 2004 Received (Date on orig SE ltr): April 29, 2004 APR - 9 2012
Dear Mr. Kassel:
This letter corrects our substantially equivalent letter of May 10, 2004.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{7}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Indications for Use
510(k) Number (if known): K024245
Envoy Patient Monitor Device Name:
Indications For Use:
The Envoy is intended for use as a multiparameter monitoring system.
The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two The Envoy can monitor ECG/neart rate, two invasive blood prossure, EtCO2
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 This effectively allows the Envoy in nibhiter a was of the hospital. Functions include
neonatal patient conditions, in many diferent areas of the hospital. Functions include neonatal patient continuous, in thany different arous of a status messages.
display of multiparameter waveforms, vital signs, alarm & status messages.
The status multiparamet
The Mennen Medical Envoy is intended for sale as a system for monitoring and The Mennen Medical Envoy is intended to sale as a system on won't of the Mennen Meditoring.
recording patient information or any in-hospital application requiring patient mon recording patient information of intended clinical applications:
- · Critical Care Patients
- · Cardiac Step-down/Telemetry Units
- · Emergency Departments
- · Intra-operative (Anesthesia) Monitoring
- · Post Anesthesia Care
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Page 1Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_/1624245
§ 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).