(63 days)
No
The summary describes a standard physiological patient monitor with a new interface for a BIS module. It mentions data acquisition, processing, and display of vital signs and the BIS index, but there is no mention of AI, ML, or any advanced algorithms beyond standard signal processing for calculating the BIS index. The focus is on equivalence to a predicate device and standard performance testing.
No.
The device is a monitor that acquires and displays physiological signals and parameters, including the BIS index, which aids in monitoring the state of the brain and the effects of anesthetic agents. It does not exert any direct therapeutic action or intervention on the patient.
Yes
The device is described as "intended for use... to monitor the state of the brain by data acquisition of EBG signals" and "may be used as an aid in monitoring the effects of certain anesthetic agents," which indicates it is used to obtain information about a patient's condition to aid in diagnosis or treatment.
No
The device description clearly states that the VitaLogik is a multiparameter physiological patient monitor with main components including a bedside computer and a display. It acquires, processes, and converts vital signs from the patient into waveforms and digital signals, indicating the presence of hardware beyond just software.
Based on the provided text, the Mennen Medical VitaLogik BIS interface is not an In Vitro Diagnostic (IVD) device.
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 obtain information for diagnostic or monitoring purposes.
- Device Function: The VitaLogik BIS interface acquires and processes physiological signals directly from the patient's body (EBG signals from the forehead). It does not analyze specimens taken from the body.
- Intended Use: The intended use is to monitor the state of the brain by acquiring EBG signals and providing a processed parameter (BIS Index) as an aid in monitoring the effects of anesthetic agents. This is a form of physiological monitoring, not in vitro analysis of a specimen.
- Device Description: The description clearly states it's a multiparameter physiological patient monitor that acquires vital signs directly from the patient.
- Lack of Specimen Handling: There is no mention of collecting, preparing, or analyzing any biological specimens.
Therefore, the Mennen Medical VitaLogik BIS interface falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VitaLogik Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediative patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, CO, Pulse Oximetry, EtCO2 and BIS. The VitaLogik 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.
VitaLogik series is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik series can monitor ECG/heart rate, invasive blood pressure channels, temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the VitaLogik series 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 VitaLogik is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring.
The following are examples of intended clinical applications:
- Critical Care Patients
- Cardiac Step-down/Telemetry Units
- Emergency Departments
- Intra-operative (Anesthesia) Monitoring
- Post Anesthesia Care
The Mennen Medical VitaLogik BIS interface 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 pediatic patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EBG 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, ORT, DSI
Device Description
The VitaLogik 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
- BBG
- BIS Interface (new subject of this application)
Main components of the VitaLogik: The VitaLogik system consists of:
(A) a Bed side computer with
(B) Display
(A) The Bed side computer acquires, processes, and converts vital signs from the patient into waveforms and digital signals.
The VitaLogik can acquire the following physiological signals of the patient:
- ECG Waveform and measures Heart Rate, ST and Arrhythmia
- Blood Pressures Waveform and measures Systole, Diastole and Mean Pressure
- Temperature As a numeric value in C or F
- SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate
- NIBP Systolic, Diastole and Mean pressure with measuring time stamp
- EtCO2 EtCO2, inCO2 and Respiration Rate
- BIS Index of conciseness and EEG waveform
(B) The Display is used to display the measurement and waveforms, and alarms. With touch screen option it provides also the control functions, replacing the use of hardware keys. 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 VitaLogik is accomplished by interaction with front panel controls. A quicknob 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 VitaLogik 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 VitaLogik monitors the patient's vital sign data derived by the VitaLogik are presented on the monitor as waveform and numeric displays. The VitaLogik acquire vital signs data from the patient, and display their waveforms and alarms indications on the VitaLogik display.
The VitaLogik is not a kit and does not contain any drug or biological products. The BIS Interface of the VitaLogik patient monitor is not sold as a stand alone device, but as part of a multiparameter physiological patient monitoring system (VitaLogik).
The BIS Interface is used to monitor dual channel EBG 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 VitaLogik monitor.
The images show a black and gray device with two cords attached to it. The device is round and has a gray center with the letters "als2" written on it. The cords are coiled and appear to be made of a flexible material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's forehead for BIS sensor.
Indicated Patient Age Range
Adult and pediatric patients.
Intended User / Care Setting
Qualified health care providers / licensed healthcare practitioner or personnel trained in its proper use. 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 VitaLogik with BIS interface as compared to the Envoy BIS module, was carried out in accordance with the test plan described in the Mennen Medical Validation Test Procedure for the VitaLogik BIS module.
The SW Test Description for the VitaLogik with BIS interface was derived from the SW Test Description for the VitaLogik, with the necessary addition of the BIS measurements
Final testing for the VitaLogik BIS Interface 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 VitaLogik BIS Interface. Electrical Safety testing and EMC 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 VitaLogik BIS Interface has been subject to extensive performance testing to ensure that the acquisition and display of the patient data and waveforms by the VitaLogik with BIS interface are equivalent to the predicate device Envoy 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.
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
Food and Drug Administration
Device Modification - VitaLogik Patient Monitor
510(k) for addition of BIS Interface
DEC 1 6 2008
Name: Registration Number: Operator Number: Address: Postal Address:
Mennen Medical Ltd. 9611022 9069173 4 Hayarden Street, Yavne, 81228, Israel PO Box 102, Rehovot, 76100, Israel
Tel: Fax: Contact person: +972-8-9323333 +972-8-9328510
Ifat Oren, Regulatory Affairs
Traditional 510(k): Device Modification - VitaLogik Patient Monitor - BIS
Terminology
VitaLogik = Subject of this 510(k). The VitaLogik Patient Monitor is a modified device, a system identical to the VitaLogik Patient Monitor with the addition of BISx Interface. The VitaLogik 5X00 was clearded by the FDA on 20th Dec, 2005 K052288 The VitaLogik 4X00 was cleared by the FDA on 21th Nov, 2007 K073140
BIS module of the Envoy monitor- The predicate device. The addition of the BIS Module to the Envoy Patient Monitor was cleared by the FDA at Oct. 2007 K071899
Intended Use of the VitaLogik Patient Monitor
The VitaLogik Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediative patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, CO, Pulse Oximetry, EtCO2 and BIS. The VitaLogik 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.
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Indications for use - VitaLogik with BIS Interface
VitaLogik series is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik series can monitor ECG/heart rate, invasive blood pressure channels, temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the VitaLogik series 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 VitaLogik is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring.
The following are examples of intended clinical applications:
-
- Critical Care Patients
-
- Cardiac Step-down/Telemetry Units
-
- Emergency Departments
-
- Intra-operative (Anesthesia) Monitoring
-
- Post Anesthesia Care
BIS - Indication for use
The Mennen Medical VitaLogik BIS interface
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 pediatic patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EBG 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.
*The Intended Use of the VitaLogik monitor as indicated above are same as the Indications For Use.
2
Device Description - VitaLogik Patient Monitor with BIS Interface
The VitaLogik 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 .
- BBG ●
- BIS Interface (new subject of this application) ●
Main components of the VitaLogik: The VitaLogik system consists of:
(A) a Bed side computer with
(B) Display
(A) The Bed side computer acquires, processes, and converts vital signs from the patient into waveforms and digital signals.
The VitaLogik can acquire the following physiological signals of the patient:
- · ECG Waveform and measures Heart Rate, ST and Arrhythmia
- · Blood Pressures Waveform and measures Systole, Diastole and Mean Pressure
- · Temperature As a numeric value in C or F
- · SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate
- · NIBP Systolic, Diastolic and Mean pressure with measuring time stamp
- · EtCO2 EtCO2, inCO2 and Respiration Rate
- · BIS Index of conciseness and EEG waveform
3
(B) The Display is used to display the measurement and waveforms, and alarms. With touch
screen option it provides also the control functions, replacing the use of hardware keys. 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 VitaLogik is accomplished by interaction with front panel controls . A quickknob 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 VitaLogik 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 VitaLogik monitors the patient's vital sign data derived by the VitaLogik are presented on the monitor as waveform and numeric displays. The VitaLogik acquire vital signs data from the patient, and display their waveforms and alarms indications on the VitaLogik display.
The VitaLogik is not a kit and does not contain any drug or biological products. The BIS Interface of the VitaLogik patient monitor is not sold as a stand alone device, but as part of a multiparameter physiological patient monitoring system (VitaLogik).
In chapter 1, page 1-2 of the VitaLogik 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 VitaLogik BIS Interface:
(Interface to Aspect BISx device cleared in K 040183)
The BIS Interface is used to monitor dual channel EBG 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 VitaLogik monitor.
4
The parameters displayed and stored by the VitaLogik monitor are the following:
| 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. |
To get these parameters we use Aspect sensor and BISx unit attached to the VitaLogik 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 VitaLogik BIS Interface and VitaLogik 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 VitaLogik by the BISx Interface. Those can not be set by Mennen Medical VitaLogik monitor. The clinical BIS alarm limits are set by the user, on the VitaLogik monitor.
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 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
- VitaLogik BIS interface receives the BISx output and transfers it to the VitaLogik bedside 3. computer for display and storage.
- BIS Display and storage: BIS is displayed as a number. EMG and SQI are displayed as vertical 4. bars, and SR and BC as numbers in the BIS display area.
- ട്. Clinical and technical alarm messages are displayed in the BIS display area.
Page 5 of 12
5
- Continuous graphic trend of the BIS index 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 VitaLogik provides long term storage and display of the BIS index and its related 8. parameters as numeric Charts and graphic Trends.
Image /page/5/Picture/4 description: The image shows a black and gray device with two cords attached to it. The device is round and has a gray center with the letters "als2" written on it. The cords are coiled and appear to be made of a flexible material.
Figure 1: BISx™ device
Substantial Equivalence Discussion
Comparison between the BIS Interface to the VitaLogik with the predicated device- BIS Module to the Envoy
Specification Comparison
| Envoy BIS Module | VitaLogik BIS Interface | |
|---|---|---|
| Part Number | 551-147-000 | VL 5X00- 640-000-000/640-OPT-080/2 |
| VL 4X00- 681-000-000/681-OPT-080/2 | ||
| 510K | K071899 | Subject of this application |
| Features | ||
| Monitoring profile | BIS numeric + Two EEG + | |
| EMG vertical bar + EMG | ||
| vertical bar + SR, BC numeric + | ||
| Trend of BIS and EMG | Same | |
| Waveform + Trend | EEG waveform and BIS + EMG | |
| graphic trend | Same | |
| Wave scale | 5, 10, 25, 50, 100 µV/cm | Same |
Page 6 of 12
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Food and Drug Administration
Device Modification – VitaLogik Patient Monitor
510(k) for addition of BIS Interface
| EEG sweep speed | 6.25, 12.5, 25 mm/sec | Same | |
|---|---|---|---|
| BIS Task window | BIS, EEG waveform, EMG, SQI, | ||
| SR, BC, | |||
| Alarm limits, | |||
| Alarm messages | Same | ||
| Data Storage | EEG waveform – 45 days | ||
| 3 month of: | |||
| BIS, | |||
| Spectral Edge Frequency (SEF), | |||
| Electromyography strength | |||
| (EMG) | |||
| Signal Quality Index (SQI) | |||
| Suppression Ratio (SR) | |||
| Burst Count (BC) | VL 5x00 | VL 4x00 | |
| Same | 6 days | ||
| Same | 10 days | ||
| Electrode | |||
| Impedance testing | Auto on connection of sensor | ||
| and Manual any time | Same | ||
| 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 | Same | |
| EEG Input signal | +/- 1µV 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 |