📊 Evidence-Based Reference
Bis Interface for Vitalogik Patient Monitors
Mennen Medical
Summary: The BIS Interface for Vitalogik Patient Monitors by Mennen Medical is a device used for monitoring depth of anesthesia. Key evidence highlights its role in translating physiological states into quantitative metrics.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K083063 ↗
Decision Date ?
December 16, 2008
Product Code ?
OLW
Device Class ?
Class 2
Evidence ?
0 studies
The BIS Interface for Vitalogik Patient Monitors was cleared by the FDA via the 510(k) pathway on December 16, 2008. It is manufactured by Mennen Medical and classified as a Class 2 device.
What It Is
The BIS Interface for Vitalogik Patient Monitors is designed to monitor the depth of anesthesia by analyzing EEG signals. It provides clinicians with quantitative metrics to assess patient status during surgical procedures.
FDA-Cleared Indications
- Use with compatible Vitalogik patient monitors to acquire and display BIS or processed EEG information.
- Monitoring processed EEG-derived information in patients receiving anesthesia or sedation.
- Use as part of a patient-monitoring system to assist clinical assessment of anesthetic depth.
Clinical Applications
- Monitoring anesthetic effect during surgery.
- Monitoring patients receiving procedural sedation when compatible BIS monitoring is indicated.
- Displaying processed EEG information alongside other physiologic vital signs on a compatible Vitalogik monitor.
Reported off-label uses
- Use of processed EEG or BIS measurements to support sedation assessment in intensive care patients.
- Use of BIS monitoring during transport or recovery to follow changes in level of consciousness.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 10 studies, with a mix of RCTs, prospective, and retrospective designs, spanning from 2022 to 2024. These studies explore various methodologies for analyzing EEG signals under anesthesia.
Reported Outcomes
Published studies report advancements in EEG signal analysis methods, such as wavelet transform-based mode decomposition, which enhance the accuracy of depth of anesthesia monitoring. These methods provide clinicians with improved tools for assessing patient status during anesthesia.
Safety Profile
Reported complications include potential inaccuracies in depth of anesthesia monitoring due to signal interference. However, no specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of large-scale, multicenter trials. Further research is needed to validate the long-term efficacy and safety of the device across diverse patient populations.
Practical Considerations
- The interface is intended for use with compatible Vitalogik patient-monitoring systems; compatibility should be confirmed before use.
- BIS and processed EEG values are adjuncts to clinical assessment and should not be used alone to determine anesthetic dosing or patient consciousness.
- Signal quality can be affected by electrode placement, poor skin contact, electrical interference, facial muscle activity, and other artifacts.
- The available FDA record does not establish that the interface itself is MRI safe; follow the manufacturer's labeling and facility MRI policy before use in or near an MRI environment.
- This is a monitoring interface rather than a therapeutic implant, and it does not have a defined implanted service life.
Frequently Asked Questions
What are the clinical indications for BIS Interface for Vitalogik Patient Monitors?
The device is indicated for monitoring the depth of anesthesia during surgical procedures.
What outcomes have been reported in clinical studies?
Studies have reported improved accuracy in depth of anesthesia monitoring using advanced EEG signal analysis methods.
What complications have been reported?
Safety data indicate potential inaccuracies due to signal interference, though specific adverse events are not detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.