Search Results

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 pediatric 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.

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

(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.

Here's an analysis of the provided text regarding the VitaLogik Patient Monitor with BIS Interface, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a 510(k) submission for a device modification, specifically the addition of a BIS Interface to the existing VitaLogik Patient Monitor. The primary goal of this submission is to demonstrate substantial equivalence to a predicate device (Envoy BIS Module). Therefore, the "acceptance criteria" are predominantly framed around matching the specifications and performance of the predicate device, rather than explicit numerical thresholds for clinical outcomes.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a numerical sample size for patients or data used in the performance testing. It refers to "extensive performance testing," "SW Validation," and "Final testing." These are likely internal verification and validation activities rather than a formal clinical study with a defined sample size for statistical inference on patient data.
• Data Provenance: Not specified. Given the nature of a 510(k) for a device modification, the testing likely involved simulated data, test bench measurements, and possibly limited internal clinical evaluations for verification, rather than large-scale prospective clinical trials. The statement that "The performance of the BIS interface was also tested by Aspect Medical as per the attached certificate (part 21)" suggests some level of external validation, but details of that testing are not provided in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study described focuses on demonstrating technical and functional equivalence to a predicate device, rather than establishing a new clinical ground truth. For a device like a patient monitor, the "ground truth" for the displayed physiological parameters is typically the actual physical measurement itself (e.g., EEG signals, blood pressure, temperature), and the device's accuracy is verified against calibrated instruments or the predicate's output.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the type of technical equivalence testing described here. Adjudication by experts is typically for subjective assessments or outcomes in clinical studies, which is not the focus of this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study assesses how human readers perform with and without AI assistance, which is not relevant for a device modification involving only an interface to display existing physiological parameters like the BIS Index. The device itself is not an "AI" in the sense of providing diagnostic or interpretive assistance beyond presenting raw and processed physiological data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a form of standalone testing was done. The VitaLogik BIS Interface itself is essentially an algorithm/hardware combination that:

• Receives data from the Aspect BISx unit.
• Transfers it to the VitaLogik bedside computer.
• Displays and stores the BIS parameter and quality parameters.

The "SW Validation of the performance of the VitaLogik with BIS interface as compared to the Envoy BIS module" and "Final testing for the VitaLogik BIS Interface included performance tests designed to ensure that the device meets all functional requirements and performance specifications" describe tests of the device's ability to accurately process, display, and store the parameters from the BISx, independent of a specific human-in-the-loop clinical outcome study. The comparison to the predicate device is a form of standalone performance assessment against an established benchmark.

7. The Type of Ground Truth Used

The "ground truth" in this context is implicitly the output of the Aspect BISx unit and the performance of the predicate Envoy BIS module. The VitaLogik BIS Interface is designed to accurately receive, display, and store the already processed BIS Index and related parameters as calculated by the BISx. The core ground truth for the measurements themselves originates from the BISx's processing of EEG signals. For the interface's performance, the ground truth is whether it accurately reflects what the BISx unit is sending and whether its display/storage matches the established predicate device's capabilities.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The VitaLogik BIS Interface is not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. It is a hardware/software interface designed to relay and display data from another cleared device (BISx). Its development involves software engineering and testing against specifications, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, as there is no "training set" for this device modification.

Ask a specific question about this device