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.

Ask a specific question about this device