# K083063: Bis Interface for Vitalogik Patient Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Mennen Medical, Ltd.
- Decided: Dec 16, 2008 after 63 days
- Product code: OLW (Index-Generating Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K060900 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071899: Bis Module for Envoy Patient Monitor, Mennen Medical, Ltd. (2007) Summary page 1.

## Indications for use
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 pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS Index, & 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.

Source page: https://510kreport.com/device/K083063
Methodology: https://510kreport.com/methodology