BIS EEG Vista Monitor System and BISX

• • Ongoing Z-2958-2018 FDA Class II ·initiated 26 Jul 2018

  Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

510(k) Number

K072286 ↗

FDA Product Code

OLW

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• A-1050 EEG Monitor

  Class II

  FDA 510(k) K952347 Active Cleared 16 Jan 1996

• Zipprep Electrode

  Class II

  FDA 510(k) K940802 Active Cleared 22 Jun 1994

• Bis Srs (Semi-Resuable Sensor)

  Class I

  FDA 510(k) K050313 Active Cleared 24 Feb 2005

• Aspect Medical Systems Zipprep EEG Sensor

  Class II

  FDA 510(k) K961821 Active Cleared 4 Oct 1996

• Bis Click Sensor/Cable

  Class II

  FDA 510(k) K091854 Active Cleared 2 Jul 2009

• A-2000 EEG Monitor with Bis

  Class II

  FDA 510(k) K974496 Active Cleared 6 Feb 1998

See all devices from Aspect Medical Systems, Inc. →

• What is the BIS EEG Vista Monitor System and BISX used for?

  The BIS EEG Vista Monitor System and BISX is designed to monitor brain function during surgical procedures by analyzing EEG signals in real-time. It calculates the Bispectral Index (BIS) score, a quantitative measure of anesthesia depth, helping clinicians maintain precise control of anesthesia in critical settings like operating rooms or intensive care units.

• How is the BIS EEG Vista Monitor System supplied?

  The system is supplied as a reusable medical device, paired with disposable sensors specifically for EEG signal acquisition. This setup ensures hygiene and reliability while allowing the reusable hardware to be used across multiple procedures.

• Is the BIS EEG Vista Monitor System sterile?

  The device itself is not classified as sterile, but it is intended for use in regulated clinical environments where proper sterilization protocols for reusable components and single-use sensor disposal are followed. The disposable sensors are designed for one-time use to maintain patient safety.

• What regulatory pathway was used for clearance of this device?

  The BIS EEG Vista Monitor System and BISX was cleared through the FDA’s 510(k) pathway, specifically under the Traditional clearance type. It is classified as a Class II device and falls under the regulatory category 21 CFR 882.1400, with an advisory committee review by the Neurology panel.

• Are there different models or sizes available for this system?

  The BIS EEG Vista Monitor System includes multiple software components, each identified by unique FEI numbers (e.g., 3005783425, 3009247326). While the hardware is standardized for reusable use, the software modules may vary in functionality or updates, but no distinct physical sizes or models are specified beyond these software identifiers.