BISX4 Module

BISX4 Module
BIS - 186-0224-USF

A mains electricity (AC-powered) device intended to be used to detect, process, and display the signals recorded from an unconscious patient (in a state of anaesthesia), showing the degree of consciousness. It is based upon the bispectral index (BIS) analysis of the electroencephalogram waveform and other features of this, enabling detection of, e.g., levels of sedation, loss of consciousness, and recall. It is used during anaesthesia administration and in trauma.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OLW

Device Name: Index-Generating Electroencephalograph Software

Device Class: 2

Physical State: Electroencephalograph analysis software, either developed by 510(k) holder for use in their own hardware or licensed from another company for use in 510(k) holder's hardware. Does NOT include electrodes, amplitude-integrated electroencephalograph, automatic event-detection software, electroencephalograph software with comparative databases (normal or otherwise) or electroencephalograph software that outputs a diagnosis or classification.

Definition: Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses software algorithms, developed from and trained with specific patient datasets, to analyze electroencephalograph from 1 to 16 electrodes at sponsor-specified locations; also may output one or several signal quality indicators

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Brain

Regulation Number: 882.1400

Third Party Flag: N

Medical Specialty: NE

Device Id: 10884521533103

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A