NA

NA - E-ENTROPY-01

A small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals measured and provided by this module. It may also register auditory evoked potentials (AEP) signals.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: ORT

Device Name: Burst Suppression Detection Software For Electroencephalograph

Device Class: 2

Physical State: Electroencephalograph analysis software. Does NOT include electrodes, electroencephalograph hardware, basic electroencephalograph software (e.g. used to display, store, archive, or manually annotate data), automatic event (i.e., seizure) detection software or automatic event-detection software used as an intermediary step in source-localization analysis.

Definition: Automatically mark or identify electroencephalograph waveforms for rhythmic patterns of burst suppression in order to aid in identification of such events and help in the review and annotation of prolonged EEG traces; software can also quantify simple characteristics of the burst suppression such as inter-burst interval or count; all output subject to verification by qualified user.

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses simple, transparent software algorithms to analyze any size montage (full or reduced) for burst suppression patterns and automatically identify areas of interest or quantify pattern characteristics.

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

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

Code: OMC

Device Name: Reduced- Montage Standard Electroencephalograph

Device Class: 2

Physical State: May include standard EEG recording hardware (e.g. headbox, cables, CPU, monitor and basic software (needed to display, store and archive EEG and allow user-only annotation and marking); does NOT include electrodes, more complex software used to analyze EEG or automatically detect events, EEG used for PSG or sleep studies, or EEG with > 16 electrodes or more electrodes.

Definition: Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses electrodes (less than < 16) placed on the scalp or within the brain, via user-specified and/or sponsor-specified locations, to record and display electrical activity of the brain

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Brain

Regulation Number: 882.1400

Third Party Flag: Y

Medical Specialty: NE

Device Id: 00840682104272

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