Search Results

The Digital NeuroPort Biopotential Signal Processing System supports recording, processing, and display of biopotential signals from user-supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electroculography (EOG), and Evoked Potential (EP).

The Digital NeuroPort Biopotential Signal Processing System is used to acquire, process, visualize, archive/record signals as acquired from user-supplied electrodes for biopotential monitoring. Signals are acquired using a headstage relay that attaches to the pedestal interface and digitizes the signal through the hub. The Digital NeuroPort System uses preamplifiers, analog to digital converters, a signal processing unit, and software running on a personal computer to visualize and record biopotentials from electrodes in contact with the body.

The document describes the Digital NeuroPort Biopotential Signal Processing System, which is a physiological signal amplifier. The device's substantial equivalence to a predicate device (K090957, NeuroPort Biopotential Signal Processing System) is affirmed based on various performance data.

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   Test / Characteristic	Acceptance Criteria	Reported Device Performance
   NeuroPlex E Functional Testing
   Mating	Screws down on pedestal and LED turns green	Pass
   Crosstalk	Isolation resistance of 1kΩ at 500 V DC	Pass
   Label Durability	IEC 60601-1:2005/A1:2012, Edition 3.1 7.1.3	Pass
   Digital Accuracy	Appropriate voltages for different filters (0.02-10 kHz Wide, 0.3-7.5 kHz Standard); Peak-to-peak of 500mV ±10%	Pass
   Input Impedance	≥10MΩ	Pass
   Impedance Measurement	820 ± 15% kOhms and 170 ± 15% kOhms	Pass
   Current Rating

Ask a specific question about this device