(190 days)
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:
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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
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).