(294 days)
The Protektor32 channel system, composed of both hardware and software, is intended to be used for intracperative neurological monitoring. The instrument uses Electroencephalogical by (EEG), Evoked Potentials (EP), Electromyography (EMG) and Transcranial Motor Evoked Potential (TcMEP ) stimulation techniques to provide the healthcare professionals with information to help assess a patient's neurological status during surgery.
The TcMEP mode is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, lornrovin, or compression) or vascular insufficiency.
The EPWorks software, an integral part of the system, is intended to allow a medical professional to manually configure stimulation and acquisition parameters and to manually create EEG, EP, EMG and TcMEP protocols according to their own requirements. The intended use for each of the software's outputs is as follows:
- The EEG, EP, and EMG waveforms are intended to help the user assess a patient's . neurological status during surgery.
- Simple waveform parameters (e.g., amplitude, latency), and user-defined Fast Fourier . transform (FFT) displays (compressed spectral array or CSA, density spectral array or DSA) are intended to help the user analyze the EEG and EP waveforms.
This device is intended to be used by qualified medical practitioners, trained in EEG, EP and EMG who will exercise professional judgment when using the information.
The Protektor32 channel system, composed of both hardware and software.
This document is a 510(k) clearance letter from the FDA for a medical device called "Protektor32." It describes the intended use and regulatory classification of the device but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information based on the given input. The letter focuses on regulatory approval and substantial equivalence to predicate devices, not on a detailed analysis of a clinical study or device performance metrics.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).