(142 days)
The systems are intended for use to monitor sensory and motor pathways and to provide information to determine the state of blood flow in the intracranial and extracranial vascular arteries in adults. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials and Doppler analysis. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The system is used in the operating room and critical care areas to provide health care professionals with information to guide surgery and to assess a patient's neurological and vascular status.
Doppler analysis is not to be used for Obstetrics.
The Eclipse Neurological Workstation with TCD and vascular Doppler, Eclipse TCD Neurovascular Workstation and CardioMon (The Systems) provide continuous monitoring of brain and neural pathways and intracranial and extracranial vascular blood flow intraoperatively or in the intensive care unit. The system has been designed to meet the requirements for comprehensive neurological monitoring in the operating room and critical care areas.
The Systems can be used to monitor neurological and vascular data using either individual or multimodality EEG, EMG, evoked potential and Doppler test protocols.
The Systems main components include: computer, internal or external Doppler, controller, digital preamplifiers, direct nerve, sensory and motor evoked potential electrical stimulators, stimulator extension modules, LED goggles and insert earphones. The Systems also provide support for the Nonin XPod pulse oximeter module and a high impedance preamplifier module to allow recording from micro electrodes.
Recording electrodes detect spontaneous or stimulus evoked electrophysiological activity and are used as inputs to the digital preamplifier. Electrophysiological signals are amplified, filtered, optically isolated and digitized. The digitized data is then routed to the digital signal processor (DSP) located in the Eclipse controller. The DSP processes the data and controls timing for the electrical, audio and visual stimulators.
The computer controls the user interface for setting parameters and the display of processed data. The computer also provides the hardware and software Doppler interface.
The TCD and vascular Doppler provide blood flow information using a spectral display and audible Doppler signal.
A built-in pulse oximeter provides pulse rate and oxygen saturation measures.
Data from external devices, such as vital signs or other physiological monitors, can be imported to the systems display screen, allowing the operator to correlate changes in neurological function with systemic changes.
In addition, a display window may be opened to observe the surgeon's microscope view or other video inputs. The systems are network compatible for data review within the hospital and permits secure information access over the Internet.
The Systems were tested functionally using accepted laboratory test procedures.
Technologically, The Systems are similar to the predicate devices.
This submission for K061639 does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The document is a 510(k) summary for the Axon Systems Eclipse TCD Neurovascular Workstation, Eclipse Neurological Workstation with TCD and Vascular Doppler, and CardioMon. It describes the device, its intended use, and lists multiple predicate devices. The majority of the provided text is the FDA's letter granting substantial equivalence.
Key information absent from the submission includes:
- Acceptance Criteria Table: There is no table outlining specific performance metrics (e.g., sensitivity, specificity, accuracy) and their corresponding acceptance thresholds.
- Reported Device Performance: The document does not present any quantitative performance data for the device.
- Study Details: There's no description of a study conducted to evaluate the device's performance against any set criteria. This means information regarding sample size, data provenance, ground truth establishment, expert involvement, or adjudication methods is not provided.
- MRMC Study: There is no mention of a multi-reader multi-case comparative effectiveness study or any effect size related to human reader improvement with AI assistance.
- Standalone Performance: The document does not describe any standalone performance evaluation of the algorithm.
- Training Set Details: There is no information regarding a training set, its size, or how its ground truth was established, as this device does not appear to involve AI/ML.
The submission states, "The Systems were tested functionally using accepted laboratory test procedures." However, it does not elaborate on what these procedures entailed, what the results were, or what the acceptance criteria for these functional tests were. For a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove specific performance against numerical acceptance criteria in the way an AI/ML device might.
§ 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).