(175 days)
The VEEGix EEG System, is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display.
The VEEGix EEG System, is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis.
The VEEGix EEG System, is intended for use in a hospital Operating Room. Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings.
The VEEGix EEG System is indicated for use on patients 18 years of age or older and is to be used by licensed medical professionals who have been adequately trained in the use and interpretation of EEG data for determination of brain state.
The VEEGix EEG System does not provide any diagnostic conclusion about the patient's condition.
The VEEGix EEG System is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition.
The VEEGix EEG System is not intended for use in life support systems.
The VEEGix™ EEG system (subject device) is a Electrocochleographic (EEG) device to allow healthcare practitioners, nurses, neurologists and qualified technicians working in hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings to observe a patient's EEG signals and its derivatives.
The use of the subject device is a straight-forward procedure of applying the VEEGix Electrode, which is a lightweight band, onto the patient's scalp in which the electrodes acquire the patient's EEG signals. Those signals are transmitted via the VEEGix EEG module) to the VEEGix iOS app (application) which display the patient's EEG measurements in real-time to allow healthcare practitioners, nurses, neurologists and qualified technicians to monitor and record those EEG measurements.
Here's a breakdown of the acceptance criteria and study details for the VEEGix EEG System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list a table of quantitative acceptance criteria with corresponding performance values for the software component of the device. Instead, the "Technology Comparison" table highlights specific technical characteristics where the VEEGix EEG System aligns with or exceeds its predicates, implying these are the implicit acceptance criteria for technical equivalence. The clinical performance section describes the methodology used to demonstrate comparable EEG signal quality to a conventional clinical EEG system, which serves as the overarching performance goal.
Implicit Acceptance Criteria and Reported Device Performance (based on "Technology Comparison" and "Clinical Performance Testing" sections):
| Acceptance Criteria (Implied) | Reported Device Performance (VEEGix EEG System) | Reference/Context |
|---|---|---|
| Technical Equivalence | ||
| Classification Regulation | Class II per 882.1400 | Same as primary predicate |
| Product Code(s) | OLT, OMC, ORT, GXY | Same as primary predicate |
| Indications for Use | Subset of primary, same as secondary predicate | No new safety/effectiveness questions |
| Modalities | EEG | Same as predicates |
| Environment of Use | Hospital OR, PACU, ICU, ED, inpatient/outpatient surgery settings | Same as primary predicate, included in secondary |
| Number of EEG Channels | 1 bipolar | Same as secondary predicate, substantially equivalent to primary |
| Number of Electrodes | 3 (Fp1, Fpz, Fp2) | Same as secondary predicate, substantially equivalent to primary |
| Sensing Electrodes | Silver, disposable | Substantially equivalent |
| Power Source | Battery | Same as predicates |
| System Components | Electrode Array, Sensor module, acquisition, Tablet for memory and data viewing | Same as primary predicate, similar to secondary |
| Screen Display Details | Raw EEG Waveforms; Signal Quality (Channel Connection, Artifact, Noise, Interference); Spectral Parameters (EEG power spectrum, SEF 95%, DSA, α, Β, δ, θ, γ) | Substantially equivalent to primary (missing 10/20 Hz markers, B band division not raising new questions), secondary display capabilities included |
| Storage for offline recording | Yes, in the tablet display | Same as primary predicate |
| Electrode Impedance | Yes | Same as primary predicate |
| Detection for Leads Off | Yes | Same as predicates |
| File output capability | Yes | Same as predicates |
| Real-time EEG Display | Yes, wireless to tablet | Same as predicates |
| Processed EEG Bandwidth | 0.5 Hz to 80 Hz | Substantially equivalent as primary predicate (0.5 Hz to 45 Hz) |
| Automatic Artifact Identification | Yes | Same as primary predicate |
| Common Mode Rejection | > 100 dB | Substantially equivalent as primary predicate (> 90 dB) |
| Amplifier Input Impedance | 200 GΩ | Substantially equivalent as primary predicate (> 500 M Ohm) |
| Electrode Impedance Test | Yes | Same as primary predicate |
| Patient Contains Isolation | Reinforced Insulation (2 MOPP), battery powered | Substantially equivalent as primary predicate |
| Event Markers | Yes, artifact detection | Same as primary predicate |
| Burst Suppression Display | Yes, Suppression Ratio (%) | Substantially equivalent as primary predicate (Burst Suppression Probability) |
| Display Interface | Tablet display indicates connection and operation | Same as primary predicate |
| Biocompatibility | Tested per ISO 10993 (cytotoxicity, irritation, sensitization) | Substantially equivalent |
| Clinical Performance | ||
| Comparable EEG signal quality to conventional clinical EEG systems | Pearson's correlation coefficient (r=0.84, p |
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).