(256 days)
The Lifelines iEEG is an EEG system that allows acquisition, display, archive, storage and analysis of physiological signals. The intended user of this product is a qualified medical practitioner trained in electroencephalography who will exercise professional judgment in using the information. The Lifelines iEEG system also includes the display of a quantitative EEG plots, power spectrum, which is intended to help the user to monitor and analyze the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user.
Lifelines iEEG is medical device used to acquire, display, archive, store and analyze EEG examinations. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of acquiring and presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The system software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
The components of Lifelines iEEG are:
This 510(k) submission for the Lifelines iEEG 2.0 device primarily focuses on demonstrating substantial equivalence to a predicate device (Natus Medical, Inc., DG Nervus/NicoletOne, K964280) rather than presenting a standalone study with acceptance criteria for clinical performance. The documentation emphasizes software verification and validation, along with conformance to various IEC standards for safety and essential performance.
Therefore, many of the requested sections related to clinical study design, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment are not explicitly addressed in this document. The device is an EEG system for acquisition, display, archive, storage, and analysis of physiological signals, and the submission argues that it is substantially equivalent to existing, legally marketed devices.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics in terms of clinical accuracy (e.g., sensitivity, specificity for diagnostic tasks) are provided in this document. The submission focuses on demonstrating substantial equivalence based on intended use, technological characteristics, and conformance to safety and performance standards.
The document highlights the following characteristics of the Subject Device (Lifelines iEEG):
| Feature/Characteristic | Subject Device Performance (Lifelines iEEG) | Predicate Device (DG Nervus/NicoletOne) |
|---|---|---|
| Intended Use | Acquisition, display, archive, storage, and analysis of physiological signals. Help user monitor and analyze EEG. Does not provide diagnostic conclusion. | Acquisition, display, store, and archive electroencephalographic signals. |
| Intended User | Qualified medical practitioner trained in Electroencephalography | Qualified medical practitioner trained in Electroencephalography |
| Population Age | All age groups | All age groups |
| Use Environment | Hospital, clinics, patients home | Hospital, clinic, patients home |
| Regulation Number | 21 CFR 882.1400 | 21 CFR 882.1400 |
| Product Code | GWQ, OLT | GWQ |
| Device allows acquisition of physiological signals | Yes | Yes |
| Device allows display, archive, review, and analysis of physiological signals | Yes | Yes |
| Identifies spikes | No | Yes |
| Identifies seizures | No | Yes |
| Displays calculated EEG measures | Yes | Yes |
| Calculated EEG measures displayed | Spectrum, Power Spectrum Density, band power, spectral edge, peak frequency | Spectrum, Spectrogram, band power, peak frequency, spectral edge |
| Users can add/delete events | Yes | Yes |
| Number of EEG channels | Software: up to 128; Hardware: up to 32 | Up to 512 |
| Type of EEG recording supported | EDF, NicoletOne, Lifelines iEEG | EDF, NicoletOne |
| Type of EEG analysis | Clinical, ambulatory, long term monitoring | Clinical, ambulatory, long term monitoring |
| Photic activation of the EEG | Yes | Yes |
| Differential input impedance | >20 Mohms | > 20MΩ |
| Common mode input impedance | >100 Mohms | > 100MΩ |
| Channel equivalent input noise |
§ 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).