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510(k) Data Aggregation
(280 days)
Trackit T4 EEG Amplifier
The Trackit T4 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
The Trackit T4 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications and due to its small size, can be used in ambulatory applications. In this situation, the EEG electrodes are fitted to the patient by a trained clinician prior to the patient being sent home. No subsequent intervention is required by the patient. Upon completion of the recording, the data which is stored on a memory card is reviewed by a clinician using review and analysis software on a PC. It is a compact USB amplifier which provides 32 channels with internal expansion option) with built-in calibration and electrode impedance measurement. Also provided is a Nonin pulse oximeter interface, a Patient Event input and an Aux DC input. Optional wireless communication is available (Bluetooth and WLAN WiFi). There are two variants of the Trackit T4 EEG Amplifier: - Trackit T4-32 providing 24 referential + 8 poly channels. . - . Trackit T4-68 providing 64 referential + 4 poly channels (using internal expansion board). Plug-on Patient Connection Units (PCUs) provide 32 channel touchproof inputs (model T4-PCU 24+8) or 68 channels (model T4-PCU 64+4). The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically approved power supply. In addition it can be battery powered in ambulatory applications. This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. The equipment does not sustain or support life.
This document describes the Lifelines Trackit T4 EEG Amplifier, which is substantially equivalent to the predicate device, Lifelines R-40 EEG Amplifier (K151600). The information provided is primarily focused on pre-clinical performance testing and safety, not on a study proving a device meets specific acceptance criteria based on diagnostic accuracy or clinical outcomes.
Here's an analysis of the provided text in the context of your request:
1. Table of acceptance criteria and the reported device performance:
The document primarily shows that the new device (T4) performs similarly to its predicate (R-40) in various technical tests. The "acceptance criteria" are implied by the "Test specification" and the "Conclusion" indicating "Same test as predicate" or noting the specific values the predicate device achieved.
| Test | Test Method | T4 subject device (Reported Performance) | R-40 predicate device | Acceptance Criteria (Implied) |
|---|---|---|---|---|
| Insulation resistance | Measure resistance between TF1 'Aux. B' socket and USB plug metalwork. | > 200 MΩ (3.1) | > 200 MΩ (3.1) | > 200 MΩ |
| Dielectric strength | Increase voltage to 1500Vrms over 10s and hold for 1 min. | No flash-over/breakdown (3.2) | No flash-over/breakdown (3.2) | No signs of flash-over or breakdown |
| Mains on Applied Parts | Measure leakage current. | ≤ 5000uA AC (3.6) | ≤ 5000uA AC (3.6) | ≤ 5000uA AC |
| Patient leakage | Measure leakage current. | ≤ 100uA AC and ≤ 10uA DC (3.8) | ≤ 100uA AC and ≤ 10uA DC (3.8) | ≤ 100uA AC and ≤ 10uA DC |
| Calibration | Check for 8mVpp ±0.4 square wave signals on all channels at 1Hz frequency. | 8mVpp ±0.4 square wave (4.4) | 8mVpp ±0.4 square wave (4.4) | 8mVpp ±0.4 square wave signals on all channels at 1Hz frequency |
| Short circuit noise | Check short circuit noise for all channels. |
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