(28 days)
The EMU128S is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals.
The EMU128S is a digital electroencephalograph.
This document describes a Special 510(k) Notification for the EMU128S device. A Special 510(k) is submitted when there are minor modifications to a legally marketed device that do not affect its fundamental intended use or alter its fundamental scientific technology. Therefore, the submission focuses on demonstrating substantial equivalence to the predicate device, rather than requiring extensive new clinical studies or detailed performance criteria beyond what was established for the predicate.
Given this context, the document outlines the substantial equivalence claim.
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate) | Reported Device Performance (EMU128S) |
|---|---|---|
| Intended Use | Acquire, store, and archive electroencephalographic signals. | Acquire, store, and archive electroencephalographic signals. |
| Technological Characteristics | Digital electroencephalograph with 128 channels. | Digital electroencephalograph with 128 channels, with the addition of a switch matrix. |
| Safety and Effectiveness | Demonstrated safe and effective through prior 510(k) clearance. | Substantially equivalent in safety and effectiveness to the predicate device due to no change in acquisition, display, storage, or archiving of EEG data. The change is the addition of a switch matrix, which facilitates external device attachments without affecting EEG data. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. For a Special 510(k) based on substantial equivalence to a predicate device for minor modifications, a new test set and clinical study proving safety and effectiveness are typically not required if the fundamental technology and intended use remain unchanged. The comparison is primarily based on engineering and design control documentation, and potentially bench testing to confirm the new component (the switch matrix) does not negatively impact performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth establishment for a test set is not typically part of a Special 510(k) for this type of modification. The assessment relies on the established safety and effectiveness of the existing predicate device.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or required. The modification (addition of a switch matrix) is an engineering change to facilitate external device attachments and does not directly involve diagnostic interpretation by human readers that would necessitate such a study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone performance study of an algorithm was conducted or required. The EMU128S is a hardware device for acquiring EEG signals, not an AI or algorithmic diagnostic tool.
7. Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate device (XLTEK 128 Channel EEG Headbox) which was previously cleared by the FDA. The current submission argues that the EMU128S, despite its modification, performs equivalently to this predicate.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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).