(149 days)
The DeltaScan Patch is applied directly to the patient's skin to record EEG signals.
The DeltaScan Patch is dedicated and only intended to be used in combination with the DeltaScan Monitor (K222680) through a proprietary connector design.
The DeltaScan Patch is a single use EEG electrode Patch, used exclusively with the DeltaScan Monitor. The DeltaScan Patch is used with the DeltaScan Monitor to enable the acquisition of EEG signals. The DeltaScan Monitor provides signal analysis technology intended for use as an adjunct to clinical judgment.
The DeltaScan Patch is used to collect EEG signals from two electrode locations see Figure 5-1 DeltaScan Patch Electrode Locations.
The provided text describes the DeltaScan Patch, a cutaneous electrode intended to record EEG signals in conjunction with the DeltaScan Monitor. However, the document primarily focuses on the substantial equivalence argument to a predicate device (Covidien BIS Sensors, K143506) and the safety testing (biocompatibility, electrical safety, mechanical testing, and shelf-life).
Crucially, the document explicitly states that "No dedicated clinical study is needed to validate the device performance" for the DeltaScan Patch. Therefore, it does not contain information about acceptance criteria for device performance in terms of signal capture quality or diagnostic accuracy, nor does it describe a study proving the device meets such criteria. The "performance data" section primarily refers to safety and functional verification, not clinical performance for its primary intended use of recording EEG signals (beyond "it transfers the electrical signals as intended").
Given this limitation in the input, I cannot populate all sections of your requested table and study description definitively. I will outline what can be inferred from the provided text, and explicitly state where information is missing due to the nature of the FDA submission for this device.
Acceptance Criteria and Reported Device Performance
As noted, the document explicitly states that "No dedicated clinical study is needed to validate the device performance" for recording EEG signals. The performance data provided relates to safety, materials, and mechanical integrity.
| Acceptance Criteria (from provided text) | Reported Device Performance (from provided text) |
|---|---|
| Biocompatibility: Meet ISO 10993-1:2018 requirements for a surface contacting device ( |
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).