(29 days)
The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.
The Ceribell Instant EEG Headband is a 10 electrode EEG headband is non-sterile and disposable for single patient use and designed to be used exclusively with the Ceribell Pocket EEG Device (K191301) for EEG acquisition and recording.
The Ceribell Instant EEG Headband is comprised of the following components:
- An elastic fabric headband
- A cable attached to the headband to allow connection to an EEG acquisition/recording device
- 10 electrode assemblies, each consisting of the following:
- Passive Silver/silver-chloride electrode
- Reservoir filled with conductive electrolyte gel
- Mechanism for dispensing gel onto patient scalp
- Scalp-contacting prongs to prepare scalp for electrode contact
This FDA 510(k) summary for the Ceribell Instant EEG Headband (K232052) explicitly states "Performance Data: None required." and that the device is identical to its predicate (K210805) with only a modified Indications for Use Statement and associated labeling.
Therefore, the provided document does not contain the information necessary to answer the questions regarding acceptance criteria and a study that proves the device meets those criteria. It indicates that no performance data was needed for this specific submission because the device is essentially a re-labeled version of a previously cleared 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).