(83 days)
Not Found
Not Found
No
The device description focuses solely on the physical and chemical properties of the electrode and its adhesive, with no mention of any computational or analytical capabilities that would involve AI or ML.
No
The device is described as an EEG cutaneous electrode, which is used for recording electrical activity, not for treating a condition. Its predicate device is also an electrode.
No
Explanation: The device description indicates it is an EEG cutaneous electrode designed to bond an Ag/AgCl disk to the skin for low impedance readings. It is an electrode for signal acquisition, not a device that processes or interprets signals for diagnostic purposes. Its function is to facilitate the acquisition of biological signals (EEG) for other diagnostic equipment.
No
The device description clearly describes a physical electrode with an adhesive component, which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs have specific intended uses related to diagnosing diseases or conditions based on in vitro examination of specimens from the human body.
- Device Description: The description clearly states the device is a "disposable EEG cutaneous electrode" used to bond an Ag/AgCl disk to the skin for EEG recordings. This is a device used on the body to measure electrical signals, not a device used to test specimens from the body.
- Anatomical Site: The anatomical site is "skin," which aligns with a device used for external measurement, not for analyzing internal specimens.
- Predicate Device(s): The predicate device listed is "Neurolink EEG/EP/EMG Surface Electrode, Electrode Cream and Collodion paste." These are all devices used for electrophysiological measurements on the body, not for in vitro diagnostics.
In summary, the description and context point to a device used for physiological measurement on the body, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The AQUABOND electrode is a disposable EEG cutaneous electrode that uses an aqueous, conductive adhesive to bond an Ag/AgCl disk to the skin. Because the adhesive is aqueous, removal is quick and unaccompanied by odors from organic solvents, as is the case with electrodes attached with pastes, such as Collodion. The AQUABOND electrode comprises a silver/silver chloride (Ag/AgCI) coated plastic base with an attached aqueous conductive adhesive component. The electrode is supplied in a dry state and when the conductive, adhesive component is wet with common tap water, it becomes sticky and can be attached to the skin, even in locations with hair, to provide a well adhering, low impedance electrode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The AQUABOND is substantially equivalent to a combination of the Neurolink EEG/EP/EMG Surface Electrode, Electrode Cream and Collodion paste.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K9644333
SUMMARY OF SAFETY AND EFFECTIVENE
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter:
Medibond Ltd. 17 Aminadav St., Tel Aviv 67067, Israel Tel: +972.3.562.7103; Fax: +972.3.561.3037
Name of the Device: AQUABOND
Predicate Devices: The AQUABOND is substantially equivalent to a combination of the Neurolink EEG/EP/EMG Surface Electrode, Electrode Cream and Collodion paste.
Description of the Device: The AQUABOND electrode is a disposable EEG cutaneous electrode that uses an aqueous, conductive adhesive to bond an Ag/AgCl disk to the skin. Because the adhesive is aqueous, removal is quick and unaccompanied by odors from organic solvents, as is the case with electrodes attached with pastes, such as Collodion. The AQUABOND electrode comprises a silver/silver chloride (Ag/AgCI) coated plastic base with an attached aqueous conductive adhesive component. The electrode is supplied in a dry state and when the conductive, adhesive component is wet with common tap water, it becomes sticky and can be attached to the skin, even in locations with hair, to provide a well adhering, low impedance electrode.
The differences between the AQUABOND and the predicate devices raise no new issues of safety or effectiveness.
- OCT. 1996
y. Tsur
Date
Dr. Yoel Tsur, President