(128 days)
AC Cream - Conductive paste is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin.
AC Cream - Conductive paste is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin.
It's characterized by pale yellow colour, no crystallization, no flocculation, bright.
AC Cream - Conductive paste function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. AC Cream - Conductive paste is for external use with recording electrodes only.
AC Cream - Conductive paste is made of powders, Potassium Chloride and Sodium Chloride as conductors, combined with thickening agents and humectants, all in an aqueous solvent.
The composition is the following: Water, Ceteareth-20, Glycerol, Propylene Glycol, Bentonite, Sodium chloride, Potassium chloride, Calcium carbonate, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin
The pH range is 6÷8, and Impedance at 10Hz is 120± 25 Ohm.
The mean impedance after 7 days use, considering the worst values detected, is around 480 ± 10 Ohm.
The Conductivity is 20 mS/cm
Shelf life of AC Cream - Conductive paste is 3 years if stored properly in the closed packaging, kept away from the sunlight and within the limit temperature
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for AC Cream - Conductive paste:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Set by Standard) | Reported Device Performance (AC Cream - Conductive paste) | Pass/Fail? |
|---|---|---|
| Biocompatibility: | Pass | |
| ISO 10993-5 (Cytotoxicity) | Yes | Pass |
| ISO 10993-10 (Irritation) | Yes | Pass |
| ISO 10993-10 (Skin Sensitization) | Yes | Pass |
| Shelf Life (Accelerated Aging - 3 years): | Pass | |
| Pale yellow color, no flocculation, bright | Exhibits pale yellow color, no flocculation, bright after 84 days (accelerated aging equivalent to 3 years) | Pass |
| Instant Impedance |
§ 882.1275 Electroconductive media.
(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).