Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K212326
    Manufacturer
    Date Cleared
    2021-12-01

    (128 days)

    Product Code
    Regulation Number
    882.1275
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    AC Cream - Conductive paste

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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

    AI/ML Overview

    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)YesPass
    ISO 10993-10 (Irritation)YesPass
    ISO 10993-10 (Skin Sensitization)YesPass
    Shelf Life (Accelerated Aging - 3 years):Pass
    Pale yellow color, no flocculation, brightExhibits pale yellow color, no flocculation, bright after 84 days (accelerated aging equivalent to 3 years)Pass
    Instant Impedance
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1