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510(k) Data Aggregation

    K Number
    K201738
    Device Name
    SubNovii Advanced Plasma Technology
    Manufacturer
    Cartessa Aesthetics
    Date Cleared
    2020-09-10

    (77 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K192813
    Why did this record match?
    Device Name :

    SubNovii Advanced Plasma Technology

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

    The SubNovii is intended for the removal and destruction of skin lesions and coaqulation of tissue.

    Device Description

    The SubNovii Advanced Plasma Technology is a handheld battery powered device that, when activated and placed in close proximity to the skin, generates an ionized electrical arc through the tip of an electrode (Tip) to the skin without the device or the electrode touching the skin. The SubNovii Advanced Plasma Technology consists of the SubNovii handpiece, single use disposable tips and a battery charger.

    AI/ML Overview

    The provided FDA 510(k) summary for the SubNovii Advanced Plasma Technology references acceptance criteria and studies primarily focused on establishing substantial equivalence to a predicate device, rather than defining novel performance criteria for a diagnostic AI device.

    Here's a breakdown of the requested information based on the provided text, with clarifications where direct answers are not available due to the nature of the submission:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from predicate equivalence)Reported Device Performance (SubNovii)
    Electrical SafetyPass (Compliance with EN 60601-1)
    Electromagnetic Compatibility (EMC)Pass (Compliance with EN 60601-1-2)
    Tissue Damage (Superficiality)Equivalent to predicate device (tissue damages
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