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510(k) Data Aggregation

    K Number
    K240226
    Device Name
    Pixie Skin Tag
    Manufacturer
    Oystershell NV
    Date Cleared
    2024-10-18

    (266 days)

    Product Code
    ORE,GEH
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K172373,K211099
    Why did this record match?
    Product Code :

    ORE

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

    Pixie® Skin Tag is a cryogenic device for home use intended to treat skin tags in persons over the age of 21.

    Device Description

    Pixie Skin Taq is a pen-like cryogenic device that utilizes pressurized nitrous oxide (NoO, liquefied) to destroy skin tag tissue. The N2O is released into a single-use, disposable applicator, cooling the applicator as the result of rapid evaporation. The cooled applicator is briefly contacted with the skin tag while the surrounding tissue is protected by a disposable thermally insulating adhesive bandage. Each Pixie Skin Tag device is supplied in a carton with instructions for use and replacement applicator tips and insulating adhesive bandages.

    AI/ML Overview

    The provided text is a 510(k) summary for the Pixie Skin Tag device. This type of submission is for establishing substantial equivalence to a predicate device, not for proving a device meets specific performance acceptance criteria via a rigorous clinical study of AI performance, especially not as would be described for an AI/ML-driven medical device.

    Therefore, the information required to answer your questions regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as typically found in submissions for AI/ML devices, is not present in this document.

    This document describes a physical medical device (a cryosurgical unit) and its comparison to a predicate device. The performance evaluations cited are limited to:

    • Bench studies: Comparison of applicator temperatures, device robustness (activation, N2O evacuation, drop protection), and thermal protection of insulating bandages.
    • Animal studies: Application to healthy rabbit skin to determine epithelial damage and wound healing.
    • Usability studies: Novice laypersons' ability to set up and apply simulated treatments after reading instructions.
    • Post-market review of complaints: For CE-marked devices and a reference Pixie device for warts, to assess safety and reported adverse events.

    In summary, this document does not contain the information needed to answer the specific questions about acceptance criteria for an AI/ML device.

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