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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
SU
Reference & Predicate Devices
K172373,K211099
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.

N/A