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510(k) Data Aggregation

    K Number
    K181911
    Device Name
    Interlude 100% Cotton Tampon
    Manufacturer
    ALBAAD fem
    Date Cleared
    2018-11-02

    (108 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K173225,K001641
    Why did this record match?
    Device Name :

    Interlude 100% Cotton Tampon

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

    Interlude 100% Cotton Tampons are inserted into the vagina and used to absorb menstrual or other discharge.

    Device Description

    Interlude 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are made from cotton absorbing fibers and cotton overwrap to which a cotton cord is sewed with a cotton sewing thread. The applicator tubes are made of cardboard and include a cylindrical barrel and a plunger. The assembled tampon with applicator is wrapped in a printed paper, polyethylene (PE), or polypropylene (PP) wrapper. The subject devices are provided with the following three absorbencies: Light:

    AI/ML Overview

    This document does not contain information about an AI/ML medical device. Instead, it is a 510(k) premarket notification for a menstrual tampon (Interlude 100% Cotton Tampon).

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth establishment, or sample sizes related to an AI/ML device. The document details the assessment of the tampon based on physical characteristics, absorbency, chemical residues, microbiology, and biocompatibility, as per FDA guidance for menstrual tampons.

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