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510(k) Data Aggregation

    K Number
    K242105
    Device Name
    SABA Tampons
    Manufacturer
    Essity Higiene Y Salud Mexico. S.A. DE C.V.
    Date Cleared
    2025-04-01

    (257 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K231341
    Why did this record match?
    Applicant Name (Manufacturer) :

    Essity Higiene Y Salud Mexico. S.A. DE C.V.

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

    The tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

    Device Description

    The SABA® Tampons are traditional unscented menstrual tampons. The SABA® Tampons are available either with a single use applicator or as a digital tampon (without an applicator). Except for the inclusion of the applicator, both types of tampons are made of the same materials. Each device consists of a tampon, including a 100% viscose pledget ("absorbent core") surrounded by a non-woven fabric cover blend of polyethylene and polyester, a removal cord of 67% polyester/33% viscose, and an applicator (only for the applicator tampon). The applicator is made of an inner tube of high-density polypropylene and an external tube of low-density polyethylene, both with 5% pink pigment. The applicator has a smooth, rounded tip to ease insertion.

    Both the applicator and applicator free SABA® Tampons are provided in three absorbencies of regular (6-9g), super (9-12g), and super plus (12-15g). Each device is individually wrapped in a metallized printed bi-oriented polypropylene lamination and packaged in sealed multi-unit containers for retail sale. It is provided non-sterile and for single use only.

    AI/ML Overview

    This document is a 510(k) clearance letter for SABA® Tampons, a type of menstrual tampon. The provided text does not contain any information about acceptance criteria or study data related to an AI/ML medical device.

    The document details the substantial equivalence of the SABA® Tampons to a predicate device (K231341) based on non-clinical performance data, biocompatibility, microbiology testing, and shelf-life testing specific to tampons. It explicitly states:

    • "No clinical studies are included in this submission."
    • "This device does not include any use of software."
    • "The device does not have any electrical source so no electrical safety or EMC testing are included in this submission."
    • "No animal studies are included in this submission."

    Therefore, it is impossible to describe acceptance criteria or a study proving device performance for an AI/ML medical device based on the provided text. The request's premise about AI/ML device evaluation is not applicable to the SABA® Tampons 510(k) submission.

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