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510(k) Data Aggregation

    K Number
    K152284
    Device Name
    COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
    Manufacturer
    COTTON HIGH TECH S.L.
    Date Cleared
    2015-12-04

    (114 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K991118,K091084
    Why did this record match?
    Device Name :

    COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS

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

    Cohitech Non Applicator Organic Cotton Tampons and Cohitech Compact Cotton Tampons (regular, super and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.

    Device Description

    The devices are conventional unscented menstrual tampons consisting of an absorbent pledget, with or without polyethylene/polyester cover and a withdrawal cord. These tampons will be provided as three absorbencies: regular, super and super plus.

    Each non applicator organic cotton tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.

    Each compact applicator organic cotton tampon is inserted into a plastic compact applicator and wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.

    AI/ML Overview

    The provided document is a 510(k) summary for Cotton High Tech S.L.'s organic cotton tampons. It details the device's characteristics, intended use, and a summary of non-clinical data used to demonstrate substantial equivalence to predicate devices. However, this document does not contain the specific information requested about acceptance criteria for a device, nor does it describe a study that proves the device meets those criteria in the way envisioned for a diagnostic or AI-powered medical device.

    The document discusses performance data related to the physical and biological properties of the tampons (e.g., absorbency, biocompatibility, microbiology), but it does not present these in the format of acceptance criteria with reported device performance in a table, nor does it involve the concepts of ground truth, expert consensus, MRMC studies, or training sets typical for AI/diagnostic device evaluations.

    Therefore, I cannot fulfill your request with the provided input text in the format you've specified because the information is not present in the document. This document is a regulatory submission for a medical device that is a physical product (menstrual tampons), not a diagnostic or AI-driven system.

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