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K Number
K151170
Device Name
Tosama 100% Organic Cotton Menstrual Tampon
Manufacturer
TOSAMA D.O.O.
Date Cleared
2015-07-02

(62 days)

Product Code
HEB
Regulation Number
884.5470
Type
Traditional
Panel
OB
Reference & Predicate Devices
K130609
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Tosama 100% Organic Cotton Menstrual Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

Device Description

The device will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in three absorbencies: Regular, Super, and Super Plus.

AI/ML Overview

This document is a 510(k) premarket notification for a menstrual tampon. It is not a study about an AI-powered medical device. Therefore, it does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets them for an AI device.

The document discusses the substantial equivalence of the "Tosama 100% Organic Cotton Menstrual Tampon" to a predicate device (Naturalena 100% Cotton Tampon). It outlines the general safety and effectiveness of the traditional medical device through non-clinical testing.

Here's why the requested information cannot be provided from this document:

  1. Nature of the Device: The device described is a physical menstrual tampon, not an AI-powered software or system.
  2. Type of Study: The document refers to "non-clinical data" and "testing" (chemical, microbiological, biocompatibility, efficacy) for the tampon, which are standard for physical medical devices to demonstrate safety and effectiveness. It does not describe a clinical study of an AI algorithm's performance.
  3. Missing AI-Specific Information: There is no mention of algorithms, machine learning, AI assistance, human readers, ground truth establishment by experts, or training/test sets in the context of AI.

The requested information is specific to the development and validation of AI/ML-based medical devices, which are not covered by this submission for a menstrual tampon.

§ 884.5470 Unscented menstrual tampon.

(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).