LogoFDA 510(k) Search
K Number
K971228
Device Name
FEMTEX 100% COTTON TAMPONS
Manufacturer
REGU-TECH ASSOC., INC.
Date Cleared
1997-04-09

(78 days)

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

Femtex tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Device Description

Femtex 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Tampons will be provided with 2 absorbencies, regular, and super. Femtex 100% Cotton Tampons are made from cotton and, cotton cord and sewing thread. The material used in Femtex tampons are similar to those used in other legally marketed tampons.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Femtex 100% Cotton Tampons) and does not contain the information requested regarding acceptance criteria, study details, or performance metrics for an AI/ML-driven device.

The request asks for details about a study that proves a device meets acceptance criteria, specifically in the context of AI/ML performance, ground truth, expert review, and statistical analysis. The provided text is for a physical product (tampons) and focuses on biocompatibility and absorbency by existing testing standards applicable to such devices, not AI/ML.

Therefore, I cannot fulfill the request based on the provided input. The input does not contain any of the following information:

  • Acceptance Criteria/Reported Device Performance Table: No such table or performance metrics are present.
  • Sample size (test set) and data provenance: Not applicable to this type of device.
  • Number/Qualifications of experts for ground truth: Not applicable.
  • Adjudication method: Not applicable.
  • MRMC comparative effectiveness study: Not applicable.
  • Standalone (algorithm only) performance: Not applicable.
  • Type of ground truth: Not applicable.
  • Sample size (training set): Not applicable.
  • How ground truth for training set was established: Not applicable.

§ 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).