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K Number
K011996
Device Name
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
Manufacturer
PROCTER & GAMBLE CO.
Date Cleared
2001-09-19

(84 days)

Product Code
HIL
Regulation Number
884.5460
Type
Traditional
Panel
OB
Reference & Predicate Devices
K980209,K990924,K001713,K021383,K031804,K041300,K050800,K061988,K070494,K080479,K092043,K100918,K111100,K120427,K130663,K140801,K150654,K160410,K170461,K180486,K190623,K200350,K201416,K211425,K220970,K230485
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TAMPAX® Pearl Scented Tampons & TAMPAX® Pearl Unscented Tampons are tampons that are used to absorb menstrual fluid.

Device Description

Each tampon is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.

AI/ML Overview

This looks like a 510(k) premarket notification for a menstrual tampon. These types of devices generally do not involve AI or complex algorithms with acceptance criteria, ground truth, or multi-reader studies in the way medical imaging or CAD devices do.

The provided text does not contain information about an AI device, acceptance criteria related to algorithmic performance, or a study proving that an AI device meets such criteria.

Instead, the submission focuses on:

  • Device Description: TAMPAX® Pearl Scented and Unscented Tampons with plastic applicators.
  • Intended Use: To be inserted into the vagina to absorb menstrual fluid.
  • Technological Characteristics: Comparison to predicate devices, noting differences in shape of the uncompressed pad, overwrap material, withdrawal cord, fragrance composition, and applicator color.
  • Safety Assessment: Relying on in vitro microbiological testing, biocompatibility testing, and safety-in-use clinical testing to demonstrate equivalence to predicate devices.
  • Effectiveness: Stating that the device complies with the syngyna absorbency requirements of 21 CFR 801.430. This is the key "acceptance criterion" for effectiveness mentioned, and it's a regulatory standard, not an AI performance metric.
  • Conclusion: The device is safe, effective, and substantially equivalent to predicate devices.

Therefore, I cannot provide the requested table or answer the questions related to AI device performance, sample sizes for test/training sets, experts for ground truth, or MRMC studies, as these concepts are not relevant to this traditional medical device submission.

§ 884.5460 Scented or scented deodorized menstrual tampon.

(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).