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K Number
K964269
Device Name
PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS
Manufacturer
PLAYTIME PRODUCTS, INC.
Date Cleared
1996-11-29

(35 days)

Product Code
HIL
Regulation Number
884.5460
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

TSST-I, Toxin testing was conducted; results are in the range of values of commercially sold tampons and there are no significant differences between Playtex Tampons #29696 and the predicate device
Dioxin Analysis
Primary Dermal Irritation in Rabbits Non-Irritating
Acute Oral Toxicity in Rats - Non-Toxic
Subacute Vaginal Irritation in Rabbits - Non-Irritating
Human Repeat Insult Patch Test Non-Irritating and not a Sensitizer
Agar Diffusion Study No zones of inhibitation were detected

AI/ML Overview

This document, K964269, is a 510(k) premarket notification for Playtex Tampons #29696, submitted on November 29, 1996. It details safety and effectiveness information for a medical device (a tampon). However, it does not contain the information requested in your prompt regarding acceptance criteria, study design for performance, or AI/software validation.

The document primarily focuses on biological safety testing for the tampon and its comparison to a predicate device, which is typical for a device of this nature in a 510(k) submission. It describes tests like:

  • TSST-I Toxin testing: Comparing levels to commercially sold tampons.
  • Dioxin Analysis: Implied to be performed, but no results are given.
  • Primary Dermal Irritation (Rabbits): Resulted in "Non-Irritating."
  • Acute Oral Toxicity (Rats): Resulted in "Non-Toxic."
  • Subacute Vaginal Irritation (Rabbits): Resulted in "Non-Irritating."
  • Human Repeat Insult Patch Test: Resulted in "Non-Irritating and not a Sensitizer."
  • Agar Diffusion Study: No zones of inhibition detected.

These are all safety tests, not performance tests in the sense of accuracy, sensitivity, or specificity for a diagnostic or AI-driven device. Therefore, I cannot extract the requested information from this document for the following reasons:

  1. AI/Software Component Absence: The document describes a physical medical device (tampon) and its biological safety. It does not refer to any AI, software, or diagnostic capabilities.
  2. Lack of Performance Metrics for AI: There are no metrics like sensitivity, specificity, AUC, F1-score, or similar performance indicators for an AI system.
  3. No Test Set/Training Set Details: Information on test set size, data provenance, ground truth establishment methods (expert consensus, pathology), number of experts, adjudication methods, or MRMC studies is not present because these concepts are not relevant to the described safety testing of a tampon.

Conclusion: The provided text is unsuitable for generating the specific table and study details you've requested, as it pertains to the biological safety of a physical medical device (tampon) and not to the performance validation of an AI-driven device or diagnostic tool.

§ 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).