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K Number
K981760
Device Name
PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598
Manufacturer
PLAYTIME PRODUCTS, INC.
Date Cleared
1998-07-22

(64 days)

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

Unscented menstrual tampons for absorption of menstrual fluid.

Device Description

Unscented menstrual tampons for the absorption of menstrual fluid.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Playtex Tampons). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving that the device meets specific performance criteria in the context of an AI/algorithm-driven device.

The document is a regulatory submission for a physical product (tampons) and focuses on demonstrating substantial equivalence according to FDA regulations existing in 1998. It references nonclinical testing related to biocompatibility and safety (e.g., sensitization, irritation, toxicity, Dioxin analysis, TSST-1 toxin testing) to show that the new tampon has the same technological characteristics and mode of action as previously cleared predicate devices.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance as outlined in your prompt because the provided text does not contain this type of information.

Specifically, it lacks:

  1. A table of acceptance criteria and reported device performance: The document mentions "nonclinical testing" but no specific performance metrics or acceptance criteria for those tests are presented in a table format.
  2. Sample size, data provenance, number of experts, adjudication method for a test set: This information is not relevant to the type of substantial equivalence submission for a physical product like a tampon.
  3. MRMC comparative effectiveness study or standalone algorithm performance: These are concepts related to AI/algorithm performance and are not applicable to the submitted document.
  4. Type of ground truth, training set sample size, how ground truth was established for a training set: Also not applicable to this type of device submission.

The document's purpose is to establish substantial equivalence for a physical medical device, not to present performance data for an AI/algorithm.

§ 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).