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K Number
K962712
Device Name
YSANPOINT) (MENSTRUAL) DIGITAL TAMPON
Manufacturer
TALBOT S. LINDSTROM
Date Cleared
1996-09-10

(60 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

used to absorb menstrual and other vaginal discharges, when inserted in the tampon also has a 100 % non-chorine bleached cotton string attached, enabling the user to remove the tampon after use.

Device Description

a digital tampon with the absorbant material being 75 % nonchlorine bleached rayon viscose, 25 % non-chlorine bleached cotton, with a non-woven cover of thermobonded rayon-polypropylene (without chemical binder)

AI/ML Overview

This document is a 510(k) summary for a digital tampon. It is a premarket notification to the FDA to market a medical device. The document states that the tampon is of "essentially the same make and construction" as existing FDA-approved products like Kotex and O.B. The "only distinguishing characteristic is the use of a patented technique for the use of hydrophilic fibers in addition to thermoplastic fibers in the non-woven fabric of the envelope."

Therefore, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as it would be understood for a diagnostic or AI/ML-based medical device. This type of submission relies on substantial equivalence to predicate devices, not on performance studies against specific acceptance criteria for diagnostic accuracy or similar metrics.

To answer your specific questions in the context of this document:

  1. A table of acceptance criteria and the reported device performance: Not applicable. This document is for a tampon, and its performance is assessed against the substantial equivalence of its construction and materials to predicate devices, not against specific quantitative performance metrics like sensitivity, specificity, or AUC as one would find for diagnostic devices.

  2. Sample size used for the test set and the data provenance: Not applicable. No test set or data provenance is mentioned as this is not a diagnostic device study.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.

  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.

  8. The sample size for the training set: Not applicable.

  9. How the ground truth for the 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).