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K Number
K961456
Device Name
PLAYTEX TAMPONS #10296
Manufacturer
PLAYTIME PRODUCTS, INC.
Date Cleared
1996-06-18

(63 days)

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

Not Found

Device Description

Not Found

AI/ML Overview

This document does not describe a medical device that uses AI or machine learning, nor does it involve the kind of "study" described in the prompt's request for acceptance criteria and performance data related to AI devices.

Instead, the provided text is a summary of safety and effectiveness tests for an epoxy-coated applicator (RAD-KOTE K261). The tests are focused on material biocompatibility and physical integrity, not diagnostic or AI-driven performance.

Therefore, I cannot fulfill the request as it is framed for an AI-enabled medical device. The information provided does not contain:

  • Acceptance criteria for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).
  • Details about test sets, training sets, data provenance, expert ground truth, or MRMC studies for AI.
  • Any mention of AI, machine learning, or algorithms.

The document lists safety tests and their results for a physical medical product component.

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JUN 18 1996

1961456

SUMMARY OF SAFETY AND EFFECTIVENESS

The following tests have been completed on an aqueous extract from the RAD-KOTE K261 epoxy coated applicator covered by this 510(k).

  • Primary Dermal Irritation in Rabbits Not a primary irritant 1.
    1. Oral Toxicity in Rats - Non-toxic
  • Subacute Vaginal Irritation in Rabbits Non-irritating ം 3.
  • Agar Diffusion Study No zones of inhibition were seen (Exhibit 6). 4.
  • ેન્ડ. Toxin Study - Results were in the range of values of commercially sold tampons (Exhibit 7).
    1. Repeat Insult Patch Test in Humans - No irritation or sensitization reported
  • Dioxin Analysis Not detectable at limits of detection of HRGG/HRMS Method *7. 8290 (Triangle Labs, North Carolina) (Exhibit 8)
  • **8. Lamination Bond Integrity Test - No delamination reported (Exhibit 9)
  • Cytotoxicity Test No evidence of cell lysis or toxicity was reported. - 9
    • Tests conducted on applicator, pledget and string.
  • ** Tests conducted on applicator only.

§ 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).