(98 days)
Kimberly-Clark* U by Kotex® Security® is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.
This device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord and an applicator. The absorbent pledget consists of a ribbon of rayon fibers and cotton, overwrapped with a non-woven fabric. A withdrawal cord is placed through the pledget and knotted. The tampon pledget is compressed. The formed pledget is inserted into a two-piece plastic applicator consisting of an inner tube (plunger), and an outer insertion tube (barrel) with flexible petals that form a closed, rounded tip. Each tampon is individually wrapped in a plastic film wrapper and multiple tampons are packaged in sealed cartons for commercial sale. Tampons are available in Regular, Super and Super Plus absorbencies in various counts.
This document describes a 510(k) premarket notification for Kimberly-Clark U by Kotex® Security® Unscented Menstrual Tampons*. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.
The information provided focuses on the biocompatibility and absorbency of the device. It does not describe an AI medical device or a clinical study with human readers. Therefore, several sections of your request are not applicable to this document.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Standard | Reported Device Performance |
|---|---|---|
| Genotoxicity Test (MLA) | ISO 10993, Part 3 | Meets |
| Genotoxicity Test (AMES) | ISO 10993, Part 3 | Meets |
| Genotoxicity Test (Mouse Micronucleus) | ISO 10993, Part 3 | Meets |
| Cytotoxicity Test | ISO 10993, Part 5 | Meets |
| Mucosal Irritation Test | ISO 10993, Part 10 | Meets |
| Mucosal Sensitization Test | ISO 10993, Part 10 | Meets |
| Acute Systemic Toxicity Test | ISO 10993, Part 11 | Meets |
| Colorant Extraction Test | USP 661 | Meets |
| Syngyna Absorbency Requirements | 21 CFR §801.430 | Complies |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the specific biocompatibility tests. It mentions that "Testing from the reference device, U by Kotex® Sleek® K112635, was used to support the safety of new applicator colors." This indicates that some of the test data was retrospective, drawn from a previously approved device. The country of origin for the data is not specified, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This document is for a medical device (menstrual tampon), not an AI device relying on expert-established ground truth from images or clinical assessments. The "ground truth" here is the physical and chemical properties of the materials and the absorbency performance as measured by standardized tests.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or adjudication of results. The results are objective measurements against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI medical device and therefore no MRMC study comparing human readers with and without AI assistance was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI medical device.
7. Type of Ground Truth Used
The ground truth used for this device's performance evaluation includes:
- Standardized Biocompatibility Test Results: Based on ISO 10993 series and USP 661, these are objective laboratory measurements of material properties and their biological interactions.
- Syngyna Absorbency Requirements: A regulatory standard (21 CFR §801.430) for measuring absorbency, representing a controlled, objective test.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for this device would be its manufacturing process and quality control.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
§ 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).