(190 days)
Kimberly-Clark* U by KOTEX® Click* 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 pleget, a withdrawal cord and an applicator. The absorbent pledget consists of a ribbon of rayon fibers. A viscose-polyester blend withdrawal cord is placed on the ribbon and the ribbon is radially wound, then, compressed into a traditional eight-groove bullet-shaped pledget, overwrapped with a non-woven fabric. The formed pledget is inserted into a three-piece plastic applicator consisting of an inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.
This document is a 510(k) Summary for a Kimberly-Clark U by KOTEX Click Unscented Menstrual Tampon**. It details the device's characteristics, safety, and effectiveness in comparison to a predicate device. This is a medical device application, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable.
Here's the information that can be extracted relevant to the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Genotoxicity Test (MLA) as per ISO 10993, Part 3 | Meets |
| Genotoxicity Test (AMES) as per ISO 10993, Part 3 | Meets |
| Genotoxicity Test (Mouse Micronucleus) as per ISO 10993, Part 3 | Meets |
| Cytotoxicity Test as per ISO 10993, Part 5 | Meets |
| Mucosal Irritation Test as per ISO 10993, Part 10 | Meets |
| Mucosal Sensitization Test as per ISO 10993, Part 10 | Meets |
| Syngyna absorbency requirements of 21 CFR § 801.430 | Complies |
The study that proves the device meets the acceptance criteria:
The document states that the "subject 510(k) device has undergone an extensive series of safety tests, including an assessment of performance characteristics, preclinical microbiological testing and biocompatibility testing." The "results of these studies support the conclusion that the subject 510(k) device is equivalent and as safe as the predicate device."
Specifically, for biocompatibility and genotoxicity, the following preclinical tests were performed:
- Genotoxicity Test (MLA)
- Genotoxicity Test (AMES)
- Genotoxicity Test (Mouse Micronucleus)
- Cytotoxicity Test
- Mucosal Irritation Test
- Mucosal Sensitization Test
For effectiveness, the device's compliance with syngyna absorbency requirements was assessed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a traditional medical device (tampon), not an AI/ML device. The "test set" here refers to materials and components of the tampon tested against specified standards. Specific sample sizes for each preclinical test are not explicitly provided in the summary but would be detailed in the full 510(k) submission. Data provenance is not specified but is assumed to be from internal lab testing or accredited external labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a traditional medical device (tampon). There is no "ground truth" in the AI/ML sense established by human experts for the performance tests. The "ground truth" is the established scientific and regulatory standard (e.g., ISO 10993 parts, 21 CFR § 801.430).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a traditional medical device (tampon). Adjudication methods like those used in clinical trials or AI/ML evaluations are not relevant here. The results of the preclinical tests are directly compared to the specified scientific standards.
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 a traditional medical device (tampon), 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 a traditional medical device (tampon), not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is the predefined standards and regulatory requirements for menstrual tampons, specifically:
- ISO 10993 standards: Part 3 for genotoxicity, Part 5 for cytotoxicity, and Part 10 for irritation and sensitization.
- 21 CFR § 801.430: For syngyna absorbency requirements.
8. The sample size for the training set
- Not Applicable. This is a traditional medical device (tampon), not an AI/ML device. There is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is a traditional medical device (tampon), not an AI/ML device. There is no "training set" or corresponding "ground truth" in this context.
§ 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).