(21 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 pledget, overwrap, a withdrawal string and an applicator. The terminology used in describing the device in rest of this 510(k) submission is as follows; Complete device: U by KOTEX Click* Unscented Menstrual Tampons with applicator Tampon component: Absorbent pledget, overwrap and a withdrawal string. Applicator: Inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip. The absorbent pledget consists of a ribbon of rayon fibers. A rayon-polyester blend withdrawal string 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 withdrawal string will be available in pink and white colors. The tampon component 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 with applicator is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.
The provided text describes a Special 510(k) for Kimberly-Clark U by KOTEX Click Unscented Menstrual Tampons. This submission is for modifications to an already legally marketed device, primarily concerning the addition of new colorants for the applicator and a minor applicator design improvement. The core tampon component remains largely unchanged.
The study presented focuses on demonstrating that the modified device is substantially equivalent to the predicate device in terms of safety and effectiveness. This is not a study to prove a device meets specific acceptance criteria related to an AI algorithm's performance. Instead, it's a regulatory submission demonstrating equivalence for a medical device (menstrual tampon).
Therefore, I cannot populate most of the requested fields because the input document does not pertain to the performance of an AI algorithm or a study designed to establish its acceptance criteria and performance against those criteria. It is a regulatory filing for a physical medical device.
However, I can extract the information related to the preclinical testing performed to demonstrate safety and effectiveness for this specific device.
1. A table of acceptance criteria and the reported device performance:
| Preclinical Test (Acceptance Criteria) | Standard (Acceptance Criteria) | Reported Performance |
|---|---|---|
| Colorant Extraction Test | USP 661 | Meets |
| Cytotoxicity Test | ISO 10993, Part 5 | Meets |
| Mucosal Irritation Test | ISO 10993, Part 10 | Meets |
| Mucosal Sensitization Test | ISO 10993, Part 10 | Meets |
| Syngyna Absorbency Requirements (Effectiveness) | 21 CFR § 801.430 | Complies (as does the predicate device) |
Important Note: The "acceptance criteria" here are the standards and regulations the device must meet to demonstrate safety and effectiveness for a menstrual tampon. This is different from the acceptance criteria for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).
The following information cannot be provided from the given document as it pertains to AI algorithm studies, which is not the subject of this 510(k) summary:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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).