(28 days)
Kimberly-Clark* U by KOTEX Sleek* 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 cord and an applicator. The terminology used in describing the device in rest of the 510(k) submission is as follows; Complete device: U by KOTEX Sleek* Unscented Menstrual Tampons with applicator Tampon component: Absorbent pledget, overwrap and a withdrawal cord. Applicator: Inner plunger tube and an outer insertion tube (barrel) formed with a closed, rounded tip with a unique textured grip. The absorbent pledget consists of a ribbon of rayon fibers. A rayon-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 withdrawal string will be available in pink and white colors. The tampon component is inserted into a two-piece plastic applicator consisting of an inner plunger 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 document describes a Special 510(k) submission for Kimberly-Clark* U by KOTEX Sleek* Unscented Menstrual Tampons, focusing on demonstrating substantial equivalence to a predicate device (Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons; K091749). The "study" described is a preclinical evaluation to support this substantial equivalence claim, rather than a clinical trial with human subjects.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Preclinical Tests) | Standard | Reported Device Performance |
|---|---|---|
| Cytotoxicity Test | ISO 10993, Part 5 | Meets |
| Mucosal Irritation Test | ISO 10993, Part 10 | Meets |
| Mucosal Sensitization Test | ISO 10993, Part 10 | Meets |
| Colorant Extraction Test | USP 661 | Meets |
| Syngyna Absorbency Requirements | 21 CFR § 801.430 | Complies |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document describes preclinical testing rather than clinical testing with human subjects. Therefore, the concept of a "test set" in the context of human data or AI model evaluation is not directly applicable. The "samples" would refer to the materials/components of the tampon and applicator that underwent the various biocompatibility and extraction tests. The document does not specify the number of individual test articles or replicates used for each preclinical test.
- Data Provenance: Not applicable in the sense of country of origin for human data. The tests are laboratory-based.
- Retrospective or Prospective: These preclinical tests are conducted prospectively as part of the device development and submission process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for preclinical tests like biocompatibility and absorbency is established by adherence to recognized international and national standards (ISO, USP, CFR) and successful completion of the specified assays. These tests are evaluated by laboratory personnel and regulatory bodies against predefined pass/fail criteria, not by experts establishing a subjective ground truth.
4. Adjudication Method:
Not applicable. The results of the preclinical tests are objective and measured against established performance standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The device in question is a menstrual tampon, and the evaluation is preclinical for safety and effectiveness, and for demonstrating substantial equivalence.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
No. This concept applies primarily to AI/ML software as a medical device. The evaluations performed here are for a physical medical device.
7. Type of Ground Truth Used:
The ground truth used for this evaluation is based on:
- Established Performance Standards: International standards (ISO 10993 for biocompatibility) and US Pharmacopeia (USP 661 for colorant extraction).
- Regulatory Requirements: 21 CFR § 801.430 for Syngyna absorbency, which defines the absorbency categories for menstrual tampons.
- Substantial Equivalence to a Predicate Device: The overarching goal is to demonstrate that the new device is as safe and effective as the legally marketed predicate device (K091749) by meeting the same standards and having similar technological characteristics.
8. Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" as this is not an AI/ML model. The "training" for such a device would refer to the historical data, scientific literature, and previous product development that informs the design and manufacturing of the tampon, but it's not a formal "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set as defined in AI/ML contexts. The "ground truth" for the device's design and manufacturing processes would be based on scientific principles, material science, engineering best practices, and historical performance data for similar predicate devices.
§ 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).