(79 days)
The TAMPAX® M Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.
Unscented menstrual tampons for absorption of menstrual fluid. The tampon is a conventional design consisting of an absorbent pledget, an overwrap, a withdrawal cord and an applicator. The materials of construction are cotton, rayon, polypropylene and polyester. The device functions by absorbing menstrual fluid after being inserted into the vagina.
This document is a 510(k) summary for a menstrual tampon, focusing on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study to prove a device meets specific performance criteria.
Therefore, many of the requested categories regarding clinical study design, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies) are not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown of the information that can be extracted, and where the requested information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Internal Standards/Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Material Safety & Biocompatibility | Established in predicate device (K081555), and biocompatibility tests for individual materials in previously cleared similar devices. | Passed (Biocompatibility testing completed; material safety established). |
| Applicator Expulsion Force | Acceptable limits (implied by comparison to predicate and safety assessment). | "Acceptable results" and "similar performance to the predicate device." |
| Applicator Click and Separation Force | Acceptable limits (implied by comparison to predicate and safety assessment). | "Acceptable results" and "similar performance to the predicate device." |
| Applicator Collapse Force | Acceptable limits (implied by comparison to predicate and safety assessment). | "Acceptable results" and "similar performance to the predicate device." |
| Tampon Pledget Exposure to Applicator Components | Negligible or no exposure. | "Negligible or no tampon pledget exposure to the applicator components." |
| Technological Characteristics (Overall Design) | Similar to predicate device (K081555) in basic component materials, overall design, and labeling. | Confirmed similar; new colors and modified applicator design, but same performance. |
| Fluid Handling Capabilities | Acquire and hold menstrual fluids similar to the predicate device. | Designed to acquire and hold menstrual fluids similar to the predicate device. (Implied equivalence through design and materials). |
| Safety and Efficacy Profiles | Equivalent to the predicate device. | Confirmed equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. This document refers to nonclinical tests and extractions, which typically involve a smaller number of physical units for engineering-style testing rather than a large clinical test set.
- Data Provenance: Not specified, but given the nature of the tests (engineering/material characterization), it would be internal lab data, likely from the US, created for this submission. It is retrospective in the sense that the testing was performed to support this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This submission focuses on nonclinical performance testing and substantial equivalence, not the establishment of ground truth by human experts for a diagnostic or prognostic device.
4. Adjudication Method for the Test Set
- Not applicable. See point 3. Testing involves objective measurements of physical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Affect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This device is a menstrual tampon, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the nonclinical tests, the "ground truth" is based on pre-defined engineering specifications, material standards, and performance characteristics of the legally marketed predicate device (K081555). For material safety, previous biocompatibility testing results for similar devices serve as a basis.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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).