(58 days)
Femtex and Private Label Plastic Applicator Tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Femtex and Private Label Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. The tampons will be provided in Regular absorbency within a slender plastic applicator.
Femtex and Private Label Slender Regular Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread.
The material used in Femtex and Private Label Slender Regular Plastic Applicator Tampons are similar to those used in other legally marketed tampons.
The provided text is for a 510(k) premarket notification for Femtex and Private Label Slender Regular Plastic Applicator Tampons. This document focuses on demonstrating substantial equivalence to a previously marketed device (K023479), rather than establishing new acceptance criteria or proving performance through a study against specific criteria. Therefore, much of the requested information regarding acceptance criteria, specific study design, and performance metrics is not explicitly stated or applicable in this type of regulatory submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. The document does not define specific quantitative acceptance criteria (e.g., minimum absorbency in Syngyna testing) that the new device must meet. Instead, it relies on the predicate device's established safety and effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative criteria for this submission. | No specific performance values were reported for the new device as compared to explicitly defined acceptance criteria. |
| Biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation) | "The results of these tests demonstrate that the tampons are equivalent in terms of safety and effectiveness to legally marketed tampons." (Implicitly, the new device met the same standards as the predicate). |
| Absorbency (Syngyna testing) | "Standard Syngyna testing confirmed the absorbency of these tampons." (Implies absorbency is within an acceptable range, likely comparable to the predicate, but specific values or criteria are not given). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated.
- Data Provenance: The document states "review of existing toxicological data in the public literature" and that "the following tests have been previously conducted on components relevant to the safety of Femtex plastic applicator tampons." This suggests that some of the data might be retrospective or historical, potentially from previous testing on similar components or the predicate device. However, it also mentions "Standard Syngyna testing confirmed the absorbency of these tampons," which implies some current testing was performed on the new device, but the details of the test set are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable and therefore not provided. The 510(k) submission for tampons does not involve expert-based ground truth establishment in the way medical diagnostic devices do. The assessments are based on laboratory testing (biocompatibility, absorbency) against defined standards or equivalency to a predicate.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Given the nature of the non-clinical tests (biocompatibility, Syngyna absorbency), no expert adjudication method (like 2+1, 3+1) would be employed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. It is not applicable to a menstrual tampon.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone study was not done. This concept is relevant for AI algorithms without human intervention. A menstrual tampon is a physical device, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical testing appears to be based on:
- Established Biocompatibility Standards: The results of cytotoxicity, sensitization, and vaginal irritation testing would be compared against recognized biological safety standards for medical devices and/or data from the predicate device to establish safety.
- Standard Absorbency Measurement (Syngyna Test): The absorbency of the tampons is measured quantitatively using a standardized laboratory method (Syngyna test), which provides an objective ground truth for absorbency.
8. Sample Size for the Training Set:
This information is not applicable and therefore not provided. Training sets are relevant for machine learning algorithms. The provided document concerns a physical medical device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and therefore not provided. (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).