(29 days)
Playtex tampons are intended to be used as scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
Playtex Sport Plastic Tampons (unscented/fresh scent) for the absorption of menstrual fluid.
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
The provided 510(k) summary (K060981) for Playtex Sport Plastic Tampons does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
The 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons, K830966, K020201, K912002). This means the manufacturer is asserting that the new device has the same technological characteristics and intended use as the previously cleared device, and therefore does not raise new questions of safety and effectiveness.
Instead of presenting specific performance acceptance criteria and a study demonstrating the device meets those criteria, the submission states:
Technological Characteristics:
"The new tampon has the same technological characteristics as the cleared tampon. The fiber, string, and materials in contact with the vaginal wall are the same or have the same mode of action. The only differences in the modified tampons from the predicate devices are: the composition of the colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger; a new fragrance; and the contoured shape of the applicator and pledget."
Performance Data:
"Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, dermal irritation, allergic contact sensitization tests, microbial agar diffusion and toxic shock syndrome toxin-1 (TSST-1) testing indicate that the modified device meets all device input requirements."
Conclusions:
"The modified Playtex tampons are substantially equivalent to the predicate tampons."
Here's a breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Meets all device input requirements based on cytotoxicity, acute systemic toxicity, vaginal irritation, dermal irritation, allergic contact sensitization, microbial agar diffusion, and TSST-1 testing. |
| Substantial Equivalence to predicate device (Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons) | Concluded to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document mentions "Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, dermal irritation, allergic contact sensitization tests, microbial agar diffusion and toxic shock syndrome toxin-1 (TSST-1) testing." However, it does not provide details on the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These tests are generally laboratory or animal studies, not human clinical trials in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This submission focuses on chemical and biological safety testing and substantial equivalence, not on interpreting images or patient data that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the device aims to assist or replace human interpretation. This submission is for a menstrual tampon.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This device is not an algorithm or AI system.
7. Type of Ground Truth Used:
- The "ground truth" used for this type of submission generally refers to established scientific/regulatory standards for biocompatibility and safety. The performance data mentioned (cytotoxicity, systemic toxicity, irritation, sensitization, microbial, TSST-1) are established methods to assess these safety aspects. There is no "ground truth" in the sense of expert consensus, pathology, or outcomes data for clinical accuracy as would be found in diagnostic device submissions.
8. Sample Size for the Training Set:
- Not applicable. This submission does not involve machine learning or AI, and therefore, there is no training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).