(22 days)
Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
This 510(k) summary is for a menstrual tampon, not a medical device that uses AI or requires complex statistical studies for its approval. Therefore, many of the requested categories regarding acceptance criteria and study design for AI/medical imaging devices are not applicable.
Here's the information that can be extracted and a clear indication of why other sections are not relevant to this specific premarket notification:
Acceptance Criteria and Device Performance for Playtex Gentle Glide Tampons
| Acceptance Criteria (from "Performance Data") | Reported Device Performance |
|---|---|
| Cytotoxicity testing: (Implied: Device must not exhibit cytotoxic effects) | "Cytotoxicity testing...indicate that the modified device meets all device input requirements." (Implies satisfactory performance, absence of cytotoxicity) |
| Acute systemic toxicity testing: (Implied: Device must not cause acute systemic toxic effects) | "acute systemic toxicity testing...indicate that the modified device meets all device input requirements." (Implies satisfactory performance, absence of acute systemic toxicity) |
| Vaginal irritation testing: (Implied: Device must not cause vaginal irritation) | "vaginal irritation testing...indicate that the modified device meets all device input requirements." (Implies satisfactory performance, absence of vaginal irritation) |
| Allergic contact sensitization tests: (Implied: Device must not cause allergic contact sensitization) | "allergic contact sensitization tests...indicate that the modified device meets all device input requirements." (Implies satisfactory performance, absence of allergic contact sensitization) |
| Microbial agar diffusion: (Implied: Device must not promote microbial growth or conversely, may need to demonstrate inhibitory properties if claimed, though typically it's about biocompatibility) | "microbial agar diffusion...indicate that the modified device meets all device input requirements." (Implies satisfactory performance related to microbial interaction, consistent with safe use) |
| Toxic Shock Syndrome Toxin-1 (TSST-1) testing: (Implied: Device must meet safety standards regarding TSST-1 production, typically by not enhancing its production or having low/negligible impact. This is a critical safety aspect for tampons.) | "toxic shock syndrome toxin-1 (TSST-1) testing indicate that the modified device meets all device input requirements." (Implies satisfactory performance, consistent with safety standards for TSST-1, which is a key regulatory requirement for tampons.) |
Note on "Device Input Requirements": The document states the device "meets all device input requirements." These "input requirements" would be the specific pass/fail criteria for each test (e.g., cytotoxicity score below a certain threshold, no irritation observed, TSST-1 production not significantly increased, etc.). The 510(k) summary only states that these requirements were met, not the specific numerical thresholds themselves.
Non-Applicable Sections and Explanations:
Due to the nature of this device (a menstrual tampon), the following information is not provided and is generally not relevant for this type of medical device submission:
- Sample size used for the test set and the data provenance: Not specified for biocompatibility/safety tests. These tests are typically conducted in vitro or on animal models, not on large human "test sets" in the way an AI algorithm is evaluated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/imaging studies (e.g., expert radiological reads) is not relevant for tampon safety testing. Biocompatibility tests rely on standardized laboratory protocols and scientific evaluation.
- Adjudication method: Not applicable for standard biocompatibility and safety testing. The results are typically objectively measured and interpreted by laboratory personnel.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study assesses how AI impacts human reader performance, which doesn't apply to a physical product like a tampon.
- Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as there is no algorithm or human-in-the-loop component for a tampon.
- The type of ground truth used: For these safety tests, the "ground truth" is established via standardized biological and chemical assay results (e.g., cell viability percentages for cytotoxicity, observed tissue reactions for irritation, quantitative measurements for TSST-1). It's not "expert consensus, pathology, or outcomes data" in the context of an AI/imaging device.
- The sample size for the training set: Not applicable. There is no AI model or "training set" for a menstrual tampon.
- How the ground truth for the training set was established: Not applicable, as there is no training set.
Summary of the Device and Basis for Substantial Equivalence:
The Playtex Gentle Glide and Playtex Gentle Glide Multipack Tampons are seeking substantial equivalence to previously cleared Playtex tampons (K961870 and K070745). The submission emphasizes that the new tampon has the "same technological characteristics" and that "The fiber, string, and materials in contact with the vaginal wall are the same or have the same mode of action." The primary differences are noted as "the absorbency (lower), the dimensions of the unformed pledget pads, and the dimensions of the final formed pledget."
The "Performance Data" section demonstrates that despite these minor changes, the modified device still meets established safety and biocompatibility standards, specifically citing:
- Cytotoxicity testing
- Acute systemic toxicity testing
- Vaginal irritation testing
- Allergic contact sensitization tests
- Microbial agar diffusion
- Toxic Shock Syndrome Toxin-1 (TSST-1) testing
The conclusion is that based on these results, the modified Playtex tampon is substantially equivalent to the predicate tampons, meaning it is as safe and effective as the legally marketed devices.
§ 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).