(17 days)
Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
Scented, Unscented menstrual tampons for the absorption of menstrual fluid.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Playtex tampons (K022882):
It is important to note that this 510(k) summary is for a modification to an existing device (Playtex tampons). The change is specifically the "composition of the colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger." Therefore, the studies focus on confirming that these colorant changes do not negatively impact the safety and performance of the tampons, rather than establishing primary efficacy for menstrual fluid absorption.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance | Notes |
|---|---|---|---|
| Biocompatibility | Human sensitization | Meets "all device input requirements" | This suggests that the modified tampons did not induce sensitization in human subjects. The specific threshold or method for "meeting requirements" is not detailed, but generally involves assessing the absence of allergic reactions. |
| Biocompatibility | Dermal irritation | Meets "all device input requirements" | This indicates the modified tampons did not cause significant skin irritation. |
| Biocompatibility | Acute oral toxicity | Meets "all device input requirements" | This is typically assessed to ensure that if accidental ingestion of components occurs, it does not lead to acute toxic effects. Given the product's use, this is likely a safety assessment of any leachables from the colorants. |
| Biocompatibility | Subacute vaginal irritation | Meets "all device input requirements" | This is a crucial test for a vaginal device, confirming the new colorants do not cause irritation to vaginal tissues over a subacute exposure period. |
| Cytotoxicity | Cytotoxicity | Meets "all device input requirements" | This test assesses whether the device materials are harmful to cells. "Meeting requirements" implies no significant cytotoxic effects were observed. |
| Material Safety | Extraction (of colorants/components) | Meets "all device input requirements" | This likely refers to testing the migration or leaching of components (especially the new colorants) from the applicator material into surrounding media, simulating conditions of use, to ensure they remain below safety thresholds. |
| Toxic Shock Syndrome | TSST-1 toxin testing | Meets "all device input requirements" | This is a critical safety test for tampons. It evaluates whether the modified device's materials promote the production of Toxic Shock Syndrome Toxin-1 (TSST-1) by Staphylococcus aureus, which is a known risk associated with tampon use. "Meeting requirements" implies it did not increase TSST-1 production compared to acceptable levels or the predicate device. |
| Technological Equivalence | Fiber, string, materials in contact with vaginal wall | Same or have the same mode of action as cleared tampon | This explicitly states that the core functional components of the tampon (absorbent material, string) were not changed, and their performance is presumed to be equivalent to the predicate device. |
| Technological Equivalence | Applicator barrel and plunger material composition | Difference only in the composition of colorants incorporated into the polyethylene resin | This is the only stated difference from the predicate, confirming that only the non-functional colorants in the applicator changed. |
Study Information Summary
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes for each of the performance tests (human sensitization, dermal irritation, etc.).
- Data Provenance: Not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. However, these types of in vitro and in vivo (animal/human) safety tests are typically prospective studies conducted in a controlled laboratory setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. These tests are laboratory-based scientific assays (e.g., cell cultures for cytotoxicity, animal models for irritation, analytical chemistry for extraction, microbiological assays for TSST-1). "Ground truth" in this context is established by the assay's results against predetermined safety thresholds, not by expert consensus on clinical findings.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective evaluations (e.g., image interpretation). These are objective laboratory tests with pre-defined criteria.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a safety and technological equivalence study for a medical device (tampons), not an AI-assisted diagnostic tool. No human readers or AI are involved in the "interpretation" of results in the way an MRMC study would apply.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device.
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The type of ground truth used:
- The "ground truth" for these studies is based on pre-established scientific safety standards and thresholds for various biological and chemical endpoints (e.g., acceptable levels of irritation, cytotoxicity, extractables, or TSST-1 production). In some cases, it would also involve comparison to the performance of the predicate device.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 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).