(20 days)
First Quality Hygienic, Inc. Femtex and Private Label Scented Plastic Applicator tampons are a menstrual tampon that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Femtex and Private Label Scented Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid, with fragrance added for aesthetic purposes. The tampons will be provided in five (5) styles/absorbencies: Light, Slender Regular, Regular, Super and Super Plus with a plastic applicator. Femtex and Private Label Scented Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread, and added fragrance.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Femtex and Private Label Scented Plastic Applicator Tampons:
It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel device performance. As such, many of the typical clinical study elements you've requested (like sample sizes for test sets, expert ground truth, MRMC studies, etc.) are not applicable or not present in these types of submissions.
The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing performed to show the device's safety and performance equivalence to existing tampons.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments / Context from Document |
|---|---|---|
| Biocompatibility: Device materials are safe for human contact (non-irritating, non-cytotoxic, non-sensitizing). | All tested components demonstrated acceptable biocompatibility. Results "demonstrate that the tampons are equivalent in terms of safety and effectiveness to legally marketed tampons." | Specific tests performed: irritation testing, cytotoxicity testing, sensitization testing, vaginal irritation testing. These tests confirm the materials used in the tampon (rayon, cotton, fragrance) are suitable for their intended use and do not pose undue biological risks. |
| Absorbency: Tampons meet "Standard Syngyna" absorbency requirements for stated absorbency levels (Light, Regular, Super, Super Plus). | "Standard Syngyna testing confirmed the absorbency of these tampons." | This is a standard in vitro test method for tampon absorbency. The document implies that the absorbency of the various tampon styles/absorbencies met the established limits or were comparable to predicate devices. |
| Substantial Equivalence: The device is as safe and effective as a legally marketed predicate device (K032173). | The FDA determined the device is "substantially equivalent" to the predicate device. | This is the overarching "acceptance criterion" for a 510(k) submission. The non-clinical tests (biocompatibility, absorbency) are submitted as evidence to support this claim. |
Further Details on the "Study" (Non-Clinical Testing)
The document refers to non-clinical testing rather than a traditional clinical study.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the non-clinical tests. These tests typically use laboratory samples of materials or finished products, not human subjects.
- Data Provenance: Not explicitly stated, but it would be laboratory testing data, presumably conducted in the United States or by a qualified lab following international standards. It is retrospective in the sense that the testing was performed on manufactured components/products, not on prospective human cohorts.
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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. For non-clinical tests like biocompatibility and Syngyna absorbency, "ground truth" is established by standard laboratory protocols and measurements, not by expert consensus on individual cases. The interpretation of the results would be done by qualified toxicologists or laboratory personnel.
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Adjudication method for the test set:
- Not Applicable. This concept applies to human reader studies or clinical trials where discordant interpretations might need resolution. Non-clinical lab tests have defined pass/fail criteria.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is a non-clinical device, not an imaging or diagnostic AI device.
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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 or AI device.
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The type of ground truth used:
- Laboratory Standard Results/Measurements: For biocompatibility, the ground truth is established by the outcome of standard toxicology assays (e.g., cell viability in cytotoxicity, animal skin reactions in irritation/sensitization). For absorbency, it's the measured fluid uptake compared to established Syngyna test standards.
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The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an artificial intelligence/machine learning device. The non-clinical tests are performed on the device or its components directly.
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How the ground truth for the training set was established:
- Not Applicable. (As above, no training set).
In summary: The provided 510(k) summary focuses on demonstrating that Femtex and Private Label Scented Plastic Applicator Tampons are substantially equivalent to existing, legally marketed tampons based on standard non-clinical safety (biocompatibility) and performance (absorbency) testing. It explicitly states "Assessment of Performance Standards: Not Applicable" in the summary because it's a predicate-based submission, not a novel device requiring new performance standards to be met. The "study" here is rigorous laboratory testing to confirm material safety and functional absorbency according to established industry and regulatory norms, rather than a clinical trial with human subjects.
§ 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).