(85 days)
o.b.® Applicator Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons.
o.b. applicator tampons are used to absorb mentrual fluid or other vaginal discharge.
o.b.® Applicator Tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies.
o.b.® Applicator Tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
The applicator consists of a cardboard laminate with a coating.
This document describes the premarket notification (510(k)) for the o.b.® Applicator Tampon, focusing on its substantial equivalence to an already marketed device. The changes relate to the applicator coating, not the tampon itself.
Here's an analysis of the provided text in the context of your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity Test | Demonstrated equivalence to legally marketed tampons. |
| Vaginal Irritation in Rabbits | Demonstrated equivalence to legally marketed tampons. |
| Microbiological Testing: | Demonstrated equivalence to legally marketed tampons. |
| Human Dermal Safety: | |
| Lack of potential for human dermal irritation | Confirmed by Repeat Insult Patch Test. |
| Lack of potential for human dermal sensitization | Confirmed by Repeat Insult Patch Test. |
| Overall Conclusion: Safety of modified applicator comparable to current legally marketed, commercial applicator tampons. | Overall Conclusion: Results of non-clinical and clinical testing indicate that the safety of modified applicator is comparable to current legally marketed, commercial applicator tampons. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Non-clinical testing: Not explicitly stated how many samples were used for cytotoxicity, vaginal irritation, and microbiological testing. It only mentions extracts of the coated applicator were tested.
- Clinical testing (Repeat Insult Patch Test): The sample size for this human study is not specified in the provided document.
- Data Provenance: Not specified. Given the manufacturer (Personal Products Company, Skillman, NJ), the testing was likely conducted in the USA or a region adhering to similar regulatory standards, but this is an inference, not explicit in the text. The type of study is a premarket approval study for a medical device modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this type of submission. This 510(k) is comparing a modified device to a predicate device based on specific non-clinical and clinical tests, not evaluating interpretations by human experts or establishing a "ground truth" for diagnostic purposes. The "ground truth" here is the safety of the materials as determined by established scientific laboratory and human safety testing protocols.
4. Adjudication Method for the Test Set
- Not applicable. As above, this submission does not involve adjudication of expert readings or diagnoses. The "adjudication" is essentially the FDA's review and concurrence with the testing results presented by the manufacturer.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not a diagnostic device or an AI-based system, so an MRMC study is not relevant to this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This is a physical medical device (tampon applicator), not an algorithm or AI system.
7. The Type of Ground Truth Used
- The ground truth used here is based on scientific laboratory test results (biocompatibility, microbiological) and human safety study outcomes (dermal irritation/sensitization). The "ground truth" is that the modified material is safe and comparable to the predicate device, as evidenced by these tests.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device. There is no "training set" in the context of an AI/ML algorithm. The "training" for the device design would be based on general scientific and engineering principles and prior knowledge about materials used in similar devices.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As mentioned, there is no "training set" in the AI/ML sense. The "ground truth" for the development of medical devices generally relies on established scientific literature, regulatory standards, and previous experience with similar materials and designs. Any modifications are then rigorously tested against these established safety and performance benchmarks.
In summary, the provided document details a 510(k) summary for a modified tampon applicator. The focus is on demonstrating substantial equivalence to a predicate device through non-clinical biocompatibility and microbiological testing, and a clinical (human) patch test for dermal safety. It does not involve AI, diagnostic accuracy, or expert consensus on interpretations, which explains why many of your questions are not applicable to this specific submission.
§ 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).