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510(k) Data Aggregation
COHITECH Cottonlock Tampons with Reusable Applicator are inserted into the vagina and used to absorb menstrual fluid.
The subject device is an unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), completely surrounded by an organic cotton cover ("security veil") and with an organic cotton string ("withdrawal cord"). These tampons will be provided on three absorbencies: regular (6-9g), super (9-12g) and super plus (12-15g). Each COHITECH Cottonlock tampon is individual wrapped in a cellulose paper along with the reusable applicator in its carrying case and packaqed in a sealed multi-unit cardboard containers for retail sale. The subject device deals with inclusion of a reusable tampon applicator, cleared under K212479, to the packaging of tampons cleared under K211775.
The provided text is a 510(k) Premarket Notification from the FDA regarding a menstrual tampon with a reusable applicator. It details the device, its intended use, and its comparison to predicate and reference devices to establish substantial equivalence.
Based on the content, this document does not describe an AI/ML-driven medical device. Therefore, a study proving an AI/ML device meets acceptance criteria, an MRMC study, or details about training and test sets, and ground truth establishment for an AI/ML model are not applicable to this document.
The document discusses the substantial equivalence of the COHITECH Cottonlock Tampons with Reusable Applicator to previously cleared devices (K211775 and K212479). The "acceptance criteria" in this context refer to the demonstration of this substantial equivalence through non-clinical testing.
Here's a breakdown of the relevant information provided, adapted to the context of a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are implicitly meeting the performance characteristics of the predicate device and the reference reusable applicator, as well as adherence to relevant FDA guidance documents. The "device performance" is based on non-clinical testing and leveraging prior clearances.
| Acceptance Criteria (Implicit) | Reported Device Performance (Demonstrated by Substantial Equivalence) |
|---|---|
| Functional Equivalence: Device performs the same intended use as predicate. | COHITECH Cottonlock Tampons with Reusable Applicator are inserted into the vagina and used to absorb menstrual fluid, which is identical to the indications for use of the predicate tampon (K211775). The reusable applicator is identical to the one cleared under K212479. |
| Material Equivalence: Materials are same as predicate/reference devices. | Tampon: 100% organic cotton (same as K211775). Withdrawal Cord: 100% organic cotton (same as K211775). Cover Material: 100% organic cotton (same as K211775). Applicator Material: Polyethylene (same as K212479). |
| Absorbency Equivalence: Tampon absorbency within defined ranges. | Regular: 6-9g; Super: 9-12g; Super Plus: 12-15g (same absorbency ranges as K211775). |
| Safety (Biocompatibility): Materials are safe for intended use. | The sponsor provided a statement certifying no changes to the tampons or applicator from their cleared versions. Therefore, new biocompatibility testing (per 2020 FDA guidance ISO 10993-1) was not considered necessary as the previously cleared components meet this criteria. |
| Performance (Bench Testing): Device performs as expected based on physical characteristics. | The sponsor leveraged testing on the K211775 tampons and K212479 reusable applicators. "Tampon compatibility testing" was performed, as per K212479. No new bench testing (per 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)") was deemed necessary due to the components being identical to previously cleared versions. |
| Reprocessing Effectiveness (for reusable components): Reusable applicator can be reprocessed safely and effectively. | No new reprocessing testing (per 2015 FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling") was deemed necessary as the reusable applicator is identical to the previously cleared version (K212479) which would have demonstrated reprocessing effectiveness. |
| Technological Characteristics: Differences do not raise new questions of safety or effectiveness. | The only technological difference is the packaging of the existing tampons with the existing reusable applicator. This difference was found not to raise new questions of safety and effectiveness. |
| Absence of Design-Related Recall: Predicate and reference devices have not been subject to design-related recalls. | Neither the predicate (K211775) nor the reference (K212479) device have been subject to a design-related recall, indicating their established safety and effectiveness. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML model. Instead, it refers to leveraging "testing on the K211775 tampons and K212479 reusable applicators." This implies that the testing performed for the original clearances of these components serves as the basis for the current submission. The data provenance would be from Cotton High Tech, S.L. and would typically be prospective non-clinical testing. Specific sample sizes for the absorbed fluid, biocompatibility, or other physical/chemical tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is not an AI/ML device requiring expert adjudication for a test set.
4. Adjudication method for the test set
Not applicable.
5. 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on:
- Established industry standards and regulatory guidance: Such as those for tampon absorbency testing, biocompatibility, and reprocessing.
- Prior successful clearances: The fact that K211775 (tampons) and K212479 (reusable applicator) were independently cleared by the FDA implies that their safety and effectiveness characteristics (their "ground truth" for performance) were established during their respective review processes. The current submission leverages this existing "ground truth."
- Bench testing: Though not detailed, "tampon compatibility testing" implies physical testing to ensure the applicator and tampon work correctly together.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
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