(59 days)
For use as a form of feminine protection, commonly employed to collect blood, help prevent leakage and to prevent staining and spotting of clothing.
Not Found
While the provided text is an FDA 510(k) clearance letter for the INSTEAD Softcup, it does not contain the detailed clinical study information required to answer your specific questions about acceptance criteria and study findings.
FDA 510(k) clearances determine substantial equivalence to a predicate device, which often relies on demonstrating similar performance characteristics, but the submission itself is a separate document that would contain the detailed study results. The letter only states that the device is "substantially equivalent" to previously marketed devices.
Therefore, I cannot provide the requested information from the given text.
To answer your request, I would need to analyze the underlying 510(k) summary document or the full 510(k) submission, which is not included in the provided snippets.
If you were to provide a document that describes the clinical performance and testing conducted for the INSTEAD Softcup, I could attempt to extract the requested information.
§ 884.5400 Menstrual cup.
(a)
Identification. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.