(88 days)
Every Cycle™ Reusable Tampon Applicator is intended to be used to insert a digital menstrual tampon into the vagina.
The Every Cycle™ Reusable Tampon Applicator is a non-sterile, single user reusable device. It is intended to be sold on its own, without a pre-loaded tampon. The applicator requires the user to load the applicator with a legally-marketed digital/non-applicator menstrual tampon. The use-life of the subject device is two years. The applicator is comprised of a barrel with a slit, plunger, large (outer) cap, storage compartment, and a small cap.
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them in the format requested.
Here's why:
- No specific acceptance criteria values: The document lists "performance data" such as "Use-life testing," "Device weight," "Dimensions," and "Functional evaluation (Tampon compatibility, Ejection force, Uncapping force)." However, it does not provide quantitative acceptance criteria for these parameters (e.g., "ejection force must be between X and Y Newtons," or "device weight must be less than Z grams"). It simply states that the tests "demonstrate that the proposed subject device met the applicable design and performance requirements."
- No reported device performance values: Similarly, while it states what was tested, it doesn't report the actual measured performance values for the Every Cycle™ Reusable Tampon Applicator (e.g., what was the measured ejection force, what was the actual device weight, what dimensions were measured).
- Study details are missing: The document mentions "Use-life testing," "Functional evaluation," and "Biocompatibility" as tests performed, but it lacks the detailed methodology, sample sizes, ground truth establishment, expert involvement, or adjudication methods typically found in a clinical study report. It only broadly refers to "applicable design and performance requirements" and "2020 FDA guidance document 'Use of International Standard ISO 10993-1'" and "2015 FDA guidance document 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'" for biocompatibility and cleaning instructions, respectively.
- The device is an applicator, not an AI/diagnostic device: The questions about "test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "ground truth type," and "training set" are highly relevant for AI/diagnostic devices. The Every Cycle™ Reusable Tampon Applicator is a physical device used to insert a tampon, not a device that generates diagnostic output or uses algorithms in a way that would require these types of evaluations. Therefore, these questions are not applicable to the information provided.
In summary, the provided document is an FDA 510(k) clearance letter and summary, which confirms substantial equivalence to a predicate device based on various performance and biocompatibility tests. It broadly states that the device met requirements but does not detail the specific quantitative acceptance criteria or the full study reports with raw data and methodology for a device of this nature.
§ 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).