(109 days)
The Unscented Menstrual Tampon is inserted into the vagina to absorb menstrual discharge.
The Unscented Menstrual Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 4 absorbencies, light (≤ 6 grams absorbency), regular (6-9 grams), super (9-12 grams) and super plus (12-15 grams). These tampons include a pledget made from viscose and cotton as well as a polyester and polypropylene overwrap. The removal string is made of polypropylene yarn and cotton yarn. The applicator tubes are made of low density polyethylene (LDPE). The assembled tampon with applicator is wrapped in a printed polyethylene wrapper.
This document describes the premarket notification for an "Unscented Menstrual Tampon" (K232598) and states its substantial equivalence to a predicate device. It is important to note that this document is for a medical device (menstrual tampons), not an AI/ML powered device, so the requested information about AI model performance, multi-reader multi-case studies, and ground truth establishment from experts or pathology will not be present.
Based on the provided document, here's what can be extracted regarding acceptance criteria and performance:
The document explicitly states: "The performance tests were conducted to demonstrate the effectiveness of the subject device; all samples met the predefined acceptance criteria."
However, the specific numerical acceptance criteria for each test and the reported device performance are not explicitly detailed in a table format with specific values within this document. Instead, it lists the types of performance characteristics assessed and implies that the device met the criteria.
Here's a breakdown of the requested information based on the provided document, with explanations for what is not applicable or not explicitly stated:
1. A table of acceptance criteria and the reported device performance
While the document states that all acceptance criteria were met, it does not provide a table with specific numerical acceptance criteria and the corresponding reported values for the subject device. It only lists the types of tests performed.
| Performance Characteristic | Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|---|
| Dimensional information | Predefined Acceptance Criteria (Implied numerical ranges based on predicate difference table) | Met predefined acceptance criteria (Implied: Total length (in ready to push position): 106-122.2 mm; Outside diameter (outer tube): 14.5-16.2 mm) |
| Absorbency range (Syngyna method per 21 CFR 801.430) | Predefined Acceptance Criteria (Implied: ≤6g, 6-9g, 9-12g, 12-15g) | Met predefined acceptance criteria |
| Chemical residues | Predefined Acceptance Criteria | Met predefined acceptance criteria |
| Withdrawal cord strength | Predefined Acceptance Criteria | Met predefined acceptance criteria |
| Fiber shedding |
§ 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).