(257 days)
The tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
The SABA® Tampons are traditional unscented menstrual tampons. The SABA® Tampons are available either with a single use applicator or as a digital tampon (without an applicator). Except for the inclusion of the applicator, both types of tampons are made of the same materials. Each device consists of a tampon, including a 100% viscose pledget ("absorbent core") surrounded by a non-woven fabric cover blend of polyethylene and polyester, a removal cord of 67% polyester/33% viscose, and an applicator (only for the applicator tampon). The applicator is made of an inner tube of high-density polypropylene and an external tube of low-density polyethylene, both with 5% pink pigment. The applicator has a smooth, rounded tip to ease insertion.
Both the applicator and applicator free SABA® Tampons are provided in three absorbencies of regular (6-9g), super (9-12g), and super plus (12-15g). Each device is individually wrapped in a metallized printed bi-oriented polypropylene lamination and packaged in sealed multi-unit containers for retail sale. It is provided non-sterile and for single use only.
This document is a 510(k) clearance letter for SABA® Tampons, a type of menstrual tampon. The provided text does not contain any information about acceptance criteria or study data related to an AI/ML medical device.
The document details the substantial equivalence of the SABA® Tampons to a predicate device (K231341) based on non-clinical performance data, biocompatibility, microbiology testing, and shelf-life testing specific to tampons. It explicitly states:
- "No clinical studies are included in this submission."
- "This device does not include any use of software."
- "The device does not have any electrical source so no electrical safety or EMC testing are included in this submission."
- "No animal studies are included in this submission."
Therefore, it is impossible to describe acceptance criteria or a study proving device performance for an AI/ML medical device based on the provided text. The request's premise about AI/ML device evaluation is not applicable to the SABA® Tampons 510(k) 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).