(81 days)
The unscented menstrual tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
The proposed device is a traditional unscented menstrual tampon, and it has two types (i.e. digital tampon and applicator tampon). Each device consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by overwap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. The proposed device is provided in 4 absorbencies: light (≤6g), regular (69g), super (912g) and super plus (12~15g). Each device is individually wrapped and packaged in sealed multi-unit containers for retail sale. And it is provided non-sterile and for single use only.
The provided text describes the 510(k) premarket notification for an Unscented Menstrual Tampon (K222046). It outlines the device's characteristics, its comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document references established guidance documents for menstrual tampons and pads for its performance characteristics. While specific numerical acceptance criteria are not explicitly listed in a consolidated table within the provided text, it states that "All samples met the predefined acceptance criteria" for performance testing.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Performance Testing | Dimensions | Met predefined acceptance criteria |
| Absorbency | Met predefined acceptance criteria | |
| Removal string strength | Met predefined acceptance criteria | |
| Fiber shedding | Met predefined acceptance criteria | |
| Tampon integrity | Met predefined acceptance criteria | |
| Chemical residues | Met predefined acceptance criteria | |
| Biocompatibility Testing | In vitro cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic |
| Skin sensitization (ISO 10993-10:2010) | Non-sensitizing | |
| Vaginal irritation (ISO 10993-10:2010) | Non-irritating | |
| Acute systemic toxicity (ISO 10993-11:2017) (tampon only) | Non-systemically toxic | |
| Microbiology Testing | Enhancement of Staphylococcus aureus growth | Does not enhance growth |
| Increase of Toxic Shock Syndrome Toxin-1 (TSST-1) production | Does not increase production | |
| Alteration of normal vaginal microflora growth | Does not alter growth |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test in the performance, biocompatibility, or microbiology testing. It only mentions "All samples met the predefined acceptance criteria."
The data provenance is from non-clinical testing performed by Suzhou Borage Medical Technology Co., Ltd. in China, or by their designated testing facilities. This is retrospective in the sense that the testing was conducted on manufactured devices for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described study is a non-clinical device performance and safety evaluation for a menstrual tampon. It does not involve establishing ground truth from expert interpretation of data like images or patient outcomes. The "ground truth" here is the objective measurement of physical, chemical, and biological properties according to established standards.
4. Adjudication Method for the Test Set
This is not applicable as the described study is a non-clinical device performance and safety evaluation. Adjudication methods like 2+1 or 3+1 are typically used for expert review of clinical data, not for objective laboratory testing.
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
This is not applicable. The submission is for a physical medical device (unscented menstrual tampon) and does not involve AI or human readers for diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This is not applicable. The submission is for a physical medical device (unscented menstrual tampon) and does not involve any algorithm or AI performance.
7. The Type of Ground Truth Used
The "ground truth" for this study is based on objective measurements and laboratory testing conforming to international standards (ISO 10993 series) and FDA guidance documents specific to menstrual tampons. This includes:
- Physical measurements: Dimensions, absorbency, removal string strength, fiber shedding, tampon integrity.
- Chemical analysis: Chemical residues.
- Biological testing: In vitro cytotoxicity, skin sensitization, vaginal irritation, acute systemic toxicity, and specific microbiological tests for Staphylococcus aureus growth, TSST-1 production, and impact on vaginal microflora.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is a physical device evaluation, not an algorithm or AI development.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
§ 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).