(168 days)
Sequel tampon with plastic applicator is an unscented tampon provided with a plastic applicator used for easing the placement of the tampon correctly into the vagina. The Sequel tampon is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
The Sequel Tampon with Plastic applicator are menstrual tampons used to absorb menstrual fluid. These Tampons are available in Regular absorbency (6-9 grams). These Tampons are made from rayon fibers and a polyethylene/polyester overwrap in which a cotton/polyester withdrawal cord is inserted. The applicator is a compact style polyethylene applicator with cylindrical barrel with a plunger. The assembled tampon with applicator is wrapped in a printed polypropylene wrapper. The tampon and applicator are single-use and non-sterile.
This document describes the premarket notification (510(k)) for the Sequel Tampon with Plastic applicator. It is a Class II device, regulated under 21 CFR § 884.5470 (Unscented menstrual tampon), with product code HEB. The predicate device is the "Interlude and Private Label Unscented 3-piece compact applicator tampon (K173225)."
The document focuses on demonstrating substantial equivalence to the predicate device, primarily through performance testing and comparison of technological characteristics. This document describes a medical device clearance, not a digital health/AI product. Therefore, the questions related to AI/MRMC studies, expert ground truth, and training sets are not applicable.
Here's an analysis based on the provided text, addressing the points where applicable:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table in the way one would for a quantifiable performance claim (e.g., sensitivity/specificity for a diagnostic device). Instead, it lists performance characteristics assessed according to FDA guidance documents for menstrual tampons. The "reported device performance" is a statement that the device met these criteria.
| Performance Characteristic (Acceptance Criteria Implicitly Met) | Reported Device Performance | Relevant Guidance Document |
|---|---|---|
| Biocompatibility: | The tampon is not cytotoxic, non-sensitizing, non-irritating, and does not have acute systemic toxicity. The applicator's biocompatibility was previously cleared. | ISO 10993-1 (2018), 2020 FDA guidance document "Use of International Standard ISO 10993-1" |
| Cytotoxicity (ISO 10993-5:2009/(R)2014) | Met | |
| Sensitization (ISO 10993-10:2021) | Met | |
| Vaginal Irritation (ISO 10993-23:2021) | Met | |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Met | |
| Performance Characteristics: | 2005 FDA guidance document "Menstrual Tampons and Pads: Information for Premarket Notification Submission (510(k)s) - Guidance for Industry and FDA Staff" | |
| Tampon Absorbency via Syngyna testing, per 21 CFR 801.430 | Met | |
| Assessment of Chemical Residues | Met | |
| String Strength | Met | |
| Fiber Shedding | Met | |
| Tampon Integrity | Met | |
| Microbial Testing (does not enhance S. aureus growth) | Met | |
| Microbial Testing (does not increase TSST-1 production) | Met | |
| Microbial Testing (does not alter normal vaginal microflora) | Met |
2. Sample size used for the test set and the data provenance
The document does not specify quantitative sample sizes for each test (e.g., number of tampons tested for absorbency, or number of biological samples for biocompatibility). It simply states that "The test results show the tampon..." met the criteria.
Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned, as these are primarily laboratory-based performance and biocompatibility tests rather than clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device clearance based on laboratory and material performance testing, not on expert-adjudicated clinical ground truth like an AI diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no clinical test set requiring adjudication in the context of this 510(k) submission.
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
Not applicable. This is a physical medical device (tampon), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by standardized laboratory methods and biocompatibility assays, as deemed appropriate by the FDA guidance documents for menstrual tampons. For example:
- Absorbency: Measured according to 21 CFR 801.430.
- Biocompatibility: Assessed using ISO 10993 standards and established toxicological endpoints.
- Microbial Testing: Standardized tests for growth of Staphylococcus aureus, TSST-1 production, and impact on vaginal microflora.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
§ 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).