(148 days)
The Lil-lets tampons (both types) are unscented tampons for:
• Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge.
• The plastic applicator is for easing the placement of the tampon correctly into the vagina (only the Lil-lets Silk Comfort Compact Plastic Applicator Tampon).
Lil-lets tampons are used to absorb menstrual fluid. Lil-lets series tampons come with a plastic applicator and without a plastic applicator in sizes: Lite, Regular, Super, Super plus and Ultra. Lil-lets tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
The provided 510(k) summary (K120481) for the Lil-lets Silk Comfort Compact Plastic Applicator Tampon & Lil-lets Non-Applicator Tampon describes pre-clinical testing to demonstrate substantial equivalence to a predicate device, MAXIM Plastic Applicator and Non Applicator Tampons (K080775). However, it does not contain a comprehensive study proving that the device meets specific acceptance criteria in the manner typically described for clinical studies of new medical devices with defined performance metrics, patient populations, and statistical analysis.
Instead, the summary focuses on non-clinical tests to ensure safety and equivalence based on existing standards and knowledge of the predicate device. The "acceptance criteria" are implied by adherence to these standards and by demonstrating that the Lil-lets tampons do not present new questions of safety or effectiveness.
Here's a breakdown of the information based on the provided text, using the requested format where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Substantial equivalence to predicate's materials (MAXIM Plastic Applicator and Non Applicator Tampons, K080775). | "No additional testing was necessary because the materials of Lil-lets tampons are substantially equivalent to MAXIM Plastic Applicator and Non Applicator Tampons, K080775." |
| Microbiology Tests | - Enhance the growth of Staphylococcus aureus (Zone of inhibition) |
- Alter the growth of normal vaginal microflora (Zone of inhibition)
- Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1) | (Not explicitly stated as "met" or specific results, but the submission implies these were assessed and deemed acceptable for substantial equivalence. The overall conclusion states substantial equivalence.) |
| Syngyna Testing | Adherence to 21 CFR 801.430(f)(2) to verify absorbency ranges as specified in the regulation. Tampons must be labeled in accordance with required ranges. | "Syngyna testing was conducted in accordance to 21 CFR 801.430(f)(2) to verify that the subject tampons met absorbency ranges as specified in the regulation. The tampons are labeled in accordance to required ranges." (This directly states the criteria were met.) |
| Physical and Chemical Tests | Internal methods for: - Fibre loss test
- Stability of digital tampons
- Withdrawal cord attachment test
- Expulsion force of applicator tampons | (Not explicitly stated as "met" or specific results, but the submission implies these were assessed and deemed acceptable for substantial equivalence. The overall conclusion states substantial equivalence.) |
| Technological Characteristics | No differences from the technical characteristics of the substantially equivalent predicate devices (MAXIM tampons under K080775), differing only in dimensions across sizes (Lite, Regular, Super, Super plus, Ultra). The tampons contain commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. | "There are no differences between the technical characteristics of the Lil-lets tampons and the predicate characteristics of the substantially equivalent devices MAXIM tampons under K080775. All sizes... have the same characteristics; they differ only in dimensions." |
Detailed Study Information:
This document is a 510(k) summary focused on demonstrating substantial equivalence for tampons, not a report of a traditional clinical performance study for a novel device. Therefore, many of the requested points do not apply or are not explicitly detailed in the provided text, as the regulatory pathway chosen (510(k)) relies heavily on comparing technical and safety characteristics to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify general "test set" sample sizes or data provenance in the context of a clinical study.
- For Syngyna testing, it states "Syngyna testing was conducted," but does not provide the number of tampons tested. This is a bench test performed in a lab, not on human subjects.
- For Microbiology and Physical/Chemical tests, no sample sizes are provided for individual tests.
- Data provenance for these non-clinical tests would likely be the manufacturing site or a contract lab performing the tests, which is in Slovenia, given the submitter's address.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable in this context. "Ground truth" in the sense of expert consensus for diagnostic performance is not relevant to non-clinical tests of tampon safety and absorbency. Expertise is implied by adherence to regulatory standards and testing methodologies by competent personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for clinical studies involving human interpretation or challenging outcomes.
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 device is a tampon, not an AI-assisted diagnostic tool or an imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (tampon), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for these non-clinical tests would be the established regulatory standards and validated test methodologies themselves (e.g., 21 CFR 801.430(f)(2) for absorbency, specific microbiological assays, internal physical testing protocols).
- For biocompatibility, the ground truth is the accepted safety profile of the predicate device's materials.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of such a device and its regulatory submission.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).