(135 days)
COHITECH Organic Cotton Non-Applicator Cottonlock Tampons (light, regular, super, and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.
The subject device is a conventional unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), completely surrounded by an organic cotton cover ("security veil") and with an organic cotton string ("withdrawal cord"). These tampons will be provided on four absorbencies: light (6g and under), regular (6-9g), super (9-12g) and super plus (12-15g). Each organic cotton non-applicator Cottonlock tampon is wrapped in a cellulose paper individual wrapper and packaged in sealed multi-unit containers for retail sale.
The provided text describes the 510(k) summary for the COHITECH Organic Cotton Non-Applicator Cottonlock Tampons, which is a menstrual tampon. The document details studies performed to demonstrate substantial equivalence to a predicate device, focusing on non-clinical data. It does not describe an AI/ML powered device, therefore no AI-specific acceptance criteria or studies are mentioned.
Here's the information as requested, adapted to what is available in the document:
1. Table of Acceptance Criteria (Performance Standards) and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Standard/Guidance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5:2009 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Vaginal Irritation | ISO 10993-10:2010 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Delayed Hypersensitivity | ISO 10993-10:2010 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Physical/Chemical Testing | ||
| Absorbency | Syngyna testing per 21 CFR 801.430(f)(2) | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Chemical Residues | FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Tampon Integrity | FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| String Strength | FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Fiber Shedding | FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Dimensional Analysis | FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005 | Acceptable (Implied by "results of the non-clinical testing were acceptable") |
| Preclinical Microbiology | ||
| S. aureus growth | Not enhance the growth of Staphylococcus aureus (FDA Guidance: 2005) | Does not enhance growth (Implied by "results of the non-clinical testing were acceptable") |
| TSST-1 production | Not increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1) (FDA Guidance: 2005) | Does not increase production (Implied by "results of the non-clinical testing were acceptable") |
| Vaginal microflora | Not alter the growth of the normal vaginal microflora (FDA Guidance: 2005) | Does not alter growth (Implied by "results of the non-clinical testing were acceptable") |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. It refers to "Biocompatibility studies" and "Preclinical microbiology" without providing the number of samples or specimens used in these tests. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated, but the studies were performed "in accordance with the 2020 FDA guidance... and standard ISO 10993-1" and "Guidance for Industry and FDA Staff - Menstrual Tampons and Pads... 2005," implying they were conducted as part of the regulatory submission process, likely prospectively for the purpose of this submission. The manufacturer is based in Spain, so it's plausible the testing involved European labs, but this is not confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and is not provided. The studies outlined are laboratory tests and measurements against established physical, chemical, and biological standards, not diagnostic assessments requiring expert interpretation of "truth."
4. Adjudication method for the test set
Not applicable. The tests are scientific measurements and biological assays, not interpretations requiring adjudication by experts.
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. The device is a menstrual tampon, not an AI-powered diagnostic or screening tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a menstrual tampon, not an AI-powered algorithm.
7. The type of ground truth used
The ground truth used for this device's evaluation is based on established physical, chemical, and biological performance standards and regulatory guidance. These include:
- ISO 10993 series for biocompatibility (e.g., Cytotoxicity, Vaginal Irritation, Delayed Hypersensitivity, Acute Systemic Toxicity).
- 21 CFR 801.430(f)(2) for absorbency (Syngyna testing).
- FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads (2005) for other performance characteristics like chemical residues, tampon integrity, string strength, fiber shedding, dimensional analysis, and preclinical microbiology regarding Staphylococcus aureus growth, TSST-1 production, and impact on vaginal microflora.
8. The sample size for the training set
Not applicable. The device is a menstrual tampon and does not involve AI/ML requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML training set for this 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).