(285 days)
The Rael Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Rael Tampon will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.
The provided text is a 510(k) Summary for the Rael Tampon. Since this is a submission for a medical device (tampon), the "device" in question is not an AI/ML imaging device, but rather a physical product. Therefore, many of the requested points related to AI/ML device studies (such as MRMC studies, training set details, and expert adjudication of ground truth for AI performance) are not applicable.
However, I can extract the relevant information regarding acceptance criteria and performance testing for the Rael Tampon as a physical medical device.
Acceptance Criteria and Device Performance for Rael Tampon
The Rael Tampon is being submitted for substantial equivalence to a predicate device (Tosama 100% Organic Cotton Menstrual Tampon, K151170). The acceptance criteria are based on meeting established standards and guidance documents for menstrual tampons. The study confirming these criteria is a non-clinical performance testing and biocompatibility testing program.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document states that the results "met the requirements" or demonstrate "comparable" characteristics, but does not provide specific numerical outcomes for every test beyond the absorbency ranges and dimensions presented in the comparison table.
| Acceptance Criteria Category | Specific Acceptance Criteria (based on FDA Guidance / ISO Standards) | Device Performance (Rael Tampon) |
|---|---|---|
| Physical Dimensions | Dimensions within acceptable ranges (e.g., comparable to predicate). | - Regular Pledget Length: 38 mm |
- Super Pledget Length: 47 mm
- Regular Pledget Diameter: 12 mm
- Super Pledget Diameter: 12 mm
- Regular Applicator Inner Length: 73 ± 5% mm
- Super Applicator Inner Length: 73 ± 5% mm
- Regular Applicator Outer Length: 76.5 ± 5% mm
- Super Applicator Outer Length: 76.5 ± 5% mm
- Regular Applicator Inner Diameter: 11.8 ± 5% mm
- Super Applicator Inner Diameter: 11.8 ± 5% mm
- Regular Applicator Outer Diameter: 14.1 ± 5% mm
- Super Applicator Outer Diameter: 14.1 ± 5% mm (All comparable to predicate) |
| Absorbency Range (Syngyna Test) | Absorbency within specified ranges for "Regular" and "Super" categories. | - Regular: 6.0 - 9.0 grams - Super: 9.0 - 12.0 grams (Comparable to predicate) |
| Chemical Residues | Levels of chemical residues within acceptable safety limits. | Met the requirements of "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff". |
| Withdrawal Cord Strength | Cord strength sufficient for safe removal. | Met the requirements of "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff". |
| Fiber Shedding | Minimal fiber shedding to ensure safety and integrity. | Met the requirements of "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff". |
| Tampon Integrity | Tampon maintains structural integrity during use. | Met the requirements of "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff". |
| Biocompatibility (ISO 10993) | - Absence of cytotoxicity (ISO 10993-5) - No sensitization (ISO 10993-10)
- No vaginal irritation (ISO 10993-10)
- Absence of acute systemic toxicity (ISO 10993-11) | Results met the requirements of the ISO standards for all categories. |
| Microbiology Testing (FDA Guidance) | - No enhancement of Staphylococcus aureus growth - No increase in Toxic Shock Syndrome Toxin-1 (TSST-1) production
- No alteration of normal vaginal microflora growth | Demonstrated to meet these criteria as per the 2005 FDA guidance document. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of tampons tested for absorbency, strength, etc.). However, it indicates that "the subject tampons and applicators" were used, implying a representative sample was tested.
Data Provenance: The tests were conducted specifically for the Rael Tampon as part of its premarket notification. The location of the testing laboratories is not specified in this summary, but it would be expected to adhere to international standards (e.g., ISO, FDA guidance) which are generally applied globally. The studies are prospective in the sense that they were performed specifically for this submission to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. For a physical medical device like a tampon, ground truth is established by objective laboratory testing against defined physical, chemical, and biological endpoints (e.g., weight, length, absorbed volume, chemical concentration, microbial growth in cultures). It does not involve expert interpretation or consensus in the way AI/ML diagnostic tools do.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods (like 2+1, 3+1) are for human interpretation of data, typically in diagnostic assessments. For laboratory testing of a physical product, the results are typically quantitative measurements or qualitative observations directly tied to predefined pass/fail criteria, not subject to human expert adjudication in the same manner.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are specific to AI/ML diagnostic tools where multiple human readers interpret cases, often with and without AI assistance, to assess the impact of the AI on human performance. This is not relevant for a physical device like a tampon.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable. This question pertains to the performance of an AI algorithm in isolation. The Rael Tampon is a physical product, not an algorithm. The performance testing conducted was "standalone" in the sense that it measured the inherent properties and safety of the tampon itself, independent of human interaction beyond normal use.
7. The Type of Ground Truth Used
The ground truth for the Rael Tampon's performance is based on objective measurements, standardized test protocols, and established safety limits defined by:
- Physical specifications (e.g., dimensions, absorbency ranges).
- Chemical safety standards (e.g., residue limits).
- Biocompatibility standards (e.g., ISO 10993 for cytotoxicity, sensitization, irritation, systemic toxicity).
- Microbiological safety criteria (e.g., impact on S. aureus growth, TSST-1 production, vaginal microflora).
These "ground truths" are derived from scientific and regulatory consensus on what constitutes a safe and effective menstrual tampon.
8. The Sample Size for the Training Set
Not Applicable. The concept of a "training set" applies to machine learning algorithms. The Rael Tampon is a manufactured product; it does not have a training set in this context. The manufacturing process is guided by design specifications and quality control, not by training data.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for this physical device, there is no ground truth needing to be established for it.
§ 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).