(38 days)
Rostam Ltd fragranced plastic applicator tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Rostam plastic applicators are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 5 absorbencies, junior (MINI), regular, slender regular, super and super plus. These Tampons are made from rayon and cotton and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons.
This document describes ROSTAM Ltd Plastic Applicator Fragranced Tampons. Here's an analysis of the provided information concerning acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility and Safety | "Biocompatibility testing and safety evaluations of tampon components was historically carried out. The results of these tests demonstrate that these Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons." |
| Absorbency | "Standard Syngyna testing confirmed the absorbency of these Tampons." |
| Skin Irritation/Sensitization | "Repeated Insult Patch Test, 100 human subjects [conducted]." (Implies the test results were acceptable for safety, though specific performance metrics are not given). |
| Equivalence to Predicate Device | "These Tampons are substantially equivalent to legally marketed Rostam Ltd. tampons with paper applicators." "The material used in these tampons are similar to those used in other legally marketed tampons." |
2. Sample Sizes and Data Provenance
- Test Set (Clinical Testing):
- Sample Size: 100 human subjects for the Repeated Insult Patch Test.
- Data Provenance: Not explicitly stated (e.g., country of origin) but "human subjects" implies prospective clinical testing.
- Training Set: Not applicable. This submission does not involve a machine learning algorithm with a training set.
- Other Testing:
- Biocompatibility and Safety Evaluations: "Historically carried out." No specific sample size or provenance given in this document.
- Syngyna Testing: Confirmed absorbency. This is an in vitro test, so human sample size is not applicable.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. The tests described (biocompatibility, absorbency, patch test) rely on laboratory measurements and clinical observations, not expert consensus for establishing ground truth in the way a diagnostic imaging study would.
4. Adjudication Method for Test Set
Not applicable. The tests described do not lend themselves to an adjudication method typically used for subjective assessments or classifications. The "Repeated Insult Patch Test" involves clinical observation of skin reactions, but an adjudication method for reconciling differing interpretations by experts is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical product (tampon), not a diagnostic imaging or AI-assisted device that would typically involve human readers interpreting cases.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. This device is a physical product, not an algorithm.
7. Type of Ground Truth Used
- Biocompatibility/Safety: Likely based on standardized assays and historical data/toxicological literature.
- Absorbency: Measured objectively using the "Standard Syngyna testing" (an in vitro laboratory method).
- Repeated Insult Patch Test: Clinical observation of skin reactions (e.g., redness, swelling, itching) in human subjects following repeated exposure to the product. The ground truth would be the presence or absence, and severity, of these reactions.
- Overall Equivalence: Based on comparison of materials, design, and performance data (biocompatibility, absorbency) against a legally marketed predicate device.
8. Sample Size for the Training Set
Not applicable. This submission does not involve a machine learning algorithm with a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).