(136 days)
The Rostam Fragranced and Unfragranced Compact Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge
Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, Light, regular and super. These Tampons are made from rayon and/or cotton polymeric overwrap and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons.
The provided text is for a 510(k) summary for a medical device (tampons). The purpose of a 510(k) summary is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to detail comprehensive device-specific performance studies with specific acceptance criteria and detailed study designs as might be found for novel, higher-risk devices.
Based on the provided text, here's what can be extracted regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility/Safety Equivalence | Demonstrated that tampons are equivalent in terms of safety and effectiveness to legally marketed tampons based on historical testing and review of existing toxicological data. |
| Absorbency | Confirmed by Standard Syngyna testing. |
| Irritation/Sensitization | Repeated Insult Patch Test on 100 human subjects showed acceptable results (implied by overall safety claim). |
2. Sample Size Used for the Test Set and Data Provenance:
- Repeated Insult Patch Test: 100 human subjects.
- Data Provenance: Not explicitly stated for all tests, but "review of existing toxicological data in the public literature" suggests some data is retrospective and potentially sourced broadly. The human patch test is prospective. No country of origin is specified.
- Syngyna Testing: No explicit sample size specified, as it's a standardized in vitro test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not mention experts being used to establish "ground truth" in the context of diagnostic performance or clinical outcomes. The assessments are primarily for safety and absorbency, which are typically evaluated by laboratory analysis or clinical safety studies, not expert consensus on ground truth in a diagnostic sense. For the patch test, the evaluation would be performed by trained dermatologists or clinicians, but the number is not specified.
4. Adjudication Method for the Test Set:
- Not applicable/Not mentioned. Adjudication methods are typically relevant for studies where multiple readers assess cases against a predefined ground truth, which is not the primary focus here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is not relevant for tampons, as they are not diagnostic devices that involve human readers interpreting results.
6. Standalone Performance Study (Algorithm Only):
- No. This is not applicable. Tampons are not an algorithm-based device.
7. Type of Ground Truth Used:
- Biocompatibility/Safety: Historical testing data, literature review, and direct results (e.g., lack of significant skin reactions in the patch test).
- Absorbency: Standardized laboratory measurements (Syngyna test) which serve as the "ground truth" for absorbency.
8. Sample Size for the Training Set:
- Not applicable. As this device is not an AI/ML diagnostic or image interpretation device, there is no "training set." The reference to "historical data" and "public literature" for safety serves a similar purpose to a knowledge base, but not a supervised machine learning training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set as defined in an AI/ML context.
Summary of Approach:
The K096671 submission for Rostam tampons primarily relies on demonstrating substantial equivalence to a previously legally marketed device (Tampax Compak Pearl Scented and unscented Tampons). This means the focus is on showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
The "studies" mentioned (Biocompatibility testing, Syngyna testing, Repeated Insult Patch Test) are primarily to confirm the safety and functional performance (absorbency) in a manner consistent with established standards for tampons and to demonstrate they meet the safety profile of predicate devices. The phrase "these Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons" is the overarching "acceptance criterion" met by the provided test results.
§ 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).