(247 days)
The Roll wadding plastic Applicator Compact size Unscented Tampons are inserted into the vagina to absorb menstrual discharge.
The Roll wadding plastic Applicator Compact size Unscented Tampon is a menstrual tampon. These tampons are unscented tampons it means without any perfume. These tampons are made from viscose material and polymeric overwrap. The withdrawal cord is made from polyester and cotton. These tampons have an applicator. The applicator is made from plastic (polyethylene). . The applicator is in a compact size meaning that the inner tube and the outer tube are slided into each other telescopically so the inner tube needs to be retracted before usage. These tampons have a Roll wadding form. In a roll tampon, the fleece band is folded and then rolled (like a Swiss roll) before being radially pressed. The Roll wadding plastic Applicator Compact size Unscented Tampon is available in 3 absorbencies: regular, super plus absorbency (regular (6-9g), super (9-12g), and super plus (12-15g)).
This document describes a 510(k) summary for the "ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS." The submission aims to demonstrate substantial equivalence to a previously cleared predicate device rather than presenting a novel device requiring extensive clinical trials for effectiveness. Therefore, the provided text focuses on conformance to existing standards and comparison with the predicate, not a study evaluating human reader improvement with AI or standalone algorithm performance.
Here's the breakdown of the acceptance criteria and the "study" (bench testing and comparison) that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Predicate Device Specification (Implicitly the Acceptance Criteria for New Device) | Reported Device Performance (New Device) |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritant, no acute systemic toxicity, no dermal irritation, no allergic contact sensitization (based on predicate) | Non-cytotoxic, non-irritant, no terminal or gross observations in reproductive tracts, no toxic signs, negligible dermal response. No potential for dermal irritation or allergic contact sensitization. |
| Microbiology | Doesn't enhance Staphylococcus aureus growth, doesn't increase TSST-1 production, no effect on culture pH, doesn't alter normal vaginal microflora (based on predicate) | Doesn't enhance Staphylococcus aureus growth, doesn't increase TSST-1 production, no effect on culture pH, doesn't alter normal vaginal microflora. |
| Absorptive Capacity (Syngina) | Within specifications for predicate devices (not quantified in text, but implied to be appropriate for absorption levels like 6-9g, 9-12g, 12-15g) | Gives similar results within predefined specifications (no specific numbers provided) |
| Fiber Loss | Less than 1 mg (for predicate) | Less than 1 mg |
| Cord Strength | Less than 50N (same as predicate Roll Digital Tampon in viscose) | Less than 50N |
| Expulsion Force of Applicator | Less than 6N (specification) | Less than 6N |
| Microbiology Batch Testing: | ||
| - Total Viable Count (TVC) | Less than 200 cfu/g of tampon | Less than 10 cfu/g of tampon |
| - Yeasts/Moulds | Less than 20 cfu/g of tampon | Less than 10 cfu/g of tampon |
| - Candida albicans | Absent in 1g of tampon (negativity) | Absent in 1g of tampon |
| - Gram-negative bacteria | Absent in 1g of tampon (negativity) | Absent in 1g of tampon |
| - Staphylococcus aureus | Absent in 1g of tampon (negativity) | Absent in 1g of tampon |
| - Pseudomonas aeruginusa | Absent in 1g of tampon (negativity) | Absent in 1g of tampon |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a clinical study with human subjects. The testing described is primarily bench testing and relies on the prior testing of the predicate device.
- Bench Testing: The sample sizes for "Absorptive Capacity (Syngina)," "Fiber loss," "Cord strength," "Expulsion force of the applicator," and "Microbiology batch testing" are not explicitly stated. These would typically involve a certain number of tampons tested per batch or per absorbency, but no specific numbers are given.
- Data Provenance: The data provenance is internal testing performed by the manufacturer (ONTEX) and reliance on prior testing of their own predicate device (K122603). The location of this testing is not specified beyond "ONTEX BVBA SPINNERIJSTRAAT 12 9240 ZELE BELGIUM". It is retrospective in the sense that the biocompatibility and broader microbiology claims are based on the predicate's past performance. New bench tests were performed for the "Performance Testing - Bench" section.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
No experts were used to establish ground truth in the context of human-reviewed data, as this is not a study assessing diagnostic accuracy or similar performance. The ground truth for bench tests is the objective measurement against a predefined specification.
4. Adjudication Method for the Test Set
Not applicable. There was no human-reviewed test set or patient data requiring adjudication in a clinical context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document presents a 510(k) summary for a menstrual tampon, which is a medical device, not a diagnostic or AI-driven system. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This submission is for a physical medical device (tampon), not an algorithm or software. Therefore, standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Objective Bench Test Specifications: For metrics like fiber loss, cord strength, expulsion force, and microbiological counts, the "ground truth" is adherence to pre-defined numerical or qualitative specifications that demonstrate safety and performance equivalent to legally marketed devices.
- Predicate Device Performance: For biocompatibility and the broader microbiological safety profile, the ground truth relies on the established safety and effectiveness of the predicate device. The new device is considered substantially equivalent because its materials, manufacturing, and intended use are identical, and its design modifications do not adversely alter the safety profile.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.
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).