(78 days)
TAMPAX® Compak Pearl Plastic Applicator Scented Tampons and TAMPAX® Compak Pearl Plastic Applicator Unscented Tampons are menstrual trim 180 that are inserted into the vagina and used to absorb menstrual fluid.
The device is a conventional menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. It is available in both scented and unscented versions.
- The absorbent pledget consists of a scented or unscented pad of rayon ● fibers overwrapped with a non-woven fabric. A cotton withdrawal cord is sewn to the pad, and the pad is compressed into a traditional bullet-shaped 彩 pledget.
- The formed pledget is inserted into a plastic applicator consisting of an inner . pusher tube and an outer insertion tube with a closed, rounded tip.
- Each tampon is wrapped in an individual plastic film wrapper and packaged . in sealed multi-unit containers for retail sale.
This document describes the Procter & Gamble Company's 510(k) submission for TAMPAX® Compak Pearl Plastic Applicator Scented and Unscented Tampons (K062638). This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a traditional artificial intelligence or medical imaging context. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.
Here is an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Compliance) |
|---|---|
| Safety (e.g., biocompatibility) | "A battery of safety tests was conducted, including in vitro microbiological testing, biocompatibility testing and extraction testing... The results of these safety tests support the conclusion that these 510(k) devices are equally as safe as the predicate devices." |
| Effectiveness (Absorbency) | "TAMPAX® Compak Pearl Plastic Applicator Scented Tampons and TAMPAX® Compak Pearl Plastic Applicator Unscented Tampons comply with the syngyna absorbency requirements of 21 CFR 801.430." |
| Substantial Equivalence to Predicate Devices (Overall) | "The results of evaluations of these devices support the conclusions that they are safe for their intended use and that they are substantially equivalent to the cited predicate devices with regard to safety and effectiveness." |
| Technological Characteristics (Material, Design, Labeling) | "These devices are similar to the predicate devices in terms of component materials, overall design and labeling. These devices incorporate a change in the fragrance (scented version), changes in the colorants used in the plastic applicators, changes in the dimensions of the pad of absorbent fibers, and a change in the pledget overwrap configuration." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a medical device submission, not an AI or diagnostic imaging study. The "tests" mentioned are referring to laboratory and performance evaluations for the tampon's physical and biological properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. Ground truth as understood in AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant here. The "truth" for safety and effectiveness is established by standardized laboratory testing and regulatory compliance.
4. Adjudication Method for the Test Set
Not applicable. This concept is not relevant to the described testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is for evaluating the performance of diagnostic systems, often in comparison to human readers. This submission is for a physical medical device (tampon).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component involved in this device.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily established through:
- Regulatory Standards: Compliance with specific CFR (Code of Federal Regulations) requirements, such as 21 CFR 801.430 for syngyna absorbency.
- Laboratory Testing: Results from in vitro microbiological testing, biocompatibility testing, and extraction testing using established scientific methodologies.
- Predicate Device Comparison: Establishing equivalence to previously approved devices.
8. The Sample Size for the Training Set
Not applicable. There is no AI model or "training set" in the context of this device submission.
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).