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510(k) Data Aggregation
(140 days)
re.t.a Reuseable Tampon Applicator
The re.t.a.™ reusable tampon applicator in intended to be used to insert a digital menstrual tampon into the vagina.
The re.t.a.™ Reusable Tampon Applicator is a non-sterile, single user reusable device. It is intended to be sold on its own, without a pre-loaded tampon. The applicator requires the user to insert a legally-marketed digital/non-applicator menstrual tampon into the applicator at the time of use. The use-life of the subject applicator is two years.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the re.t.a.™ Reusable Tampon Applicator.
It's important to note that the provided 510(k) summary is for a physical medical device (a tampon applicator), not an AI/software medical device. Therefore, many of the typical questions for AI/software (like human reader improvement, standalone algorithm performance, number of experts, adjudication methods, training set details) are not applicable to this submission. The acceptance criteria and testing focus on mechanical, functional, and biological safety aspects of the device.
Acceptance Criteria and Device Performance Study for re.t.a.™ Reusable Tampon Applicator
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Functional Evaluation | Weight | Assessed (Specific values not provided in summary, but implied to meet requirements for proper function). |
| Physical dimensions | Assessed (Specific values not provided, but implied to meet requirements for proper function and compatibility). | |
| Outer cover uncap-force (Ease of removing the outer cover) | Assessed (Specific force not provided, but implied to meet usability requirements). | |
| Tampon compatibility testing (Ability to be used with various digital tampons) | Assessed (Implied to be compatible with "Digital tampons of various sizes"). | |
| Ejection force (Ease of pushing the tampon out) | Assessed (Specific force not provided, but implied to meet usability requirements). | |
| Durability/Use-life | Use-life testing (Ability to function for the stated lifespan of 2 years) | Assessed (Device is stated to have a "2 years" use-life, and testing implicitly confirms this). |
| Biocompatibility | Cytotoxicity (Assessment of potential cell damage) | Assessed (Indicates no unacceptable cytotoxicity). |
| Vaginal irritation (Assessment of potential irritation to vaginal tissue) | Assessed (Indicates no unacceptable vaginal irritation). | |
| Sensitization (Assessment of potential allergic reactions) | Assessed (Indicates no unacceptable sensitization). | |
| Hygiene/Maintenance | Cleaning Validation (Effectiveness of cleaning procedures for reuse) | Assessed (Implied that cleaning procedures are validated to be effective, supporting its "Reusable" classification). |
| Substantial Equivalence | Comparison to Predicate Device (K091749) regarding safety and effectiveness | The device was found to be "substantially equivalent" to the predicate, meaning its differences "do not raise different questions of safety or effectiveness." This overarching criterion implies all individual performance tests support this conclusion. |
| Intended Use | The re.t.a.™ reusable tampon applicator is intended to be used to insert a digital menstrual tampon into the vagina. | The device's design and functional tests demonstrate it fulfills this intended use. It is an accessory to a Class II tampon device, aligning its intended use with the general function of a tampon applicator. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample sizes used for any of the performance tests (functional, use-life, biocompatibility, cleaning validation). It also does not provide details on the data provenance in terms of country of origin or whether the studies were retrospective or prospective, as these are typically not relevant for the type of bench and lab testing described for this physical device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This summary is for a physical device, not an AI/software device that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for this device would be established by objective measurements against engineering specifications, biological safety standards, and validated test methods.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in image analysis or diagnostic studies where there's variability in human interpretation. For a physical device undergoing functional, mechanical, and biocompatibility testing, these methods are not used. Results are usually determined by passing or failing predefined metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices (especially AI/imaging) to assess the impact of a device on human reader performance. This device is a physical, reusable tampon applicator, so an MRMC study is not appropriate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This concept applies to AI algorithms. The re.t.a.™ is a physical medical device; thus, no "standalone algorithm performance" assessment was performed or is relevant.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance studies would be based on:
- Engineering Specifications: Pre-defined physical dimensions, force tolerances (e.g., for uncap-force, ejection force), weight limits.
- Performance Standards: Industry or internal standards for functional reliability over time (use-life).
- Biocompatibility Standards: Established ISO standards (e.g., ISO 10993 series) for cytotoxicity, irritation, and sensitization, determined through laboratory tests.
- Microbiological Standards: Standards for cleaning effectiveness (e.g., reduction of microbial load).
- Reference Tampon Specifications: Compatibility with legally marketed digital menstrual tampons, requiring measurement against their standardized dimensions and features.
8. The Sample Size for the Training Set
Not applicable. This submission is for a physical device, not an AI/machine learning model. Therefore, there is no "training set" in the computational sense. The device's design and manufacturing processes are refined through engineering, testing, and validation, not through machine learning training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI model, there is no ground truth established for a training set.
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