(266 days)
The Sunny Cup and Applicator is a receptacle placed in the vagina to collect blood and cellular debris that is exuded from the uterus via the cervix during menstruation.
The Sunny Cup and Applicator is an over the counter (OTC) medical device consisting of a reusable silicone menstrual cup with a lubricious coating and a reusable applicator with a nylon body and a thermoplastic polyurethane (TPU) tip with a lubricious coating. The Sunny Cup is a soft receptacle designed for placement within the vaginal canal to hold up to 25 mL of menstrual fluid and can remain within the body for up to 12 hours. The Sunny Cup is also designed with grip lines and a stem on the distal end to allow for easy location and manipulation of the Sunny Cup during removal.
The Applicator component enables the insertion process for the user and consists of a barrel, a pusher, and a pusher base, functioning similarly to a tampon applicator. For the insertion process, the Sunny Cup is folded and placed in the Applicator barrel. The pusher component is then used to deploy the Cup through the Applicator. The Sunny Cup then unfolds upon deployment to create a seal in the vaginal canal and collect menstrual fluid. After 12 hours, the Sunny Cup is removed manually by squeezing the grip lines to break the seal and pulling the Cup out by the grip lines along the base of the Cup. The Cup component should be cleaned via boiling at the start of each menstrual cycle, and the Cup and Applicator components should be cleaned with warm water and mild, fragrance-free soap between uses. The Sunny Cup and Applicator may be reused by a single patient for up to a year or until discoloration or damage is evident.
The provided text describes the "Sunny Cup and Applicator," a menstrual cup device, and its substantial equivalence to a predicate device, the "SckoonCup." However, the document does not contain information related to acceptance criteria, specific device performance metrics, or study details such as sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies.
The document primarily focuses on demonstrating substantial equivalence to a predicate device, outlining comparisons in technological characteristics, materials, and intended use. The performance testing mentioned is "Bench performance testing" and "Biocompatibility Testing," which verified certain aspects but aren't presented with acceptance criteria or specific quantitative outcomes in the provided summary.
Therefore, most of the requested information cannot be extracted from this document, as it is a 510(k) summary, not a detailed study report.
Here's a summary of the available information and the missing details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | - Bench Testing: Verified the Cup and Applicator can withstand anticipated applied forces during cup deployment. |
- Bench Testing: Verified the Cup met the 25 mL volume capacity.
- Bench Testing: Verified the Cup met folding requirements throughout its use-life.
- Biocompatibility Testing: Demonstrated non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic for both cup and applicator.
- Reprocessing and Cleaning Validation: Demonstrated acceptability of cleaning procedures and ability to withstand repeated reprocessing. |
Missing Details: Specific numerical acceptance criteria (e.g., minimum force withstood, specific ranges for chemical levels, cleanliness thresholds) are not provided. The performance is reported qualitatively as "met the prespecified requirements" or "demonstrated acceptability."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance (country of origin, retrospective/prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable, as no clinical study or expert-adjudicated test set is mentioned.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable, as no clinical study or expert-adjudicated test set is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, a MRMC study was not done. The device is a physical medical device (menstrual cup and applicator), not an AI-powered diagnostic or assistive tool.
- Effect size of human readers with/without AI: Not applicable, as no AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable, as the document describes bench testing and biocompatibility. The "ground truth" for these tests would be established by validated test methods and standards (e.g., ISO 10993 standards for biocompatibility), not clinical ground truth types like pathology or expert consensus.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
- How Ground Truth was Established: Not applicable.
§ 884.5400 Menstrual cup.
(a)
Identification. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.