(413 days)
The MoonCup® is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
The MoonCup® menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available in two sizes: Style A - After childbirth; Style B Before childbirth and/or C-section. The cup remains entirely within the vagina and does not touch the cervix but the stem remains outside the body to ensure retrieval of the cup.
The provided document, K040335, is a 510(k) Premarket Notification for the MoonCup® menstrual cup. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against acceptance criteria through a clinical study in the same way a PMA submission would.
Therefore, the document does not contain information about acceptance criteria, a specific study proving device performance against those criteria, sample sizes for test sets, expert ground truth establishment, or multi-reader multi-case studies.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on materials, dimensions, intended use, and indications for use.
Here's an analysis based on the information provided, noting what is explicitly stated and what is absent:
Summary of Device Acceptance Criteria and Performance (Based on K040335):
The K040335 submission for the MoonCup® menstrual cup is a 510(k) Premarket Notification. For 510(k) submissions, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative metrics through a clinical study. Therefore, the document does not present a table of acceptance criteria and reported device performance in the manner requested for a clinical evaluation.
Instead, the document asserts substantial equivalence based on the following:
| Aspect | Predicate Device(s) (K021356, K870803, K803250) | MoonCup® Claimed Performance/Characteristics |
|---|---|---|
| Material | DivaCup™ (K021356) uses silicone | Manufactured from a soft silicone elastomer (similar to DivaCup™) |
| Dimensions | Not explicitly detailed for predicates | Two styles: A (after childbirth), B (before childbirth/C-section). Holds one ounce of fluid. |
| Intended Use | Receptacle in vagina to collect menstrual blood and cellular debris | Receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation. |
| Indication for Use | Same as intended use defined above | Same as intended use defined above |
| Reusability | Implied for predicates (menstrual cups) | Reusable |
| Placement | Internally worn | Internally worn, remains entirely within the vagina, stem outside for retrieval. |
| Wear Time | Not explicitly detailed for predicates | May remain in the body for up to 12 hours |
Detailed Information as Requested (with emphasis on what is not present in a 510(k) for this type of device):
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly defined in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) because this is a 510(k) for a menstrual cup, which primarily relies on substantial equivalence to predicates for safety and effectiveness. The "acceptance" is the FDA's determination of substantial equivalence.
- Reported Device Performance: The "performance" described is largely descriptive (e.g., made of silicone, holds one ounce, two sizes, reusable, placed internally for up to 12 hours) and aligns with the characteristics of the predicate devices. There are no performance metrics from a dedicated clinical study as would be seen for higher-risk devices or those requiring a PMA.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The document does not describe a clinical test set in this manner. Substantial equivalence for this device is based on material properties, design, and intended use, not clinical trial data comparing performance in a patient cohort. Biocompatibility data for the silicone elastomer is referenced via a master file and MDSS, but this is material testing, not a clinical test set for performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. There is no "test set" requiring ground truth establishment by experts in the context a diagnostic or imaging device. The device itself (a menstrual cup) does not generate diagnostic data that would necessitate expert adjudication for ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication related to performance metrics is described.
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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:
- Not Applicable. The MoonCup® is a physical medical device (menstrual cup), not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. As there is no clinical test set for performance metrics, there is no "ground truth" established in this sense. The basis for safety and effectiveness is largely historical use and characterization of materials.
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The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device. No "training set" in that context is mentioned or implied.
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How the ground truth for the training set was established:
- Not Applicable. As above, no training set or ground truth in this context is mentioned. The "truth" for substantial equivalence lies in the established characteristics and safety profile of identical or very similar predicate devices.
Conclusion Regarding the Document's Content:
The K040335 submission for the MoonCup® is a typical 510(k) Premarket Notification for a Class II medical device. It successfully demonstrates substantial equivalence to predicate devices (DivaCup™, The Keeper®, Tassaway) based on shared characteristics like materials (silicone), intended use (collecting menstrual flow), and general design principles. The FDA's letter of March 30, 2005, confirms that the device was found substantially equivalent, allowing it to proceed to market under general controls. The document explicitly states that the silicone elastomer's properties are described in a master file at the FDA, including data on biocompatibility and toxicity testing as required by FDA's G95-1 memorandum, further supporting the safety aspect. However, it does not present a clinical study with acceptance criteria and measured performance outcomes as one might expect for a novel device or a higher-risk diagnostic tool requiring more extensive clinical validation.
§ 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.