(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.
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Premarket Notification [510(k)] Summary
[As required by section 807.92(c)]
Submitter: Morris Waxler, Ph.D.
FDA Regulatory Affairs Specialist LaFollette, Godfrey & Kahn One East Main Street Madison, WI 53701-2719 TEL: 608-284-2638 FAX: 608-257-0609
New device:
Trade or proprietary name: MoonCup® Common or usual name: Menstrual Cup Classification name of the device: 21 CFR §884.5400
Predicates: DivaCup™ - Menstrual Solution (K021356) The Keeper® (K870803) Tassaway (K803250)
Description of the Device:
General. 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. See the instruction brochure for information about how to use and care for the MoonCup® menstrual cup.
Material. The MoonCup® menstrual cup is manufactured from a soft silicone elastomer. The properties of the silicone are described in a master file at FDA. The Materials Data Safe Sheet (MDSS) and the Product Specifications Sheet for the silicone were submitted. The master file and the MDSS provides data on all of the biocompatibility or toxicity testing required according to FDA's memorandum to guidance G95-1. The silicone elastomer is well characterized chemically and physically and has a long history of safe use as a medical device in long-term contact with the human body.
Intended Use/Indication for Use: 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® is placed low enough in the vagina to be retrieved readily and, at the same time, to prevent it's touching the cervix or interfering with menstrual flow through it.
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Substantial Equivalence
The MoonCup® is substantially equivalent to the DivaCup™ (K021356), The Keeper® (K870803), and the Tassaway (K803250) in materials, dimensions, intended use, and indication for use. The MoonCup® is made of silicone similar to the DivaCup™. The MoonCup® can hold approximately one ounce of menstrual fluid is inserted into the vagina with a stem slightly protruding to aid removal.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows a circular seal with an eagle-like bird in the center. The bird is facing left and has three lines above it, possibly representing feathers or motion. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle, following its curvature. The seal appears to be a logo or emblem, possibly associated with a government agency.
MAR 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MoonCup, LLC c/o Morris Waxler, Ph.D. FDA Regulatory Affairs Specialist LaFollette, Godfrey & Kahn One East Main Street P.O. Box 2719 MADISON WI 53701-2719
Re: K040335
Trade/Device Name: MoonCup® Menstrual Cup, Styles A and B Regulation Number: 21 CFR §884.5400 Regulation Name: Menstrual cup Regulatory Class: II Product Code: HHE Dated: March 7, 2005 Received: March 9, 2005
Dear Dr. Waxler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (05) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hanteeing your
premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket notification: "The PDA mailing of oation for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific advice for your de restled wing numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entired, cornation on your responsibilities under the Act from the 807.97). Tou may ootain outer gollerial missistance at its toll-free number (800) DIVISION of Sillan Manufacturers, Internet address http://www.fda.gov/cdrl/dsmadsmam.html
Sincercly yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 长 040335
Device Name: MoonCup® ________________________________________________________________________________________________________________________________________________________
.
Indications for Use: 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.
Over-The-Counter Use _ V Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broador
DIVISION SIGN-OFF
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040335
§ 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.