(273 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.
Not Found
The provided text is an FDA 510(k) clearance letter for the Mooncup Menstrual Cup. This document is a regulatory approval, not a scientific study describing device performance against acceptance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in this document.
The document confirms that the Mooncup Menstrual Cup (K060852) has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Here's a breakdown of what is available in relation to your request, and why other parts cannot be answered from this text:
1. A table of acceptance criteria and the reported device performance:
- Not provided. This document is an approval letter, not a performance report. It states that the device is "substantially equivalent" to predicate devices, but does not detail specific performance metrics or acceptance criteria for that substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. This document does not refer to a "test set" in the context of a performance study. "Substantial equivalence" typically involves comparing device features and indications for use to an existing device, rather than a clinical trial with a test set.
3. 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/Not provided. No "ground truth" establishment for a test set is discussed. The FDA's determination is based on a review of the company's submission against regulatory requirements and comparison to predicate devices, not on an independent expert adjudication of performance data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No "test set" or adjudication method is described.
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:
- Not applicable/Not provided. This device is a menstrual cup, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI performance is irrelevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This device is a physical menstrual cup, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided. No "ground truth" as it pertains to performance evaluation of a diagnostic or AI device is mentioned. The "ground truth" for regulatory approval in this context is the existing regulatory framework and the characteristics of legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. There is no "training set" for this device.
In summary: The provided text is a regulatory approval letter based on "substantial equivalence" to existing devices, not a study report detailing performance data against specific acceptance criteria. Therefore, most of your questions are outside the scope of this document.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Su Hardy Managing Director Mooncup Ltd Dolphin House, 40 Arundel Place Brighton BN2 1GD UNITED KINGDOM
DEC 2 6 2006
Re: K060852
Trade/Device Name: Mooncup Menstrual Cup Regulation Number: 21 CFR 884.5400 Regulation Name: Menstrual cup Regulatory Class: II Product Code: HHE Dated: December 8, 2006 Received: December 18, 2006
Dear Ms. Hardy:
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.
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Protecting and Promoting Public Health
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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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
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): K060852
Device Name: Mooncup Menstrual Cup
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.
Prescription Use: NO (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: YES (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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§ 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.