(273 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical menstrual cup, with no mention of AI, ML, or any computational processing.
No.
The device's function is to collect menstrual blood and cellular debris, which is a collection/containment purpose rather than a therapeutic one (i.e., treating or preventing a disease or condition).
No
The Mooncup is described as a receptacle to collect menstrual discharge, which is a collection function, not a diagnostic one. There is no mention of it analyzing or interpreting the collected material for medical diagnosis.
No
The device description clearly indicates a physical receptacle (Mooncup) placed in the vagina, which is a hardware component, not software.
Based on the provided information, the Mooncup is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to collect menstrual fluid, not to test or analyze it for diagnostic purposes. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosing, monitoring, or treating a disease or condition.
- Device Description: While the description is "Not Found," the intended use clearly describes a physical collection device.
- Lack of Diagnostic Elements: There is no mention of any testing, analysis, or measurement of the collected fluid.
The Mooncup is a medical device, but it falls under a different category than IVDs. It's a device for managing menstruation.
N/A
Intended Use / 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.
Product codes
HHE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, uterus, cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged in a circular pattern around the left side of the eagle, and the word "SERVICES" is at the bottom.
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.
Image /page/0/Picture/10 description: The image is a circular seal or logo. The text "1906-2006" is at the top of the seal. Below that is the text "PDA Centennial" in a stylized font. There are three stars below the word "Centennial".
Protecting and Promoting Public Health
1
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
2
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
Page 1 of 1