(273 days)
Not Found
No
The device description and intended use clearly define a simple, non-electronic menstrual cup made of silicone. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No
The device description states it is a receptacle to collect blood and cellular debris during menstruation, which is not a therapeutic function.
No
The Device Description states that the BelleCup is a "Menstrual cup," and its Intended Use is to "collect blood and cellular debris" during menstruation. This function is for collection, not for diagnosing any medical condition.
No
The device description clearly states the device is manufactured from a single component of silicone elastomer, indicating it is a physical object, not software.
Based on the provided information, the BelleCup is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to collect menstrual fluid, which is a physical collection of biological material for disposal or hygiene purposes. It is not intended for the in vitro examination of specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Description: The description clearly states it's a menstrual cup, a physical receptacle.
- Regulation Number: The regulation number 21 CFR 884.5400 is for "Menstrual cup," which falls under the Obstetrics/Gynecology panel, not the IVD panel.
- Lack of IVD Characteristics: There is no mention of analyzing the collected fluid, using reagents, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) outside of the body to gain information about a person's health. The BelleCup's function is purely for collection.
N/A
Intended Use / Indications for Use
The device 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 Bellecup 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. .
Product codes
HHE
Device Description
Trade Name: BelleCup
Common Name: Menstrual Cup
Device Class: II
Review Panel: Obstetrics/Gynecology
Product Code: HHE
Regulation Number: 21 CFR 884.5400
Total Volume: 35ml
The device is manufactured from a single component, LIM6040-D2 silicone elastomer, which is compliant with 21 CFR 177.2600 (Rubber articles intended for repeated use).
The BelleCup is not supplied sterile.
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
Not applicable.
Key Metrics
Not applicable.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Page 1 of 3
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMVDA 1990 and 21 CFR §807.92.
510(k) number:
-
Submitter's Identification: Librette, Inc. 9540 Bobby McLamb Dr Linden, NC 28356 USA Submitter Phone: 910- 892-7154 Submitter Fax: 877- 248-9191 Submitter Contact: Carissa Ulvestad Title: Owner Date Summary Prepared: June 25, 2010
-
Name of the Device: BelleCup
-
Predicate Device Information: MoonCup 510(k) Number: K040335 MoonCup LLC. One E. Main St. Madision, WI 53701
-
Device Description:
Device:
Trade Name: BelleCup Common Name: Menstrual Cup Device Class: II Review Panel: Obstetrics/Gynecology Product Code: HHE Regulation Number: 21 CFR 884.5400
Intended Use of the Device:
The device is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
JUN 2 8 2010
1
Device Drawings:
Total Volume: 35ml
Image /page/1/Figure/5 description: The image shows two diagrams of a device, with measurements provided in millimeters. The diagram on the left shows a cross-sectional view with dimensions of 45mm and 74.01mm labeled. Another dimension of 43.73mm is also labeled on the left diagram. The text indicates that the units for the device are in millimeters.
Components:
The device is manufactured from a single component, LIM6040-D2 silicone elastomer, which is compliant with 21 CFR 177.2600 (Rubber articles intended for repeated use).
Biocompatibility information for the device material are exhibited in Appendix 2 -Testing.
Sterility The BelleCup is not supplied sterile.
2
5. Comparison to Predicate Devices:
Technical characteristics of the device compared to the predicate device:
| Feature | BelleCup | MoonCup, K040335 |
|---|---|---|
| Manufacturer | Librette, Inc. | MoonCup, LLC |
| Intended Use | The device 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 | ||
| Bellecup 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. . | Same | |
| Material | Soft Silicone Elastomer | Same |
| Sterility | Not Sterile | Same |
6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Not applicable.
- Discussion of Clinical Tests Performed:
Not applicable
8. Conclusions:
The subject device has the same intended use and similar characteristics as the predicate device. No new questions of safety or effectiveness are raised by differences in technology or materials. Thus, the BelleCup is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around a central emblem. The emblem features a stylized image of an eagle or bird-like figure with three wing-like shapes extending from its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
· Librette, Inc. c/o Mr. Neal Kolber Project Manager Emergo Group 1705 S. Capital of Texas Highway, Suite 500 AUSTIN TX 78746
JUN 2 8 2010
Re: K092985
Trade/Device Name: BelleCup Regulation Number: 21 CFR $884.5400 Regulation Name: Menstrual Cup Regulatory Class: II Product Code: HHE Dated: June 6, 2010 Received: June 8, 2010
Dear Mr. Kolber:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related
4
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adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K092985
Device Namc: BelleCup
Indications for Use: The BelleCup 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number