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.

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 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.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called "BelleCup," a menstrual cup. The submission focuses on demonstrating substantial equivalence to a predicate device, the MoonCup (K040335).

Based on the provided text, the acceptance criteria and the study that proves the device meets those criteria are not applicable in the traditional sense of a clinical performance study with specific acceptance metrics for accuracy, sensitivity, or other performance characteristics of the device itself.

Here's why and the information that is available:

Nature of the Device: The BelleCup is a menstrual cup, a direct collection device. Its primary function is containment, not diagnosis or therapy that requires complex performance metrics.
510(k) Pathway: The submission is a 510(k), which generally aims to demonstrate "substantial equivalence" to a predicate device already on the market, rather than prove de novo safety and effectiveness through extensive clinical trials for performance.
Content of the Submission: The core of this submission focuses on comparing the BelleCup's intended use, material, and sterility to the predicate device. It explicitly states "Not applicable" for both "Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence" and "Discussion of Clinical Tests Performed."

Therefore, for the BelleCup, the "acceptance criteria" are essentially met by demonstrating that it is substantially equivalent to a legally marketed predicate device (MoonCup). The "study" that proves this is the comparative analysis presented in section 5, which highlights the similarities between the BelleCup and the MoonCup.

Here's the breakdown of the requested information based on the provided text:

Requirement	Information from Text
1. Table of acceptance criteria and the reported device performance	Acceptance Criteria (Implicit for 510(k) for this device type): Substantial equivalence to the predicate device in terms of intended use, material, and sterility. Reported Device Performance: The 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. (This is the conclusion of equivalence, not a direct performance metric).
2. Sample size used for the test set and the data provenance (e.g., country of origin, retrospective/prospective)	Not applicable. No clinical performance test set or data provenance is mentioned. The "test" for this 510(k) is the comparison to the predicate.
3. Number of experts used to establish the ground truth for the test set and their qualifications	Not applicable. No test set requiring expert ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set	Not applicable. No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size of human readers improve with AI vs without AI assistance	Not applicable. This device is not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done	Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)	Not applicable. The "ground truth" for this 510(k) is the established regulatory status and safety/effectiveness profile of the predicate device.
8. The sample size for the training set	Not applicable. No machine learning or training set is involved.
9. How the ground truth for the training set was established	Not applicable. No machine learning or training set is involved.

In summary, the BelleCup's regulatory acceptance is based on demonstrating "substantial equivalence" to a predicate menstrual cup, the MoonCup. This involved comparing the device's fundamental characteristics (intended use, material, sterility) rather than conducting clinical performance studies with specific acceptance criteria, test sets, or expert ground truths as would be expected for diagnostic or more complex therapeutic devices. The text explicitly states that non-clinical and clinical tests were "Not applicable" for the determination of substantial equivalence in this context.

Summary

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K092985

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

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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.

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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 placedin the vagina to collect blood andcellular debris that is extrudedfrom the uterus via the cervixduring menstruation. TheBellecup is placed low enough inthe vagina to be retrieved readilyand, at the same time, to preventit's touching the cervix orinterfering with menstrual flowthrough 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.

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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

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Page 2 -

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

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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

Regulation Number and Section

§ 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.