FEMMYCYCLE

K121857 · Femcap Incorporated · HHE · Nov 15, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K121857
• Device Name: FEMMYCYCLE
• Applicant: Femcap Incorporated
• Product Code: HHE · Obstetrics/Gynecology
• Decision Date: Nov 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5400
• Device Class: Class 2

Indications for Use

The FemmyCycle® is a receptacle placed in the vagina to collect blood and cellular debris that is exuded from the uterus via the cervix during menstruation.

Device Story

FemmyCycle is a menstrual cup designed for intravaginal insertion to collect menstrual fluid and cellular debris. It functions as a passive receptacle; no active components, sensors, or software. Used by individuals during menstruation for personal hygiene management. Device is intended for over-the-counter use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical-grade silicone menstrual cup. Passive device; no energy source, connectivity, or software. Sterilization method not specified in document.

Indications for Use

Indicated for menstruating individuals requiring a vaginal receptacle for the collection of menstrual fluid and cellular debris.

Regulatory Classification

Identification

A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.

Special Controls

*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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle, while the caduceus is positioned in the center.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 15, 2012

FemCap Incorporated % Albert Rego, Ph.D. Regulatory Consultant 27001 La Paz Road, Suite 312 MISSION VIEJO CA 92691

Re: K121857

Trade/Device Name: FemmyCycle® Regulation Number: 21 CFR§ 884.5400 Regulation Name: Menstrual cup Regulatory Class: II Product Code: HHE Dated: October 27, 2012 Received: November 5, 2012

Dear Dr. Rego:

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 for use surfal 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 r lease be active a are a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Albert Rego, Ph.D.

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 (reporting of medical device-related 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K121857

Device Name:

FemmyCycle®

Indications for Use:

The FemmyCycle® is a receptacle placed in the vagina to collect blood and cellular debris that is exuded from the uterus via the cervix during menstruation.

Prescription Use (Part 12 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use X (Part 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)

Benjamin R. Fisher -S 2012.11.15 17;1 8:08 -05'00'

sion Signductive. Gastro-Renal, and