MOONCUP, STYLE A & B

K040335 · Mooncup, LLC · HHE · Mar 30, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K040335
• Device Name: MOONCUP, STYLE A & B
• Applicant: Mooncup, LLC
• Product Code: HHE · Obstetrics/Gynecology
• Decision Date: Mar 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5400
• Device Class: Class 2

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. The MoonCup® 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.

Device Story

MoonCup is a reusable, soft silicone elastomer menstrual cup designed for internal vaginal use. It functions as a receptacle to collect menstrual blood and cellular debris; it does not absorb fluid. The device is inserted into the vagina, positioned low to avoid cervical contact, and can remain in place for up to 12 hours. A stem remains outside the body to facilitate retrieval. It is an over-the-counter device intended for self-use by women. By collecting rather than absorbing flow, it provides a non-absorbent alternative for menstrual hygiene management.

Clinical Evidence

No clinical data. Biocompatibility and toxicity testing were performed according to FDA guidance G95-1, supported by a master file for the silicone elastomer.

Technological Characteristics

Soft silicone elastomer menstrual cup. Two sizes: Style A (post-childbirth) and Style B (pre-childbirth/C-section). Capacity: approximately one ounce. Mechanical collection principle; non-absorbent. Biocompatibility data provided via master file.

Indications for Use

Indicated for use as a menstrual cup to collect menstrual fluid in women. Available in two sizes: Style A for women after childbirth, and Style B for women before childbirth and/or C-section.

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.

Predicate Devices

• DivaCup™ - Menstrual Solution (K021356)
• The Keeper® (K870803)
• Tassaway (K803250)

Submission Summary (Full Text)

{0}------------------------------------------------

K040335

# Premarket Notification [510(k)] Summary

[As required by section 807.92(c)]

Submitter: Morris Waxler, Ph.D.

FDA Regulatory Affairs Specialist LaFollette, Godfrey & Kahn One East Main Street Madison, WI 53701-2719 TEL: [phone] FAX: [phone]

### New device:

Trade or proprietary name: MoonCup® Common or usual name: Menstrual Cup Classification name of the device: 21 CFR §884.5400

Predicates: DivaCup™ - Menstrual Solution (K021356) The Keeper® (K870803) Tassaway (K803250)

#### Description of the Device:

General. The MoonCup® menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available in two sizes:

- . Style A - After childbirth;
- Style B Before childbirth and/or C-section. .

The cup remains entirely within the vagina and does not touch the cervix but the stem remains outside the body to ensure retrieval of the cup. See the instruction brochure for information about how to use and care for the MoonCup® menstrual cup.

Material. The MoonCup® menstrual cup is manufactured from a soft silicone elastomer. The properties of the silicone are described in a master file at FDA. The Materials Data Safe Sheet (MDSS) and the Product Specifications Sheet for the silicone were submitted. The master file and the MDSS provides data on all of the biocompatibility or toxicity testing required according to FDA's memorandum to guidance G95-1. The silicone elastomer is well characterized chemically and physically and has a long history of safe use as a medical device in long-term contact with the human body.

Intended Use/Indication 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. The MoonCup® 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.

{1}------------------------------------------------

## Substantial Equivalence

The MoonCup® is substantially equivalent to the DivaCup™ (K021356), The Keeper® (K870803), and the Tassaway (K803250) in materials, dimensions, intended use, and indication for use. The MoonCup® is made of silicone similar to the DivaCup™. The MoonCup® can hold approximately one ounce of menstrual fluid is inserted into the vagina with a stem slightly protruding to aid removal.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows a circular seal with an eagle-like bird in the center. The bird is facing left and has three lines above it, possibly representing feathers or motion. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle, following its curvature. The seal appears to be a logo or emblem, possibly associated with a government agency.

MAR 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MoonCup, LLC c/o Morris Waxler, Ph.D. FDA Regulatory Affairs Specialist LaFollette, Godfrey & Kahn One East Main Street P.O. Box 2719 MADISON WI 53701-2719

Re: K040335

Trade/Device Name: MoonCup® Menstrual Cup, Styles A and B Regulation Number: 21 CFR §884.5400 Regulation Name: Menstrual cup Regulatory Class: II Product Code: HHE Dated: March 7, 2005 Received: March 9, 2005

Dear Dr. Waxler:

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.

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 (05) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hanteeing your
premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket notification: "The PDA mailing of oation 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 11 you desire specific advice for your de restled wing numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entired, cornation on your responsibilities under the Act from the 807.97). Tou may ootain outer gollerial missistance at its toll-free number (800) DIVISION of Sillan Manufacturers, Internet address http://www.fda.gov/cdrl/dsmadsmam.html

Sincercly yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): 长 040335

Device Name: MoonCup® ________________________________________________________________________________________________________________________________________________________

.

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.

#### Over-The-Counter Use _ V Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broador
DIVISION SIGN-OFF

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040335