← Product Code [HHE](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE) · K140626

# MELUNA CLASSIC/SPORT MENSTRUAL CUP (K140626)

_Meluna · HHE · Jul 10, 2014 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K140626

## Device Facts

- **Applicant:** Meluna
- **Product Code:** [HHE](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE.md)
- **Decision Date:** Jul 10, 2014
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5400
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Indications for Use

The MeLuna Menstrual Cup 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 Story

MeLuna Menstrual Cup is a reusable, internal vaginal receptacle designed to collect menstrual flow and cellular debris. Constructed from thermoplastic elastomer (TPE), the device is available in multiple sizes (Shorty and Regular classifications) and two firmness levels (Classic, shore rating 40; Sport, shore rating 50). The device is intended for over-the-counter use. It functions by being inserted into the vagina to hold fluid rather than absorbing it. The user removes, cleans, and disinfects the cup for reuse. The device provides a non-absorbent alternative for menstrual management.

## Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO-10993-1:2009 (R2013) for cytotoxicity, sensitization, and acute systemic toxicity. Use-life testing supported a three-year duration. Cleaning and disinfection procedures were validated.

## Technological Characteristics

Material: Thermoplastic elastomer (TPE). Firmness: Classic (shore 40) and Sport (shore 50). Form factor: Reusable cup in various sizes (Shorty/Regular, diameters 39-48mm). Biocompatibility: ISO-10993-1:2009 (R2013).

## Regulatory 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

- Diva Cup ([K021356](/device/K021356.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# JUL 1 0 2014

# 510(k) Summary

510 (K) Number K140626

| SPONSOR                                |                                                 |          |  |  |  |
|----------------------------------------|-------------------------------------------------|----------|--|--|--|
| Company Name:                          | MeLuna                                          |          |  |  |  |
| Company Address                        | Industriestr 7<br>Gunzenhausen, GERMANY 91710   |          |  |  |  |
| Telephone:                             | 210.391.8558                                    |          |  |  |  |
| Contact Person:                        | Karin Baker                                     |          |  |  |  |
| Summary Preparation Date: July 8, 2014 |                                                 |          |  |  |  |
| DEVICE NAME                            |                                                 |          |  |  |  |
| Trade Name:                            | MeLuna Menstrual Cup (Models Classic and Sport) |          |  |  |  |
| Common/Usual Name:                     | Menstrual Cup                                   |          |  |  |  |
| Classification Name:                   | Menstrual Cup                                   |          |  |  |  |
| Regulation Number:                     | 21 CFR 884.5400                                 |          |  |  |  |
| HHE<br>Product Code:                   |                                                 |          |  |  |  |
| Device Class:                          | Class II .                                      |          |  |  |  |
| PREDICATE DEVICE                       |                                                 |          |  |  |  |
| Company                                | Product                                         | 510(k) # |  |  |  |

| Company                  | Product  | 510(K) # |
|--------------------------|----------|----------|
| Diva International, Inc. | Diva Cup | K021356  |

#### DEVICE DESCRIPTION

The MeLuna Menstrual Cup is a soft small TPE (Thermoplastic elastomer) menstrual cup that is placed internally in the vagina. The MeLuna is reusable and holds menstrual flow instead of absorbing it. It is available in two size classifications: Standard and Shorty, with cup diameters the same for both Shorty and Regular, but cup capacity and cup length varying between the two classifications.

|          | Capacity     | Diameter        | Cup Length |           |
|----------|--------------|-----------------|------------|-----------|
| Shorty-  | Regular      | Shorty/Regular  | Shorty     | Regular   |
| S - 10ml | S - 15 ml    | Small - 39 mm   | S - 35 mm  | S - 46 mm |
| M - 12ml | M - 20ml L   | Medium- 42 mm   | M- 38 mm   | M - 50mm  |
| - 15ml   | L - 24 ml XL | Large - 45 mm   | L - 41 mm  | L - 53mm  |
| - 18ml   | XL - 30 ml   | X Large - 48 mm | XL - 43 mm | XL - 57mm |

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The cups are available in two different firmness levels referred to as Classic or Sport. The Classic material has a shore rating of 40; the firmer Sport model has a shore rating of 50.

## INDICATIONS FOR USE

The MeLuna Menstrual Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.

# COMPARISON OF PREDICATE PRODUCT TECHNICAL CHARACTERISTICS

The MeLuna Menstrual Cup is similar to the predicate device in indications for use, operating principle, and device design. The MeLuna differs from the predicate device in material, and in slight differences in dimensions and capacity. These differences do not raise new types of safety or effectiveness questions.

# NON-CLINICAL PERFORMANCE DATA BIOCOMPATIBILITY

The MeLuna Menstrual Cup was tested in accordance with the testing requirements of ISO-10993-1:2009 (R2013), "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for cytotoxicity, sensitization, and acute systemic toxicity testing. In addition, a use-life testing supported a three-years use-life, and cleaning/disinfection validation testing demonstrated acceptability of cleaning and disinfection procedures included in the Instructions for Use.

# CONCLUSION

The MeLuna Menstrual Cup is similar to the predicate products in indications for use, operating principle, and device design. The differences in material, dimensions and capacity do not introduce new issues in terms of safety and efficacy, and MeLuna concludes that the MeLuna Menstrual Cup is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an eagle-like symbol with three tail feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 10. 2014

Meluna % Yolanda Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, MD 21114

K140626 Re:

> Trade/Device Name: MeLuna Menstrual Cup (Models Classic and Sport) Regulation Number: 21 CFR§ 884.5400 Regulation Name: Menstrual Cup Regulatory Class: Class II Product Code: HHE Dated: June 3, 2014 Received: June 5, 2014

Dear Yolanda Smith,

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 ffor 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 cvaluate 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 (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Yolanda Smith

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)796-7100 or at its Internet address

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

Sincerely yours,

Glenn B. Bell -S

for

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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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) KI40626

Device Name

MeLuna Menstrual Cup (Models Classic and Sport)

## Indications for Use (Describe)

The MeLuna Menstrual Cup is a receptacle placed in the vagina to collular debris that is extruded from the uterus via the cervix during menstruation.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# Glenn ByBell -S for BRF

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