MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON

K092054 · Tosama D.D. · HEB · Jul 29, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K092054
• Device Name: MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
• Applicant: Tosama D.D.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Jul 29, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

The MOXIE unscented menstrual tampon is intended for intravaginal absorption of menstrual or other vaginal discharge.

Device Story

MOXIE tampons are unscented menstrual hygiene products designed for intravaginal absorption of menstrual or vaginal discharge. Available in two configurations: plastic applicator and non-applicator, across multiple sizes (Regular, Super, Super Plus, Ultra). Device consists of commercial cotton and rayon absorbent material, a polyethylene/polyester cover, and a cotton or rayon string. Plastic applicator version facilitates correct vaginal placement. Used by women for personal hygiene; over-the-counter availability. Safety established through biocompatibility and microbiological testing, demonstrating equivalence to legally marketed predicate tampons.

Clinical Evidence

Preclinical and clinical testing conducted. Results indicate safety is comparable to legally marketed commercial tampons. Testing included microbiological and clinical assessments.

Technological Characteristics

Materials: commercial cotton and rayon, polyethylene/polyester cover, cotton or rayon string. Form factor: tampons with or without plastic applicator in various sizes (Regular, Super, Super Plus, Ultra). Non-electronic, mechanical absorption device.

Indications for Use

Indicated for women's personal hygiene for intravaginal absorption of menstrual or other vaginal discharge. Plastic applicator version indicated for easing placement into the vagina.

Regulatory Classification

Identification

An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

Predicate Devices

• MAXIM Plastic Applicator and Non Applicator tampons (K080775)
• TAMPAX COMPAK
• COMPACT PLASTIC APPLICATOR
• o.b. ® Non Applicator Tampons

Submission Summary (Full Text)

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JUL 2 9 2009

K092054

## 510(k) Summary of Safety and Effectiveness

The MOXIE Plastic Applicator and Non Applicator Tampons are identical to MAXIM Plastic Applicator and Non Applicator tampons under K080775. The information below is identical to that approved for the MAXIM devices under K080775.

Device name (trade names):

MOXIE Compact, Plastic Applicator, Regular , Super plus and Ultra

MOXIE Non Applicator, Regular, Super ,Super plus and Ultra

#### Classification name

Unscented menstrual tampons

Device description

The MOXIE tampons are used to absorb menstrual fluid.

The MOXIE series tampons come with a plastic applicator and without a plastic applicator in sizes: Regular, Super ,Super plus and Ultra.

The MOXIE tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.

#### Equivalence to a legally marketed device

The MOXIE Plastic Applicator tampons are substantially equivalent to current commercilly marketed TAMPAX COMPAK, COMPACT PLASTIC APPLICATOR and the MOXIE Non Applicator Tampons are substantially equivalent to o.b. ® Non Applicator Tampons.

#### Intended use

The MOXIE unscented menstrual tampon is intended for intravaginal absorption of menstrual or other vaginal discharge.

This is the same intended use as current commercial tampons.

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#### Technological

There are no differences between the technical characteristics of the MOXIE tampons and the predicate characteristic of the substantial equivalent devices MAXIM tampons under K080775.

#### Biocompatibility

Biocompatability and microbiological testing has been conducted on tampons made with these commercial materials. The results of these tests demonstrate that the Moxie tampons are equivalent to legally marketed tampons. This testing included :

- · Microbiological testing
- Clinical Testing

Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons.

#### Conclusion

The MOXIE Plastic Applicator Tampons and Moxie Non Applicator Tampons are identical to MAXIM Plastic Applicator Tampons and MAXIM Non Applicator Tampons approved for market under K080775.

#### Contact

Submitted by Tosama d.d., Šaranovičeva cesta 35, Vir, 1230 Domžale, Slovenia

Contact person: Antonija Videnšek / [phone]

Signed by Quality Manager Antonija Videnšek

Ardenses

Date : June 19, 2009

#### Exhibit 116 005

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract depiction of an eagle with three stylized wing segments, symbolizing health, services, and human needs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 9 2009

Ms. Antonija Videnšek Quality Manager TOSAMA d.d. Tovarna sanitetnega materiala d.d. Vir. Šaranovičeva cesta 35 1230 Domžale SLOVENIA

Re: K092054

> Trade/Device Name: MOXIE Plastic Applicator Tampon & MOXIE Non-Applicator Tampon Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: June 22, 2009 Received: July 7, 2009

Dear Ms. Videnšek:

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 (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 (reporting of medical

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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/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/cdrl/mdr/ 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/cdrh/industry/support/index.html.

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

#### K092054 510K Number (if known):

Device Name:

MOXIE Plastic Applicator Tampon & MOXIE Non-Applicator Tampon

#### Indications for Use:

The MOXIE tampons (both types) are unscented tampons for:

• Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge.

• The plastic applicator is for easing the placement of the tam pon correctly into the vagina (only the MOXIE Plastic Applicator Tampon).

Prescription Use AND/OR Over-The Counter Use

(Part 21CFR 801 Subpart C) (Optional Format 1-2- 96)

(Part 21 CFR 801 Subpart O)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Noleen

erlas leun

Reproductive, Abdominal.

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Exhibit 116 006