MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS

K080775 · Tosama D.D. · HEB · Sep 10, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K080775
• Device Name: MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS
• Applicant: Tosama D.D.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Sep 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

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

Device Story

Maxim tampons are unscented menstrual hygiene products designed for intravaginal absorption of menstrual or vaginal discharge. Available in both plastic applicator and non-applicator configurations, they are offered in Regular, Super, Super plus, and Ultra sizes. The device is intended for over-the-counter use by women. The plastic applicator facilitates correct vaginal placement. The device functions through physical absorption of fluids using a core of commercial cotton and rayon, enclosed in a polyethylene/polyester cover, with a cotton or rayon string for removal. The device is used by the patient for personal hygiene management.

Clinical Evidence

Preclinical and clinical testing conducted. Testing included microbiological assessment and clinical evaluation to demonstrate safety and performance equivalence to legally marketed tampons.

Technological Characteristics

Materials: commercial cotton and rayon core, polyethylene/polyester cover, cotton or rayon string. Absorbency: 15-18 grams per Syngyna test method (21 CFR 801.430). Form factor: Regular, Super, Super plus, Ultra sizes; plastic applicator or non-applicator options.

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

• TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPO
• o.b.® Non-applicator Tampons

Submission Summary (Full Text)

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## SEP 1 0 2008

## 510(k) Summary of Safety and Effectiveness

| Device name<br>(trade names): | Maxim Compact, plastic Applicator, Regular & Super<br>Maxim Compact, plastic Applicator, Super plus & Ultra<br>Maxim Non Applicator, Regular & Super<br>Maxim Non Applicator, Super plus & Ultra |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification name | Unscented menstrual tampons |
| Device description | The Maxim tampons are used to absorb menstrual fluid.<br>The Maxim series tampons comes with plastic applicator and without in<br>sizes: Regular, Super, Super plus, Ultra.<br>The Maxim tampons are made of commercial cotton and rayon, a<br>polyethylene/polyester cover, and cotton or rayon string. |
| Equivalence to a<br>legally marketed<br>device | The Maxim tampons are substantially equivalent to current commercial<br>TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPO<br>And o.b.® Non-applicator Tampons. |
| Intended use | The Maxim unscented menstrual tampon is intended for intravaginal<br>absorption of menstrual or other vaginal discharge.<br>This is the same intended use as current commercial tampons. |
| Technological | The only difference between the modified ob® tampons and the predicate<br>characteristics tampons is the absorbency has increased to 15-18 grams<br>absorbency measured by the syngyna test method (21 CFR 801.430). This<br>is accomplished by slight increases in the weight and dimensions of the<br>tampons |
| Biocompatibility | Biocompatability and microbiological testing has been conducted on<br>tampons made with these commercial materials. The results of these tests<br>demonstrate that the Maxim tampons are equivalent to legally marketed<br>tampons. This testing included :<br>- Microbiological testing<br>- Clinical Testing |
| Conclusion | Results of preclinical and clinical testing indicate that the safety of the<br>modified tampon is comparable to current legally marketed, commercial<br>tampons. |
| Contact | Submitted by Tosama d.d., Saranoviceva cesta 35, Vir, 1230 Domzale,<br>Slovenia<br>Contact person: Antonija Vidensek / [phone] |
| Date | This Summary was prepared on October 20., 2007 |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines representing its wings and body. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2008

Tosama d.d. % Mr. Harry van Vugt Responsible Third Party Official KEMA Quality B. V. 4377 County Line Road CHALFONT PA 18914

Re: K080775

Trade Name: MAXIM Plastic Applicator Tampon & MAXIM Non-Applicator Tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: August 21, 2008 Received: August 26, 2008

Dear Mr. van Vugt:

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 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.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Arne M. Whang

Joyce M. Whang, Ph.D. 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

K080775 510K Number (if known):

MAXIM Plastic Applicator Tampon & MAXIM non-Applicator Tampon Device Name:

Indications for Use:

The MAXIM 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 tampon correctly into . the vagina (only the MAXIM Plastic Applicator Tampon).

| Prescription Use | |
|----------------------------|--|
| (Part 21CFR 801 Subpart D) | |

AND/OR

| Over-The Counter Use | X |
|----------------------------|---|
| (Part 21CFR 801 Subpart C) | |
| (Optional Format 1-2-96) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulu

Anden-

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

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