TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)

K061486 · Procter & Gamble Co. · HEB · Aug 1, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K061486
• Device Name: TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
• Applicant: Procter & Gamble Co.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Aug 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

The device is intended to be inserted into the vagina to absorb menstrual fluid.

Device Story

Unscented menstrual tampon; consists of absorbent cotton/rayon pledget, cotton withdrawal cord, and flushable paper applicator (inner pusher tube, outer insertion tube). Inserted into vagina to absorb menstrual fluid. Design modification involves applicator grip. Safety established via biocompatibility and in vitro testing; effectiveness verified via syngyna absorbency requirements (21 CFR §801.430).

Clinical Evidence

Bench testing only. No clinical data provided. Safety supported by biocompatibility testing and effectiveness supported by compliance with syngyna absorbency requirements (21 CFR §801.430).

Technological Characteristics

Materials: cotton and/or rayon fibers, non-woven fabric overwrap, cotton cord, paper applicator. Form factor: bullet-shaped compressed pledget with flushable paper applicator. Standards: 21 CFR §801.430 (syngyna absorbency).

Indications for Use

Indicated for use by individuals requiring absorption of menstrual fluid via intravaginal insertion. Over-the-counter use.

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® Tampons (K040999)

Submission Summary (Full Text)

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K06 1486

## 510(K) SUMMARY FOR TAMPAX® TAMPONS 5.0 SUMMARY OF SAFETY AND EFFECTIVENESS

| Submission Date: | May 30, 2006 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |

Applicant Information:

| Company Name: | The Procter & Gamble Company |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Address: | 6110 Center Hill Avenue<br>Cincinnati, OH 45224 |
| Contact Person: | Philip J. Phillips, MBA<br>Director, Medical Device Practice<br>Becker & Associates Consulting, Inc.<br>[phone] (voice)<br>[phone] (fax) |
| Device Information: | |
| Trade Name: | TAMPAX® Tampons |
| Common Name: | Unscented Menstrual Tampon |
| Classification Name: | Unscented Menstrual Tampon (per 21 CFR<br>§884.5470) |
| Device Class: | II |
| Predicate Device: | TAMPAX® Tampons,<br>The Procter & Gamble Company, K040999 |
| Device Description: | The device is a conventional unscented menstrual<br>tampon consisting of an absorbent pledget, a<br>withdrawal cord, and an applicator.<br>The absorbent pledget consists of a pad of cotton<br>and/or rayon fibers overwrapped with a non-woven<br>fabric. A cotton withdrawal cord is sewn to the<br>pad, and the pad is compressed into a traditional<br>bullet-shaped pledget. The formed pledget is inserted into a flushable<br>paper applicator consisting of an inner pusher |

0018

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tube and an outer insertion tube with an open distal end.

- Each tampon is wrapped in an individual wrapper . and packaged in sealed multi-unit containers for retail sale.
Intended Use: The device is intended to be inserted into the vagina to absorb menstrual fluid.

## Comparison to Predicate Device:

Technological Characteristics: The device is similar to the predicate device in terms of component materials, overall design, and labeling. It differs from the predicate device in the design of the applicator grip.

Safety Assessment: The same materials are used in both the predicate device and this device. Therefore, the in vitro and biocompatibility testing performed on the predicate device apply to this device as well. The results of these safety tests support the conclusion that this device is safe for use.

Effectiveness: The device complies with the syngyna absorbency requirements of 21 CFR §801.430. Therefore, additional testing of these tampons is not necessary to establish their equivalence to the predicate device in terms of effectiveness.

- The results of evaluations of this device (TAMPAX® Conclusions: Tampons) support the conclusions that it is safe for its intended use and that it is substantially equivalent to the cited predicate device with regards to safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines extending from its back, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 0 1 2006

The Procter & Gamble Company c/o Philip J. Phillips, M.B.A. Director, Medical Device Practice Becker & Associates Consulting, Inc. 2001 Pennsylvania Avenue, N.W., Suite 575 WASHINGTON DC 20006

Re: K061486

Trade/Device Name: TAMPAX® Tampons Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: May 30, 2006 Received: May 31, 2006

Dear Mr. Phillips:

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 ass mated in 28, 1976, the enactment date of the Medical Device Amendments, or to devices that prov to thay 20, 177 de 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 Applerial), it they of bally of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Protecting and Promoting Public Health

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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 (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.

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). 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/edrh/industry/support/index.html.

Sincerely 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

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## 4.0 Statement of Indications for Use

| 510(k) Number (if known): | K061486 |
|---------------------------|-------------------------------|
| Device Name: | TAMPAX ^® Tampons |

Indications for Use:

TAMPAX® Tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Prescription Use (Part 21 CFR 801 Supbart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number J

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