TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS

K011996 · Procter & Gamble Co. · HIL · Sep 19, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K011996
• Device Name: TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
• Applicant: Procter & Gamble Co.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Sep 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5460
• Device Class: Class 2

Indications for Use

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

Device Story

TAMPAX Pearl tampons (scented and unscented) are menstrual hygiene devices designed for vaginal insertion to absorb menstrual fluid. The device consists of an absorbent pad, a withdrawal cord, and a plastic applicator. Key design features include a specific uncompressed absorbent pad shape, pad overwrap material, absorbent fiber in the withdrawal cord, and a colored plastic applicator. The device is intended for over-the-counter use by consumers. Safety is established through in vitro microbiological testing, biocompatibility testing, and clinical safety-in-use testing. Effectiveness is verified via compliance with syngyna absorbency requirements (21 CFR 801.430).

Clinical Evidence

Safety-in-use clinical testing was conducted on the finished product. No specific performance metrics (e.g., p-values) were provided, but results supported the conclusion of safety equivalent to predicate devices. Effectiveness was established via bench testing (syngyna absorbency requirements per 21 CFR 801.430).

Technological Characteristics

Menstrual tampon with plastic applicator. Features include uncompressed absorbent pad, pad overwrap, and absorbent fiber-containing withdrawal cord. Complies with 21 CFR 801.430 syngyna absorbency requirements. Biocompatibility and microbiological safety testing performed.

Indications for Use

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

Regulatory Classification

Identification

A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.

Submission Summary (Full Text)

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SEP 1 9 2001

K011996
Page 1 of 2

## ORIGINAL 510(k) APPLICATION (TRADITIONAL)

## 1. General Information

| | A. Application Date: | June 26, 2001 |
|--|--------------------------------------------|--------------------------------------------------------------------|
| | B. Applicant Name: | The Procter & Gamble Company<br>Feminine Care Global Business Unit |
| | Address: | 6110 Center Hill Avenue<br>Cincinnati, OH 45224 |
| | Establishment Registration Number: 1523399 | |
| | Contact Person: | Mark M. Anderson, Ph.D.<br>Regulatory Affairs Manager |
| | Phone: | [phone] |
| | FAX: | [phone] |
| | E-mail: | [e-mail] |

C. Trade Name of the Device:

TAMPAX® Pearl Scented Tampons - Plastic Applicator (Junior, Regular, Super, and Super Plus Absorbencies)

TAMPAX® Pearl Tampons (unscented) - Plastic Applicator (Junior, Requiar, Super, and Super Plus Absorbencies)

D. Common Name of the Device: Scented Menstrual Tampon, Unscented Menstrual Tampon

E. Manufacturing Facility:

Tambrands Manufacturing Inc. 2879 Hotel Road Auburn, ME 04210

Establishment Registration Number: 1219109

| Phone: | [phone] |
|----------|------------------------------------|
| FAX: | [phone] |
| Contact: | Jeff Gendron, Site Quality Manager |
| E-mail: | [e-mail] |

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K011996
Page 2 of 2

- Each tampon is wrapped in an individual plastic film wrapper and ◆ packaged in sealed multi-unit containers for retail sale.
- Intended Uses: The device is intended to be inserted into the vagina to absorb menstrual fluid.
- Technological Characteristics: The device is similar to the predicate devices in terms of component materials, overall design (see Device Description, above), and labeling. This device differs from the predicate devices in the shape of the uncompressed absorbent pad, the composition of the pad overwrap material, the inclusion of absorbent fiber in a portion of the withdrawal cord, the composition of the fragrance used in the scented tampon, and the color of the plastic applicator.
- Safety Assessment: This 510(k) device was subjected to an extensive battery of safety tests, including in vitro microbiological testing, biocompatibility testing, and safety-in-use clinical testing of the finished product. The results of these safety tests support the conclusion that this 510(k) device is equally as safe as the predicate devices.
- Effectiveness: TAMPAX® Pearl Scented Satin Tampons and TAMPAX® Pearl Unscented Tampons comply 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 tampons in terms of effectiveness.
- Conclusions: The results of evaluations of this device support the conclusions that it is safe for its intended use and that it is substantially equivalent to the cited predicate devices with regard 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 and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2001

Mark M. Anderson, Ph.D. Regulatory Affairs Manager The Procter & Gamble Company 6110 Center Hill Avenue CINCINNATI OH 45224

Re: K011996

Trade/Device Name: Scented and Unscented Menstrual Tampons Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or unscented deodorized Menstrual tampon Product Code: 85 HIL Regulatory Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Product Code: 85 HEB Regulatory Class: II Dated: June 26, 2001 Received: June 27, 2001

Dear Dr. Anderson:

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); 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.

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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.html.

Sincerely vours.

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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## 3. Statement of Indications for Use

510(k) Number (if known): _ ¥011996

Device Name: TAMPAX® Pearl Scented Tampons & TAMPAX® Pearl Tampons (unscented)

Indications for Use: 7

.

TAMPAX® Pearl Scented Tampons & TAMPAX® Pearl Unscented Tampons are TAMI FOT T Carr Occhild Tampons that and used to absorb menstrual fluid.

(Please do not write below this line-continue on another page, if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

**Over-The-Counter Use**

Nancy C. Brady D'Amico

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K011996

(Optional Format 1-2-96)

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