TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED

K081555 · Procter & Gamble Co. · HIL · Jun 27, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K081555
• Device Name: TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
• Applicant: Procter & Gamble Co.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Jun 27, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5460
• Device Class: Class 2

Indications for Use

TAMPAX® Pearl Plastic™ unscented and scented Tampons are intended to be inserted into the vagina to absorb menstrual fluid.

Device Story

TAMPAX Pearl Plastic Tampons are menstrual hygiene products designed for intravaginal insertion to absorb menstrual fluid. The device consists of an absorbent material housed in a plastic applicator. It is intended for over-the-counter use by individuals during menstruation. The device functions by physical absorption of fluid; it does not involve electronic components, software, or automated analysis. The device is used by the patient for personal hygiene management.

Clinical Evidence

No clinical data. Safety assessment relied on bench testing, including in vitro microbiological testing, biocompatibility evaluation, and extraction testing.

Technological Characteristics

Menstrual tampon consisting of absorbent material and plastic applicator. Design and materials are consistent with predicate devices for fluid absorption. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by individuals requiring absorption of menstrual fluid via intravaginal insertion.

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.

Predicate Devices

• TAMPAX Pearl Tampons unscented and scented (K011996)
• TAMPAX Pearl Tampons unscented and scented (K040312)
• TAMPAX Pearl Tampons unscented and scented (K051290)

Submission Summary (Full Text)

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## JUN 2 7 2008

## Section 5: 510(k) Summary

| Submitted by: | The Procter & Gamble Company<br>6110 Center Hill Avenue<br>Cincinnati, OH 45224 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lenore Faulhaber, Ph.D., M.B.A.<br>Regulatory Affairs Manager<br>[phone] (voice)<br>[phone] (FAX) |
| Date Summary Prepared: | June 2, 2008 |
| Trade Name: | TAMPAX® Pearl Tampons, unscented and scented |
| Common Name: | Unscented Tampon and Scented Tampon |
| Classification Name: | Unscented menstrual tampon (21 CFR 884.5470)<br>Scented or scented deodorized menstrual tampon<br>(21 CFR 884.5460) |
| Predicate Devices: | TAMPAX Pearl Tampons® unscented and scented<br>K011996; K040312; K051290 |
| Device Description: | Scented or scented deodorized, unscented menstrual<br>tampons for absorption of menstrual fluid. |
| Intended Use: | TAMPAX Pearl Tampons® unscented and scented are<br>intended to be inserted into the vagina to absorb menstrual<br>fluid |

Technological Characteristics: The device is similar to the predicate devices in terms of basic component materials, overall design and labeling. The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices.

Safety Assessment: A battery of safety evaluations were conducted, including in vitro microbiological testing, biocompatibility evaluation and extraction testing, to evaluate the safety profile of the 510(k) device. The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices.

Conclusions: The results of evaluations for this device support the conclusions that it is safe for its intended use and substantially equivalent to the cited predicate devices.

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Image /page/1/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 stripes representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2008

Lenore Faulhaber, Ph.D., M.B.A. Regulatory Affairs Manager The Proctor & Gamble Company 6110 Center Hill Avenue CINCINNATI OH 45224

Re: K081555

Trade Name: TAMPAX® Pearl Plastic Tampons (Scented and Unscented) Regulation Number: 884.5460, 884.5470 Regulation Name: Menstrual Tampons (scented, unscented) Regulatory Class: II Product Code: HIL Dated: June 2, 2008 Received: June 3, 2008

Dear Dr. Faulhaber:

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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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.

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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## Indications for Use Statement

| 510(k) Number (if known) | K081555 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Device Name | TAMPAX® Pearl Plastic™ Tampons |
| Indications for Use | The TAMPAX® Pearl Plastic™ unscented and scented Tampons are intended to be inserted into the vagina 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

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Hulut lener

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(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K081555