TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)

K051290 · Procter & Gamble Co. · HEB · Dec 27, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K051290
• Device Name: TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)
• Applicant: Procter & Gamble Co.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Dec 27, 2005
• 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

Menstrual tampon consisting of absorbent pledget, withdrawal cord, and plastic applicator. Pledget composed of cotton and/or rayon fibers, overwrapped with non-woven fabric; scented versions include fragrance. Plastic applicator features outer insertion tube and inner pusher tube with flexible petals forming a rounded tip. Used by individuals for menstrual fluid absorption. Device inserted vaginally; functions via mechanical absorption of fluid. Output is the absorbed fluid retained within the pledget. Benefits include menstrual hygiene management. No clinical decision-making or healthcare provider intervention required; intended for over-the-counter use.

Clinical Evidence

Safety assessment included a battery of in vitro and clinical testing. Effectiveness established via compliance with 21 CFR 801.430 absorbency requirements. No specific clinical trial metrics (e.g., p-values, AUC) provided; results support safety and effectiveness equivalent to predicates.

Technological Characteristics

Absorbent pledget of cotton/rayon fibers; non-woven overwrap; cotton withdrawal cord. Plastic applicator (outer/inner tubes). Scented/unscented variants. Complies with 21 CFR 801.430 absorbency requirements. Non-sterile, over-the-counter device.

Indications for Use

Indicated for use by menstruating individuals for the absorption of menstrual fluid. Specifically indicated for the heaviest menstrual flow; not for use on days of light or moderate flow.

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® Pearl Plastic Applicator Tampons, Procter & Gamble (K011996)
• TAMPAX® Pearl Plastic Applicator Tampons, Procter & Gamble (K040312)

Submission Summary (Full Text)

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DEC 2 7 2005

K05/290

## 4. 510(k) Summary

| Submitted by: | The Procter & Gamble Company<br>6110 Center Hill Avenue<br>Cincinnati, OH 45224 |
|------------------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Mark M. Anderson, Regulatory Affairs Manager<br>[phone] (voice) [phone] (FAX) |
| Date Summary Prepared: | May 10, 2005 |
| Trade Name: | TAMPAX® Pearl Plastic Applicator Tampons<br>(unscented and scented) |
| Common Name: | Unscented Menstrual Tampon;<br>Scented Menstrual Tampon |
| Classification Name: | Unscented Menstrual Tampon (21 CFR 884.5470); |
| | Scented or Scented Deodorized Menstrual Tampon<br>(21 CFR 884.5460) |
| Predicate Devices: | TAMPAX® Pearl Plastic Applicator Tampons,<br>Procter & Gamble, K011996 |
| | TAMPAX® Pearl Plastic Applicator Tampons,<br>Procter & Gamble, K040312 |

Device Description: The device is a conventional menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and a plastic applicator. It is available in both scented and unscented versions.

- The absorbent pledget consists of a chevron-shaped pad of cotton and/or . rayon fibers. The pad is overwrapped with a non-woven fabric. A cotton withdrawal cord with absorbent rayon fibers adjacent to the pad is sewn to the pad. For scented tampons, fragrance is applied to the pad. For both scented and unscented tampons, the pad is compressed into a traditional bullet-shaped pledget.
- The formed pledget is inserted into a plastic applicator consisting of an . outer insertion tube and an inner pusher tube. Flexible petals form a closed, rounded tip at the distal end of the outer applicator tube.
- Each tampon is wrapped in an individual plastic film wrapper and . packaged in sealed multi-unit containers for retail sale.

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- 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 Childlogical onaracterials and overall design (see Device Description, terms of component maternation the predicate devices in the amounts of above). The dovice uned and the dimensions of the finished tampons as well as in the colorants used in certain components.
- Safety Assessment: The 510(k) device was subjected to a battery of safety tery hoooonline. - vitro and clinical testing. The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices.
- Effectiveness: The 510(k) device 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 2005

Mark M. Anderson, Ph.D. Regulatory Affairs Manager The Proctor & Gamble Company The Winton Hill Business Center Product Safety & Regulatory Affairs 6110 Center Hill Avenue CINCINNATI OH 45224

Re: K051290

Trade/Device Name: TAMPAX® Pearl Plastic Applicator Tampons, Ultra Absorbency (unscented and scented) Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: September 28, 2005 Received: September 30, 2005

Dear Dr. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have re re re re read on 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 the chero, to e enactment date of the Medical Device Amendments, or to devices that have been reasy 20, 1770, also claims 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 do not require approvate or a 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 11 your do rise as the subject to such additional controls. Existing major regulations affecting your Apploval), It they of basyer we device built of firther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I rease of advisor ination 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 I caral bailers and registration and listing (21 CFR Part 807); and 807); labeling Act 3 requirements, moduler for ing practice requirements as set forth in the quality systems (QS) (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 Sceion 510(k) I his letter will anow you to begin harketing your .
premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket nothleation. The I DA multing of basisting 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 If you desire spective advice for your device of our of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx<br>21 CFR 884.xxxx<br>21 CFR 892.xxxx<br>Other | (Gastroenterology/Renal/Urology)<br>(Obstetrics/Gynecology)<br>(Radiology) | 240-276-0115<br>240-276-0115<br>240-276-0120<br>240-276-0100 |
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation childer, "First and on your responsibilities under the Act from the 190 807.97). You may outlin outcr general mional 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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## ATTACHMENT 1

## 3. Statement of Indications for Use

510(k) Number (if known): ___K051290

TAMPAX® Pearl Plastic Applicator Tampons, Ultra Device Name: Absorbency (unscented and scented)

Indications for Use:

TAMPAX® Pearl Plastic Applicator Tampons, Ultra Absorbency (unscented and TAMI AX T Can Place of Private are inserted into the vagina and used to scented) are monotract tampers of heaviest menstrual flow. Ultra absorbency should not be used on days of light or moderate flow.

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

Over-The-Counter Use سل (21 CFR Part 801 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Syzmanski

(Division Sign-Off) Division of Reproductive and Radiological Th 510(k) Number

(Revised 09/28/2005)