TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED

K131543 · Procter & Gamble Co. · HEB · Jun 20, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K131543
• Device Name: TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
• Applicant: Procter & Gamble Co.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Jun 20, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

TAMPAX® L Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.

Device Story

TAMPAX® L Plastic Applicator Tampons are unscented menstrual tampons designed for intravaginal insertion to absorb menstrual fluid. The device consists of an absorbent pledget (cotton/rayon), overwrap, withdrawal cord, and plastic applicator. It functions via passive absorption of fluid. The device is intended for over-the-counter use by consumers. Changes from the predicate include a new applicator color and modified applicator dimensions for certain absorbencies. The pledget design remains unchanged from the predicate device.

Clinical Evidence

No clinical data. Bench testing only. Nonclinical evaluations included Syngyna testing, expulsion force, and tampon withdrawal cord anchor strength, all of which showed results within acceptable limits and similar to the predicate device. Applicator extraction testing confirmed negligible pledget exposure to applicator components.

Technological Characteristics

Materials: cotton, rayon, polypropylene, polyester. Design: chevron-shaped absorbent fiber pad, widthwise overwrap, lengthwise sewn withdrawal cord with blue dyed polypropylene fibers. Energy source: none (passive). Connectivity: none. Sterilization: not specified. Software: none.

Indications for Use

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

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® Tampons, unscented (K081555)

Submission Summary (Full Text)

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JUN 2 0 2013

The Procter & Gamble Company The Winton Hill Business Center Product Safety & Regulatory Affairs 6110 Center Hill Avenue Cincinnati, OH 45224 www.pg.com

K131543

Page 1 of 2

### Section 5: 510(k) Summary

| Submitted by: | The Procter & Gamble Company<br>6110 Center Hill Avenue<br>Cincinnati, OH 45224 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathleen Blieszner, Ph.D.<br>Regulatory Affairs Manager<br>[phone] (voice)<br>[phone] (FAX) |
| Date Summary Prepared: | May 28, 2013 |
| Trade Name: | TAMPAX® L Plastic Applicator Tampons,<br>unscented |
| Common Name: | Unscented Tampon |
| Classification Name: | Unscented menstrual tampon (21 CFR 884.5470,<br>Product Code HEB) |
| Predicate Device: | TAMPAX Pearl® Tampons, unscented<br>K081555 |
| Device Description: | Unscented menstrual tampons for absorption of<br>menstrual fluid. The tampon is a conventional<br>design consisting of an absorbent pledget, an<br>overwrap, a withdrawal cord and an applicator.<br>The materials of construction are cotton, rayon,<br>polypropylene and polyester. The device<br>functions by absorbing menstrual fluid after<br>being inserted into the vagina. |
| Intended Use: | TAMPAX® L Plastic Applicator Tampons,<br>unscented, are intended to be inserted into the<br>vagina to absorb menstrual fluid. |

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Image /page/1/Picture/7 description: The image shows the logo for Procter and Gamble, often referred to as P&G. The logo consists of the letters "P" and "G" connected by an ampersand symbol. The letters are in a bold, stylized font, giving the logo a classic and recognizable appearance.

Technological Characteristics: The device is similar to the predicate device in terms of basic component materials, overall design and labeling. Both the predicate and the 510(k) device have a chevron-shaped pad of absorbent fibers overwrapped widthwise: a cotton withdrawal cord sewn lengthwise through the middle of the overwrapped pad with blue dyed polypropylene fibers knitted into the cord at the base of the pledget. The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate device. A new color has been added to the applicator and applicator dimensions for some absorbencies have been changed. The subject device and the predicate device have the same performance characteristics and equivalent safety and efficacy profiles.

- Safety Assessment: Tampon material safety and design have been established in 510(k) submission K081555. Biocompatibility testing of each material in the tampon has been completed in previously cleared similar 510(k) devices.
- Nonclinical Tests: Extractions of the 510(k) device plastic applicators were performed under exaggerated conditions to confirm negligible or no tampon pledget exposure to the applicator components. Results of the Syngyna, expulsion force, and tampon withdrawal cord anchor strength testing show no change in parameters from the predicate device and confirm that the changes do not impact safety of the device.
- Conclusions: The tampon pledget design was not changed from the predicate device. The results of evaluation of the nonclinical testing for this device support the conclusions that the subject device is safe for its intended use and is substantially equivalent to the cited predicate device. Syngyna, expulsion force and tampon withdrawal cord anchor strength testing results are within acceptable limits and similar to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 or bird symbol, with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### June 20, 2013

The Procter & Gamble Company % Kathleen Blieszner, Ph.D. Regulatory Affairs Manager 6110 Center Hill Avenue CINCINNATI OH 45224

Re: K131543

Trade/Device Name: TAMPAX® L Plastic Applicator Tampons, unscented Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: May 28, 2013 Received: May 29, 2013

Dear Dr. Blieszner:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Kathleen Blieszner, Ph.D.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely,

# Herbert P. Derner -S

for

Benjamin R. Fisher, Ph.D. -Director-

Division of Reproductive, Gastro-Renal, and Urological 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) | K131543 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Device Name | TAMPAX® L Plastic Applicator Tampons, unscented |
| Indications for Use | The TAMPAX® L Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid. |

Prescription Use (Per 21 CFR 801. 109)
OR
Over-The-Counter Use
X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S

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