TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED

K113699 · The Procter & Gamble Company · HEB · Jan 12, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K113699
• Device Name: TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED
• Applicant: The Procter & Gamble Company
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Jan 12, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

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

Device Story

TAMPAX® V Plastic Applicator Tampons are unscented menstrual tampons designed for the absorption of menstrual fluid. The device consists of an absorbent pledget, a non-woven overwrap, a withdrawal cord, and a plastic applicator. The pledget features a rounded tip and an extended overwrap at the withdrawal end. The device is intended for over-the-counter use by individuals to manage menstrual flow. Upon insertion into the vagina, the absorbent material captures and retains menstrual fluid. The device is a modification of a previously cleared design, maintaining equivalent performance characteristics regarding fluid handling, safety, and efficacy.

Clinical Evidence

No clinical trials were conducted. Evidence consists of non-clinical bench testing and consumer preference in-use testing. Bench testing included Syngyna fluid absorption, expulsion force, withdrawal cord anchor strength, and S. aureus growth/TSST-1 toxin production assays. Results confirmed that modifications did not negatively impact safety or performance compared to the predicate. Consumer preference in-use testing confirmed comfort and reported no adverse events.

Technological Characteristics

Materials: cotton, rayon, polypropylene, polyester. Design: absorbent pledget with non-woven overwrap, withdrawal cord, and plastic applicator. Rounded pledget tip. Fluid handling via absorption. Non-sterile, over-the-counter device.

Indications for Use

Indicated for use by individuals requiring absorption of menstrual fluid via vaginal 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® Tampons, unscented (K061486)

Submission Summary (Full Text)

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K 113699

## JAN 1 2 2012

| 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: | 10 January 2012 |
| Trade Name: | TAMPAX® V Plastic Applicator Tampons,<br>unscented |
| Common Name: | Unscented Tampon |
| Classification Name: | Unscented menstrual tampon (21 CFR 884.5470) |
| Predicate Devices: | TAMPAX® Tampons, unscented<br>K061486 |
| 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. The<br>materials of construction are cotton, rayon,<br>polypropylene and polyester. The device functions<br>by absorbing menstrual fluid after being inserted<br>into the vagina. |
| Intended Use: | TAMPAX® V Plastic Applicator Tampons,<br>unscented are intended to be inserted into the vagina<br>to absorb menstrual fluid. |

Section 5: 510(k) Summary

Technological Characteristics: The device is similar to the predicate devices in terms of basic component materials, overall design and labeling. Both the predicate and the 510(k) device have an absorbent pledget with a non-woven overwrap and a withdrawal cord. The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate device. In the subject device, the overwrap has been extended at the withdrawal end of the tampon. The absorbent pledget has a rounded tip. Minor material changes have been made to the overwrap, the withdrawal cord and the sewing thread. In addition, a plastic applicator will be used. The subject device and the predicate device have the same performance characteristics and equivalent safety and efficacy profiles.

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- Safety Assessment: Tampon material safety and design have been established in 510(k) submission K061486. Biocompatibility testing of each material in the tampon has been completed in previously cleared similar 510(k) devices.
- Nonclinical Tests: Results of the Syngyna, expulsion force, and tampon withdrawal cord anchor strength testing show no change from the predicate device and confirm that the material changes do not impact safety of the device. There was no adverse impact of the modifications of the 510(k) device on S. aureus growth and TSST-1 toxin production.
- Consumer Preference In-use Testing: Consumer preference in-use testing confirmed that the tampon and applicator are comfortable to use. There were no reports of adverse events.
- Conclusions: The results of evaluations of both the nonclinical and the consumer preference in-use 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, tampon withdrawal cord anchor strength. S. aureus growth and TSST-1 production, and consumer preference inuse testing results are within acceptable limits and similar to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the caduceus.

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

JAN 1 2 2012

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

Re: K113699

Trade/Device Name: TAMPAX® V Plastic Applicator Tampons, unscented Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: December 15, 2011 Received: December 16, 2011

Dear Dr. Blieszner:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave 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 for are candine 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 1 ou mayy atterest provisions of the Act include requirements for annual registration, listing 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 your de 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 r leave or acterination 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); medical device reporting (reporting of medical

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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 yours,

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) | K 113699 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Device Name | TAMPAX® V Plastic Applicator Tampons, unscented |
| Indications for Use | The TAMPAX® V Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid. |

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use | X |
|-------------------------------------------------------------------|---------|----------------------|---|
| (Division Sign-Off) | | | |
| Division of Reproductive, Gastro-Renal, and<br>Urological Devices | | | |
| 510(k) Number | K113699 | | |