PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD

K111684 · Playtex Manufacturing, Inc. · HIL · Feb 3, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K111684
• Device Name: PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
• Applicant: Playtex Manufacturing, Inc.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Feb 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5460
• Device Class: Class 2

Indications for Use

Playtex scented or scented deodorized menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid; Playtex unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

Device Story

Menstrual tampons designed for vaginal insertion to absorb menstrual fluid. Subject device incorporates OdorShield™ technology for odor control, previously cleared in predicate devices. Device consists of fiber, string, and materials contacting vaginal wall. Used by consumers in home/personal settings. Performance verified via Syngyna testing per 21 CFR 801.430(f)(2) to ensure absorbency ranges. Safety established through biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity) and microbiological testing (TSST-1, Zone of Inhibition). Clinical assessment via randomized double-blind study using colposcopy to evaluate vaginal health over two menstrual cycles. OdorShield™ efficacy validated via expert panel and consumer testing.

Clinical Evidence

Clinical evaluation included a randomized double-blind study with a panel of women over two menstrual cycles. Safety was assessed via colposcopy at baseline, midpoint, and termination. Biocompatibility testing included ISO Agar Overlay (cytotoxicity), Human Repeat Insult Patch Test (sensitization), and Human Vaginal Irritation Study (irritation and acute systemic toxicity). Microbiology testing included Zone of Inhibition and TSST-1 testing. OdorShield™ technology efficacy was validated through expert panel assessment and consumer testing. Syngyna testing confirmed absorbency ranges per 21 CFR 801.430(f)(2).

Technological Characteristics

Menstrual tampons composed of fiber and string materials. Mode of action is physical absorption of menstrual fluid. Incorporates OdorShield™ odor-absorbing technology. Tested for biocompatibility per ISO standards. Absorbency ranges verified via Syngyna testing (6-15g). No electronic or software components.

Indications for Use

Indicated for use by women for the absorption of menstrual fluid. Available in Regular (6-9g), Super (9-12g), and Super Plus (12-15g) absorbency ranges.

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

• Playtex® Non-deodorant Sport (unscented) (K060981)
• Playtex Deodorant Sport (fresh scent) Tampons (K060981)
• Playtex Gentle Glide Tampons (K070745)

Submission Summary (Full Text)

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FEB - 3 2012

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## 510(k) Summary

| Name of 510(k) Sponsor: | Playtex Products LLC | | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | 6 Research Drive | | |
| | Shelton, CT 06484 | | |
| Contact Information: | Pushpa Rao, Ph.D., D.A.B.T., R.A.C. | | |
| | Senior Manager, Product Safety/Regulatory Affairs | | |
| | Research & Development | | |
| | Playtex Products, LLC | | |
| | 75 Commerce Drive<br>Allendale, NJ 07401 | | |
| | Telephone: [phone] | | |
| | Facsimile: 201-785-8202 | | |
| Date Submitted: | June 15, 2011 | | |
| Submission #: | K111684 | | |
| Reason for Submission: | The submission was filed to clear changes to the tampon treatment to include the<br>OdorShield™ technology and show substantial equivalence of the subject tampon<br>to the predicate devices. | | |
| Name of Device | | | |
| Trade Name | Playtex Sport (Unscented) Tampons with OdorShield™;<br>Playtex Sport (Scented) Tampons with OdorShield™ | | |
| Common Name | Menstrual Tampon, Scented and Unscented<br>Tampon, Menstrual Scented and Unscented | | |
| Classification Name | Tampon | | |
| Regulation Number | § 884.5460<br>§ 884.5470 | | |
| Product Code | HIL, HEB | | |
| Predicate Devices | Playtex® Non-deodorant Sport (unscented), Playtex Deodorant Sport (fresh scent)<br>Tampons (K060981)<br>Playtex Gentle Glide Tampons (K070745) | | |
| Device Description | Scented or scented deodorized, unscented menstrual tampons for the absorption of<br>menstrual fluid. | | |

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| Intended Use | Playtex scented or scented deodorized menstrual tampons are intended to be<br>inserted into the vagina and used to absorb menstrual fluid; |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Playtex unscented menstrual tampons are intended to be inserted into the vagina and<br>used to absorb menstrual fluid. |
| Technological<br>Characteristics | The new tampon has the same technological characteristics as the predicate device<br>(K060981). The fiber, string and materials in contact with the vaginal wall are the<br>same or have the same mode of action. The only difference is the modified use of<br>the odor absorbing technology which is already used in the currently marketed<br>Playtex Gentle Glide devices (K070745). |
| Biocompatibility Tests | Biocompatibility and microbiological studies were conducted in accordance with<br>the FDA guidance and applicable standards on the subject tampons. The testing<br>included:<br>Cytotoxicity - ISO Agar Overlay<br>Sensitization - Human Repeat Insult Patch Test<br>Irritation - Human Vaginal Irritation Study<br>Acute Systemic Toxicity - Human Vaginal Irritation Study |
| | The test articles, polar and non-polar extracts of the subject tampons were<br>evaluated for sensitization potential under occlusion using, a nine patch induction<br>phase over a period of three weeks, two week rest and challenge; The response to<br>challenge was monitored post patch over a 72 hour period. |
| | Both scented and unscented tampons were provided to a panel of women of<br>appropriate age over 2 menstrual cycles in randomized double-blind study. Expert<br>assessments were made at baseline, midpoint and termination of study by<br>colposcopy. |
| Microbiology Tests | Zone of Inhibition<br>TSST-1 Testing |
| Odor Absorption<br>Testing | Testing included expert panel assessment on OdorShield™ Technology and<br>later validated in consumer testing. |
| Syngyna Testing: | Syngyna testing was conducted in accordance to 21 CFR 801.430(f)(2) to<br>verify that the subject tampons met absorbency ranges as specified in the<br>regulation.<br>• Absorbs menstrual flow 6-9 grams (Regular)<br>• Absorbs menstrual flow 9-12 grams (Super)<br>• Absorbs menstrual flow 12-15 grams (Super Plus)<br>The tampons are labeled in accordance to these ranges. |
| Conclusion | Results of performance testing indicate that the subject tampon is<br>substantially equivalent to the predicate devices |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Pushpa Rao, Ph.D. Global Manager Product Safety/Regulatory Affairs Playtex Manufacturing Inc. 75 Commerce Drive ALLENDALE NJ 07401

FEB - 3 2012

Re: K111684

Trade/Device Name: Playtex Sport (Scented) with OdorShield™ Regulation Number: 21 CFR§ 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HIL Dated: January 26, 2012 Received: January 27, 2012

Dear Dr. Rao:

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. 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. 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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin K. Ticho

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

## 510(k) Number (if known):

Device Name:

Playtex Sport (Unscented) with OdorShield™

#### Indications for Use:

Playtex Unscented deodorized menstrual tampon are intended to be inserted into the vagina and used to absorb menstrual fluid.

Absorbency Ranges:

Absorbs menstrual flow 6-9 grams (Regular)

Absorbs menstrual flow 9-12 grams (Super)

Absorbs menstrual flow 12-15 grams (Super Plus)

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helen Glenn

CONFIDENTIAL 510

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## Indications for Use

## 510(k) Number (if known):

Device Name:

Playtex Sport (Scented) with OdorShield™

### Indications for Use:

Playtex Scented or scented deodorized menstrual tampon are intended to be inserted into the vagina and used to absorb menstrual fluid.

Absorbency Ranges:

Absorbs menstrual flow 6-9 grams (Regular)

Absorbs menstrual flow 9-12 grams (Super)

| Prescription<br>(Part 21 CFR 801 Subpart D) | Use |
|---------------------------------------------|-----|
|---------------------------------------------|-----|

AND/OR

| Over-The-Counter<br>(21 CFR 801 Subpart C) | Use _X_ |
|--------------------------------------------|---------|
|--------------------------------------------|---------|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign-Off)

Concurrence of CDRH, Office of Division of Reproductive (ODE), Gastro-Renal, and Urological Devices

| 510(k) Number | K111684 |
|---------------|---------|
|---------------|---------|

#### CONFIDENTIAL