PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS

K132819 · Playtex Manufacturing, Inc. · HIL · Oct 9, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K132819
• Device Name: PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
• Applicant: Playtex Manufacturing, Inc.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Oct 9, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5460
• Device Class: Class 2

Indications for Use

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

Device Story

Menstrual tampon consisting of pledget, string, and applicator (barrel and plunger). Used for absorption of menstrual fluid. Inserted into vagina by user. Modification involves change in colorant composition of polyethylene resin used in applicator. No changes to pledget or absorbency ranges. Device functions via physical absorption of fluid. Benefit is management of menstrual flow.

Clinical Evidence

Bench testing only. Syngyna testing confirmed absorbency ranges are identical to predicate and comply with 21 CFR §801.430(f)(2). Leaching studies performed to assess safety of modified applicator colorant.

Technological Characteristics

Menstrual tampon comprising pledget, string, and applicator. Applicator manufactured from polyethylene resin with modified colorant composition. Same design, absorbency, and mode of action as predicate. No electronic or software components.

Indications for Use

Indicated for use by individuals requiring absorption of menstrual fluid. Available in Light (<6g), 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® Sport (Scented) Tampons with Odorshield ™ and Playtex® Sport (Unscented) Tampons with Odorshield™ (K111684)

Submission Summary (Full Text)

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## 510(k) Summary

| Name of 510(k) Sponsor | Playtex Products, LLC<br>6 Research Drive<br>Shelton, CT 06484 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Pushpa Rao, Ph.D., D.A.B.T., R.A.C.<br>Senior Manager, Product Safety/North America Regulatory Affairs<br>Research & Development<br>Playtex Products, LLC<br>75 Commerce Drive<br>Allendale, NJ 07401<br>Telephone: [phone]<br>Facsimile: 201-785-8202 |
| Summary prepared on | September 5, 2013 |
| Pre-Market Notification # | |
| Reason for Submission | Changes were made to the applicator color compared to the predicate device.<br>These changes do not affect the intended use or alter the fundamental scientific<br>technology of the device. In addition, the efficacy of the device has not been<br>affected as there were no changes made to the tampon pledget and absorbency<br>ranges. A risk assessment is provided in this Special 510(k) pre-market<br>notification and confirms that these changes do not raise any safety concerns<br>for the proposed device. |
| Name of Device | |
| Trade Name | Playtex® (Scented) Sport Fresh Balance™ Tampons<br>Playtex® (Unscented) Sport Fresh Balance™ Tampons |
| Common Name | Menstrual Tampon, Scented and Unscented |
| Classification Name | Scented or scented deodorized menstrual tampon and Unscented menstrual<br>tampon |
| Classification Code | HIL, HEB |
| Predicate Devices | Playtex® Sport (Scented) Tampons with Odorshield ™ and Playtex® Sport<br>(Unscented) Tampons with Odorshield™ (K111684) |
| Device Description | Scented (or scented deodorized) and unscented menstrual tampons for the<br>absorption of menstrual fluid. The tampon consists of a pledget, string and<br>applicator (barrel and plunger). |
| Intended Use | Playtex scented and unscented menstrual tampons are intended to be inserted<br>into the vagina and used to absorb menstrual fluid. |
| Technological<br>Characteristics | The modified tampons have the same technological characteristics as the<br>predicate devices (K111684) as they have the same design, absorbency and |
| | mode of action. The fiber and materials in contact with the vaginal wall are<br>also the same. The only difference in the modified tampons from the predicate<br>tampons is the composition of the colorants incorporated into the polyethylene<br>resin used to manufacture the applicator. |
| Biocompatibility Tests | Deemed not applicable for the modified device based on the results of the<br>Leaching Studies. Biocompatibility testing was performed on the predicate<br>device to confirm the tampon material safety. |
| Performance Testing | No changes were made to the tampon pledget. Syngyna testing was performed<br>and the results confirmed that the absorbance ranges are the same as the<br>predicate device and comply with 21 CFR §801.430(f)(2). |
| Conclusion | As confirmed by our risk assessment and leaching studies, the proposed<br>modification on the applicator colorant has no impact on the safety or efficacy<br>of the device. The proposed device is substantially equivalent to the predicate<br>device. |

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

October 9, 2013

Playtex Manufacturing, Inc. Playtex Products, LLC % Pushpa Rao, Ph.D., D.A.B.T, R.A.C Senior Manager, Product Safety/North America Regulatory Affairs 75 Commerce Drive Allendale, NJ 07401

Re: K132819

> Trade/Device Name: Playtex® (Scented) Sport Fresh Balance™ Tampons Playtex® (Unscented) Sport Fresh Balance™ Tampons Regulation Number: 21 CFR§ 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: 11 Product Code: HIL, HEB Dated: September 5, 2013 Received: September 9, 2013

Dear Pushpa 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 mislcading.

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.

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Page 2 - Pushps Rao, Ph.D., D.A.B.T., R.A.C.

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -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

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

#### Device Name: K132819

Playtex® (Scented) Sport Fresh Balance™ Tampons Playtex® (Unscented) Sport Fresh Balance™ Tampons

#### Indications For Use:

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

Absorbency Ranges:

Absorbs menstrual flow < 6 grams (Light)

Absorbs menstrual flow 6-9 grams (Regular)

Absorbs menstrual flow 9-12 grams (Super)

Absorbs menstrual flow 12-15 grams (Super Plus)

Prescription Use Over-The-Counter Use X AND/OR . (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE)

Herbert P. Lerner 2013.10.09 14:26:00 -04'00'

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