U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS

K103311 · Kimberly Clark Corporation · HEB · Dec 10, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K103311
• Device Name: U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
• Applicant: Kimberly Clark Corporation
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Dec 10, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

Kimberly-Clark* U by KOTEX Click* is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.

Device Story

Device is an unscented menstrual tampon consisting of an absorbent rayon pledget, overwrap, withdrawal cord, and a three-piece plastic telescoping applicator. The applicator features an inner plunger, a clear middle tube, and an outer barrel with a rounded tip. The device is intended for over-the-counter use by females to absorb menstrual fluid. The subject device introduces new black, violet, and orange pearlescent colorants to the applicator plastic. The tampon component remains identical to the predicate. The device is used by the patient for personal hygiene during menstruation.

Clinical Evidence

Bench testing only. Biocompatibility testing included cytotoxicity (ISO 10993-5), mucosal irritation (ISO 10993-10), mucosal sensitization (ISO 10993-10), and acute systemic toxicity (ISO 10993-11), all of which met requirements. Absorbency performance complies with 21 CFR 801.430.

Technological Characteristics

Materials: 100% rayon radially-wound eight-groove bullet-shaped pledget, non-woven overwrap, rayon-polyester blend withdrawal cord, and plastic telescoping applicator. The applicator is modified with black, violet, or orange pearlescent colorants. The device is a non-sterile, over-the-counter menstrual product.

Indications for Use

Indicated for use by females to absorb menstrual fluid.

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

• Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons (K091749)

Submission Summary (Full Text)

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# ്യ Kimberly-Clark Corporation

K103311

# Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons

#### Section 5. 510(k) SUMMARY

DEC 1 0 2010

### SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

| Submitter's Name: | Kimberly-Clark Corporation |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 2100 Winchester Road<br>Neenah, WI 54956 |
| | Mailing address for regulatory correspondence:<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076-2199 |
| Submitter's Phone No: | 770-587-7131 |
| Submitter's Fax No. | 920-380-6308 |
| Date of Preparation: | November 09, 2010 |
| Name of Device<br>Trade Name: | U by KOTEX Click* Unscented Menstrual Tampons;<br>Regular, Super and Super Plus absorbencies (Applicators in<br>violet and orange pearlescent colors) |
| Common Name: | Menstrual Tampon, Unscented |
| Classification Name: | Tampon, Menstrual, Unscented |
| Product Code: | HEB |
| Legally marketed device<br>to which equivalency is<br>claimed: | Kimberly-Clark* U by KOTEX Click* Unscented Menstrual<br>Tampons; Regular, Super and Super Plus absorbencies<br>(Applicators in lime green, pink, blue and yellow pearlescent<br>colors) - K091749 |
| Description of the device: | This device is a conventional unscented menstrual tampon<br>consisting of an absorbent pledget, overwrap, a withdrawal<br>cord and an applicator. The terminology used in describing<br>the device in rest of the 510(k) submission is as follows; |
| | Complete device: U by KOTEX Click* Unscented<br>Menstrual Tampons with applicator |
| | Tampon component: Absorbent pledget, overwrap and a<br>withdrawal cord. |
| | Applicator: Inner plunger tube, a clear middle telescopic<br>tube and an outer insertion tube (barrel) formed with a<br>closed, rounded tip. |
| | The absorbent pledget consists of a ribbon of rayon fibers.<br>A rayon-polyester blend withdrawal cord is placed on the |

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# දිග්‍රී Kimberly-Clark Corporation

## Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons

| ribbon and the ribbon is radially wound, then compressed<br>into a traditional eight-groove bullet-shaped pledget,<br>overwrapped with a non-woven fabric. The tampon<br>component is inserted into a three-piece plastic applicator<br>consisting of an inner plunger tube, a clear middle<br>telescopic tube and an outer insertion tube (barrel) formed<br>with a closed, rounded tip. Each tampon with applicator is<br>wrapped in an individual plastic film wrapper and packaged<br>in sealed multi-unit containers for retail sale. | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Summary of technological<br>characteristics compared to the<br>predicate device: | The currently marketed predicate device has four<br>applicators in lime green, pink, blue and yellow pearlescent<br>colors. The modification is to add three new colorants in<br>black, violet and orange pearlescent colors to the individual<br>subject device applicator presentations which were not part<br>of the predicate device. All other raw materials used in the<br>manufacture of the subject applicators remain unchanged<br>as compared to the predicate device. The tampon<br>component of the subject device (pledget, overwrap and<br>withdrawal string) remains completely unchanged as<br>compared to the predicate device. Thus, the only difference<br>between the subject and the predicate device is in the<br>addition of three new applicators in black, violet and orange<br>pearlescent colors. The fundamental scientific technology<br>and intended use remains exactly the same between the<br>subject and the predicate devices. All performance<br>characteristics, product efficacy and safety considerations<br>between the subject device and the predicate have been<br>shown to be equivalent.<br>The subject device is thus composed of a 100% rayon<br>radially-wound eight-groove bullet-shaped pledget, an<br>overwrap and a withdrawal string and a three piece<br>telescoping plastic applicators in black, violet and orange<br>pearlescent colors. The predicate device is also composed<br>of a 100% rayon radially-wound eight-groove bullet-shaped<br>pledget, an overwrap and a withdrawal string and a three<br>piece telescoping plastic applicator, but the applicators<br>presentations are available in lime green, pink, blue and<br>yellow pearlescent colors. | | |
| Brief description of preclinical<br>toxicology: (biocompatibility)<br>tests | Preclinical Tests<br>Cytotoxicity Test<br>Mucosal Irritation Test<br>Mucosal Sensitization<br>Test<br>Acute Systemic Toxicity<br>Test | Standard<br>ISO 10993, Part 5<br>ISO 10993, Part 10<br>ISO 10993, Part 10<br>ISO 10993, Part 11 | Performance<br>Meets<br>Meets<br>Meets<br>Meets |
| Safety Assessment: | The subject 510(k) device has undergone applicator color | | |

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Image /page/2/Picture/0 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a stylized symbol on the left, followed by the company name "Kimberly-Clark Corporation" in bold, black font. The symbol appears to be a stylized representation of a cross or star within a circle.

## Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons

| | extraction and biocompatibility testing. The results of these<br>studies support the conclusion that the subject 510(k) device<br>is equivalent and as safe as the predicate device, the<br>Kimberly-Clark* U by KOTEX Click* Unscented Menstrual<br>Tampons with applicator. |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Effectiveness: | The subject 510(k) device complies with the syngyna<br>absorbency requirements of 21 CFR § 801.430 as does the<br>predicate device, the Kimberly-Clark* U by KOTEX Click*<br>Unscented Menstrual Tampons. |
| Conclusions: | The results of performance and safety assessments of the<br>subject device support the conclusion that it is safe for its<br>intended use and that it is substantially equivalent to the<br>predicate device, the Kimberly-Clark* U by KOTEX Click*<br>Unscented Menstrual Tampons. |

.

*Trademark of Kimberly-Clark Worldwide, Inc.

. . .

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Ms. Cheryl Sanzare Associate Director, Global Regulatory Affairs Kimberly Clark Corporation 1400 Holcomb Bridge Road ROSWELL GA 30076

DEC 1 0 2010

Re: K103311

> Trade Name: Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons Regulation Number: 21 CFR 8884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: November 9, 2010 Received: November 10, 2010

Dear Ms. Sanzare:

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 of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,**

Hukut Zemin us

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

#### Enclosure

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# K103311

Image /page/5/Picture/1 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol to the left of the company name. The company name is written in a combination of bold and regular font styles. The word "Kimberly-Clark" is in bold, while "Corporation" is in a regular font.

:

DEC 1 0 2010

#### INDICATIONS FOR USE

| Applicant: | Kimberly-Clark Corporation |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K103311 |
| Device Name: | Kimberly-Clark* U by KOTEX Click* Unscented Menstrual<br>Tampons |
| Indications for<br>Use: | Kimberly-Clark* U by KOTEX Click* is an unscented menstrual<br>tampon inserted into the vagina to absorb menstrual fluid. |

Prescription Use Per 21CFR 801.109 Subpart D Over-The-Counter X Per 21CFR 801.109 Subpart C

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

OR

Concurrence of CDRH Office of Device Evaluation (ODE)

Helen Remm

ive, Gastro-Renal, and