U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS

K113036 · Kimberly-Clark Corporation · HEB · Nov 2, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K113036
• Device Name: U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS
• Applicant: Kimberly-Clark Corporation
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Nov 2, 2011
• 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 a conventional unscented menstrual tampon consisting of an absorbent rayon pledget, overwrap, withdrawal string, and a three-piece telescoping plastic applicator. The pledget is radially wound, eight-groove, bullet-shaped, and compressed. The applicator includes an inner plunger, a clear middle telescopic tube, and an outer insertion barrel with a closed, rounded tip. Used by consumers for menstrual fluid management. The device is provided in individual plastic film wrappers and multi-unit retail containers. The modification from the predicate involves the addition of magenta and navy blue pearlescent colorants to the applicator and an applicator design improvement. The tampon component remains unchanged except for the removal of pink dye from the white withdrawal string variant. The device functions by physical absorption of fluid; it does not involve electronic or algorithmic components.

Clinical Evidence

Bench testing only. The device underwent colorant extraction testing (USP 661), cytotoxicity testing (ISO 10993-5), and mucosal irritation/sensitization testing (ISO 10993-10). All tests met established standards. Absorbency performance was verified to comply with 21 CFR 801.430 (Syngyna test).

Technological Characteristics

Materials: 100% rayon fiber pledget, non-woven overwrap, rayon-polyester blend withdrawal string, plastic applicator (inner plunger, middle telescopic tube, outer barrel). Design: Radially-wound, eight-groove, bullet-shaped pledget. Applicator: Three-piece telescoping plastic. Colorants: Magenta and navy blue pearlescent. Standards: USP 661 (colorant extraction), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), 21 CFR 801.430 (absorbency).

Indications for Use

Indicated for use by menstruating individuals for the 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

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

Submission Summary (Full Text)

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NOV - 2 2011 K113036
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# Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons

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

### SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

| Submitter's Name: | Kimberly-Clark Corporation |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 2100 Winchester Road<br>Neenah, WI 54956<br>Mailing address for regulatory correspondence:<br>2001 Marathon Avenue<br>Neenah, WI 54956 |
| Submitter's Phone No: | 920-721-4570 |
| Submitter's Fax No. | 920-380-6467 |
| Date of Preparation: | October 11, 2011 |
| Name of Device:<br>Trade Name: | U by KOTEX Click* Unscented Menstrual Tampons; Regular<br>Super and Super Plus absorbencies (Applicators in magenta<br>and navy blue pearlescent colors) |
| Common Name: | Menstrual Tampon, Unscented |
| Classification Name: | Tampon, Menstrual, Unscented |
| Product Code: | HEB |
| Classification: | 21 CFR 884.5470 |
| 510(k) Number: | K113036 |
| 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>string and an applicator. The terminology used in<br>describing the device in rest of this 510(k) submission is as<br>follows;<br><br>Complete device: U by KOTEX Click* Unscented<br>Menstrual Tampons with applicator<br><br>Tampon component: Absorbent pledget, overwrap and a<br>withdrawal string. |
| | Applicator: Inner plunger tube, a clear middle telescopic<br>tube and an outer insertion tube (barrel) formed with a<br>closed, rounded tip.<br><br>The absorbent pledget consists of a ribbon of rayon fibers.<br>A rayon-polyester blend withdrawal string is placed on the<br>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 withdrawal<br>string will be available in pink and white colors. The<br>tampon component is inserted into a three-piece plastic<br>applicator consisting of an inner plunger tube, a clear<br>middle telescopic tube and an outer insertion tube (barrel)<br>formed with a closed, rounded tip. Each tampon with<br>applicator is wrapped in an individual plastic film wrapper |
| Summary of technological<br>characteristics compared to the<br>predicate device: | and packaged in sealed multi-unit containers for retail sale.<br><br>The currently marketed predicate device has four<br>applicators in lime green, pink, blue, yellow, (K091749)<br>pearlescent colors. The modification is to add two new<br>colorants in magenta and navy blue to the individual subject<br>device applicator presentations which were not part of the<br>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 (absorbent pledget,<br>overwrap and withdrawal string) remains unchanged as<br>compared to the predicate devices except for the removal<br>of pink dye in the white withdrawal string variant. The<br>difference between the subject and the predicate device<br>applicators is in the addition of two new applicators in<br>magenta and navy blue pearlescent colors and an<br>applicator design improvement. The fundamental scientific<br>technology and intended use remains exactly the same<br>between the subject and the predicate device. All<br>performance characteristics, product efficacy and safety<br>considerations between the subject device and predicate<br>have been shown to be equivalent.<br><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 magenta and navy blue<br>pearlescent colors. The withdrawal string will be available in<br>pink and white colors. No changes were made to the<br>tampon component itself. The predicate device is also<br>composed of a 100% rayon radially-wound eight-groove<br>bullet-shaped pledget, an overwrap and a withdrawal string<br>and a three piece telescoping plastic applicator, but the<br>applicators presentations are available in lime green, pink, |

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K113036
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# Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons

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# ഇ്ദു Kimberly-Clark Corporation

K113036
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# Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons

| | blue, yellow (K091749) pearlescent colors. | | |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------|
| Brief description of preclinical<br>testing: (colorant extraction<br>and biocompatibility) tests | Preclinical Tests<br>Colorant Extraction Test<br>Cytotoxicity Test<br>Mucosal Irritation Test<br>Mucosal Sensitization<br>Test | Standard<br>USP 661<br>ISO 10993, Part 5<br>ISO 10993, Part 10<br>ISO 10993, Part 10 | Performance<br>Meets<br>Meets<br>Meets<br>Meets |
| Safety Assessment: | The subject 510(k) device has undergone colorant<br>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 predicate device, the Kimberly-<br>Clark* U by KOTEX Click* Unscented Menstrual Tampons<br>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, 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<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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

NOV - 2 2011

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

Ms. Lori J. Barr Associate Director, Regulatory Affairs Kimberly-Clark Corporation 2100 Winchester Road NEENAH WI 54956

Re: K113036

Trade/Device Name: Kimberly-Clark* U by KOTEX Click* Unscented

Menstrual Tampons Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: October 11, 2011 Received: October 12, 2011

Dear Ms. Barr:

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/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,

Hubert Heman MD

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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Image /page/5/Picture/0 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular emblem on the left, followed by the company name in bold, sans-serif font. The emblem features a stylized "KC" within a circle, and the text is horizontally aligned.

#### INDICATIONS FOR USE

| Applicant: | Kimberly-Clark Corporation |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K113036 |
| 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 OR Per 21CFR 801.109 Subpart D

Over-The-Counter _ × Per 21CFR 801.109 Subpart C

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

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