U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS

K112635 · Kimberly-Clark Corp. · HEB · Oct 7, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K112635
• Device Name: U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
• Applicant: Kimberly-Clark Corp.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Oct 7, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

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

Device Story

Device is an unscented menstrual tampon consisting of a 100% rayon radially-wound eight-groove bullet-shaped absorbent pledget, overwrap, and withdrawal cord. The tampon is inserted into the vagina using a two-piece plastic applicator (inner plunger tube and outer insertion tube with a closed, rounded tip and textured grip). The device is intended for over-the-counter use by consumers. The applicator is available in various pearlescent colors. The device functions by absorbing menstrual fluid during use. It is a modification of a predicate device, replacing a three-piece telescopic applicator with a full-size two-piece applicator and introducing new colorants.

Clinical Evidence

Bench testing only. Biocompatibility testing included cytotoxicity, mucosal irritation, and mucosal sensitization (ISO 10993). Colorant extraction testing performed per USP 661. Absorbency performance verified against Syngyna requirements (21 CFR 801.430).

Technological Characteristics

Materials: 100% rayon fibers, non-woven fabric overwrap, rayon-polyester blend withdrawal cord, plastic applicator. Design: Eight-groove bullet-shaped pledget. Applicator: Two-piece plastic (inner plunger, outer barrel). Standards: ISO 10993 (biocompatibility), USP 661 (colorant extraction), 21 CFR 801.430 (absorbency).

Indications for Use

Indicated for use by individuals requiring vaginal absorption of 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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Image /page/0/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name in bold, sans-serif font. The words "Kimberly-Clark" are in a larger font size than "Corporation". The overall design is simple and professional.

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## Special 510(k) for Kimberly-Clark* U by KOTEX Sleek* 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><br>Mailing address for regulatory correspondence:<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076-2199 |
| Submitter's Phone No: | 770-587-8083 |
| Submitter's Fax No. | 920-225-3632 |
| Date of Preparation: | September 07, 2011 |
| Name of Device<br>Trade Name: | U by KOTEX Sleek* Unscented Menstrual Tampons;<br>Regular, Super and Super Plus absorbencies (Applicators in<br>Black, Purple, Blue, Emerald (green), Coral Orange and<br>Chartreuse (yellow) pearlescent colors) |
| Common Name: | Menstrual Tampon, Unscented |
| Classification Name: | Tampon, Menstrual, Unscented |
| Product Code: | HEB |
| Classification: | 21CFR884.5470 |
| 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;<br><br>Complete device: U by KOTEX Sleek* Unscented<br>Menstrual Tampons with applicator<br><br>Tampon component: Absorbent pledget, overwrap and a<br>withdrawal cord.<br><br>Applicator: Inner plunger tube and an outer insertion tube<br>(barrel) formed with a closed, rounded tip with a unique |
| | textured grip. |
| | The absorbent pledget consists of a ribbon of rayon fibers.<br>A rayon-polyester blend withdrawal cord 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 two-piece plastic<br>applicator consisting of an inner plunger tube and an outer<br>insertion tube (barrel) formed with a closed, rounded tip.<br>Each tampon with applicator is wrapped in an individual<br>plastic film wrapper and packaged in sealed multi-unit<br>containers for retail sale. |
| Summary of technological<br>characteristics compared to the<br>predicate device: | Kimberly Clark U by KOTEX Click* Unscented Menstrual<br>Tampons predicate device (K091749) has a compact<br>applicator with an inner plunger tube, a clear middle<br>telescopic tube and an outer insertion tube (barrel) formed<br>with a closed, rounded tip and is presented in lime green,<br>pink, blue and yellow pearlescent colors. |
| | The modification in the subject device is in providing a full<br>size applicator with a unique grip and in adding new<br>colorants to the applicator presentations. The modified<br>applicator now has an inner plunger tube and an outer<br>insertion tube (barrel) formed with a closed, rounded tip but<br>does not have the middle telescopic tube and is presented<br>in black, purple, blue, emerald (green), coral orange and<br>chartreuse (yellow) pearlescent colors. There are no<br>significant differences with respect to the other raw<br>materials used in the manufacture of the subject applicators<br>as compared to the predicate device. |
| | The fundamental scientific technology and intended use<br>remains exactly the same between the subject and the<br>predicate devices. All performance characteristics, product<br>efficacy and safety considerations between the subject<br>device and the predicate have been shown to be<br>equivalent. |
| | 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 two piece plastic<br>applicators in black, purple, blue, Emerald (green), coral<br>orange and chartreuse (yellow) pearlescent colors. The<br>withdrawal string will be available in pink and white colors.<br>No changes were made to the tampon component itself.<br>The predicate device is also composed of a 100% rayon<br>radially-wound eight-groove bullet-shaped pledget, an<br>overwrap and a withdrawal string and a three piece |

# Page 1 of 3 - Section 5. 510(k) Summary

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K112635
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Image /page/1/Picture/1 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name in bold, sans-serif font. The text is black, and the overall design is simple and corporate.

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

# Page 2 of 3 - Section 5. 510(k) Summary

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Image /page/2/Picture/0 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name "Kimberly-Clark Corporation" in a combination of bold and regular fonts. The word "Kimberly-Clark" is in bold, while "Corporation" is in a lighter, regular font.

K112635
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# Special 510(k) for Kimberly-Clark* U by KOTEX Sleek* Unscented Menstrual Tampons

| | telescoping plastic applicator, and the applicators presentations are available in lime green, pink, blue and yellow pearlescent colors. | | |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------|
| Brief description of preclinical testing: biocompatibility and colorant extration tests | Preclinical Tests<br>Cytotoxicity Test<br>Mucosal Irritation Test<br>Mucosal Sensitization Test<br>Colorant Extraction test | Standard<br>ISO 10993, Part 5<br>ISO 10993, Part 10<br>ISO 10993, Part 10<br>USP 661 | Performance<br>Meets<br>Meets<br>Meets<br>Meets |
| Safety Assessment: | The subject 510(k) device has undergone colorant extraction and biocompatibility testing. The results of these studies support the conclusion that the subject 510(k) device is equivalent and as safe as the predicate device, the Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons with applicator. | | |
| Effectiveness: | The subject 510(k) device complies with the Syngyna absorbency requirements of 21 CFR § 801.430 as does the predicate device, the Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons. | | |
| Conclusions: | The results of performance and safety assessments of the subject device support the conclusion that it is safe for its intended use and that it is substantially equivalent to the predicate device, the Kimberly-Clark* U by KOTEX Click* 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 consists of a stylized eagle with three lines representing its wings. The eagle is facing to the right. The text "U.S. Department of Health & Human Services USA" is arranged in a circular pattern around the eagle.

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

Swarna Mukund. Ph.D. Regulatory Affairs Technical Leader Kimberly-Clark Corporation 1400 Holcomb Bridge Road ROSWELL GA 30076 -

్ట్రాని nC.T

Re: K112635

Trade/Device Name: Kimberly-Clark* U by KOTEX Sleek* Unscented Menstrual Tampons Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: September 7. 2011 Received: September 9, 2011

Dear Dr. Mukund:

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 ad relies ovents (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 n you assire sportio aarro aarra boutl DA/Centers Offices/CDRH/CDRHOffices/ucm11.5809.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/McdicalDevices/Safety/ReportalProblem/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 rou that be suall 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,

Hubert Lemmer 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 symbol with a stylized cross inside, followed by the company name in bold, sans-serif font. The text is horizontally aligned and the logo is in black and white.

### INDICATIONS FOR USE

| Applicant: | Kimberly-Clark Corporation |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K112635 |
| Device Name: | Kimberly-Clark* U by KOTEX Sleek* Unscented Menstrual Tampons |
| Indications for Use: | Kimberly-Clark* U by KOTEX Sleek* is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid. |

Prescription Use 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)

OR

Concurrence of CDRH Office of Device Evaluation (ODE)

Herbert Leiner

vision Sign-Off of Reproductive, Gastro-Renal, alcal Devices 510(k) Number