U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS

K091749 · Kimberly-Clark Corp. · HEB · Dec 23, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K091749
• Device Name: U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
• Applicant: Kimberly-Clark Corp.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Traditional
• 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, withdrawal cord, and three-piece plastic applicator. Pledget is radially wound, compressed into an eight-groove bullet shape, and overwrapped with non-woven fabric. Applicator includes inner plunger, clear middle telescopic tube, and outer insertion barrel with rounded tip. Device is for over-the-counter use by patients for menstrual fluid absorption. Safety and effectiveness are supported by biocompatibility testing (ISO 10993), microbiological testing, and compliance with syngyna absorbency requirements (21 CFR 801.430).

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (genotoxicity, cytotoxicity, mucosal irritation, mucosal sensitization per ISO 10993), microbiological testing, and performance testing (syngyna absorbency per 21 CFR 801.430).

Technological Characteristics

Materials: Rayon fibers (pledget), viscose-polyester blend (cord), non-woven fabric (overwrap), plastic (applicator). Design: Three-piece telescoping applicator, eight-groove bullet-shaped pledget. Standards: ISO 10993 (biocompatibility), 21 CFR 801.430 (syngyna absorbency).

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* KOTEX® Security® Tampons (K864750)

Submission Summary (Full Text)

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

### Section 5. 510(k) SUMMARY

DEC 2 3 2009

# 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: | 770-587-7131 |
| Submitter's Fax No. | 920-380-6308 |
| Date of Preparation: | June 1, 2009 |
| Name of Device<br>Trade Name: | U by KOTEX Click* Unscented Menstrual Tampons; Regular,<br>Super and Super Plus absorbencies |
| 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* KOTEX® Security® Tampons – K864750 |
| Description of the device: | This device is a conventional unscented menstrual tampon<br>consisting of an absorbent pleget, a withdrawal cord and an<br>applicator. The absorbent pledget consists of a ribbon of rayon<br>fibers. A viscose-polyester blend withdrawal cord is placed on<br>the 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 formed pledget is<br>inserted into a three-piece plastic applicator consisting of an<br>inner plunger tube, a clear middle telescopic tube and an outer<br>insertion tube (barrel) formed with a closed, rounded tip. Each<br>tampon is wrapped in an individual plastic film wrapper and<br>packaged in sealed multi-unit containers for retail sale. |

® Registered Trademark and *Trademark of Kimberly-Clark Worldwide, Inc.

ﻟﻤﺴﺘﻤﺮ

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# නිල Kimberly-Clark Corporation

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

## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

(Continued)

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| Summary of<br>technological<br>characteristics<br>compared to the<br>predicate device: | The device is similar to the predicate device in terms of component<br>materials, overall design, packaging and labeling. This device differs<br>from the predicate device in the exact design and composition of its<br>pledget, i.e. 100% rayon radially-wound eight-groove bullet-shaped<br>pledget as compared to a rectangular pad consisting of a 70/30<br>cotton/rayon blend compressed into a bullet shape. Color of the<br>subject device and predicate applicators are also different. The<br>subject device is composed of a three piece telescoping plastic<br>applicator in lime green, pink, blue and yellow pearlescent colors<br>whereas the predicate device consists of a two-piece lavender<br>pearlescent plastic applicator. | | |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|----------------|
| Brief description of<br>preclinical<br>toxicology:<br>(biocompatibility)<br>tests | Preclinical Tests | Standard | Performance |
| | Genotoxicity Test (MLA)<br>Genotoxicity Test (AMES) | ISO 10993, Part 3<br>ISO 10993, Part 3 | Meets<br>Meets |
| | Genotoxicity Test<br>(Mouse Micronucleus) | ISO 10993, Part 3 | Meets |
| | Cytotoxicity Test | ISO 10993, Part 5 | Meets |
| | Mucosal Irritation Test | ISO 10993, Part 10 | Meets |
| | Mucosal Sensitization Test | ISO 10993, Part 10 | Meets |
| Safety Assessment: | The subject 510(k) device has undergone an extensive series of<br>safety tests, including an assessment of performance characteristics,<br>preclinical microbiological testing and biocompatibility testing. The<br>results of these studies support the conclusion that the subject 510(k)<br>device is equivalent and as safe as the predicate device, the<br>Kimberly-Clark* KOTEX® Security® Tampon. | | |
| Effectiveness: | Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons<br>comply with the syngyna absorbency requirements of 21 CFR §<br>801.430 as does the predicate device, the Kimberly-Clark* KOTEX®<br>Security® Tampons. | | |
| Conclusions: | The results of the extensive performance assessments, in vitro<br>microbiological and biocompatibility testing of the subject device,<br>Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons,<br>support the conclusion that it is safe for its intended use and that it is<br>substantially equivalent to the predicate device, the Kimberly-Clark*<br>KOTEX® Security® Tampon. | | |

® Registered Trademark and * Trademark of Kimberly-Clark Worldwide, Inc.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.

#### 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

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

DEC. 2 3 2009

Re: K091749

Trade/Device Name: U By Kotex® Click™ Menstrual Tampon (Unscented) Regulation Number: 21 CFR §884.5470 Regulation Name: Menstrual tampon Regulatory Class: II Product Code: HEB Dated: December 11, 2009 Received: December 14, 2009

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.

. ..

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/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,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# (Kimberly-Clark Corporation

## INDICATIONS FOR USE

| Applicant: | Kimberly-Clark Corporation |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K091749 |
| 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 X Per 21CFR 801.109 Subpart C

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Hory M. White
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_