U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS

K141294 · Kimberly-Clark Corp. · HEB · Aug 25, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K141294
• Device Name: U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
• Applicant: Kimberly-Clark Corp.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Aug 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

Kimberly-Clark* U by Kotex® Security® is an unscented menstrual tampon intended to be inserted into the vagina to absorb menstrual fluid.

Device Story

Device is a conventional unscented menstrual tampon; consists of absorbent pledget (rayon fibers and cotton, overwrapped with non-woven fabric), withdrawal cord, and two-piece plastic applicator (inner plunger, outer barrel with flexible petals). Used by patients for menstrual fluid absorption. Device is inserted into the vagina; functions via physical absorption. No electronic or software components. Benefits include menstrual hygiene management.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including syngyna absorbency testing per 21 CFR 801.430, in vitro microbiological testing, and biocompatibility testing (genotoxicity, cytotoxicity, mucosal irritation/sensitization, acute systemic toxicity, and colorant extraction) conducted per ISO 10993 and USP 661 standards.

Technological Characteristics

Materials: rayon fibers, cotton, non-woven fabric, plastic applicator. Design: compressed pledget with withdrawal cord. Energy: none (mechanical). Connectivity: none. Sterilization: not specified. Standards: ISO 10993 (biocompatibility), USP 661 (colorant extraction), 21 CFR 801.430 (syngyna 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® Security® Unscented Menstrual Tampons (K896994)

Reference Devices

• Kimberly-Clark* U by Kotex® Sleek® Unscented Menstrual Tampons (K112635)

Submission Summary (Full Text)

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

August 25, 2014

Kimberly-Clark Corp. Charnelle Thomas Global Regulatory Affairs Specialist 1400 Holcomb Bridge Road Rowell, GA 30076

Re: K141294

> Trade/Device Name: U by Kotex Security Unscented Menstrual Tampons Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: June 17, 2014 Received: June 19, 2014

Dear Charnelle Thomas,

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.

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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 vours.

# Benjamin R. Fisher -S

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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Image /page/2/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized "K" inside, followed by the company name in bold, sans-serif font. The words "Kimberly-Clark" are in a larger, bolder font than the word "Corporation."

# INDICATIONS FOR USE

| Applicant: | Kimberly-Clark Corporation |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K141294 |
| Device Name: | Kimberly-Clark* U by Kotex® Security® Unscented<br>Menstrual Tampons |
| Indications for Use: | Kimberly-Clark* U by Kotex® Security® is an unscented<br>menstrual tampon inserted into the vagina to absorb<br>menstrual fluid. |
| Prescription Use<br>Per 21CFR 801.109 Subpart D | OR Over-The-Counter <span style="text-decoration: underline;">X</span><br>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)

Page 1 of 1 - Section 4. Indications for Use

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# ්‍යු Kimberly-Clark Corporation

# Traditional 510(k) for Kimberly-Clark* U by Kotex® Security® 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 |
| | Mailing address for regulatory correspondence:<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076-2199 |
| Submitter's Phone No: | 678-352-6031 |
| Submitter's Fax No. | 920-225-4979 |
| Date of Preparation: | August 25, 2014 |
| Name of Device<br>Trade Name: | U by Kotex® Security® Unscented Menstrual Tampons; Regular,<br>Super and Super Plus absorbencies |
| Common Name: | Menstrual Tampon, Unscented |
| Classification Name: | Tampon, Menstrual, Unscented |
| Product Code: | HEB |
| Classification: | 21 CFR 884.5470 |
| Predicate Device: | Kimberly-Clark* U by Kotex® Security® Unscented Menstrual<br>Tampons K896994 |
| Reference Device: | Kimberly-Clark* U by Kotex® Sleek® Unscented Menstrual<br>Tampons K112635 |
| Description of the device: | This device is a conventional unscented menstrual tampon consisting<br>of an absorbent pledget, a withdrawal cord and an applicator. The<br>absorbent pledget consists of a ribbon of rayon fibers and cotton,<br>overwrapped with a non-woven fabric. A withdrawal cord is placed<br>through the pledget and knotted. The tampon pledget is compressed.<br>The formed pledget is inserted into a two-piece plastic applicator<br>consisting of an inner tube (plunger), and an outer insertion tube<br>(barrel) with flexible petals that form a closed, rounded tip. Each<br>tampon is individually wrapped in a plastic film wrapper and multiple<br>tampons are packaged in sealed cartons for commercial sale.<br>Tampons are available in Regular, Super and Super Plus<br>absorbencies in various counts. |

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

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# Traditional 510(k) for Kimberly-Clark* U by Kotex® Security® Unscented Menstrual Tampons

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION (Continued)

| Indications for<br>Use: | Kimberly-Clark* U by Kotex® Security® is an unscented menstrual<br>tampon intended to be inserted into the vagina to absorb<br>menstrual fluid. | | |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------|
| Summary of<br>technological<br>characteristics<br>compared to the<br>predicate device: | The device is the same as the predicate device with regards to the<br>tampon component materials and overall design. The difference<br>between the subject and predicate device applicator is in the addition<br>of two new applicator colors, emerald green and royal blue. The<br>subject device applicator is the same as the predicate device applicator<br>in all other respects. There will also be minor changes to the<br>brandname, packaging and labeling. The brandname will change from<br>Kotex® Security® Natural Balance to U by Kotex® Security®. | | |
| Brief description<br>of preclinical<br>toxicology:<br>(biocompatibility)<br>tests | Testing from the reference device, U by Kotex® Sleek® K112635,<br>was used to support the safety of new applicator colors.<br><br>Preclinical Tests<br>Genotoxicity Test (MLA)<br>Genotoxicity Test (AMES)<br>Genotoxicity Test<br>(Mouse Micronucleus)<br>Cytotoxicity Test<br>Mucosal Irritation Test<br>Mucosal Sensitization Test<br>Acute Systemic Toxicity Test<br>Colorant Extraction Test | Standard | Performance |
| | | ISO 10993, Part 3 | Meets |
| | | ISO 10993, Part 3 | Meets |
| | | ISO 10993, Part 3 | Meets |
| | | ISO 10993, Part 5 | Meets |
| | | ISO 10993, Part 10 | Meets |
| | | ISO 10993, Part 10 | Meets |
| | | ISO 10993, Part11 | Meets |
| | | USP 661 | Meets |
| Safety Assessment: | The subject 510(k) device has undergone an extensive series of<br>safety tests, including an assessment of performance<br>characteristics, preclinical microbiological testing and<br>biocompatibility testing. Testing from the reference device, U by<br>Kotex® Sleek® K112635, was used to support the safety of new<br>applicator colors. The results of these studies support the<br>conclusion that the subject 510(k) device is equivalent and as safe<br>as the predicate device, the Kimberly- Clark* Kotex® Security®<br>Tampon. | | |

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

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Image /page/5/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a stylized "K" symbol to the left of the company name. The company name is written in a combination of bold and regular font weights, with "Kimberly-Clark" in bold and "Corporation" in a lighter weight.

# Traditional 510(k) for Kimberly-Clark* U by Kotex® Security® Unscented Menstrual Tampons

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION (Continued)

| Effectiveness: | Kimberly-Clark* U by Kotex® Security® Unscented Menstrual<br>Tampons comply with the syngyna absorbency requirements of 21<br>CFR §801.430 as does the predicate device, the Kimberly-Clark*<br>Kotex® Security® Tampon. |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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® Security® Unscented Menstrual<br>Tampons, support the conclusion that it is safe for its intended use<br>and that it is substantially equivalent to the predicate device, the<br>Kimberly- Clark* Kotex® Security® Tampon. |

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