(98 days)
Kimberly-Clark* U by Kotex® Security® is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.
This device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord and an applicator. The absorbent pledget consists of a ribbon of rayon fibers and cotton, overwrapped with a non-woven fabric. A withdrawal cord is placed through the pledget and knotted. The tampon pledget is compressed. The formed pledget is inserted into a two-piece plastic applicator consisting of an inner tube (plunger), and an outer insertion tube (barrel) with flexible petals that form a closed, rounded tip. Each tampon is individually wrapped in a plastic film wrapper and multiple tampons are packaged in sealed cartons for commercial sale. Tampons are available in Regular, Super and Super Plus absorbencies in various counts.
This document describes a 510(k) premarket notification for Kimberly-Clark U by Kotex® Security® Unscented Menstrual Tampons*. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.
The information provided focuses on the biocompatibility and absorbency of the device. It does not describe an AI medical device or a clinical study with human readers. Therefore, several sections of your request are not applicable to this document.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Standard | Reported Device Performance |
|---|---|---|
| Genotoxicity Test (MLA) | ISO 10993, Part 3 | Meets |
| Genotoxicity Test (AMES) | ISO 10993, Part 3 | Meets |
| Genotoxicity Test (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 |
| Acute Systemic Toxicity Test | ISO 10993, Part 11 | Meets |
| Colorant Extraction Test | USP 661 | Meets |
| Syngyna Absorbency Requirements | 21 CFR §801.430 | Complies |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the specific biocompatibility tests. It mentions that "Testing from the reference device, U by Kotex® Sleek® K112635, was used to support the safety of new applicator colors." This indicates that some of the test data was retrospective, drawn from a previously approved device. The country of origin for the data is not specified, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This document is for a medical device (menstrual tampon), not an AI device relying on expert-established ground truth from images or clinical assessments. The "ground truth" here is the physical and chemical properties of the materials and the absorbency performance as measured by standardized tests.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or adjudication of results. The results are objective measurements against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI medical device and therefore no MRMC study comparing human readers with and without AI assistance was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI medical device.
7. Type of Ground Truth Used
The ground truth used for this device's performance evaluation includes:
- Standardized Biocompatibility Test Results: Based on ISO 10993 series and USP 661, these are objective laboratory measurements of material properties and their biological interactions.
- Syngyna Absorbency Requirements: A regulatory standard (21 CFR §801.430) for measuring absorbency, representing a controlled, objective test.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for this device would be its manufacturing process and quality control.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
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 (800) 638-2041 or (301) 796-7100 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® UnscentedMenstrual Tampons |
| Indications for Use: | Kimberly-Clark* U by Kotex® Security® is an unscentedmenstrual tampon inserted into the vagina to absorbmenstrual fluid. |
| Prescription UsePer 21CFR 801.109 Subpart D | OR Over-The-Counter XPer 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 RoadNeenah, WI 54956 |
| Mailing address for regulatory correspondence:1400 Holcomb Bridge RoadRoswell, 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 DeviceTrade Name: | U by Kotex® Security® Unscented Menstrual Tampons; Regular,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 MenstrualTampons K896994 |
| Reference Device: | Kimberly-Clark* U by Kotex® Sleek® Unscented MenstrualTampons K112635 |
| Description of the device: | This device is a conventional unscented menstrual tampon consistingof an absorbent pledget, a withdrawal cord and an applicator. Theabsorbent pledget consists of a ribbon of rayon fibers and cotton,overwrapped with a non-woven fabric. A withdrawal cord is placedthrough the pledget and knotted. The tampon pledget is compressed.The formed pledget is inserted into a two-piece plastic applicatorconsisting of an inner tube (plunger), and an outer insertion tube(barrel) with flexible petals that form a closed, rounded tip. Eachtampon is individually wrapped in a plastic film wrapper and multipletampons are packaged in sealed cartons for commercial sale.Tampons are available in Regular, Super and Super Plusabsorbencies 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 forUse: | Kimberly-Clark* U by Kotex® Security® is an unscented menstrualtampon intended to be inserted into the vagina to absorbmenstrual fluid. | ||
|---|---|---|---|
| Summary oftechnologicalcharacteristicscompared to thepredicate device: | The device is the same as the predicate device with regards to thetampon component materials and overall design. The differencebetween the subject and predicate device applicator is in the additionof two new applicator colors, emerald green and royal blue. Thesubject device applicator is the same as the predicate device applicatorin all other respects. There will also be minor changes to thebrandname, packaging and labeling. The brandname will change fromKotex® Security® Natural Balance to U by Kotex® Security®. | ||
| Brief descriptionof preclinicaltoxicology:(biocompatibility)tests | Testing from the reference device, U by Kotex® Sleek® K112635,was used to support the safety of new applicator colors.Preclinical TestsGenotoxicity Test (MLA)Genotoxicity Test (AMES)Genotoxicity Test(Mouse Micronucleus)Cytotoxicity TestMucosal Irritation TestMucosal Sensitization TestAcute Systemic Toxicity TestColorant 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 ofsafety tests, including an assessment of performancecharacteristics, preclinical microbiological testing andbiocompatibility testing. Testing from the reference device, U byKotex® Sleek® K112635, was used to support the safety of newapplicator colors. The results of these studies support theconclusion that the subject 510(k) device is equivalent and as safeas the predicate device, the Kimberly- Clark* Kotex® Security®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 MenstrualTampons comply with the syngyna absorbency requirements of 21CFR §801.430 as does the predicate device, the Kimberly-Clark*Kotex® Security® Tampon. |
|---|---|
| Conclusions: | The results of the extensive performance assessments, in vitromicrobiological and biocompatibility testing of the subject device,Kimberly-ClarkU by Kotex® Security® Unscented MenstrualTampons, support the conclusion that it is safe for its intended useand that it is substantially equivalent to the predicate device, theKimberly- Clark Kotex® Security® Tampon. |
® Registered Trademark and *Trademark of Kimberly-Clark Worldwide, Inc.
§ 884.5470 Unscented menstrual tampon.
(a)
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.(b)
Classification. Class II (performance standards).