(28 days)
Kimberly-Clark* U by KOTEX Sleek* 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, overwrap, a withdrawal cord and an applicator. The terminology used in describing the device in rest of the 510(k) submission is as follows; Complete device: U by KOTEX Sleek* Unscented Menstrual Tampons with applicator Tampon component: Absorbent pledget, overwrap and a withdrawal cord. Applicator: Inner plunger tube and an outer insertion tube (barrel) formed with a closed, rounded tip with a unique textured grip. The absorbent pledget consists of a ribbon of rayon fibers. A rayon-polyester blend withdrawal cord is placed on the ribbon and the ribbon is radially wound, then compressed into a traditional eight-groove bullet-shaped pledget, overwrapped with a non-woven fabric. The withdrawal string will be available in pink and white colors. The tampon component is inserted into a two-piece plastic applicator consisting of an inner plunger tube and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon with applicator is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.
The provided document describes a Special 510(k) submission for Kimberly-Clark* U by KOTEX Sleek* Unscented Menstrual Tampons, focusing on demonstrating substantial equivalence to a predicate device (Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons; K091749). The "study" described is a preclinical evaluation to support this substantial equivalence claim, rather than a clinical trial with human subjects.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Preclinical Tests) | Standard | Reported Device Performance |
|---|---|---|
| Cytotoxicity Test | ISO 10993, Part 5 | Meets |
| Mucosal Irritation Test | ISO 10993, Part 10 | Meets |
| Mucosal Sensitization Test | ISO 10993, Part 10 | Meets |
| Colorant Extraction Test | USP 661 | Meets |
| Syngyna Absorbency Requirements | 21 CFR § 801.430 | Complies |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document describes preclinical testing rather than clinical testing with human subjects. Therefore, the concept of a "test set" in the context of human data or AI model evaluation is not directly applicable. The "samples" would refer to the materials/components of the tampon and applicator that underwent the various biocompatibility and extraction tests. The document does not specify the number of individual test articles or replicates used for each preclinical test.
- Data Provenance: Not applicable in the sense of country of origin for human data. The tests are laboratory-based.
- Retrospective or Prospective: These preclinical tests are conducted prospectively as part of the device development and submission process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for preclinical tests like biocompatibility and absorbency is established by adherence to recognized international and national standards (ISO, USP, CFR) and successful completion of the specified assays. These tests are evaluated by laboratory personnel and regulatory bodies against predefined pass/fail criteria, not by experts establishing a subjective ground truth.
4. Adjudication Method:
Not applicable. The results of the preclinical tests are objective and measured against established performance standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The device in question is a menstrual tampon, and the evaluation is preclinical for safety and effectiveness, and for demonstrating substantial equivalence.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
No. This concept applies primarily to AI/ML software as a medical device. The evaluations performed here are for a physical medical device.
7. Type of Ground Truth Used:
The ground truth used for this evaluation is based on:
- Established Performance Standards: International standards (ISO 10993 for biocompatibility) and US Pharmacopeia (USP 661 for colorant extraction).
- Regulatory Requirements: 21 CFR § 801.430 for Syngyna absorbency, which defines the absorbency categories for menstrual tampons.
- Substantial Equivalence to a Predicate Device: The overarching goal is to demonstrate that the new device is as safe and effective as the legally marketed predicate device (K091749) by meeting the same standards and having similar technological characteristics.
8. Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" as this is not an AI/ML model. The "training" for such a device would refer to the historical data, scientific literature, and previous product development that informs the design and manufacturing of the tampon, but it's not a formal "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set as defined in AI/ML contexts. The "ground truth" for the device's design and manufacturing processes would be based on scientific principles, material science, engineering best practices, and historical performance data for similar predicate devices.
{0}------------------------------------------------
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.
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 RoadNeenah, WI 54956Mailing address for regulatory correspondence:1400 Holcomb Bridge RoadRoswell, 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 DeviceTrade Name: | U by KOTEX Sleek* Unscented Menstrual Tampons;Regular, Super and Super Plus absorbencies (Applicators inBlack, Purple, Blue, Emerald (green), Coral Orange andChartreuse (yellow) pearlescent colors) |
| Common Name: | Menstrual Tampon, Unscented |
| Classification Name: | Tampon, Menstrual, Unscented |
| Product Code: | HEB |
| Classification: | 21CFR884.5470 |
| Legally marketed deviceto which equivalency isclaimed: | Kimberly-Clark* U by KOTEX Click* Unscented MenstrualTampons; Regular, Super and Super Plus absorbencies(Applicators in lime green, pink, blue and yellow pearlescentcolors) - K091749 |
| Description of the device: | This device is a conventional unscented menstrual tamponconsisting of an absorbent pledget, overwrap, a withdrawalcord and an applicator. The terminology used in describingthe device in rest of the 510(k) submission is as follows;Complete device: U by KOTEX Sleek* UnscentedMenstrual Tampons with applicatorTampon component: Absorbent pledget, overwrap and awithdrawal cord.Applicator: Inner plunger tube and an outer insertion tube(barrel) formed with a closed, rounded tip with a unique |
| textured grip. | |
| The absorbent pledget consists of a ribbon of rayon fibers.A rayon-polyester blend withdrawal cord is placed on theribbon and the ribbon is radially wound, then compressedinto a traditional eight-groove bullet-shaped pledget,overwrapped with a non-woven fabric. The withdrawalstring will be available in pink and white colors. Thetampon component is inserted into a two-piece plasticapplicator consisting of an inner plunger tube and an outerinsertion tube (barrel) formed with a closed, rounded tip.Each tampon with applicator is wrapped in an individualplastic film wrapper and packaged in sealed multi-unitcontainers for retail sale. | |
| Summary of technologicalcharacteristics compared to thepredicate device: | Kimberly Clark U by KOTEX Click* Unscented MenstrualTampons predicate device (K091749) has a compactapplicator with an inner plunger tube, a clear middletelescopic tube and an outer insertion tube (barrel) formedwith a closed, rounded tip and is presented in lime green,pink, blue and yellow pearlescent colors. |
| The modification in the subject device is in providing a fullsize applicator with a unique grip and in adding newcolorants to the applicator presentations. The modifiedapplicator now has an inner plunger tube and an outerinsertion tube (barrel) formed with a closed, rounded tip butdoes not have the middle telescopic tube and is presentedin black, purple, blue, emerald (green), coral orange andchartreuse (yellow) pearlescent colors. There are nosignificant differences with respect to the other rawmaterials used in the manufacture of the subject applicatorsas compared to the predicate device. | |
| The fundamental scientific technology and intended useremains exactly the same between the subject and thepredicate devices. All performance characteristics, productefficacy and safety considerations between the subjectdevice and the predicate have been shown to beequivalent. | |
| The subject device is thus composed of a 100% rayonradially-wound eight-groove bullet-shaped pledget, anoverwrap and a withdrawal string and a two piece plasticapplicators in black, purple, blue, Emerald (green), coralorange and chartreuse (yellow) pearlescent colors. Thewithdrawal string will be available in pink and white colors.No changes were made to the tampon component itself.The predicate device is also composed of a 100% rayonradially-wound eight-groove bullet-shaped pledget, anoverwrap and a withdrawal string and a three piece |
Page 1 of 3 - Section 5. 510(k) Summary
{1}------------------------------------------------
K112635
Page 2 of 3
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
{2}------------------------------------------------
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
Page 3 of 3
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 TestsCytotoxicity TestMucosal Irritation TestMucosal Sensitization TestColorant Extraction test | StandardISO 10993, Part 5ISO 10993, Part 10ISO 10993, Part 10USP 661 | PerformanceMeetsMeetsMeetsMeets |
| 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.
{3}------------------------------------------------
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
{4}------------------------------------------------
Page 2
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 (800) 638-2041 or (301) 796-7100 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
{5}------------------------------------------------
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
§ 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).