(30 days)
Kimberly-Clark* U by KOTEX Click* 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 Click* Unscented Menstrual Tampons with applicator Tampon component: Absorbent pledget, overwrap and a withdrawal cord. Applicator: Inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip. 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 tampon component is inserted into a three-piece plastic applicator consisting of an inner plunger tube, a clear middle telescopic 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.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons, formatted according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Biocompatibility Tests: | |
| 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 |
| Effectiveness: | |
| 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 size used for the test set of the preclinical or effectiveness studies. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies listed (e.g., biocompatibility tests, syngyna absorbency) are laboratory-based tests with objective criteria, rather than expert-driven assessments requiring a "ground truth" established by human experts.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are laboratory-based and do not involve human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or implied. The submission is for a modification (new applicator colors) to an already legally marketed device, and the focus is on demonstrating equivalence through preclinical and performance tests, not on improving human reader performance with AI.
6. Standalone (Algorithm Only) Performance Study
This is not applicable as the device is a physical menstrual tampon and not an algorithm or AI-driven system.
7. Type of Ground Truth Used
The "ground truth" for the acceptance criteria mentioned generally refers to:
- Established biological responses/endpoints: For biocompatibility tests (e.g., cell viability for cytotoxicity, inflammatory response for irritation/sensitization, systemic effects for toxicity).
- Standardized physical measurement: For syngyna absorbency, the ground truth is a specific absorbency value determined by the standardized test method outlined in 21 CFR § 801.430.
8. Sample Size for the Training Set
This is not applicable as the device is not an AI/ML algorithm that requires a training set. The existing device (predicate) serves as a basis for substantial equivalence for the modified device.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated in point 8.
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്യ Kimberly-Clark Corporation
Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons
Section 5. 510(k) SUMMARY
DEC 1 0 2010
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: | 770-587-7131 |
| Submitter's Fax No. | 920-380-6308 |
| Date of Preparation: | November 09, 2010 |
| Name of DeviceTrade Name: | U by KOTEX Click* Unscented Menstrual Tampons;Regular, Super and Super Plus absorbencies (Applicators inviolet and orange pearlescent colors) |
| Common Name: | Menstrual Tampon, Unscented |
| Classification Name: | Tampon, Menstrual, Unscented |
| Product Code: | HEB |
| 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 Click* UnscentedMenstrual Tampons with applicator | |
| Tampon component: Absorbent pledget, overwrap and awithdrawal cord. | |
| Applicator: Inner plunger tube, a clear middle telescopictube and an outer insertion tube (barrel) formed with aclosed, rounded tip. | |
| The absorbent pledget consists of a ribbon of rayon fibers.A rayon-polyester blend withdrawal cord is placed on the |
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දිග්රී Kimberly-Clark Corporation
Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons
| ribbon and the ribbon is radially wound, then compressedinto a traditional eight-groove bullet-shaped pledget,overwrapped with a non-woven fabric. The tamponcomponent is inserted into a three-piece plastic applicatorconsisting of an inner plunger tube, a clear middletelescopic tube and an outer insertion tube (barrel) formedwith a closed, rounded tip. Each tampon with applicator iswrapped in an individual plastic film wrapper and packagedin sealed multi-unit containers for retail sale. | |||
|---|---|---|---|
| Summary of technologicalcharacteristics compared to thepredicate device: | The currently marketed predicate device has fourapplicators in lime green, pink, blue and yellow pearlescentcolors. The modification is to add three new colorants inblack, violet and orange pearlescent colors to the individualsubject device applicator presentations which were not partof the predicate device. All other raw materials used in themanufacture of the subject applicators remain unchangedas compared to the predicate device. The tamponcomponent of the subject device (pledget, overwrap andwithdrawal string) remains completely unchanged ascompared to the predicate device. Thus, the only differencebetween the subject and the predicate device is in theaddition of three new applicators in black, violet and orangepearlescent colors. The fundamental scientific technologyand intended use remains exactly the same between thesubject and the predicate devices. All performancecharacteristics, product efficacy and safety considerationsbetween the subject device and the predicate have beenshown to be equivalent.The subject device is thus composed of a 100% rayonradially-wound eight-groove bullet-shaped pledget, anoverwrap and a withdrawal string and a three piecetelescoping plastic applicators in black, violet and orangepearlescent colors. The predicate device is also composedof a 100% rayon radially-wound eight-groove bullet-shapedpledget, an overwrap and a withdrawal string and a threepiece telescoping plastic applicator, but the applicatorspresentations are available in lime green, pink, blue andyellow pearlescent colors. | ||
| Brief description of preclinicaltoxicology: (biocompatibility)tests | Preclinical TestsCytotoxicity TestMucosal Irritation TestMucosal SensitizationTestAcute Systemic ToxicityTest | StandardISO 10993, Part 5ISO 10993, Part 10ISO 10993, Part 10ISO 10993, Part 11 | PerformanceMeetsMeetsMeetsMeets |
| Safety Assessment: | The subject 510(k) device has undergone applicator color |
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Image /page/2/Picture/0 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a stylized symbol on the left, followed by the company name "Kimberly-Clark Corporation" in bold, black font. The symbol appears to be a stylized representation of a cross or star within a circle.
Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons
| extraction and biocompatibility testing. The results of thesestudies support the conclusion that the subject 510(k) deviceis equivalent and as safe as the predicate device, theKimberly-Clark* U by KOTEX Click* Unscented MenstrualTampons with applicator. | |
|---|---|
| Effectiveness: | The subject 510(k) device complies with the syngynaabsorbency requirements of 21 CFR § 801.430 as does thepredicate device, the Kimberly-Clark* U by KOTEX Click*Unscented Menstrual Tampons. |
| Conclusions: | The results of performance and safety assessments of thesubject device support the conclusion that it is safe for itsintended use and that it is substantially equivalent to thepredicate 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Cheryl Sanzare Associate Director, Global Regulatory Affairs Kimberly Clark Corporation 1400 Holcomb Bridge Road ROSWELL GA 30076
DEC 1 0 2010
Re: K103311
Trade Name: Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons Regulation Number: 21 CFR 8884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: November 9, 2010 Received: November 10, 2010
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. 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 quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hukut Zemin us
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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K103311
Image /page/5/Picture/1 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol to the left of the company name. The company name is written in a combination of bold and regular font styles. The word "Kimberly-Clark" is in bold, while "Corporation" is in a regular font.
:
DEC 1 0 2010
INDICATIONS FOR USE
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K103311 |
| Device Name: | Kimberly-Clark* U by KOTEX Click* Unscented MenstrualTampons |
| Indications forUse: | Kimberly-Clark* U by KOTEX Click* is an unscented menstrualtampon inserted into the vagina to absorb menstrual fluid. |
Prescription Use 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)
OR
Concurrence of CDRH Office of Device Evaluation (ODE)
Helen Remm
ive, Gastro-Renal, and
§ 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).