(21 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 string and an applicator. The terminology used in describing the device in rest of this 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 string. 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 string 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 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.
The provided text describes a Special 510(k) for Kimberly-Clark U by KOTEX Click Unscented Menstrual Tampons. This submission is for modifications to an already legally marketed device, primarily concerning the addition of new colorants for the applicator and a minor applicator design improvement. The core tampon component remains largely unchanged.
The study presented focuses on demonstrating that the modified device is substantially equivalent to the predicate device in terms of safety and effectiveness. This is not a study to prove a device meets specific acceptance criteria related to an AI algorithm's performance. Instead, it's a regulatory submission demonstrating equivalence for a medical device (menstrual tampon).
Therefore, I cannot populate most of the requested fields because the input document does not pertain to the performance of an AI algorithm or a study designed to establish its acceptance criteria and performance against those criteria. It is a regulatory filing for a physical medical device.
However, I can extract the information related to the preclinical testing performed to demonstrate safety and effectiveness for this specific device.
1. A table of acceptance criteria and the reported device performance:
| Preclinical Test (Acceptance Criteria) | Standard (Acceptance Criteria) | Reported Performance |
|---|---|---|
| Colorant Extraction Test | USP 661 | Meets |
| Cytotoxicity Test | ISO 10993, Part 5 | Meets |
| Mucosal Irritation Test | ISO 10993, Part 10 | Meets |
| Mucosal Sensitization Test | ISO 10993, Part 10 | Meets |
| Syngyna Absorbency Requirements (Effectiveness) | 21 CFR § 801.430 | Complies (as does the predicate device) |
Important Note: The "acceptance criteria" here are the standards and regulations the device must meet to demonstrate safety and effectiveness for a menstrual tampon. This is different from the acceptance criteria for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).
The following information cannot be provided from the given document as it pertains to AI algorithm studies, which is not the subject of this 510(k) summary:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
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Image /page/0/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a stylized symbol on the left, followed by the text "Kimberly-Clark Corporation". The text is in a sans-serif font, with "Kimberly-Clark" in bold and "Corporation" in a regular weight.
NOV - 2 2011 K113036
Page 1 of 3
Special 510(k) for Kimberly-Clark* U by KOTEX Click* 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:2001 Marathon AvenueNeenah, WI 54956 |
| Submitter's Phone No: | 920-721-4570 |
| Submitter's Fax No. | 920-380-6467 |
| Date of Preparation: | October 11, 2011 |
| Name of Device:Trade Name: | U by KOTEX Click* Unscented Menstrual Tampons; RegularSuper and Super Plus absorbencies (Applicators in magentaand navy blue pearlescent colors) |
| Common Name: | Menstrual Tampon, Unscented |
| Classification Name: | Tampon, Menstrual, Unscented |
| Product Code: | HEB |
| Classification: | 21 CFR 884.5470 |
| 510(k) Number: | K113036 |
| 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 withdrawalstring and an applicator. The terminology used indescribing the device in rest of this 510(k) submission is asfollows;Complete device: U by KOTEX Click* UnscentedMenstrual Tampons with applicatorTampon component: Absorbent pledget, overwrap and awithdrawal string. |
| 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 string 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 three-piece plasticapplicator consisting of an inner plunger tube, a clearmiddle telescopic tube and an outer insertion tube (barrel)formed with a closed, rounded tip. Each tampon withapplicator is wrapped in an individual plastic film wrapper | |
| Summary of technologicalcharacteristics compared to thepredicate device: | and packaged in sealed multi-unit containers for retail sale.The currently marketed predicate device has fourapplicators in lime green, pink, blue, yellow, (K091749)pearlescent colors. The modification is to add two newcolorants in magenta and navy blue to the individual subjectdevice applicator presentations which were not part of thepredicate 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 (absorbent pledget,overwrap and withdrawal string) remains unchanged ascompared to the predicate devices except for the removalof pink dye in the white withdrawal string variant. Thedifference between the subject and the predicate deviceapplicators is in the addition of two new applicators inmagenta and navy blue pearlescent colors and anapplicator design improvement. The fundamental scientifictechnology and intended use remains exactly the samebetween the subject and the predicate device. Allperformance characteristics, product efficacy and safetyconsiderations between the subject device and predicatehave been shown 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 magenta and navy bluepearlescent colors. The withdrawal string will be available inpink and white colors. No changes were made to thetampon component itself. The predicate device is alsocomposed of a 100% rayon radially-wound eight-groovebullet-shaped pledget, an overwrap and a withdrawal stringand a three piece telescoping plastic applicator, but theapplicators presentations are available in lime green, pink, |
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K113036
Page 2 of 3
Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons
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ഇ്ദു Kimberly-Clark Corporation
K113036
Page 3 of 3
Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons
| blue, yellow (K091749) pearlescent colors. | |||
|---|---|---|---|
| Brief description of preclinicaltesting: (colorant extractionand biocompatibility) tests | Preclinical TestsColorant Extraction TestCytotoxicity TestMucosal Irritation TestMucosal SensitizationTest | StandardUSP 661ISO 10993, Part 5ISO 10993, Part 10ISO 10993, Part 10 | PerformanceMeetsMeetsMeetsMeets |
| Safety Assessment: | The subject 510(k) device has undergone colorantextraction and biocompatibility testing. The results of thesestudies support the conclusion that the subject 510(k) deviceis equivalent and as safe as predicate device, the Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tamponswith applicator. | ||
| Effectiveness: | The subject 510(k) device complies with the syngynaabsorbency requirements of 21 CFR § 801.430 as does thepredicate device, 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 topredicate 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
NOV - 2 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Lori J. Barr Associate Director, Regulatory Affairs Kimberly-Clark Corporation 2100 Winchester Road NEENAH WI 54956
Re: K113036
Trade/Device Name: Kimberly-Clark* U by KOTEX Click* Unscented
Menstrual Tampons Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: October 11, 2011 Received: October 12, 2011
Dear Ms. Barr:
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/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,
Hubert Heman 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
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Image /page/5/Picture/0 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular emblem on the left, followed by the company name in bold, sans-serif font. The emblem features a stylized "KC" within a circle, and the text is horizontally aligned.
INDICATIONS FOR USE
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K113036 |
| 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 OR 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)
Concurrence of CDRH Office of Device Evaluation (ODE)
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n of Reproductive, Gastro-Renal, and 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).