(190 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 pleget, a withdrawal cord and an applicator. The absorbent pledget consists of a ribbon of rayon fibers. A viscose-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 formed pledget 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 is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.
This document is a 510(k) Summary for a Kimberly-Clark U by KOTEX Click Unscented Menstrual Tampon**. It details the device's characteristics, safety, and effectiveness in comparison to a predicate device. This is a medical device application, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable.
Here's the information that can be extracted relevant to the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Genotoxicity Test (MLA) as per ISO 10993, Part 3 | Meets |
| Genotoxicity Test (AMES) as per ISO 10993, Part 3 | Meets |
| Genotoxicity Test (Mouse Micronucleus) as per ISO 10993, Part 3 | Meets |
| Cytotoxicity Test as per ISO 10993, Part 5 | Meets |
| Mucosal Irritation Test as per ISO 10993, Part 10 | Meets |
| Mucosal Sensitization Test as per ISO 10993, Part 10 | Meets |
| Syngyna absorbency requirements of 21 CFR § 801.430 | Complies |
The study that proves the device meets the acceptance criteria:
The document states that the "subject 510(k) device has undergone an extensive series of safety tests, including an assessment of performance characteristics, preclinical microbiological testing 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."
Specifically, for biocompatibility and genotoxicity, the following preclinical tests were performed:
- Genotoxicity Test (MLA)
- Genotoxicity Test (AMES)
- Genotoxicity Test (Mouse Micronucleus)
- Cytotoxicity Test
- Mucosal Irritation Test
- Mucosal Sensitization Test
For effectiveness, the device's compliance with syngyna absorbency requirements was assessed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a traditional medical device (tampon), not an AI/ML device. The "test set" here refers to materials and components of the tampon tested against specified standards. Specific sample sizes for each preclinical test are not explicitly provided in the summary but would be detailed in the full 510(k) submission. Data provenance is not specified but is assumed to be from internal lab testing or accredited external labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a traditional medical device (tampon). There is no "ground truth" in the AI/ML sense established by human experts for the performance tests. The "ground truth" is the established scientific and regulatory standard (e.g., ISO 10993 parts, 21 CFR § 801.430).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a traditional medical device (tampon). Adjudication methods like those used in clinical trials or AI/ML evaluations are not relevant here. The results of the preclinical tests are directly compared to the specified scientific standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a traditional medical device (tampon), not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a traditional medical device (tampon), not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is the predefined standards and regulatory requirements for menstrual tampons, specifically:
- ISO 10993 standards: Part 3 for genotoxicity, Part 5 for cytotoxicity, and Part 10 for irritation and sensitization.
- 21 CFR § 801.430: For syngyna absorbency requirements.
8. The sample size for the training set
- Not Applicable. This is a traditional medical device (tampon), not an AI/ML device. There is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is a traditional medical device (tampon), not an AI/ML device. There is no "training set" or corresponding "ground truth" in this context.
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Image /page/0/Picture/1 description: The image shows the Kimberly-Clark Corporation logo. The logo consists of a circular emblem with a stylized "KC" inside, followed by the company name "Kimberly-Clark Corporation" in bold, sans-serif font. The text is all in black, and the background is white.
Traditional 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons
Section 5. 510(k) SUMMARY
DEC 2 3 2009
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: | 770-587-7131 |
| Submitter's Fax No. | 920-380-6308 |
| Date of Preparation: | June 1, 2009 |
| Name of DeviceTrade Name: | U by KOTEX Click* Unscented Menstrual Tampons; Regular,Super and Super Plus absorbencies |
| Common Name: | Menstrual Tampon, Unscented |
| Classification Name: | Tampon, Menstrual, Unscented |
| Product Code: | HEB |
| Legally marketed deviceto which equivalency isclaimed: | Kimberly-Clark* KOTEX® Security® Tampons – K864750 |
| Description of the device: | This device is a conventional unscented menstrual tamponconsisting of an absorbent pleget, a withdrawal cord and anapplicator. The absorbent pledget consists of a ribbon of rayonfibers. A viscose-polyester blend withdrawal cord is placed onthe ribbon and the ribbon is radially wound, then, compressedinto a traditional eight-groove bullet-shaped pledget,overwrapped with a non-woven fabric. The formed pledget isinserted into a three-piece plastic applicator consisting of aninner plunger tube, a clear middle telescopic tube and an outerinsertion tube (barrel) formed with a closed, rounded tip. Eachtampon is wrapped in an individual plastic film wrapper andpackaged in sealed multi-unit containers for retail sale. |
® Registered Trademark and *Trademark of Kimberly-Clark Worldwide, Inc.
ﻟﻤﺴﺘﻤﺮ
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නිල Kimberly-Clark Corporation
Traditional 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
(Continued)
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| Summary oftechnologicalcharacteristicscompared to thepredicate device: | The device is similar to the predicate device in terms of componentmaterials, overall design, packaging and labeling. This device differsfrom the predicate device in the exact design and composition of itspledget, i.e. 100% rayon radially-wound eight-groove bullet-shapedpledget as compared to a rectangular pad consisting of a 70/30cotton/rayon blend compressed into a bullet shape. Color of thesubject device and predicate applicators are also different. Thesubject device is composed of a three piece telescoping plasticapplicator in lime green, pink, blue and yellow pearlescent colorswhereas the predicate device consists of a two-piece lavenderpearlescent plastic applicator. | ||
|---|---|---|---|
| Brief description ofpreclinicaltoxicology:(biocompatibility)tests | Preclinical Tests | Standard | Performance |
| Genotoxicity Test (MLA)Genotoxicity Test (AMES) | ISO 10993, Part 3ISO 10993, Part 3 | MeetsMeets | |
| 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 | |
| Safety Assessment: | The subject 510(k) device has undergone an extensive series ofsafety tests, including an assessment of performance characteristics,preclinical microbiological testing and biocompatibility testing. Theresults of these studies support the conclusion that the subject 510(k)device is equivalent and as safe as the predicate device, theKimberly-Clark* KOTEX® Security® Tampon. | ||
| Effectiveness: | Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tamponscomply with the syngyna absorbency requirements of 21 CFR §801.430 as does the predicate device, the Kimberly-Clark* KOTEX®Security® Tampons. | ||
| Conclusions: | The results of the extensive performance assessments, in vitromicrobiological and biocompatibility testing of the subject device,Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons,support the conclusion that it is safe for its intended use and that it issubstantially equivalent to the predicate device, the Kimberly-Clark*KOTEX® Security® Tampon. |
® Registered Trademark and * Trademark of Kimberly-Clark Worldwide, Inc.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Cheryl M. Sanzare Associate Director Global Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road ROSWELL GA 30076
DEC. 2 3 2009
Re: K091749
Trade/Device Name: U By Kotex® Click™ Menstrual Tampon (Unscented) Regulation Number: 21 CFR §884.5470 Regulation Name: Menstrual tampon Regulatory Class: II Product Code: HEB Dated: December 11, 2009 Received: December 14, 2009
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.
. ..
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 (reporting of medical
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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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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(Kimberly-Clark Corporation
INDICATIONS FOR USE
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K091749 |
| 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 X 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)
Hory M. White
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological 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).