The U by Kotex® Click® Unscented Menstrual Tampon is a conventional unscented menstrual tampon consisting of an absorbent pledget and a telescoping three-piece plastic applicator. The device will be manufactured in Regular, Super, and Super Plus absorbencies. The absorbent pledget consists of an absorbent core of radially wound rayon ribbon compressed into a grooved cylinder with a rounded, bullet-like tip, a non-woven overwrap cover, and a rayon-polyester blend withdrawal string. The three-piece applicator consists of an outer insertion tube (barrel) with a textured grip and formed with a closed, rounded tip in a petal-like design, a clear middle telescopic tube (telescope), and an elongated insertion tube (plunger). Each tampon is individually sealed in a plastic film primary wrapper and then packaged in sealed multi-unit containers for retail sale.

AI/ML Overview

The document describes a 510(k) submission for a medical device, which generally means comparing a new device to a legally marketed predicate device to demonstrate substantial equivalence. For this type of submission, extensive acceptance criteria and detailed clinical studies as might be found for novel technologies are often not present in the same format. Instead, the focus is on showing that the modified device performs as safely and effectively as the predicate.

Based on the provided text, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance for a test set. Instead, it states that the device was assessed against various standards and guidance documents. The "Performance" column in Table 05-02 indicates the outcome of the tests, rather than specific numerical acceptance criteria. Similarly, for other performance characteristics, the document states they "were assessed in accordance with the 2005 FDA guidance document," implying compliance with the requirements within that guidance, but without listing specific numerical targets.

However, we can infer some "performance" outcomes from the biocompatibility tests:

Acceptance Criteria (Implied)	Reported Device Performance
Non-Genotoxic (MLA)	Non-Genotoxic
Non-Genotoxic (AMES)	Non-Genotoxic
Non-Genotoxic (Mouse Micronucleus)	Non-Genotoxic
Non-cytotoxic	Non-cytotoxic
Non-irritating	Non-irritating
Non-sensitizing	Non-sensitizing
Not Systemically Toxic	Not Systemically Toxic
Absorbency range in accordance with FDA guidance	Assessed and implies compliance
Chemical residues in accordance with FDA guidance	Assessed and implies compliance
Withdrawal string strength in accordance with FDA guidance	Assessed and implies compliance
Fiber Shedding in accordance with FDA guidance	Assessed and implies compliance
Wet and Dry Tampon Integrity in accordance with FDA guidance	Assessed and implies compliance
Expulsion Force in accordance with FDA guidance	Assessed and implies compliance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "No clinical tests were performed as part of this device modification." Therefore, there is no clinical test set, sample size, or specific data provenance (country, retrospective/prospective) for clinical performance in the traditional sense. The performance data discussed relates to non-clinical laboratory testing. The document does not specify sample sizes for these non-clinical tests (e.g., how many tampons were tested for absorbency, string strength, etc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Since no clinical tests were performed and no human interpretation of data for diagnostic purposes is relevant to this device, no "experts" in the context of establishing ground truth for a test set are mentioned. The testing was conducted against regulatory standards and guidelines by presumably qualified laboratory personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is a menstrual tampon, and the performance assessment is based on physical and chemical properties and biocompatibility, not on a diagnostic interpretation requiring adjudication of results from multiple readers.

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 device is a menstrual tampon and does not involve AI or human readers for diagnostic purposes.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical medical device (menstrual tampon), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is defined by the established regulatory standards and guidance documents (e.g., ISO 10993 series for biocompatibility, 2005 FDA guidance for tampons for performance characteristics). Compliance with these standards indicates acceptable performance. There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic devices.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable for the reason mentioned above.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".

January 6, 2023

Kimberly-Clark Corporation % Dave Yungvirt Official Correspondent Third Party Review Group, LLC 25 Independence Blvd Warren, NJ 07059

Re: K223749

Trade/Device Name: U by Kotex® Click® Unscented Menstrual Tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: December 11, 2022 Received: December 14, 2022

Dear Dave Yungvirt:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason Roberts -S

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223749

Device Name

U by Kotex® Click® Unscented Menstrual Tampon

Indications for Use (Describe)

U by Kotex® Click® Unscented Menstrual Tampon is an unscented tampon inserted into the vagina to absorb menstrual fluid.

Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D)

| X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a stylized symbol to the left of the company name. The text "Kimberly-Clark Corporation" is written in a bold, sans-serif font, with the "Corporation" part in a slightly lighter weight font. The entire logo is in black and white.

510(k) Summary

1. Submitter Information

Applicant	Kimberly-Clark Corporation
Address:	2100 Winchester RoadNeenah, WI 54956

2. Correspondent Information

Contact:	Jeremy D. Paulsen
	Sr. Regulatory Affairs Product Manager
Address:	2100 Winchester Road
	Neenah, WI 54956
Phone:	+1 (920) 721-2552
Email:	Jeremy.paulsen@kcc.com

1. Date Prepared: January 3, 2023

4. Device Information

Trade Name:	U by Kotex® Click® Unscented Menstrual Tampon
Common Name:	Tampon, Menstrual, Unscented
Regulation Number:	21 CFR 884.5470
Regulation Name:	Unscented Menstrual Tampon
Regulatory Class:	Class II
Product Code:	HEB
Classification Panel:	OBGYN, Obstetrics/Gynecology

5. Predicate Device Information

Kimberly-Clark's U by Kotex® Click® Unscented Menstrual Tampon (K172118). This device has not been subject to a design-related recall.

6. Device Description

The three-piece applicator consists of an outer insertion tube (barrel) with a textured grip and formed with a closed, rounded tip in a petal-like design, a clear middle telescopic tube (telescope), and an elongated insertion tube (plunger). Each tampon is individually sealed in a plastic film primary wrapper and then packaged in sealed multi-unit containers for retail sale.

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3 Kimberly-Clark Corporation

7. Indications for Use

The Kimberly-Clark U by Kotex® Click® Unscented Menstrual Tampon is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.

8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The subject device and the predicate device have the same functional design, intended use and indications for use. In addition, both have the same material composition and are produced using the same manufacturing processes.

Summary of technological characteristics compared to the predicate device:

The device is the same as the predicate device with respect to materials and functional design.

The difference between the subject and predicate device is the placement distance of the withdrawal string from the edge of the absorbent pledget ribbon prior to rolling and compressing. There are minor differences in the applicator's barrel diameter and weight of the reqular absorbent pledget compared to that of the predicate device. The subject device applicator is the same as the predicate device applicator in all other respects. There will also be minor changes to the packaging artwork and labeling.

Table 05-01 below compares the U by Kotex® Click® Unscented Menstrual Tampon to the predicate device with respect to indications for use, principles of operation, technological characteristics, and materials.

	Table 05-01: Summary of technological characteristics compared to the predicate
device:

CharacteristicDescription	Subject Device	Predicate Device
Trade Name	Same	U by Kotex® Click®Unscented MenstrualTampon
Product Code	Same	HEB
510(k) Number	TBD	K172118
CommonName	Same	Tampon, Menstrual,Unscented
ClassificationName	Same	Tampon, Menstrual,Unscented (21 CFR884.5470, Product CodeHEB)
Indications foruse	Same	The Kimberly-Clark U byKotex® Click® UnscentedMenstrual Tampon is an
CharacteristicDescription	Subject Device	Predicate Device
		unscented menstrualtampon inserted into thevagina to absorb menstrualfluid.
PatientPopulation	Same	Menstruating Women
Absorbencies	Same	Regular (6-9g), Super (9-12g), Super Plus (12-15g)
Sterile	Same	No
Single Use	Same	Yes
Description ofthe device:	Same	Conventional unscentedmenstrual tamponconsisting of an absorbentpledget and a plasticapplicator.The absorbent pledgetconsists of a ribbon of rayonfibers. A rayon -polyesterblend withdrawal string isplaced on the ribbon andthe ribbon is radially wound,then compressed into atraditional eight groovebullet-shaped pledget,overwrapped with a non-woven cover material. Theabsorbent pledget isinserted into a three-pieceplastic applicator consistingof an inner tube (plunger), aclear middle telescopic tube(telescope), and an outerinsertion tube (barrel)formed with a closed,rounded tip.Each tampon (absorbentpledget with applicator) iswrapped in an individualplastic film wrapper, andpackaged in a sealed multi-unit container for retail sale.
WithdrawalString	Similar	String target location:
CharacteristicDescription	Subject Device	Predicate Device
Location fromthe edge of therayon ribbon	Subject and predicatedevices differ with regardsto where the withdrawalstring is looped aroundrayon ribbon. Thisdifference does not raisenew concerns of safety orefficacy as supported by theperformance data.String target location:150mm	80mm
ApplicatorBarrelDiameter forSuper	12.9mm inner, and 14.16mm outer diameter	14.20 mm inner, and 15.60mm outer diameter
AbsorbentPledget:Composition &Weight:Regular	1.53 g	1.48 g
Complies withISO 10993series	Same	Yes
Complies withpre-clinicalmicrobiologyrequirementsof FDAGuidance forTampons*	Same	Yes

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erly-Clark Corporation

*2005 FDA guidance document "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and Staff"

9. Overview of Non-Clinical Performance Data

Safety Assessment:

No clinical tests were performed as part of this device modification.

In addition to verifying performance and characteristics, the subject 510(k) device has been assessed for safety according to ISO 10993-1 (2018) and the FDA guidance for Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1:

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3 Kimberly-Clark Corporation

Evaluation and testing within a risk management process" (2020) and US FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Biocompatibility of the subject device is inclusive of the absorbent pledget (includes absorbent core, overwrap cover, and withdrawal string) and three-piece plastic applicator consisting of an inner tube (plunger), a clear middle telescopic tube (telescope), and an outer insertion tube (barrel). Table 05-02 below provides a brief description of the biological endpoints assessed by recognized standards.

Preclinical Tests	Standard	Performance
Genotoxicity Test (MLA)	ISO 10993-3 (2014)	Non-Genotoxic
Genotoxicity Test (AMES)	ISO 10993-3 (2014)	Non-Genotoxic
Genotoxicity Test (MouseMicronucleus)	ISO 10993-3 (2014)	Non-Genotoxic
Cytotoxicity Test	ISO 10993-5 (2009)	Non-cytotoxic
Mucosal Irritation Test	ISO 10993-23 (2021)	Non-irritating
Mucosal Sensitization Test	ISO 10993-10 (2021)	Non-sensitizing
Acute Systemic Toxicity Test	ISO 10993-11 (2017)	Not Systemically Toxic

Table 05-02: Preclinical Toxicology (Biocompatibility) Tests

The finished subject device, U by Kotex® Click® Unscented Menstrual Tampon, is identical in composition, manufacturing processes, toxicologic profile, and performance to the commercially available predicate. As there are no new or different risks identified, there is no change to the strategy for safety, biocompatibility assessment, or pre-clinical microbiological risk, necessitating additional testing.

Performance Characteristics

The following performance characteristics were assessed in accordance with the 2005 FDA quidance document "Menstrual Tampons and Pads: Information for Premarket Notification Submission (510(k)s) - Guidance for Industry and FDA Staff"

Absorbency range Chemical residues Withdrawal string strength Fiber Shedding Wet and Dry Tampon Integrity Expulsion Force

10. Conclusion/Statement of Substantial Equivalence

The subject and predicate devices have the same intended use and fundamental technological characteristics. The difference in technological characteristics between the subject and predicate devices does not raise new questions of safety or effectiveness. The performance data demonstrate that the U by Kotex® Click® Unscented Menstrual Tampon is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).