The subject devices are conventional unscented menstrual tampons consisting of an absorbent pledget, an overwrap, a withdrawal string, and a plastic applicator. 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 bulletshaped pledget, overwrapped with a non-woven cover material. The tampon component is inserted into a three-piece plastic applicator consisting of an inner tube (plunger), a clear middle telescopic tube (telescope), and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon component with applicator is wrapped in an individual plastic film wrapper, and packaged in a sealed multi-unit container for retail sale. Tampons are available in Regular, Super and Super Plus absorbencies in various counts.

AI/ML Overview

The document you provided is a 510(k) Premarket Notification from the FDA for a menstrual tampon. This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. It doesn't typically contain detailed clinical study reports for AI algorithms.

However, I can extract the acceptance criteria and the self-reported study details regarding the performance testing of the U by Kotex® Click® Unscented Menstrual Tampons as described in the document.

Please note: The requested information regarding sample sizes for training/test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and how ground truth for training data was established are not applicable in this context, as the device is a physical menstrual tampon, not an AI/software device. The "studies" referenced are laboratory performance tests for physical and chemical properties and biocompatibility.

Here's the information extracted from your document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility	- Non-cytotoxic (per ISO 10993-5:2009) - Non-sensitizing (per ISO 10993-10:2010) - Non-irritating (per ISO 10993-10:2010) - Non-toxic (Acute Systemic Toxicity per ISO 10993-11:2006)	- The pledget was demonstrated to be non-cytotoxic. - The pledget was demonstrated to be non-sensitizing. - The pledget was demonstrated to be non-irritating. - The pledget was demonstrated to be non-toxic.
Performance Testing (Syngyna Absorbency)	Absorbency range meets requirements of 21 CFR §801.430(f)(2) for each absorbency level (Regular, Super, Super Plus) - Specific numerical ranges are not provided in this document, but implied by regulatory compliance.	The subject tampons met the requirements of 21 CFR §801.430(f)(2) for each absorbency level.
Chemical Residues	- No detectable 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) - No detectable 2,3,7,8-tetrachlorofuran dioxin (TCDF) - No detectable pesticide residues - No detectable herbicide residues	There were no detectable 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD); 2,3,7,8-tetrachlorofuran dioxin (TCDF); or any pesticide and herbicide residues.
Mechanical Performance	- String strength: ≥ 10 lb force - Fiber shedding: ≤ 2 mg/tampon - Tampon integrity (dry): ≥ 20 daN - Tampon integrity (wet): ≥ 15 daN	- The subject tampons met the string strength specification of ≥ 10 lb force. - The subject tampons met the fiber shedding specification of ≤ 2 mg/tampon. - The subject tampons met the tampon integrity (dry) specification of ≥ 20 daN. - The subject tampons met the tampon integrity (wet) specification of ≥ 15 daN.
Microbiology Testing	- Bioburden: Total Aerobic Microbial Count (TAMC) ≤ 200 cfu/g (per USP <61>) - Bioburden: Total Yeast/Mold Count (TYMC) ≤ 20 cfu/g (per USP <61>) - Absence of pathogenic organisms (S. aureus, E. coli, P. aeruginosa, Salmonella species, C. albicans, C. sakazakii) (per USP <62>) - No alteration of normal vaginal microflora growth - No increase in production of Toxic Shock Syndrome Toxin-1 (TSST-1) - No enhancement of S. aureus growth	- The subject tampons passed the Bioburden test with TAMC ≤ 200 cfu/g and TYMC ≤ 20 cfu/g. - The subject tampons passed the test for absence of pathogenic organisms (S. aureus; E. coli; P. aeruginosa; Salmonella species; C. albicans; and C. sakazakii). - The subject tampons did not alter growth of normal vaginal microflora. - The subject tampons did not increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1). - The subject tampons did not enhance the growth of S. aureus.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated in the document for each test. The document mentions "The following studies have been performed..." and refers to compliance with ISO standards and FDA guidance, which would typically involve specific sample sizes per test methodology, but these are not detailed in this summary.
Data Provenance: The studies were performed by Kimberly-Clark Corporation to support the substantial equivalence of their device. The exact country of origin for the data generation process is not specified beyond Kimberly-Clark having their main address in Neenah, WI, USA. The studies are prospective in the sense that they are laboratory tests performed on the new device to demonstrate its properties.

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

Not Applicable. This is a physical medical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established analytical and biological methodologies (e.g., ISO standards, USP chapters).

4. Adjudication method for the test set:

Not Applicable. As this is not an AI algorithm or clinical trial with subjective assessments, there is no adjudication method by experts. The results are based on objective laboratory measurements against predefined thresholds.

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 physical medical device (menstrual tampon), not an AI-assisted diagnostic or imaging device.

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

Not Applicable. This refers to a physical product, not an AI algorithm.

7. The type of ground truth used:

For biocompatibility: Ground truth is established by the specified ISO 10993 standards.
For performance testing (Syngyna absorbency): Ground truth is established by the FDA Guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions" issued July 27, 2005, and specifically 21 CFR §801.430(f)(2).
For chemical residues: Ground truth is established by analytical chemistry methods for detecting specific compounds.
For mechanical performance: Ground truth is established by design specifications (e.g., ≥ 10 lb force, ≤ 2 mg/tampon) based on industry standards and safety considerations.
For microbiology testing: Ground truth is established by reference to USP <61> and <62>, as well as established microbiological methods for assessing impact on microflora and toxin production.

8. The sample size for the training set:

Not Applicable. This is a physical product, not an AI product that requires a training set.

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

Not Applicable. As above, no training set for this type of device.

Summary

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October 11, 2017

Kimberly-Clark Corporation Lori J. Barr Kimberly-Clark Corp. 2001 Marathon Ave. Neenah, WI 54956

Re: K172118

Trade/Device Name: 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: July 10, 2017 Received: July 13, 2017

Dear Lori J. 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.

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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); 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 contact the Division of Industry and Consumer Education (DICE) 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. 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 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 Industry and Consumer Education (DICE) 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,

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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October 11, 2017

Kimberly-Clark Corporation Lori J. Barr Kimberly-Clark Corp. 2001 Marathon Ave. Neenah, WI 54956

Re: K172118

Dear Lori J. Barr:

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Sincerely,

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Summary (K172118)

l. Submitter

Submitter/Address:	Kimberly-Clark Corporation2100 Winchester RoadNeenah, WI 54956
Contact Person:Phone:Fax:Email:	Lori J. Barr920-721-4570920.380.6467lori.barr@kcc.com

II. Date Prepared:

.............................................................................................................................................................................. General Information

Device Name:	U by Kotex® Click® Unscented Menstrual Tampons
Common Name:	Unscented Menstrual Tampon
Classification Name:	Unscented Menstrual Tampon (21 CFR 884.5470)
Product Code:	HEB (tampon, menstrual, unscented)
Regulatory Class:	II

October 10, 2017

IV. Predicate Device:

U by Kotex® Click® Unscented Menstrual Tampons (K113036) manufactured by Kimberly-Clark Corporation. This predicate device has not been subject to any design related recalls.

V. Description of the Device:

VI. Indications for Use

The U by Kotex® Click® Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual fluid.

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Image /page/5/Picture/1 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a stylized "KC" symbol on the left, followed by the company name in a combination of bold and regular fonts. The word "Kimberly-Clark" is in bold, while "Corporation" is in a lighter, regular font.

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

Criteria	K172118 (subject device)	K113036 (predicate device)
Indications for Use	Same as predicate	Kimberly-Clark U by Kotex Click is an unscentedmenstrual tampon inserted into the vagina to absorbmenstrual fluid.
Design - absorbentpledget	Same as predicate	The absorbent pledget consists of a ribbon of rayonfibers. A rayon-polyester blend withdrawal string isplaced on the ribbon and the ribbon is radiallywound, then compressed into a traditional eight-groove bullet-shaped pledget, overwrapped with anon-woven cover material.The pledget provides three absorbencies: regular,super, and super plus.
Design - Applicator	Same as predicate	The three-piece plastic applicator consisting of aninner tube (plunger), a clear middle telescopic tube(telescope), and an outer insertion tube (barrel)formed with a closed, rounded tip.
Material	The non-woven polyester/polyethylene covering the pledget used in the subjectdevices are from different suppliers. There are no other changes in materialsused in the subject and predicate devices.
The subject and predicate devices have the same indication – an unscented menstrual tampon insertedinto the vagina to absorb menstrual fluid.
The subject and predicate devices have the same design. The non-woven polyester/polyethylenecovering the pledget used in the subject devices are from different suppliers. This difference in

technological characteristics does not raise different questions for safety and effectiveness.

VIII. Summary of Non-Clinical Performance Testing:

The following studies have been performed to support substantial equivalence to the predicate device:

. Biocompatibility testing in accordance with the ISO 10993-1:2009. The testing demonstrated that the pledget is non-cytotoxic, non-sensitizing, non-irritating, and non-toxic.
- - Cytotoxicity testing per 10993-5:2009
- - Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010
- - Vaginal Irritation testing per ISO 10993-10:2010
- Acute Systemic Toxicity testing per ISO 10993-11:2006 *
Performance testing in accordance with the FDA Guidance, "Menstrual Tampons and Pads: Information for Premarket Notification Submissions" issued July 27, 2005. The testing confirmed that the design output meets the design inputs and specifications for the device. The testing criteria are as follows:
- - Syngyna (absorbency range) – The subject tampons met the requirements of 21 CFR §801.430(f)(2) for each absorbency level.

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Image /page/6/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a stylized "KC" symbol enclosed in a circle, followed by the company name "Kimberly-Clark" in bold, and "Corporation" in a lighter font. The logo is simple and professional, and it is easily recognizable.

- Chemical residues - There were no detectable 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD); 2,3,7,8-tetrachlorofuran dioxin (TCDF); or any pesticide and herbicide residues
Mechanical performance The subject tampons met the following design * specifications:
- String strength: ≥ 10 lb force
- Fiber shedding: ≤2 mg/tampon
- Tampon integrity: ≥20 daN dry and ≥15 daN wet
- Microbiology testing - The subject tampons passed the following tests:
  - Bioburden: Total Aerobic Microbial Count (TAMC) ≤200 cfu/g and Total Yeast/Mold Count (TYMC) ≤20 cfu/q per USP <61>; Absence of pathogenic orqanisms (S. aureus; E. coli; P. aeruginosa; Salmonella species; C. albicans; and C. sakazakii) per USP <62>
  - Vaginal microflora: The subject tampons did not alter growth of normal vaginal microflora, increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1), or enhance the growth of S. aureus.

XI. Conclusion:

The subject and predicate devices have the same intended use. There is a difference in the supplier for the material used in the subject device. However, this difference in technological characteristics does not raise different questions of safety or effectiveness. The performance data demonstrate that the subject device 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).