(23 days)
Not Found
No
The device description and performance studies indicate a conventional mechanical device for menstrual fluid absorption, with no mention of AI or ML technologies.
No.
The device is described as a menstrual tampon whose purpose is solely to absorb menstrual fluid, not to treat or cure any medical condition.
No
The device is a menstrual tampon designed to absorb fluid, not to diagnose a medical condition.
No
The device description clearly details a physical tampon with an applicator, made of materials like rayon, polyester, and plastic. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The U by Kotex® Click® Unscented Menstrual Tampon is a device inserted into the vagina to absorb menstrual fluid. It does not perform any diagnostic tests on the fluid or the body.
- Intended Use: The intended use clearly states it's for absorbing menstrual fluid, not for diagnosing any condition.
- Lack of Diagnostic Elements: The device description details its physical components for absorption and insertion, not any components for chemical analysis, biological detection, or other diagnostic processes.
- Performance Studies: The performance studies listed focus on physical characteristics like absorbency, strength, and integrity, not on diagnostic accuracy metrics like sensitivity or specificity.
Therefore, based on the provided information, the U by Kotex® Click® Unscented Menstrual Tampon is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
U by Kotex® Click® Unscented Menstrual Tampon is an unscented tampon inserted into the vagina to absorb menstrual fluid.
Product codes
HEB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical tests were performed as part of this device modification.
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: 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 assessments were conducted on the absorbent pledget and three-piece plastic applicator.
Preclinical Toxicology (Biocompatibility) Tests:
- Genotoxicity Test (MLA): Non-Genotoxic (ISO 10993-3 (2014))
- Genotoxicity Test (AMES): Non-Genotoxic (ISO 10993-3 (2014))
- Genotoxicity Test (Mouse Micronucleus): Non-Genotoxic (ISO 10993-3 (2014))
- Cytotoxicity Test: Non-cytotoxic (ISO 10993-5 (2009))
- Mucosal Irritation Test: Non-irritating (ISO 10993-23 (2021))
- Mucosal Sensitization Test: Non-sensitizing (ISO 10993-10 (2021))
- Acute Systemic Toxicity Test: Not Systemically Toxic (ISO 10993-11 (2017))
Performance Characteristics assessed in accordance with the 2005 FDA guidance 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
Conclusion: The performance data demonstrate that the U by Kotex® Click® Unscented Menstrual Tampon is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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.
1
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
2
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 Road |
| Neenah, 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 |
-
- 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 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.
4
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: |
| Characteristic
| Description | Subject Device | Predicate Device |
|---|---|---|
| Trade Name | Same | U by Kotex® Click® |
| Unscented Menstrual | ||
| Tampon | ||
| Product Code | Same | HEB |
| 510(k) Number | TBD | K172118 |
| Common | ||
| Name | Same | Tampon, Menstrual, |
| Unscented | ||
| Classification | ||
| Name | Same | Tampon, Menstrual, |
| Unscented (21 CFR | ||
| 884.5470, Product Code | ||
| HEB) | ||
| Indications for | ||
| use | Same | The Kimberly-Clark U by |
| Kotex® Click® Unscented | ||
| Menstrual Tampon is an | ||
| Characteristic | ||
| Description | Subject Device | Predicate Device |
| unscented menstrual | ||
| tampon inserted into the | ||
| vagina to absorb menstrual | ||
| fluid. | ||
| Patient | ||
| Population | Same | Menstruating Women |
| Absorbencies | Same | Regular (6-9g), Super (9- |
| 12g), Super Plus (12-15g) | ||
| Sterile | Same | No |
| Single Use | Same | Yes |
| Description of | ||
| the device: | Same | Conventional unscented |
| menstrual tampon | ||
| consisting of an absorbent | ||
| pledget 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
bullet-shaped pledget,
overwrapped with a non-
woven cover material. The
absorbent pledget 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 (absorbent
pledget with applicator) is
wrapped in an individual
plastic film wrapper, and
packaged in a sealed multi-
unit container for retail sale. |
| Withdrawal
String | Similar | String target location: |
| Characteristic
Description | Subject Device | Predicate Device |
| Location from
the edge of the
rayon ribbon | Subject and predicate
devices differ with regards
to where the withdrawal
string is looped around
rayon ribbon. This
difference does not raise
new concerns of safety or
efficacy as supported by the
performance data.
String target location:
150mm | 80mm |
| Applicator
Barrel
Diameter for
Super | 12.9mm inner, and 14.16
mm outer diameter | 14.20 mm inner, and 15.60
mm outer diameter |
| Absorbent
Pledget:
Composition &
Weight:
Regular | 1.53 g | 1.48 g |
| Complies with
ISO 10993
series | Same | Yes |
| Complies with
pre-clinical
microbiology
requirements
of FDA
Guidance for
Tampons* | Same | Yes |
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്
6
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:
7
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 (Mouse | ||
| Micronucleus) | 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.