(98 days)
No
The device description and performance studies describe a conventional menstrual tampon with no mention of AI or ML capabilities.
No.
The device's intended use is to absorb menstrual fluid, which is not considered a therapeutic function. Therapeutic devices are designed to treat, cure, mitigate, or prevent disease.
No
The device is described as an unscented menstrual tampon intended to absorb menstrual fluid, not to diagnose any condition.
No
The device description clearly outlines a physical product (tampon with applicator) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to absorb menstrual fluid within the vagina. This is a physical function within the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a physical device for absorption, not a reagent, instrument, or system intended for use in the diagnosis of disease or other conditions.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting specific markers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on safety (genotoxicity, irritation, etc.) and effectiveness in terms of absorbency, which are relevant to a medical device for absorption, not a diagnostic device.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This tampon does not fit that description.
N/A
Intended Use / Indications for Use
Kimberly-Clark* U by Kotex® Security® is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.
Product codes (comma separated list FDA assigned to the subject device)
HEB
Device Description
This device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord and an applicator. The absorbent pledget consists of a ribbon of rayon fibers and cotton, overwrapped with a non-woven fabric. A withdrawal cord is placed through the pledget and knotted. The tampon pledget is compressed. The formed pledget is inserted into a two-piece plastic applicator consisting of an inner tube (plunger), and an outer insertion tube (barrel) with flexible petals that form a closed, rounded tip. Each tampon is individually wrapped in a plastic film wrapper and multiple tampons are packaged in sealed cartons for commercial sale. Tampons are available in Regular, Super and Super Plus absorbencies in various counts.
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
Not Found
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)
Preclinical Tests
Genotoxicity Test (MLA) - Standard: ISO 10993, Part 3 - Performance: Meets
Genotoxicity Test (AMES) - Standard: ISO 10993, Part 3 - Performance: Meets
Genotoxicity Test (Mouse Micronucleus) - Standard: ISO 10993, Part 3 - Performance: Meets
Cytotoxicity Test - Standard: ISO 10993, Part 5 - Performance: Meets
Mucosal Irritation Test - Standard: ISO 10993, Part 10 - Performance: Meets
Mucosal Sensitization Test - Standard: ISO 10993, Part 10 - Performance: Meets
Acute Systemic Toxicity Test - Standard: ISO 10993, Part11 - Performance: Meets
Colorant Extraction Test - Standard: USP 661 - Performance: Meets
Safety Assessment: 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. Testing from the reference device, U by Kotex® Sleek® K112635, was used to support the safety of new applicator colors. The results of these studies support the conclusion that the subject 510(k) device is equivalent and as safe as the predicate device, the Kimberly- Clark* Kotex® Security® Tampon.
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.
Kimberly-Clark* U by Kotex® Security® Unscented Menstrual Tampons K896994
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.
Kimberly-Clark* U by Kotex® Sleek® Unscented Menstrual Tampons K112635
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2014
Kimberly-Clark Corp. Charnelle Thomas Global Regulatory Affairs Specialist 1400 Holcomb Bridge Road Rowell, GA 30076
Re: K141294
Trade/Device Name: U by Kotex Security Unscented Menstrual Tampons Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: June 17, 2014 Received: June 19, 2014
Dear Charnelle Thomas,
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.
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 (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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Benjamin R. Fisher -S
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
2
Image /page/2/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized "K" inside, followed by the company name in bold, sans-serif font. The words "Kimberly-Clark" are in a larger, bolder font than the word "Corporation."
INDICATIONS FOR USE
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K141294 |
| Device Name: | Kimberly-Clark* U by Kotex® Security® Unscented |
| Menstrual Tampons | |
| Indications for Use: | Kimberly-Clark* U by Kotex® Security® is an unscented |
| menstrual tampon inserted into the vagina to absorb | |
| menstrual fluid. | |
| Prescription Use | |
| Per 21CFR 801.109 Subpart D | OR 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)
Page 1 of 1 - Section 4. Indications for Use
3
්යු Kimberly-Clark Corporation
Traditional 510(k) for Kimberly-Clark* U by Kotex® Security® 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 Road |
| Neenah, WI 54956 | |
| Mailing address for regulatory correspondence: | |
| 1400 Holcomb Bridge Road | |
| Roswell, GA 30076-2199 | |
| Submitter's Phone No: | 678-352-6031 |
| Submitter's Fax No. | 920-225-4979 |
| Date of Preparation: | August 25, 2014 |
| Name of Device | |
| Trade Name: | U by Kotex® Security® Unscented Menstrual Tampons; Regular, |
| Super and Super Plus absorbencies | |
| Common Name: | Menstrual Tampon, Unscented |
| Classification Name: | Tampon, Menstrual, Unscented |
| Product Code: | HEB |
| Classification: | 21 CFR 884.5470 |
| Predicate Device: | Kimberly-Clark* U by Kotex® Security® Unscented Menstrual |
| Tampons K896994 | |
| Reference Device: | Kimberly-Clark* U by Kotex® Sleek® Unscented Menstrual |
| Tampons K112635 | |
| Description of the device: | This device is a conventional unscented menstrual tampon consisting |
| of an absorbent pledget, a withdrawal cord and an applicator. The | |
| absorbent pledget consists of a ribbon of rayon fibers and cotton, | |
| overwrapped with a non-woven fabric. A withdrawal cord is placed | |
| through the pledget and knotted. The tampon pledget is compressed. | |
| The formed pledget is inserted into a two-piece plastic applicator | |
| consisting of an inner tube (plunger), and an outer insertion tube | |
| (barrel) with flexible petals that form a closed, rounded tip. Each | |
| tampon is individually wrapped in a plastic film wrapper and multiple | |
| tampons are packaged in sealed cartons for commercial sale. | |
| Tampons are available in Regular, Super and Super Plus | |
| absorbencies in various counts. |
®Registered Trademark and *Trademark of Kimberly-Clark Worldwide, Inc.
4
Traditional 510(k) for Kimberly-Clark* U by Kotex® Security® Unscented Menstrual Tampons
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION (Continued)
| Indications for
Use: | Kimberly-Clark* U by Kotex® Security® is an unscented menstrual
tampon intended to be inserted into the vagina to absorb
menstrual fluid. | | |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------|
| Summary of
technological
characteristics
compared to the
predicate device: | The device is the same as the predicate device with regards to the
tampon component materials and overall design. The difference
between the subject and predicate device applicator is in the addition
of two new applicator colors, emerald green and royal blue. The
subject device applicator is the same as the predicate device applicator
in all other respects. There will also be minor changes to the
brandname, packaging and labeling. The brandname will change from
Kotex® Security® Natural Balance to U by Kotex® Security®. | | |
| Brief description
of preclinical
toxicology:
(biocompatibility)
tests | Testing from the reference device, U by Kotex® Sleek® K112635,
was used to support the safety of new applicator colors.
Preclinical Tests
Genotoxicity Test (MLA)
Genotoxicity Test (AMES)
Genotoxicity Test
(Mouse Micronucleus)
Cytotoxicity Test
Mucosal Irritation Test
Mucosal Sensitization Test
Acute Systemic Toxicity Test
Colorant Extraction Test | Standard | Performance |
| | | ISO 10993, Part 3 | Meets |
| | | ISO 10993, Part 3 | Meets |
| | | ISO 10993, Part 3 | Meets |
| | | ISO 10993, Part 5 | Meets |
| | | ISO 10993, Part 10 | Meets |
| | | ISO 10993, Part 10 | Meets |
| | | ISO 10993, Part11 | Meets |
| | | USP 661 | Meets |
| Safety Assessment: | 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. Testing from the reference device, U by
Kotex® Sleek® K112635, was used to support the safety of new
applicator colors. The results of these studies support the
conclusion that the subject 510(k) device is equivalent and as safe
as the predicate device, the Kimberly- Clark* Kotex® Security®
Tampon. | | |
®Registered Trademark and *Trademark of Kimberly-Clark Worldwide, Inc.
5
Image /page/5/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a stylized "K" symbol to the left of the company name. The company name is written in a combination of bold and regular font weights, with "Kimberly-Clark" in bold and "Corporation" in a lighter weight.
Traditional 510(k) for Kimberly-Clark* U by Kotex® Security® Unscented Menstrual Tampons
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION (Continued)
| Effectiveness: | Kimberly-Clark* U by Kotex® Security® Unscented Menstrual
Tampons comply with the syngyna absorbency requirements of 21
CFR §801.430 as does the predicate device, the Kimberly-Clark*
Kotex® Security® Tampon. |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions: | The results of the extensive performance assessments, in vitro
microbiological and biocompatibility testing of the subject device,
Kimberly-ClarkU by Kotex® Security® Unscented Menstrual
Tampons, support the conclusion that it is safe for its intended use
and that it is substantially equivalent to the predicate device, the
Kimberly- Clark Kotex® Security® Tampon. |
® Registered Trademark and *Trademark of Kimberly-Clark Worldwide, Inc.