(190 days)
Not Found
No
The device description and performance studies focus on the physical components and absorbency of a conventional tampon, with no mention of AI or ML.
No.
The device is intended to absorb menstrual fluid, which is a supportive function rather than a therapeutic treatment for a disease or condition.
No
Explanation: The intended use of the device is to absorb menstrual fluid, not to diagnose a condition.
No
The device description clearly outlines a physical product (tampon with applicator) made of materials like rayon, viscose-polyester, and plastic. It does not mention any software components.
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 and insertion, not a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Anatomical Site: The vagina is the site of use, but the device's function is absorption, not diagnostic testing of vaginal fluid.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information about a person's health status. This tampon does not fit that description.
N/A
Intended Use / Indications for Use
Kimberly-Clark* U by KOTEX® Click* is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.
Product codes
HEB
Device Description
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.
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
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. 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.
Effectiveness: Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons comply 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 vitro microbiological 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 is substantially equivalent to the predicate device, the Kimberly-Clark* KOTEX® Security® Tampon.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s):
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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 Road |
| Neenah, WI 54956 |
Mailing address for regulatory correspondence:
1400 Holcomb Bridge Road
Roswell, 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 Device
Trade 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 device
to which equivalency is
claimed: | Kimberly-Clark* KOTEX® Security® Tampons – K864750 |
| Description of the device: | 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. |
® Registered Trademark and *Trademark of Kimberly-Clark Worldwide, Inc.
ﻟﻤﺴﺘﻤﺮ
1
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)
1
ってい
| Summary of
technological
characteristics
compared to the
predicate device: | The device is similar to the predicate device in terms of component
materials, overall design, packaging and labeling. This device differs
from the predicate device in the exact design and composition of its
pledget, i.e. 100% rayon radially-wound eight-groove bullet-shaped
pledget as compared to a rectangular pad consisting of a 70/30
cotton/rayon blend compressed into a bullet shape. Color of the
subject device and predicate applicators are also different. The
subject device is composed of a three piece telescoping plastic
applicator in lime green, pink, blue and yellow pearlescent colors
whereas the predicate device consists of a two-piece lavender
pearlescent plastic applicator. | | |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|----------------|
| Brief description of
preclinical
toxicology:
(biocompatibility)
tests | Preclinical Tests | Standard | Performance |
| | Genotoxicity Test (MLA)
Genotoxicity Test (AMES) | ISO 10993, Part 3
ISO 10993, Part 3 | Meets
Meets |
| | 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 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, the
Kimberly-Clark* KOTEX® Security® Tampon. | | |
| Effectiveness: | Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons
comply 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 vitro
microbiological 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 is
substantially equivalent to the predicate device, the Kimberly-Clark*
KOTEX® Security® Tampon. | | |
® Registered Trademark and * Trademark of Kimberly-Clark Worldwide, Inc.
2
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
3
Page 2 -
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
4
(Kimberly-Clark Corporation
INDICATIONS FOR USE
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K091749 |
| Device Name: | Kimberly-Clark* U by KOTEX Click* Unscented Menstrual |
| Tampons | |
| Indications for | |
| Use: | Kimberly-Clark* U by KOTEX® Click* is an unscented menstrual |
| tampon 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_