(28 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological compatibility of a conventional menstrual tampon, with no mention of AI or ML technologies.
No.
The device is a menstrual tampon, which is used for absorption of menstrual fluid, not for treating a disease or condition.
No
Explanation: The device description clearly states its purpose is to "absorb menstrual fluid," not to diagnose any medical condition. The summary of performance studies also focuses on safety and absorbency, not diagnostic accuracy.
No
The device description clearly outlines a physical product (tampon, applicator, withdrawal cord) and the performance studies focus on biological and physical properties, not software validation.
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" by being "inserted into the vagina." This is a physical function within the body, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details a physical absorbent product with an applicator. There is no mention of reagents, assays, or any components designed to detect or measure substances in a biological sample for diagnostic purposes.
- Lack of Diagnostic Information: The document does not mention any diagnostic claims, analysis of biological samples, or the provision of information for the diagnosis, monitoring, or treatment of a disease or condition.
- Performance Studies: The performance studies listed (Cytotoxicity, Mucosal Irritation, Sensitization, Colorant Extraction, and absorbency) are related to the safety and physical function of the device, not its diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. This device is a physical product for menstrual fluid absorption.
N/A
Intended Use / Indications for Use
Kimberly-Clark* U by KOTEX Sleek* 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, overwrap, a withdrawal cord and an applicator. The terminology used in describing the device in rest of the 510(k) submission is as follows;
Complete device: U by KOTEX Sleek* Unscented Menstrual Tampons with applicator
Tampon component: Absorbent pledget, overwrap and a withdrawal cord.
Applicator: Inner plunger tube and an outer insertion tube (barrel) formed with a closed, rounded tip with a unique textured grip.
The absorbent pledget consists of a ribbon of rayon fibers. A rayon-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 withdrawal string will be available in pink and white colors. The tampon component is inserted into a two-piece plastic applicator consisting of an inner plunger tube and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon with applicator 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 included Cytotoxicity Test, Mucosal Irritation Test, Mucosal Sensitization Test, and Colorant Extraction test, all of which met their respective ISO or USP standards. The safety assessment concluded that the subject device is equivalent and as safe as the predicate device based on these tests. Effectiveness was assessed by compliance with the Syngyna absorbency requirements of 21 CFR § 801.430, which the subject device met, similar 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).
0
Image /page/0/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name in bold, sans-serif font. The words "Kimberly-Clark" are in a larger font size than "Corporation". The overall design is simple and professional.
Special 510(k) for Kimberly-Clark* U by KOTEX Sleek* 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: | 770-587-8083 |
| Submitter's Fax No. | 920-225-3632 |
| Date of Preparation: | September 07, 2011 |
| Name of Device
Trade Name: | U by KOTEX Sleek* Unscented Menstrual Tampons;
Regular, Super and Super Plus absorbencies (Applicators in
Black, Purple, Blue, Emerald (green), Coral Orange and
Chartreuse (yellow) pearlescent colors) |
| Common Name: | Menstrual Tampon, Unscented |
| Classification Name: | Tampon, Menstrual, Unscented |
| Product Code: | HEB |
| Classification: | 21CFR884.5470 |
| Legally marketed device
to which equivalency is
claimed: | Kimberly-Clark* U by KOTEX Click* Unscented Menstrual
Tampons; Regular, Super and Super Plus absorbencies
(Applicators in lime green, pink, blue and yellow pearlescent
colors) - K091749 |
| Description of the device: | This device is a conventional unscented menstrual tampon
consisting of an absorbent pledget, overwrap, a withdrawal
cord and an applicator. The terminology used in describing
the device in rest of the 510(k) submission is as follows;
Complete device: U by KOTEX Sleek* Unscented
Menstrual Tampons with applicator
Tampon component: Absorbent pledget, overwrap and a
withdrawal cord.
Applicator: Inner plunger tube and an outer insertion tube
(barrel) formed with a closed, rounded tip with a unique |
| | textured grip. |
| | The absorbent pledget consists of a ribbon of rayon fibers.
A rayon-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 withdrawal
string will be available in pink and white colors. The
tampon component is inserted into a two-piece plastic
applicator consisting of an inner plunger tube and an outer
insertion tube (barrel) formed with a closed, rounded tip.
Each tampon with applicator is wrapped in an individual
plastic film wrapper and packaged in sealed multi-unit
containers for retail sale. |
| Summary of technological
characteristics compared to the
predicate device: | Kimberly Clark U by KOTEX Click* Unscented Menstrual
Tampons predicate device (K091749) has a compact
applicator with an inner plunger tube, a clear middle
telescopic tube and an outer insertion tube (barrel) formed
with a closed, rounded tip and is presented in lime green,
pink, blue and yellow pearlescent colors. |
| | The modification in the subject device is in providing a full
size applicator with a unique grip and in adding new
colorants to the applicator presentations. The modified
applicator now has an inner plunger tube and an outer
insertion tube (barrel) formed with a closed, rounded tip but
does not have the middle telescopic tube and is presented
in black, purple, blue, emerald (green), coral orange and
chartreuse (yellow) pearlescent colors. There are no
significant differences with respect to the other raw
materials used in the manufacture of the subject applicators
as compared to the predicate device. |
| | The fundamental scientific technology and intended use
remains exactly the same between the subject and the
predicate devices. All performance characteristics, product
efficacy and safety considerations between the subject
device and the predicate have been shown to be
equivalent. |
| | The subject device is thus composed of a 100% rayon
radially-wound eight-groove bullet-shaped pledget, an
overwrap and a withdrawal string and a two piece plastic
applicators in black, purple, blue, Emerald (green), coral
orange and chartreuse (yellow) pearlescent colors. The
withdrawal string will be available in pink and white colors.
No changes were made to the tampon component itself.
The predicate device is also composed of a 100% rayon
radially-wound eight-groove bullet-shaped pledget, an
overwrap and a withdrawal string and a three piece |
Page 1 of 3 - Section 5. 510(k) Summary
1
K112635
Page 2 of 3
Image /page/1/Picture/1 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name in bold, sans-serif font. The text is black, and the overall design is simple and corporate.
Special 510(k) for Kimberly-Clark* U by KOTEX Sleek* Unscented Menstrual Tampons
Page 2 of 3 - Section 5. 510(k) Summary
2
Image /page/2/Picture/0 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name "Kimberly-Clark Corporation" in a combination of bold and regular fonts. The word "Kimberly-Clark" is in bold, while "Corporation" is in a lighter, regular font.
K112635
Page 3 of 3
Special 510(k) for Kimberly-Clark* U by KOTEX Sleek* Unscented Menstrual Tampons
| telescoping plastic applicator, and the applicators presentations are available in lime green, pink, blue and yellow pearlescent colors. | |||
|---|---|---|---|
| Brief description of preclinical testing: biocompatibility and colorant extration tests | Preclinical Tests | ||
| Cytotoxicity Test | |||
| Mucosal Irritation Test | |||
| Mucosal Sensitization Test | |||
| Colorant Extraction test | Standard | ||
| ISO 10993, Part 5 | |||
| ISO 10993, Part 10 | |||
| ISO 10993, Part 10 | |||
| USP 661 | Performance | ||
| Meets | |||
| Meets | |||
| Meets | |||
| Meets | |||
| Safety Assessment: | The subject 510(k) device has undergone colorant extraction 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* U by KOTEX Click* Unscented Menstrual Tampons with applicator. | ||
| Effectiveness: | The subject 510(k) device complies with the Syngyna absorbency requirements of 21 CFR § 801.430 as does the predicate device, the Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons. | ||
| Conclusions: | The results of performance and safety assessments of the subject device support the conclusion that it is safe for its intended use and that it is substantially equivalent to the predicate device, the Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons. |
*Trademark of Kimberly-Clark Worldwide, Inc.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is facing to the right. The text "U.S. Department of Health & Human Services USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring. MD 20993-0002
Swarna Mukund. Ph.D. Regulatory Affairs Technical Leader Kimberly-Clark Corporation 1400 Holcomb Bridge Road ROSWELL GA 30076 -
్ట్రాని nC.T
Re: K112635
Trade/Device Name: Kimberly-Clark* U by KOTEX Sleek* Unscented Menstrual Tampons Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: September 7. 2011 Received: September 9, 2011
Dear Dr. Mukund:
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. 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
4
Page 2
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the ad relies ovents (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 n you assire sportio aarro aarra boutl DA/Centers Offices/CDRH/CDRHOffices/ucm11.5809.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/McdicalDevices/Safety/ReportalProblem/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 rou that be suall 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 yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
5
Image /page/5/Picture/0 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name in bold, sans-serif font. The text is horizontally aligned and the logo is in black and white.
INDICATIONS FOR USE
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K112635 |
| Device Name: | Kimberly-Clark* U by KOTEX Sleek* Unscented Menstrual Tampons |
| Indications for Use: | Kimberly-Clark* U by KOTEX Sleek* is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid. |
Prescription Use Per 21CFR 801.109 Subpart D
Over-The-Counter × Per 21CFR 801.109 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH Office of Device Evaluation (ODE)
Herbert Leiner
vision Sign-Off of Reproductive, Gastro-Renal, alcal Devices 510(k) Number