(21 days)
Not Found
No
The device description details a conventional menstrual tampon with an applicator, and there is no mention of AI or ML technology in the provided text.
No.
The product information describes a menstrual tampon, which is used for absorption of menstrual fluid, not for therapy or treatment of any medical condition.
No.
The device is described as a menstrual tampon used to absorb menstrual fluid, and its performance studies are related to material safety and absorbency, not diagnosis of any condition.
No
The device description clearly outlines a physical product (tampon with applicator) made of materials like rayon and plastic, and the performance studies focus on material safety and absorbency, 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 test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical product designed for absorption and insertion. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information
- Using reagents or assays
The device is clearly described as a menstrual tampon, which is a Class II medical device regulated for its physical properties and safety for internal use.
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 pledget, overwrap, a withdrawal string and an applicator. The terminology used in describing the device in rest of this 510(k) submission is as follows;
Complete device: U by KOTEX Click* Unscented Menstrual Tampons with applicator
Tampon component: Absorbent pledget, overwrap and a withdrawal string.
Applicator: Inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip.
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 fabric. The withdrawal string will be available in pink and white colors. The tampon component 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 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 Colorant Extraction Test, Cytotoxicity Test, Mucosal Irritation Test, and Mucosal Sensitization Test. These tests met the standards USP 661, ISO 10993, Part 5, and ISO 10993, Part 10. The safety assessment states that the results of these studies support the conclusion that the subject 510(k) device is equivalent and as safe as the predicate device. The effectiveness assessment states that the subject 510(k) device complies with the syngyna absorbency requirements of 21 CFR 801.430, similar to the predicate device. The overall conclusion is that the performance and safety assessments support the conclusion that the subject device is safe for its intended use and substantially equivalent to the predicate device.
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/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a stylized symbol on the left, followed by the text "Kimberly-Clark Corporation". The text is in a sans-serif font, with "Kimberly-Clark" in bold and "Corporation" in a regular weight.
NOV - 2 2011 K113036
Page 1 of 3
Special 510(k) for Kimberly-Clark* U by KOTEX Click* 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: | |
| 2001 Marathon Avenue | |
| Neenah, WI 54956 | |
| Submitter's Phone No: | 920-721-4570 |
| Submitter's Fax No. | 920-380-6467 |
| Date of Preparation: | October 11, 2011 |
| Name of Device: | |
| Trade Name: | U by KOTEX Click* Unscented Menstrual Tampons; Regular |
| Super and Super Plus absorbencies (Applicators in magenta | |
| and navy blue pearlescent colors) | |
| Common Name: | Menstrual Tampon, Unscented |
| Classification Name: | Tampon, Menstrual, Unscented |
| Product Code: | HEB |
| Classification: | 21 CFR 884.5470 |
| 510(k) Number: | K113036 |
| 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 | |
| string and an applicator. The terminology used in | |
| describing the device in rest of this 510(k) submission is as | |
| follows; |
Complete device: U by KOTEX Click* Unscented
Menstrual Tampons with applicator
Tampon component: Absorbent pledget, overwrap and a
withdrawal string. |
| | Applicator: Inner plunger tube, a clear middle telescopic
tube and an outer insertion tube (barrel) formed with a
closed, rounded tip.
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 fabric. The withdrawal
string will be available in pink and white colors. The
tampon component 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 with
applicator is wrapped in an individual plastic film wrapper |
| Summary of technological
characteristics compared to the
predicate device: | and packaged in sealed multi-unit containers for retail sale.
The currently marketed predicate device has four
applicators in lime green, pink, blue, yellow, (K091749)
pearlescent colors. The modification is to add two new
colorants in magenta and navy blue to the individual subject
device applicator presentations which were not part of the
predicate device. All other raw materials used in the
manufacture of the subject applicators remain unchanged
as compared to the predicate device. The tampon
component of the subject device (absorbent pledget,
overwrap and withdrawal string) remains unchanged as
compared to the predicate devices except for the removal
of pink dye in the white withdrawal string variant. The
difference between the subject and the predicate device
applicators is in the addition of two new applicators in
magenta and navy blue pearlescent colors and an
applicator design improvement. The fundamental scientific
technology and intended use remains exactly the same
between the subject and the predicate device. All
performance characteristics, product efficacy and safety
considerations between the subject device and 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 three piece
telescoping plastic applicators in magenta and navy blue
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 telescoping plastic applicator, but the
applicators presentations are available in lime green, pink, |
1
. 2
K113036
Page 2 of 3
Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons
2
ഇ്ദു Kimberly-Clark Corporation
K113036
Page 3 of 3
Special 510(k) for Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons
| blue, yellow (K091749) pearlescent colors. | |||
|---|---|---|---|
| Brief description of preclinical | |||
| testing: (colorant extraction | |||
| and biocompatibility) tests | Preclinical Tests | ||
| Colorant Extraction Test | |||
| Cytotoxicity Test | |||
| Mucosal Irritation Test | |||
| Mucosal Sensitization | |||
| Test | Standard | ||
| USP 661 | |||
| ISO 10993, Part 5 | |||
| ISO 10993, Part 10 | |||
| ISO 10993, Part 10 | 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 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, 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 | |||
| 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 features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
NOV - 2 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Lori J. Barr Associate Director, Regulatory Affairs Kimberly-Clark Corporation 2100 Winchester Road NEENAH WI 54956
Re: K113036
Trade/Device Name: Kimberly-Clark* 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: October 11, 2011 Received: October 12, 2011
Dear Ms. 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. 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 quality systems (OS) 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/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,
Hubert Heman 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 emblem on the left, followed by the company name in bold, sans-serif font. The emblem features a stylized "KC" within a circle, and the text is horizontally aligned.
INDICATIONS FOR USE
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K113036 |
| 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 _ × 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)
tom m why
on Sign-On )
n of Reproductive, Gastro-Renal, and 510(k) Number