(90 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a conventional menstrual tampon, with no mention of AI or ML technology.
No
The device is a menstrual tampon, used for fluid absorption, not for treating or preventing a disease or condition.
No
The device is a menstrual tampon designed to absorb fluid, not to diagnose a condition or disease.
No
The device description clearly outlines a physical product consisting of an absorbent pledget, withdrawal string, and a plastic applicator, which are hardware components.
No, 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 taken from the body.
- Device Description: The description details the physical components of a tampon designed for absorption. There are no mentions of reagents, test strips, or any components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies focus on physical properties (absorbency, string strength, fiber shedding, integrity), chemical residues, and microbiological safety related to the device's use within the body. They do not involve evaluating the device's ability to detect or measure a substance or condition in a biological sample.
- Anatomical Site: The anatomical site is the vagina, where the device is used in vivo (within the living body), not in vitro (in glass or outside the living body).
In vitro diagnostics are devices used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to detect diseases, conditions, or infections. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The U by Kotex® Click® Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual fluid.
Product codes
HEB
Device Description
The subject devices are conventional unscented menstrual tampons consisting of an absorbent pledget, an overwrap, a withdrawal string, 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 bulletshaped pledget, overwrapped with a non-woven cover material. The tampon component 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 component with applicator is wrapped in an individual plastic film wrapper, and packaged in a sealed multi-unit container for retail 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
The following studies have been performed to support substantial equivalence to the predicate device:
- Biocompatibility testing in accordance with the ISO 10993-1:2009. The testing demonstrated that the pledget is non-cytotoxic, non-sensitizing, non-irritating, and non-toxic.
- Cytotoxicity testing per 10993-5:2009
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010
- Vaginal Irritation testing per ISO 10993-10:2010
- Acute Systemic Toxicity testing per ISO 10993-11:2006
- Performance testing in accordance with the FDA Guidance, "Menstrual Tampons and Pads: Information for Premarket Notification Submissions" issued July 27, 2005. The testing confirmed that the design output meets the design inputs and specifications for the device. The testing criteria are as follows:
- Syngyna (absorbency range) – The subject tampons met the requirements of 21 CFR §801.430(f)(2) for each absorbency level.
- Chemical residues - There were no detectable 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD); 2,3,7,8-tetrachlorofuran dioxin (TCDF); or any pesticide and herbicide residues
- Mechanical performance The subject tampons met the following design specifications:
- String strength: >= 10 lb force
- Fiber shedding: =20 daN dry and >=15 daN wet
- Microbiology testing - The subject tampons passed the following tests:
- Bioburden: Total Aerobic Microbial Count (TAMC) ; Absence of pathogenic orqanisms (S. aureus; E. coli; P. aeruginosa; Salmonella species; C. albicans; and C. sakazakii) per USP
- Vaginal microflora: The subject tampons did not alter growth of normal vaginal microflora, increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1), or enhance the growth of S. aureus.
Key Metrics
- String strength: >= 10 lb force
- Fiber shedding: =20 daN dry and >=15 daN wet
- Total Aerobic Microbial Count (TAMC)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 11, 2017
Kimberly-Clark Corporation Lori J. Barr Kimberly-Clark Corp. 2001 Marathon Ave. Neenah, WI 54956
Re: K172118
Trade/Device Name: 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: July 10, 2017 Received: July 13, 2017
Dear Lori J. 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.
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); 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 contact the Division of Industry and Consumer Education (DICE) 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. 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 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 Industry and Consumer Education (DICE) 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,
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 11, 2017
Kimberly-Clark Corporation Lori J. Barr Kimberly-Clark Corp. 2001 Marathon Ave. Neenah, WI 54956
Re: K172118
Trade/Device Name: 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: July 10, 2017 Received: July 13, 2017
Dear Lori J. 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.
3
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); 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 contact the Division of Industry and Consumer Education (DICE) 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. 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 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 Industry and Consumer Education (DICE) 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,
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
4
Image /page/4/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a stylized "K" symbol on the left, followed by the text "Kimberly-Clark Corporation" in a bold, sans-serif font. The text is black, and the logo is simple and modern.
510(k) Summary (K172118)
l. Submitter
| Submitter/Address: | Kimberly-Clark Corporation
2100 Winchester Road
Neenah, WI 54956 |
|---------------------------------------------|------------------------------------------------------------------------|
| Contact Person:
Phone:
Fax:
Email: | Lori J. Barr
920-721-4570
920.380.6467
lori.barr@kcc.com |
- II. Date Prepared:
.............................................................................................................................................................................. General Information
| Device Name: | U by Kotex® Click® Unscented Menstrual Tampons |
|---|---|
| Common Name: | Unscented Menstrual Tampon |
| Classification Name: | Unscented Menstrual Tampon (21 CFR 884.5470) |
| Product Code: | HEB (tampon, menstrual, unscented) |
| Regulatory Class: | II |
October 10, 2017
IV. Predicate Device:
U by Kotex® Click® Unscented Menstrual Tampons (K113036) manufactured by Kimberly-Clark Corporation. This predicate device has not been subject to any design related recalls.
V. Description of the Device:
The subject devices are conventional unscented menstrual tampons consisting of an absorbent pledget, an overwrap, a withdrawal string, 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 bulletshaped pledget, overwrapped with a non-woven cover material. The tampon component 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 component with applicator is wrapped in an individual plastic film wrapper, and packaged in a sealed multi-unit container for retail sale. Tampons are available in Regular, Super and Super Plus absorbencies in various counts.
VI. Indications for Use
The U by Kotex® Click® Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual fluid.
5
Image /page/5/Picture/1 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a stylized "KC" symbol on the left, followed by the company name in a combination of bold and regular fonts. The word "Kimberly-Clark" is in bold, while "Corporation" is in a lighter, regular font.
Comparison of Intended Use and Technological Characteristics with the Predicate Device VII.
| Criteria | K172118 (subject device) | K113036 (predicate device) |
|---|---|---|
| Indications for Use | Same as predicate | Kimberly-Clark U by Kotex Click is an unscented |
| menstrual tampon inserted into the vagina to absorb | ||
| menstrual fluid. | ||
| Design - absorbent | ||
| pledget | Same as predicate | 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 pledget provides three absorbencies: regular,
super, and super plus. |
| Design - Applicator | Same as predicate | The 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. |
| Material | The non-woven polyester/polyethylene covering the pledget used in the subject
devices are from different suppliers. There are no other changes in materials
used in the subject and predicate devices. | |
| The subject and predicate devices have the same indication – an unscented menstrual tampon inserted
into the vagina to absorb menstrual fluid. | | |
| The subject and predicate devices have the same design. The non-woven polyester/polyethylene
covering the pledget used in the subject devices are from different suppliers. This difference in | | |
technological characteristics does not raise different questions for safety and effectiveness.
VIII. Summary of Non-Clinical Performance Testing:
The following studies have been performed to support substantial equivalence to the predicate device:
- . Biocompatibility testing in accordance with the ISO 10993-1:2009. The testing demonstrated that the pledget is non-cytotoxic, non-sensitizing, non-irritating, and non-toxic.
-
- Cytotoxicity testing per 10993-5:2009
-
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010
-
- Vaginal Irritation testing per ISO 10993-10:2010
- Acute Systemic Toxicity testing per ISO 10993-11:2006 *
-
- Performance testing in accordance with the FDA Guidance, "Menstrual Tampons and Pads: Information for Premarket Notification Submissions" issued July 27, 2005. The testing confirmed that the design output meets the design inputs and specifications for the device. The testing criteria are as follows:
-
- Syngyna (absorbency range) – The subject tampons met the requirements of 21 CFR §801.430(f)(2) for each absorbency level.
-
6
Image /page/6/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a stylized "KC" symbol enclosed in a circle, followed by the company name "Kimberly-Clark" in bold, and "Corporation" in a lighter font. The logo is simple and professional, and it is easily recognizable.
-
- Chemical residues - There were no detectable 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD); 2,3,7,8-tetrachlorofuran dioxin (TCDF); or any pesticide and herbicide residues
- Mechanical performance The subject tampons met the following design * specifications:
- String strength: ≥ 10 lb force
- Fiber shedding: ≤2 mg/tampon
- Tampon integrity: ≥20 daN dry and ≥15 daN wet
-
- Microbiology testing - The subject tampons passed the following tests:
- Bioburden: Total Aerobic Microbial Count (TAMC) ≤200 cfu/g and Total Yeast/Mold Count (TYMC) ≤20 cfu/q per USP ; Absence of pathogenic orqanisms (S. aureus; E. coli; P. aeruginosa; Salmonella species; C. albicans; and C. sakazakii) per USP
- Vaginal microflora: The subject tampons did not alter growth of normal vaginal microflora, increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1), or enhance the growth of S. aureus.
- Microbiology testing - The subject tampons passed the following tests:
XI. Conclusion:
The subject and predicate devices have the same intended use. There is a difference in the supplier for the material used in the subject device. However, this difference in technological characteristics does not raise different questions of safety or effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.