(163 days)
No
The device description and performance studies focus on conventional physical and microbiological properties of a menstrual tampon. There is no mention of AI or ML in the intended use, device description, or performance testing.
No
The device is a menstrual tampon used for absorbing menstrual fluid, which is a consumer product for personal hygiene rather than a device intended to treat or prevent a disease or condition.
No
The device description clearly states it is an "unscented menstrual tampon that are inserted into the vagina and used to absorb menstrual fluid." Its intended use is for fluid absorption, not for diagnosing any medical condition. The performance studies focus on physical characteristics, absorbency, and microbial safety, not diagnostic capabilities.
No
The device description clearly states it is a physical tampon with an absorbent pledget, withdrawal cord, and applicator, and the performance studies focus on physical characteristics and microbiology, not software functionality.
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 insertion 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 a physical product for absorption, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information.
- Performance Studies: The performance studies focus on physical characteristics (dimensions, absorbency, strength, shedding) and microbial safety, which are relevant to a medical device for absorption, not an IVD.
- Predicate Devices: The predicate devices are also menstrual tampons, which are not IVDs.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
COHITECH Organic cotton cardboard applicator tampons light are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Product codes
HEB
Device Description
The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord and an applicator. It will be provided on light absorbency (6g and under). Each tampon is wrapped in an individual 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
Performance testing: The following performance characteristics were assessed in accordance with the 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)": Dimensions, Absorbency range, Withdrawal cord strength, Fiber shedding.
Microbiology testing: Total aerobic microbial count: ≤2 x 102 cfu, Yeast and mold: ≤2 x 101 cfu, Enterobacteriaceae family: ≤101 cfu, Escherichia coli: ≤10¹ cfu, Pseudomonas aeruginosa: Absence in 1g, Staphylococcus aureus: Absence in 1g, Candida albicans: Absence in 25g.
Biocompatibility testing: The subject device is made from the same materials used in the prior submission for the larger tampon versions (K091084). Therefore, new biocompatibility testing is not required to support this Special 510(k).
Key Metrics
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
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March 15, 2019
Cotton High Tech, SL Anna Garcia Llado Quality Manager Colonia La Rabeia, S/N Balsareny, Barcelona 08660 Spain
Re: K182813
Trade/Device Name: COHITECH Organic Cotton Cardboard Applicator Tampons Light Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: February 12, 2019 Received: February 15, 2019
Dear Anna Garcia Llado:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -S
for
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
COHITECH Organic Cotton Cardboard Applicator Tampons Light
Indications for Use (Describe)
COHITECH Organic cotton cardboard applicator tampons light are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K182813
1. Submitter Information
| Applicant: | COTTON HIGH TECH S.L |
|---|---|
| Contact: | Anna Garcia Llado |
| Address: | Colònia La Rabeia, s/n |
| 08660 Balsareny | |
| BARCELONA | |
| SPAIN | |
| Phone: | + 34 93 839 16 28 |
| Fax: | + 34 93 839 19 44 |
2. Correspondent Information
| Contact: | Anna Garcia Llado |
|---|---|
| Address: | Colònia La Rabeia, s/n |
| 08660 Balsareny | |
| BARCELONA | |
| SPAIN | |
| Phone: | + 34 93 839 16 28 |
| Fax: | + 34 93 839 19 44 |
| Email: | agarcia@cohitech.net |
- Date prepared: September 28, 2018
4. Device Information
| Device Name: | COHITECH ORGANIC COTTON CARDBOARD APPLICATOR TAMPONS LIGHT |
|---|---|
| Common Name: | Unscented Menstrual Tampon |
| Regulation Number: | 21 CFR 884.5470 |
| Regulation Name: | Unscented Menstrual Tampon |
| Regulatory Class: | Class II |
| Product Code: | HEB (Tampon, Menstrual, Unscented) |
5. Predicate Device Information
Maxim menstrual tampons and Organyc menstrual tampons (K091084) manufactured by Cotton High Tech S.L.
This predicate device has not been subject to a design-related recall.
6. Device Description
The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord and an applicator. It will be provided on light absorbency (6g and under). Each tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
4
7. Indications for Use
COHITECH Organic cotton cardboard applicator tampons light are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
This submission deals with the addition of a new light version to an existing family of tampons (Regular, Super, and Super Plus) that was cleared under K091084
| Devices | K182813 (subject device) | K091084 (predicate device) |
|---|---|---|
| Intended use | Same as the predicate device | The device is intended to be inserted into |
| the vagina to absorb menstrual fluid | ||
| Design (pledget) | Same as the predicate device | Cylindrical shape. Applicator with silky |
| and rounded tip | ||
| Absorbency | Light | Regular, Super, Super Plus |
| Material | Same as the predicate device | 100% Organic Cotton |
The subject device has the same intended use and technological characteristics, with the exception of changes to the pledget to achieve the lower absorbency, and the applicator to accommodate the smaller tampon size. The differences in technological characteristics do not raise different questions of safety or effectiveness.
9. Summary of Non-Clinical Performance Testing
Performance testing
The following performance characteristics were assessed in accordance with the 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)":
- Dimensions ●
- Absorbency range
- Withdrawal cord strength ●
- . Fiber shedding
A declaration of conformity statement has been provided, which states the verification activities, as required by the risk analysis, for the modification were performed and the results demonstrated that the predetermined acceptance criteria were met. In addition, a statement confirming that the manufacturing facility is also in conformance with the design control requirements, has been provided by the sponsor.
Microbiology testing
The sponsor has relied on prior testing included in K091084 to meet the 2005 FDA guidance requirements for microbiology testing as mentioned above. The sponsor has certified that the device materials are the same and provided acceptable rationales supporting how testing on the larger versions of the device are supportive of the light version of the device.
In addition, microbiological testing data on the subject device has been provided as listed below:
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- Total aerobic microbial count: ≤2 x 102 cfu ●
- . Yeast and mold: ≤2 x 101 cfu
- Enterobacteriaceae family: ≤101 cfu
- Escherichia coli: ≤10¹ cfu ●
- Pseudomonas aeruginosa: Absence in 1g
- Staphylococcus aureus: Absence in 1g ●
- . Candida albicans: Absence in 25g
Biocompatibility testing
The subject device is made from the same materials used in the prior submission for the larger tampon versions (K091084). Therefore, new biocompatibility testing is not required to support this Special 510(k). A statement certifying that the materials of the new light version of the device are identical to the devices cleared in K091084 was included.
10. Conclusion
The performance data demonstrate that the subject devices are substantially equivalent to the predicate device.