(28 days)
No
The device description and performance studies focus on the physical components and their compatibility, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is described as a menstrual tampon used to absorb menstrual fluid, which is a feminine hygiene product, not a therapeutic device intended to treat or prevent a disease or condition.
No
The device is described as a menstrual tampon used to absorb menstrual fluid, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical medical device (tampons and a reusable applicator) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The COHITECH Cottonlock Tampons with Reusable Applicator are designed to be inserted into the vagina to absorb menstrual fluid. This is a physical function within the body, not an examination of a specimen outside the body.
- Intended Use: The intended use clearly states "inserted into the vagina and used to absorb menstrual fluid." This aligns with a medical device for managing a physiological process, not an IVD for diagnostic purposes.
The description and intended use clearly indicate this is a medical device for menstrual hygiene, not an IVD.
N/A
Intended Use / Indications for Use
COHITECH Cottonlock Tampons with Reusable Applicator are inserted into the vagina and used to absorb menstrual fluid.
Product codes (comma separated list FDA assigned to the subject device)
HEB
Device Description
The subject device is an unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), completely surrounded by an organic cotton cover ("security veil") and with an organic cotton string ("withdrawal cord"). These tampons will be provided on three absorbencies: regular (6-9g), super (9-12g) and super plus (12-15g). Each COHITECH Cottonlock tampon is individual wrapped in a cellulose paper along with the reusable applicator in its carrying case and packaqed in a sealed multi-unit cardboard containers for retail sale. The subject device deals with inclusion of a reusable tampon applicator, cleared under K212479, to the packaging of tampons cleared under K211775. The tampons are marketed with the appropriate cleared COHITECH Reusable Tampon Applicator (K212479):
- Size 1 (suitable for regular and super tampons)
- Size 2 (suitable for super and super plus tampons)
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)
As the subject tampon is identical to the tampons cleared under K211775 and the reusable tampon applicator is identical to the applicators cleared under K212479, the sponsor leveraged testing on the K211775 tampons and K212479 reusable applicators to support the performance of the proposed COHITECH Cottonlock Tampons with Reusable Applicator. To support the modifications to the subject device, the following design verification and validation activities were performed:
- Tampon compatibility testing, as performed in K212479
The sponsor provided a statement certifying that there were no changes to the tampons or applicator from their cleared versions. Therefore, new bench testing (per the 2005 FDA guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s), biocompatibility testing (per the 2020 FDA guidance document Use of International Standard ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"), or reprocessing testing (per the 2015 FDA guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling) on the tampon or applicator is not necessary to address the device changes in the subject 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.
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 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
February 25, 2022
Cotton High Tech, S.L. Anna Garcia Lladó Regulatory and Product Certification Manager Colònia La Rabeia, S/N Balsareny, Barcelona 08660 Spain
Re: K220238
Trade/Device Name: COHITECH Cottonlock Tampons with Reusable Applicator Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: January 25, 2022 Received: January 28, 2022
Dear Anna Garcia Lladó:
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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220238
Device Name
COHITECH Cottonlock Tampons with Reusable Applicator
Indications for Use (Describe)
COHITECH Cottonlock Tampons with Reusable Applicator 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary 807.92(c)
| SUBMITTER NAME: | COTTON HIGH TECH S.L. |
|---|---|
| SUBMITTER ADDRESS: | Colònia La Rabeia, s/n |
| 08660 Balsareny | |
| BARCELONA | |
| SPAIN | |
| CONTACT: | Anna Garcia, Regulatory and Product Certification Manager |
| TELEPHONE: | + 34 93 839 16 28 |
| FAX: | + 34 93 839 19 44 |
| e-mail: | agarcia@cohitech.net |
| Summary Preparation Date: | 02/24/2021 |
| DEVICE TRADE NAME: | COHITECH Cottonlock Tampons with Reusable Applicator |
| COMMON NAME: | Unscented Menstrual Tampon |
| REGULATION NAME: | TAMPON, MENSTRUAL, UNSCENTED |
21 CFR 884.5470
HEB (Unscented Menstrual Tampon)
F REGULATION NUMBER: PRODUCT CODE: DEVICE CLASS:
807.92(a)(3)
PREDICATE DEVICE Legally Marketed Equivalent Device
| Company | Product | 510(k)# |
|---|---|---|
| Cotton High Tech, S.L. | COHITECH ORGANIC | |
| COTTON NON-APPLICATOR | ||
| COTTONLOCK TAMPONS | K211775 |
ll
REFERENCE DEVICE
Legally Marketed Reference Device
| Company | Product | 510(k)# |
|---|---|---|
| Cotton High Tech, S.L. | COHITECH REUSABLE | |
| TAMPON APPLICATOR | K212479 |
Neither the predicate or reference device have been subject to a design-related recall.
DEVICE DESCRIPTION:
The subject device is an unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), completely surrounded by an organic cotton cover ("security veil") and with an organic cotton string ("withdrawal cord"). These tampons will be provided on three absorbencies: regular (6-9g), super (9-12g) and super plus (12-15g).
4
Each COHITECH Cottonlock tampon is individual wrapped in a cellulose paper along with the reusable applicator in its carrying case and packaqed in a sealed multi-unit cardboard containers for retail sale.
The subject device deals with inclusion of a reusable tampon applicator, cleared under K212479, to the packaging of tampons cleared under K211775. The tampons are marketed with the appropriate cleared COHITECH Reusable Tampon Applicator (K212479):
- Size 1 (suitable for regular and super tampons) ।
- Size 2 (suitable for super and super plus tampons) -
The device trade name, COHITECH Cottonlock Tampons with Reusable Applicator, could be put into the market with various brands.
INDICATIONS FOR USE:
COHITECH Cottonlock Tampons with Reusable Applicator are inserted into the vagina and used to absorb menstrual fluid.
| Device & Predicate
| Device(s): | K220238 | K211775 |
|---|---|---|
| Trade Name | COHITECH Cottonlock Tampons | |
| with Reusable Applicator | COHITECH Organic | |
| Cotton Non-Applicator | ||
| Cottonlock Tampons | ||
| Indications for Use | COHITECH Cottonlock Tampons | |
| with Reusable Applicator are | ||
| inserted into the vagina and used | ||
| to absorb menstrual fluid. | COHITECH Organic | |
| Cotton Non-Applicator | ||
| Cottonlock Tampons | ||
| are inserted into the | ||
| vagina and used to | ||
| absorb menstrual fluid. | ||
| Components | Tampon, Applicator (telescoping) | Tampon |
| Tampon Material | 100% organic cotton | 100% organic cotton |
| Withdrawal Cord | ||
| Material | 100% organic cotton | 100% organic cotton |
| Cover Material | 100% organic cotton | 100% organic cotton |
| Tampon Absorbency | N/A | Light: 6 g and under |
| Regular: 6-9g | Regular: 6-9g | |
| Super: 9-12g | Super: 9-12g | |
| Super Plus: 12-15g | Super Plus: 12-15g | |
| Applicator Material | Polyethylene | N/A |
COMPARISON OF INDICATIONS FOR USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
5
| Applicator Colors | Super-super plus: Violet
Regular-super: Pink | N/A |
| ------------------- | ------------------------------------------------- | ----- |
|---|
COHITECH Cottonlock Tampons with Reusable Applicator have the same technological characteristics that the predicate COHITECH Organic Cotton Cottonlock Tampons in regard to materials, manufacturing and specifications, with the exception of the addition of the reusable applicator to insert the tampon. The subject and predicate devices have similar indications for use statements and have the same intended use. The differences do not raise different questions of safety and effectiveness.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
As the subject tampon is identical to the tampons cleared under K211775 and the reusable tampon applicator is identical to the applicators cleared under K212479, the sponsor leveraged testing on the K211775 tampons and K212479 reusable applicators to support the performance of the proposed COHITECH Cottonlock Tampons with Reusable Applicator. To support the modifications to the subject device, the following design verification and validation activities were performed:
- Tampon compatibility testing, as performed in K212479 ●
The sponsor provided a statement certifying that there were no changes to the tampons or applicator from their cleared versions. Therefore, new bench testing (per the 2005 FDA guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s), biocompatibility testing (per the 2020 FDA guidance document Use of International Standard ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"), or reprocessing testing (per the 2015 FDA guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling) on the tampon or applicator is not necessary to address the device changes in the subject device.
CONCLUSION:
The subject and predicate device have the same intended use and the technological differences do not raise different questions of safety or effectiveness. The results of the non-clinical testing described above demonstrate that the COHITECH Cottonlock Tampons with Reusable Applicator is substantially equivalent to the predicate device.