(60 days)
Not Found
No
The device description and performance studies focus on the physical properties, functionality, and biocompatibility of a mechanical tampon applicator. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is used to insert a tampon, which is a menstrual product, not a therapeutic device. It does not treat or prevent any medical condition.
No
Explanation: The device is intended to assist in the insertion of tampons, not to diagnose any medical condition.
No
The device description explicitly details physical components made of polyethylene and polypropylene, along with their dimensions and weight. This indicates a hardware device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "insert a digital menstrual tampon into the vagina." This is a physical action performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a physical applicator for a tampon. It does not involve any reagents, analysis of biological samples, or diagnostic procedures.
- Lack of Diagnostic Language: The description and performance studies focus on the physical properties, functionality, biocompatibility, and reprocessing of the applicator. There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
- Anatomical Site: The anatomical site is the vagina, which is where the device is used for insertion, not where a sample is taken for diagnostic testing.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to provide information about a person's health or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
COHITECH Reusable Tampon Applicator is intended to be used to insert a digital menstrual tampon into the vagina.
Product codes
HEB, HIL
Device Description
The COHITECH Reusable Tampon Applicator is a non-sterile, single user, reusable medical device. It is intended to be sold on its own, without a pre-loaded tampon. The applicator requires the user to load the applicator with a legally marketed digital menstrual tampon. The use-life of the subject applicator is 4 years. The applicator requires the user to clean and disinfect the applicator before initial use, before longterm storage and at the end of the menstrual cycle, as well as to clean the device after each use.
The device consists of a polyethylene outer tampon housing and inner pusher, a polypropylene storage case, and a carrying case (optional).
This device is available in two sizes, one size for reqular and super digital tampons and another for super and super plus digital tampons. The total applicator length is 73.3 ± 0.2 mm for both sizes. The overall applicator diameter (outer housing and inner pusher) is 16 ± 0.1 mm for the regular/super digital tampon applicator and 19 ± 0.1 mm for the super/super plus digital tampon applicator. The applicator weight is 5.4 ± 0.2 for the regular/super tampon applicator and 5.7 ± 0.2 g for the super/super plus tampon applicator. The storage case weight is 7.9 ± 0.1 g and carrying case weight is 26.9 ± 0.1 g
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
Bench Testing:
The following performance characteristics were assessed to demonstrate that the proposed subject device met applicable design and performance requirements:
- Device weight o
- o Physical dimensions
- Functional evaluation, including: o
- Injection force of the inner pusher into the outer tampon housing с component
- Ejection force of the inner pusher out of the outer tampon housing o component
- Tampon compatibility and ejection force testing o
- o Use-life testing
The results of the non-clinical performance data were acceptable and met the established acceptance criteria.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
October 8, 2021
Cotton High Tech S.L. Anna Garcia Regulatory Affairs and Product Certification Manager Colònia La Rabeia S/N Balsareny, Barcelona 08660 Spain
Re: K212479
Trade/Device Name: COHITECH Reusable Tampon Applicator Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB, HIL Dated: August 5, 2021 Received: August 9, 2021
Dear Anna Garcia:
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) K212479
Device Name COHITECH Reusable Tampon Applicator
Indications for Use (Describe)
COHITECH Reusable Tampon Applicator is intended to be used to insert a digital menstrual tampon into the vagina.
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
Image /page/3/Picture/0 description: The image shows the logo for "COHITECH Cotton High Tech S.L.". The word "COHITECH" is in large, bold, black letters at the top of the image. Below that, in smaller gray letters, is the phrase "Cotton High Tech S.L.". Below the text is a large blue circle with a white circle in the center, creating a ring shape.
K212479 Page 1 of 4
510(k) Summary K212479
| SUBMITTER NAME: | Cotton High Tech S.L. |
|---|---|
| SUBMITTER ADDRESS: | Colònia La Rabeia, s/n |
| 08660 Balsareny | |
| BARCELONA | |
| SPAIN | |
| CONTACT: | Anna Garcia |
| Regulatory Affairs and Product Certification Manager | |
| PHONE: | + 34 93 839 16 28 |
| FAX: | + 34 93 839 19 44 |
| e-mail: | agarcia@cohitech.net |
| Summary Preparation Date: | 10/04/2021 |
| DEVICE TRADE NAME: | COHITECH Reusable Tampon Applicator |
| COMMON NAME: | Reusable Tampon Applicator |
| REGULATION NUMBER: | 21 CFR 884.5470 |
| REGULATION NAME: | Unscented Menstrual Tampon |
| REGULATORY CLASS: | II |
| PRODUCT CODE: | HEB (unscented menstrual tampon) and |
| HIL (scented-deodorized menstrual tampon) |
PREDICATE DEVICE:
| Company | Product | 510(k)# |
|---|---|---|
| THINX INC. | re.t.a™ Reusable Tampon Applicator | K180850 |
The predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION:
The COHITECH Reusable Tampon Applicator is a non-sterile, single user, reusable medical device. It is intended to be sold on its own, without a pre-loaded tampon. The applicator requires the user to load the applicator with a legally marketed digital menstrual tampon. The use-life of the subject applicator is 4 years. The applicator requires the user to clean and disinfect the applicator before initial use, before longterm storage and at the end of the menstrual cycle, as well as to clean the device after each use.
4
Image /page/4/Picture/0 description: The image shows the logo for "COHITECH Cotton High Tech S.L.". The word "COHITECH" is in large, bold, black letters at the top. Below that, in smaller gray letters, is the phrase "Cotton High Tech S.L." Underneath the text is a large blue circle with a white circle in the center, creating a ring shape.
The device consists of a polyethylene outer tampon housing and inner pusher, a polypropylene storage case, and a carrying case (optional).
This device is available in two sizes, one size for reqular and super digital tampons and another for super and super plus digital tampons. The total applicator length is 73.3 ± 0.2 mm for both sizes. The overall applicator diameter (outer housing and inner pusher) is 16 ± 0.1 mm for the regular/super digital tampon applicator and 19 ± 0.1 mm for the super/super plus digital tampon applicator. The applicator weight is 5.4 ± 0.2 for the regular/super tampon applicator and 5.7 ± 0.2 g for the super/super plus tampon applicator. The storage case weight is 7.9 ± 0.1 g and carrying case weight is 26.9 ± 0.1 g
INDICATIONS FOR USE STATEMENT:
COHITECH Reusable Tampon Applicator is intended to be used to insert a digital menstrual tampon into the vagina.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS AND INDICATIONS FOR USE:
The following table compares the technological characteristics and indications for use statement of the subject and the predicate device:
| Description | Subject Device | Predicate Device |
|---|---|---|
| Device Name | COHITECH Reusable | |
| Tampon Applicator | re.t.a™ Reusable | |
| Tampon Applicator | ||
| Manufacturer | ||
| Applicant | / | |
| Cotton High Tech, S.L. | THINX INC | |
| 510(k) Number | K212479 | K180850 |
| Product Code | HEB, HIL | HEB, HIL |
| Regulation Number | 884.5470 | 884.5470 |
| Indication for use | COHITECH Reusable | |
| Tampon Applicator is | ||
| intended to be used to | ||
| insert a digital | ||
| menstrual tampon into | ||
| the vagina. | The re.t.a.™ reusable | |
| tampon applicator is | ||
| intended to be used to | ||
| insert a digital | ||
| menstrual tampon into | ||
| the vagina. | ||
| Usability | Reusable | Reusable |
| Use-life | 4 years | 2 years |
| Tampon compatibility | Digital tampons of | |
| various sizes (regular, | ||
| super, and super plus). | Digital tampons of | |
| various sizes | ||
| Device Design | Outer tampon housing | |
| and inner pusher | Sleeve with slit, pusher | |
| and outer cover |
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Image /page/5/Picture/0 description: The image shows the logo for "COHITECH Cotton High Tech S.L.". The word "COHITECH" is in large, bold, black letters at the top. Below that, in smaller gray letters, is the phrase "Cotton High Tech S.L." Underneath the text is a large blue circle with a smaller white circle inside, creating a ring shape.
The subject and predicate device have the same intended use - to deliver digital menstrual tampons into the vagina. The subject device differs from the predicate device in technological characteristics. The subject device has a different device design, use-life, and material composition.
The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.
SUMMARY DISCUSSION OF NON-CLINICAL PERFORMANCE DATA
Biocompatibility
The following biocompatibility studies were performed in accordance with the 2020 FDA quidance Use of International Standard ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and standard ISO 10993-1:
- Cytotoxicity (ISO 10993-5:2009) O
- Vaginal Irritation (ISO 10993-10:2010) O
- Delayed Hypersensitivity (ISO 10993-10:2010) O
The results showed that the subject device was non-cytotoxic, non-irritating, and a non-sensitizer.
Bench Testing
The following performance characteristics were assessed to demonstrate that the proposed subject device met applicable design and performance requirements:
- Device weight o
- o Physical dimensions
- Functional evaluation, including: o
- Injection force of the inner pusher into the outer tampon housing с component
- Ejection force of the inner pusher out of the outer tampon housing o component
- Tampon compatibility and ejection force testing o
- o Use-life testing
The results of the non-clinical performance data were acceptable and met the established acceptance criteria.
Reprocessing, Cleaning, and Disinfecting
The cleaning instructions provided for the COHITECH Reusable Tampon Applicator were developed per the recommendations in the 2015 FDA quidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and
6
Image /page/6/Picture/0 description: The image shows the logo for "COHITECH Cotton High Tech S.L.". The word "COHITECH" is in large, bold, black letters at the top. Below that, in smaller gray letters, is the phrase "Cotton High Tech S.L.". Below the text is a large blue circle with a white circle in the center.
Labeling." The COHITECH Reusable Tampon Applicator should be washed with unscented soap after every use and disinfected in 70% isopropyl alcohol after every menstrual cycle.
The COHITECH Reusable Tampon Applicator is not provided sterile and is not intended to be sterilized by users.
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 COHITECH Reusable Tampon Applicator is substantially equivalent to the predicate device.