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

AI/ML Overview

The provided text describes a 510(k) premarket notification for the COHITECH Reusable Tampon Applicator. This device is not an AI/ML device, therefore, many of the requested categories in the prompt are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device (re.t.a™ Reusable Tampon Applicator) through non-clinical performance data, rather than clinical studies involving human readers or sophisticated ground truth establishment.

Here's a summary of the acceptance criteria and performance as presented in the document, along with explanations for the inapplicable sections:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Non-cytotoxic	Non-cytotoxic
	Non-irritating	Non-irritating
	Non-sensitizer	Non-sensitizer
Bench Testing	Device weight met specifications (implied)	5.4 ± 0.2 g (regular/super), 5.7 ± 0.2 g (super/super plus)
	Physical dimensions met specifications (implied)	Total applicator length: 73.3 ± 0.2 mm; Overall applicator diameter: 16 ± 0.1 mm (regular/super), 19 ± 0.1 mm (super/super plus)
	Functional evaluation (Injection force, Ejection force, Tampon compatibility) met specifications (implied)	Results were acceptable and met established acceptance criteria.
	Use-life testing met specifications (implied)	Results were acceptable and met established acceptance criteria.
Reprocessing, Cleaning, and Disinfecting	Cleaning instructions and validated reprocessing met specifications (implied)	Cleaning instructions developed per FDA guidance, demonstrated effective for daily cleaning and end-of-cycle disinfection.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests, summarized under "SUMMARY DISCUSSION OF NON-CLINICAL PERFORMANCE DATA" on page 5 and 6 of the document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the document. For non-clinical bench testing and biocompatibility, sample sizes are typically determined by relevant ISO standards or engineering validation protocols, but the exact numbers are not provided.
Data Provenance: Not explicitly stated, but the studies were performed in accordance with FDA guidance and ISO standards, suggesting they were conducted in a controlled, prospective manner following established protocols for medical device testing. The submitting company, Cotton High Tech S.L., is located in Spain.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Inapplicable: This is not an AI/ML device or a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device's acceptance criteria primarily refers to engineering specifications, physical measurements, and biological responses to materials as assessed by standard laboratory testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Inapplicable: As this is a physical medical device, not an AI/ML diagnostic, there is no expert adjudication process for image or data interpretation. The test results are based on objective physical and chemical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Inapplicable: This is not an AI/ML device, nor is it a diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Inapplicable: This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Type of Ground Truth: For biocompatibility, the ground truth is based on the biological response of cells/tissues to the device materials, as defined by international standards (ISO 10993). For bench testing, the ground truth is the engineering specifications, physical dimensions, and functional performance requirements of the device.

8. The sample size for the training set

Inapplicable: This is not an AI/ML device and therefore does not have a "training set" in that context.

9. How the ground truth for the training set was established

Inapplicable: As there is no AI/ML training set, this question is not relevant.

Summary

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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.

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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

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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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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/n08660 BalsarenyBARCELONASPAIN
CONTACT:	Anna GarciaRegulatory 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) andHIL (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:

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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).

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 ReusableTampon Applicator	re.t.a™ ReusableTampon Applicator
ManufacturerApplicant	/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 ReusableTampon Applicator isintended to be used toinsert a digitalmenstrual tampon intothe vagina.	The re.t.a.™ reusabletampon applicator isintended to be used toinsert a digitalmenstrual tampon intothe vagina.
Usability	Reusable	Reusable
Use-life	4 years	2 years
Tampon compatibility	Digital tampons ofvarious sizes (regular,super, and super plus).	Digital tampons ofvarious sizes
Device Design	Outer tampon housingand inner pusher	Sleeve with slit, pusherand 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

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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.

Regulation Number and Section

§ 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).