COHITECH Organic cotton cardboard applicator tampons light are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for COHITECH Organic Cotton Cardboard Applicator Tampons Light. The submission seeks to add a "light" absorbency version to an existing family of tampons (Regular, Super, and Super Plus) previously cleared under K091084.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document doesn't explicitly present a single table with acceptance criteria and reported device performance side-by-side. Instead, it lists the performance characteristics assessed and implies that these assessments met predetermined acceptance criteria based on the 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)".

Performance Characteristics Assessed (Implied Acceptance Criteria Met):

Acceptance Criteria Category (Derived)	Specific Criteria / Test	Reported Device Performance (Implied Achievement)
Physical Performance	Dimensions	Met predetermined acceptance criteria
	Absorbency range	Met predetermined acceptance criteria
	Withdrawal cord strength	Met predetermined acceptance criteria
	Fiber shedding	Met predetermined acceptance criteria
Microbiological Purity	Total aerobic microbial count	≤2 x 10² cfu (within limits)
	Yeast and mold	≤2 x 10¹ cfu (within limits)
	Enterobacteriaceae family	≤10¹ cfu (within limits)
	Escherichia coli	≤10¹ cfu (within limits)
	Pseudomonas aeruginosa	Absence in 1g (met)
	Staphylococcus aureus	Absence in 1g (met)
	Candida albicans	Absence in 25g (met)
Biocompatibility	Material composition (identical to predicate device)	Demonstrated identical materials; no new testing required

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state the sample sizes for the performance tests (dimensions, absorbency, withdrawal cord strength, fiber shedding, or microbiology testing). It refers to "verification activities" and "testing on the subject device."
Data Provenance: The document does not specify the country of origin for the data. The studies appear to be retrospective in the sense that they are conducted to demonstrate equivalence for regulatory approval, rather than being part of an ongoing clinical trial. The microbiology testing includes data on the "subject device," indicating it was specifically tested. For biocompatibility, reliance was placed on prior testing from K091084, with a certification that materials are the same.

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

This information is not applicable to this type of device (menstrual tampons). The "ground truth" here is defined by established engineering and microbiological performance standards and guidance documents (e.g., 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)"). There are no "experts" in the sense of clinical reviewers establishing a diagnostic ground truth, but rather testing engineers and microbiologists performing standardized tests.

4. Adjudication method for the test set:

This is not applicable as it's not a diagnostic device involving human interpretation. The "adjudication" is based on comparing test results against predefined thresholds in established standards.

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:

This is not applicable. This is not an AI/CAD device. It is a physical medical device (menstrual tampon).

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

This is not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

The "ground truth" for the device's performance is based on:

Established industry standards and regulatory guidance: Specifically, the "2005 FDA guidance 'Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)'". This guidance outlines the required performance characteristics and likely specifies the methodology and acceptable ranges for these tests.
Predicate device characteristics: The subject device is compared to a legally marketed predicate device (Maxim menstrual tampons and Organyc menstrual tampons, K091084). The "ground truth" for the predicate device's safety and effectiveness was established during its own clearance process, and the subject device aims to demonstrate substantial equivalence to this established benchmark.

8. The sample size for the training set:

This is not applicable. This is not a machine learning or AI device that requires a training set.

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

This is not applicable. There is no training set for this device.

Summary

{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.

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182813

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMBnumber."

{3}------------------------------------------------

510(k) Summary - K182813

1. Submitter Information

Applicant:	COTTON HIGH TECH S.L
Contact:	Anna Garcia Llado
Address:	Colònia La Rabeia, s/n08660 BalsarenyBARCELONASPAIN
Phone:	+ 34 93 839 16 28
Fax:	+ 34 93 839 19 44

2. Correspondent Information

Contact:	Anna Garcia Llado
Address:	Colònia La Rabeia, s/n08660 BalsarenyBARCELONASPAIN
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

{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 intothe vagina to absorb menstrual fluid
Design (pledget)	Same as the predicate device	Cylindrical shape. Applicator with silkyand 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:

{5}------------------------------------------------

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.

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).