COHITECH Organic Cotton Non-Applicator Cottonlock Tampons (light, regular, super, and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.

Device Description

The subject device is a conventional 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 four absorbencies: light (6g and under), regular (6-9g), super (9-12g) and super plus (12-15g). Each organic cotton non-applicator Cottonlock tampon is wrapped in a cellulose paper individual wrapper and packaged in sealed multi-unit containers for retail sale.

AI/ML Overview

The provided text describes the 510(k) summary for the COHITECH Organic Cotton Non-Applicator Cottonlock Tampons, which is a menstrual tampon. The document details studies performed to demonstrate substantial equivalence to a predicate device, focusing on non-clinical data. It does not describe an AI/ML powered device, therefore no AI-specific acceptance criteria or studies are mentioned.

Here's the information as requested, adapted to what is available in the document:

1. Table of Acceptance Criteria (Performance Standards) and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Standard/Guidance)	Reported Device Performance
Biocompatibility
Cytotoxicity	ISO 10993-5:2009	Acceptable (Implied by "results of the non-clinical testing were acceptable")
Vaginal Irritation	ISO 10993-10:2010	Acceptable (Implied by "results of the non-clinical testing were acceptable")
Delayed Hypersensitivity	ISO 10993-10:2010	Acceptable (Implied by "results of the non-clinical testing were acceptable")
Acute Systemic Toxicity	ISO 10993-11:2017	Acceptable (Implied by "results of the non-clinical testing were acceptable")
Physical/Chemical Testing
Absorbency	Syngyna testing per 21 CFR 801.430(f)(2)	Acceptable (Implied by "results of the non-clinical testing were acceptable")
Chemical Residues	FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005	Acceptable (Implied by "results of the non-clinical testing were acceptable")
Tampon Integrity	FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005	Acceptable (Implied by "results of the non-clinical testing were acceptable")
String Strength	FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005	Acceptable (Implied by "results of the non-clinical testing were acceptable")
Fiber Shedding	FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005	Acceptable (Implied by "results of the non-clinical testing were acceptable")
Dimensional Analysis	FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: 2005	Acceptable (Implied by "results of the non-clinical testing were acceptable")
Preclinical Microbiology
S. aureus growth	Not enhance the growth of Staphylococcus aureus (FDA Guidance: 2005)	Does not enhance growth (Implied by "results of the non-clinical testing were acceptable")
TSST-1 production	Not increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1) (FDA Guidance: 2005)	Does not increase production (Implied by "results of the non-clinical testing were acceptable")
Vaginal microflora	Not alter the growth of the normal vaginal microflora (FDA Guidance: 2005)	Does not alter growth (Implied by "results of the non-clinical testing were acceptable")

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

The document does not specify exact sample sizes for each test. It refers to "Biocompatibility studies" and "Preclinical microbiology" without providing the number of samples or specimens used in these tests. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated, but the studies were performed "in accordance with the 2020 FDA guidance... and standard ISO 10993-1" and "Guidance for Industry and FDA Staff - Menstrual Tampons and Pads... 2005," implying they were conducted as part of the regulatory submission process, likely prospectively for the purpose of this submission. The manufacturer is based in Spain, so it's plausible the testing involved European labs, but this is not confirmed.

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 and is not provided. The studies outlined are laboratory tests and measurements against established physical, chemical, and biological standards, not diagnostic assessments requiring expert interpretation of "truth."

4. Adjudication method for the test set

Not applicable. The tests are scientific measurements and biological assays, not interpretations requiring adjudication by experts.

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

Not applicable. The device is a menstrual tampon, not an AI-powered diagnostic or screening tool.

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

Not applicable. The device is a menstrual tampon, not an AI-powered algorithm.

7. The type of ground truth used

The ground truth used for this device's evaluation is based on established physical, chemical, and biological performance standards and regulatory guidance. These include:

ISO 10993 series for biocompatibility (e.g., Cytotoxicity, Vaginal Irritation, Delayed Hypersensitivity, Acute Systemic Toxicity).
21 CFR 801.430(f)(2) for absorbency (Syngyna testing).
FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads (2005) for other performance characteristics like chemical residues, tampon integrity, string strength, fiber shedding, dimensional analysis, and preclinical microbiology regarding Staphylococcus aureus growth, TSST-1 production, and impact on vaginal microflora.

8. The sample size for the training set

Not applicable. The device is a menstrual tampon and does not involve AI/ML requiring a training set.

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

Not applicable. There is no AI/ML training set for this device.

Summary

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October 22, 2021

Cotton High Tech S.L. Míriam Carrero Quality Technician Colònia La Rabeia, S/N Balsareny, Barcelona 08660 Spain

Re: K211775

Trade/Device Name: COHITECH Organic Cotton Non-Applicator Cottonlock Tampons Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: September 17, 2021 Received: September 20, 2021

Dear Míriam Carrero:

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) K211775

Device Name

COHITECH Organic Cotton Non-Applicator Cottonlock Tampons

Indications for Use (Describe)

COHITECH Organic Cotton Non-Applicator Cottonlock Tampons (light, regular, super, and super plus absorbencies) 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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Image /page/3/Picture/1 description: The image shows the logo for COHITECH, a company named Cotton High Tech S.L. The logo features the company name in bold, black letters at the top, with the full name in smaller, gray letters underneath. Below the text is a blue circle with a white center, creating a ring shape.

SECTION 5: 510(k) SUMMARY

510(k) Summary

SUBMITTER NAME:	Cotton High Tech S.L.
SUBMITTER ADDRESS:	Colònia La Rabeia, s/n08660BalsarenyBarcelonaSpain
PHONE:	+ 34 93 839 16 28
FAX:	+ 34 93 839 19 44
CONTACT:	Míriam CarreroQuality Technician
e-mail:	mcarrero@cohitech.net
Summary Preparation Date:	10/18/2021
DEVICE TRADE NAME:	COHITECH Organic Cotton Non-Applicator Cottonlock Tampons
COMMON/USUAL NAME:	Menstrual Tampon
REGLATION NUMBER:	21 CFR 884.5470
REGULATION NAME:	Unscented Menstrual Tampon
PRODUCT CODE:	HEB (Unscented Menstrual Tampon
REGULATORY CLASS:	II

PREDICATE DEVICE

Legally Marketed Equivalent Device

Company	Device name	Code	510k#
Cotton High Tech S.L.	Cohitech Non Applicator Organic Cotton TamponsCohitech Compact Applicator Organic CottonTampons	HEB	K152284

The predicate device has not been subject to a design-related recall.

DEVICE DESCRIPTION:

Each organic cotton non-applicator Cottonlock tampon is wrapped in a cellulose paper individual wrapper and packaged in sealed multi-unit containers for retail sale.

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Image /page/4/Picture/1 description: The image shows the logo for COHITECH Cotton High Tech S.L. The logo features the word "COHITECH" in bold, black letters at the top. Below the company name is the text "Cotton High Tech S.L." in a smaller, gray font. A blue circle with a white center is located below the company information.

SECTION 5: 510(k) SUMMARY

Device trade name COHITECH Organic Cotton Non-Applicator Cottonlock Tampons could be put into the market with various brands.

Additional information can be found in Table 5.1.

INDICATIONS FOR USE:

COHITECH Organic Cotton Non-Applicator Cottonlock Tampons (light, regular, super, and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.

COMPARISON OF INDICATIONS FOR USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

Description	Subject Device	Predicate Device
Device Name	COHITECH Organic Cotton Non-Applicator Cottonlock Tampons	COHITECH Non Applicator OrganicCotton Tampons
Manufacturer/Applicant	Cotton High Tech S.L.	Cotton High Tech S.L.
K Number	K211775	K152284
Product Code	HEB	HEB
Regulation Number	884.5470	884.5470
Indications for Use	COHITECH Organic Cotton Non-Applicator Cottonlock Tampons(light, regular, super, and super plusabsorbencies) are inserted into thevagina and used toabsorbmenstrual fluid.	Cohitech Non Applicator OrganicCotton Tampon and CohitechCompact Applicator Organic CottonTampon are inserted into the vaginaand used to absorb menstrual fluid.
Design	Cylindrical Shape	Cylindrical Shape
Material composition
Tampon	100% without Chlorine (CI)bleached organic cotton fibersWith smooth nonwoven organiccotton cover (security veil)	100% without Chlorine (CI) bleachedorganic cotton fibersWith or without smooth nonwovenPE/PET cover
Withdrawal cord	Organic Cotton	Organic Cotton
Packaging	Wrapping foil, cellulose paper	Wrapping foil, polypropylene
Device specifications - LIGHT
Length	36 - 41 mm	N/A
Diameter	11 – 14 mm	N/A
Absorbency	6 g and under	N/A
Tampon weight	With wrapping: 1.5 g - 2.3 gWithout wrapping: 1.3 g - 2.1 g	N/A
Absorbent coreweight	0.3g – 1.1 g	N/A

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Image /page/5/Picture/1 description: The image shows the logo for COHITECH, a company named Cotton High Tech S.L. The logo features the company name in bold, black letters at the top, with the full name in smaller, gray letters underneath. Below the name is a blue circle with a white center, resembling a ring or a stylized letter 'O'.

SECTION 5: 510(k) SUMMARY

Device specifications - REGULAR
Length	40 - 45 mm	43-46 mm
Diameter	12 - 15 mm	12 - 13mm
Absorbency	6-9 g	6-9 g
Tampon weight	With wrapping: 1.8g - 2.8gWithout wrapping: 1.5g - 2.5g	With wrapping: 2.2-3.2gWithout wrapping: 2.1-3.1g
Absorbent core weight	0.4g - 1.4 g	1.90 - 2.90 g
Device specifications - SUPER
Length	48 - 53 mm	48 – 51 mm
Diameter	12 - 15 mm	12 - 13 mm
Absorbency	9-12 g	9-12 g
Tampon weight	With wrapping: 2.6 g - 3.6 gWithout wrapping: 2.3 g - 3.3 g	With wrapping: 2.5 g - 3.5 gWithout wrapping: 2.4 g - 3.4 g
Absorbent core weight	1.0g - 2.0 g	2.2g - 3.2 g
Device specifications - SUPER PLUS
Length	50 - 55 mm	48 – 51 mm
Diameter	15 – 18 mm	14 - 15 mm
Absorbency	12-15 g	12 -15 g
Tampon weight	With wrapping: 3.6 g – 4.6 gWithout wrapping: 3.3 g - 4.3 g	With wrapping: 3.5 g - 4.5 gWithout wrapping: 3.4 g - 4.4 g
Absorbent core weight	2.0 g - 3.0 g	3.2g - 4.2 g

Table 5.1 - Comparison of indications for use and technological characteristics

COHITECH Organic Cotton Non-Applicator Cottonlock Tampons are similar to the predicate device "COHITECH Non Applicator Organic Cotton Tampons" in terms of overall design. Both the predicate and the subject device have the same cylindricalshaped ribbon of absorbent fibers asymmetrically folded, rolled and compressed and a string ("withdrawal cord") looped around the rectangular ribbon.

The materials of the pledget ("absorbent core") and the string ("withdrawal cord") of both subject and predicate devices are the same (organic cotton) and they both include regular, super, and super plus absorbencies. The subject device includes a light absorbency while the predicate device does not. The difference in absorbency levels does not raise different questions of safety and effectiveness.

The differences in technological characteristics between the subject and the predicate devices include their weight, dimensions, nonwoven (security veil) material and packaging

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Image /page/6/Picture/1 description: The image shows a logo for a company called "COHITECH Cotton High Tech S.L.". The company name is written in black, with "COHITECH" in a larger font size than "Cotton High Tech S.L.". Below the company name is a blue circle with a white center. The logo is simple and modern, and the colors are clean and professional.

SECTION 5: 510(k) SUMMARY

materials. However, these differences do not raise different questions of safety and effectiveness.

SUMMARY DISCUSSION OF NON-CLINICAL DATA

Biocompatibility

Biocompatibility studies were performed in accordance with the 2020 FDA guidance 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
Vaqinal Irritation (ISO 10993-10:2010) o
Delayed Hypersensitivity (ISO 10993-10:2010) O
Acute Systemic Toxicity (ISO 10993-11:2017) O

The following performance characteristics were assessed in accordance with the Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) issued on July 27, 2005:

Absorbency (Syngyna testing per 21 CFR 801.430(f)(2)) O
Chemical residues O
Tampon integrity O
String strength O
Fiber shedding O
Dimensional analysis O
Preclinical Microbiology O

Preclinical Microbiology

Preclinical microbiology was conducted per Guidance for Industry and FDA Staff -Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) issued on July 27, 2005 and demonstrate that the subject device in its final, manufactured form, does not:

Enhance the growth of Staphylococcus aureus o
Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1) O
Alter the growth of the normal vaginal microflora O

The results of the non-clinical testing were acceptable.

CONCLUSIONS:

The results of the non-clinical testing described above demonstrate that COHITECH Organic Cotton Non-Applicator Cottonlock Tampons 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).