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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding a menstrual tampon with a reusable applicator. It details the device, its intended use, and its comparison to predicate and reference devices to establish substantial equivalence.

Based on the content, this document does not describe an AI/ML-driven medical device. Therefore, a study proving an AI/ML device meets acceptance criteria, an MRMC study, or details about training and test sets, and ground truth establishment for an AI/ML model are not applicable to this document.

The document discusses the substantial equivalence of the COHITECH Cottonlock Tampons with Reusable Applicator to previously cleared devices (K211775 and K212479). The "acceptance criteria" in this context refer to the demonstration of this substantial equivalence through non-clinical testing.

Here's a breakdown of the relevant information provided, adapted to the context of a non-AI/ML device:

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

The "acceptance criteria" here are implicitly meeting the performance characteristics of the predicate device and the reference reusable applicator, as well as adherence to relevant FDA guidance documents. The "device performance" is based on non-clinical testing and leveraging prior clearances.

Acceptance Criteria (Implicit)	Reported Device Performance (Demonstrated by Substantial Equivalence)
Functional Equivalence: Device performs the same intended use as predicate.	COHITECH Cottonlock Tampons with Reusable Applicator are inserted into the vagina and used to absorb menstrual fluid, which is identical to the indications for use of the predicate tampon (K211775). The reusable applicator is identical to the one cleared under K212479.
Material Equivalence: Materials are same as predicate/reference devices.	Tampon: 100% organic cotton (same as K211775). Withdrawal Cord: 100% organic cotton (same as K211775). Cover Material: 100% organic cotton (same as K211775). Applicator Material: Polyethylene (same as K212479).
Absorbency Equivalence: Tampon absorbency within defined ranges.	Regular: 6-9g; Super: 9-12g; Super Plus: 12-15g (same absorbency ranges as K211775).
Safety (Biocompatibility): Materials are safe for intended use.	The sponsor provided a statement certifying no changes to the tampons or applicator from their cleared versions. Therefore, new biocompatibility testing (per 2020 FDA guidance ISO 10993-1) was not considered necessary as the previously cleared components meet this criteria.
Performance (Bench Testing): Device performs as expected based on physical characteristics.	The sponsor leveraged testing on the K211775 tampons and K212479 reusable applicators. "Tampon compatibility testing" was performed, as per K212479. No new bench testing (per 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)") was deemed necessary due to the components being identical to previously cleared versions.
Reprocessing Effectiveness (for reusable components): Reusable applicator can be reprocessed safely and effectively.	No new reprocessing testing (per 2015 FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling") was deemed necessary as the reusable applicator is identical to the previously cleared version (K212479) which would have demonstrated reprocessing effectiveness.
Technological Characteristics: Differences do not raise new questions of safety or effectiveness.	The only technological difference is the packaging of the existing tampons with the existing reusable applicator. This difference was found not to raise new questions of safety and effectiveness.
Absence of Design-Related Recall: Predicate and reference devices have not been subject to design-related recalls.	Neither the predicate (K211775) nor the reference (K212479) device have been subject to a design-related recall, indicating their established safety and effectiveness.

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

The document does not specify a "test set" in the context of an AI/ML model. Instead, it refers to leveraging "testing on the K211775 tampons and K212479 reusable applicators." This implies that the testing performed for the original clearances of these components serves as the basis for the current submission. The data provenance would be from Cotton High Tech, S.L. and would typically be prospective non-clinical testing. Specific sample sizes for the absorbed fluid, biocompatibility, or other physical/chemical tests are not provided in this summary.

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

Not applicable, as this is not an AI/ML device requiring expert adjudication for a test set.

4. Adjudication method for the test set

Not applicable.

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.

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

Not applicable.

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

The "ground truth" for this device's performance relies on:

Established industry standards and regulatory guidance: Such as those for tampon absorbency testing, biocompatibility, and reprocessing.
Prior successful clearances: The fact that K211775 (tampons) and K212479 (reusable applicator) were independently cleared by the FDA implies that their safety and effectiveness characteristics (their "ground truth" for performance) were established during their respective review processes. The current submission leverages this existing "ground truth."
Bench testing: Though not detailed, "tampon compatibility testing" implies physical testing to ensure the applicator and tampon work correctly together.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary

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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.

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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) 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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510(k) Summary 807.92(c)

SUBMITTER NAME:	COTTON HIGH TECH S.L.
SUBMITTER ADDRESS:	Colònia La Rabeia, s/n08660 BalsarenyBARCELONASPAIN
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 ORGANICCOTTON NON-APPLICATORCOTTONLOCK TAMPONS	K211775

REFERENCE DEVICE

Legally Marketed Reference Device

Company	Product	510(k)#
Cotton High Tech, S.L.	COHITECH REUSABLETAMPON APPLICATOR	K212479

Neither the predicate or reference device have been subject to a design-related recall.

DEVICE DESCRIPTION:

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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 & PredicateDevice(s):	K220238	K211775
Trade Name	COHITECH Cottonlock Tamponswith Reusable Applicator	COHITECH OrganicCotton Non-ApplicatorCottonlock Tampons
Indications for Use	COHITECH Cottonlock Tamponswith Reusable Applicator areinserted into the vagina and usedto absorb menstrual fluid.	COHITECH OrganicCotton Non-ApplicatorCottonlock Tamponsare inserted into thevagina and used toabsorb menstrual fluid.
Components	Tampon, Applicator (telescoping)	Tampon
Tampon Material	100% organic cotton	100% organic cotton
Withdrawal CordMaterial	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:

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Applicator Colors	Super-super plus: VioletRegular-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.

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).