CottonDay Tampon will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device: the CottonDay Tampon. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on a study with a test set, ground truth, and expert evaluation as would be the case for a novel AI/ML device.

Therefore, many of the requested elements for an AI/ML device (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for a tampon.

The "acceptance criteria" in this context are the regulatory requirements for showing substantial equivalence for medical devices like tampons, primarily through non-clinical performance testing and biocompatibility.

Here's how to interpret the information provided in the context of the requested parameters, with explanations for why certain elements are not present:

1. A table of Acceptance Criteria and the Reported Device Performance

For this type of device, "acceptance criteria" are typically defined by recognized standards and FDA guidance for tampons. The document doesn't provide a strict pass/fail table with numerical thresholds for every test, but rather states that tests were performed "in accordance with" guidance and "met the requirements."

Acceptance Criteria (Based on FDA Guidance & ISO Standards)	Reported Device Performance
Non-Clinical Performance Testing (per 2005 FDA Guidance: "Menstrual Tampons and Pads")
Dimensions (Pledget Length, Pledget Diameter, Applicator Inner/Outer Length & Diameter)	Compared to Predicate:- Pledget Length: Regular 38mm (Predicate 43-46mm), Super 47mm (Predicate 48-51mm)- Pledget Diameter: Regular 12mm (Predicate 11-12mm), Super 12mm (Predicate 12-13mm)- Applicator Inner Length: Regular 73 ± 5% (Predicate 120 ± 5%), Super 73 ± 5% (Predicate 120 ± 5%)- Applicator Outer Length: Regular 76.5 ± 5% (Predicate 120 ± 5%), Super 76.5 ± 5% (Predicate 120 ± 5%)- Applicator Inner Diameter: Regular 11.8 ± 5% (Predicate 13mm), Super 11.8 ± 5% (Predicate 16mm)- Applicator Outer Diameter: Regular 14.1 ± 5% (Predicate 13mm), Super 14.1 ± 5% (Predicate 16mm)Note: "Differences in technological characteristics do not raise different questions of safety and effectiveness."
Absorbency Range (Syngyna Absorbency)	Compared to Predicate:- Regular: 6.0 - 9.0 (Predicate 6.0)- Super: 9.0 - 12.0 (Predicate 9.0 - 12.0)Note: "Differences in technological characteristics do not raise different questions of safety and effectiveness."
Chemical Residues	Assessed in accordance with guidance; implied to meet requirements.
Withdrawal Cord Strength	Assessed in accordance with guidance; implied to meet requirements.
Fiber Shedding	Assessed in accordance with guidance; implied to meet requirements.
Tampon Integrity	Assessed in accordance with guidance; implied to meet requirements.
Biocompatibility Testing (per ISO 10993-1, 10993-5, 10993-10, 10993-11)
Cytotoxicity (MEM Elution Test)	Results met the requirements of ISO 10993-5:2009.
Sensitization (Guinea Pig Maximization Test)	Results met the requirements of ISO 10993-10:2010.
Irritation (Vaginal Irritation Test)	Results met the requirements of ISO 10993-10:2010.
Acute Systemic Toxicity	Results met the requirements of ISO 10993-11:2006.
Microbiology Testing (per 2005 FDA Guidance)
Does not enhance Staphylococcus aureus growth	Conducted; implied to demonstrate no enhancement.
Does not increase TSST-1 production	Conducted; implied to demonstrate no increase.
Does not alter normal vaginal microflora	Conducted; implied to demonstrate no alteration.

Study to Prove Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is the non-clinical performance, biocompatibility, and microbiology testing summarized in section 9 of the 510(k) summary. These tests are standard for tampons and are designed to address the safety and effectiveness concerns for such a device.

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

Sample Size for Test Set: Not explicitly stated in the document. For physical and chemical tests on medical devices, sample sizes are typically defined by the relevant standards and validated test procedures. These are not 'datasets' in the AI/ML sense but rather physical units of the product.
Data Provenance: Not explicitly stated. These tests are typically conducted in accredited labs (often contract research organizations) and are generally prospective, specific to the device being submitted. Country of origin for testing is not provided, but the applicant (Taebong Co., Ltd.) is from Korea.

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

Not Applicable. For a tampon, "ground truth" as per AI/ML terminology (e.g., annotated images by radiologists) does not apply. The "truth" is established by the results of standardized instrumental and biological tests measured against predefined chemical/physical/biological thresholds. The expertise lies in the certified laboratory personnel performing the tests according to published standards.

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

Not Applicable. Adjudication is relevant for subjective human interpretation tasks (like image review). These are objective laboratory tests. Results are typically quantitative measurements compared to specified limits.

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:

No. This is not an AI/ML device. MRMC studies are used to evaluate diagnostic accuracy and impact of AI on human performance in diagnostic tasks, which is not relevant for a tampon.

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

Not Applicable. This is not an AI/ML algorithm.

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

Not Applicable (in the AI/ML sense). The "ground truth" is defined by the established, scientifically validated standards and guidance documents (e.g., ISO 10993 series, FDA guidance for tampons) that specify acceptable limits for physical, chemical, and biological properties.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no training set.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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July 22, 2019

Taebong Co., Ltd Joyce Kwun President Provision Consulting Group, Inc. 3350 Shelby St., Ste 200 Ontario, CA 91764

Re: K182817

Trade/Device Name: CottonDay Tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: June 10, 2019 Received: June 12, 2019

Dear Joyce Kwun:

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.

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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. 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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.

Sharon M. Andrews Assistant Division 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)

K182817

Device Name CottonDay Tampon

Indications for Use (Describe)

The CottonDay Tampon is intended for insertion into the absorption of menstrual or other vaginal discharge.

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 - K182817

1. Submitter Information

Applicant:	Taebong Co., Ltd.
Contact:	Ha Neul Jeong
Address:	684-2 Illgok-Dong, Buk-GuGwangju Gwangyeogsi, KOREA,REPUBLIC OF 500-866

2. Correspondent Information

Contact:	Joyce Kwun
	Provision Consulting Group, Inc.
Address:	3350 Shelby St. Ste 200, Ontario, CA 91764
Phone:	+1-909-493-3276 (O)
	+1-909-680-8562 (M)
Email:	info@provisionfda.com

Date Prepared: July 18, 2019 3.

4. Device Information

Device Name:	CottonDay Tampon
Common Name:	Unscented Menstrual Tampon
Regulation Number:	21 CFR 884.5470
Regulation Name:	Tampon, Menstrual, Unscented
Regulatory Class:	Class II
Product Code:	HEB

5. Predicate Device Information

Tosama 100% Organic Cotton Menstrual Tampon (K151170). This predicate device has not been subject to a design-related recall.

6. Device Description

7. Indications for Use

The CottonDay Tampon is intended for insertion into the absorption of menstrual or other vaginal discharge.

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		Subject Device (K182817)	Predicate Device(K151170)
Product Name		CottonDay Tampon	Tosama 100% Organic CottonMenstrual Tampon
ClassificationRegulation		884.5470	884.5470
Product Code		HEB	HEB
Intended Use		The device is intended forinsertion into the vaginafor the absorption ofmenstrual or other vaginaldischarge.	The device isintended for insertioninto the vagina for theabsorption ofmenstrual or othervaginal discharge.
Sterile?		No	No
Design		Tampon with cylindricalshape and bullet-like tip.Applicator with smooth,rounded tip.	Tampon withcylindrical shape andbullet-like tip.Applicator withsmooth, rounded tip.
Syngyna Absorbency(gram)		Regular 6.0 - 9.0	Regular 6.0
		Super 9.0 - 12.0	Super 9.0 - 12.0
Pledget Length (mm)		Regular 38	Regular 43.0 - 46.0
		Super 47	Super 48.0 - 51.0
Pledget Diameter(mm)		Regular 12	Regular 11.0 - 12.0
		Super 12	Super 12.0 - 13.0
Applicator InnerLength (mm)		Regular 73 ± 5%	Regular 120 ± 5%
		Super 73 ± 5%	Super 120 ± 5%
Applicator OuterLength (mm)		Regular 76.5 ± 5%	Regular 120 ± 5%
		Super 76.5 ± 5%	Super 120 ± 5%
Applicator InnerDiameter (mm)		Regular 11.8 ± 5%	Regular 13
		Super 11.8 ± 5%	Super 16
Applicator OuterDiameter (mm)		Regular 14.1 ± 5%	Regular 13
		Super 14.1 ± 5%	Super 16
Materials	Pledget	100% Organic Cotton	100% Organic Cotton
	Applicator	Polyethylene	TPO

Comparison of Intended Use and Technological Characteristics with the Predicate Device 8.

The subject and predicate devices have the same intended use - to absorb menstrual or other discharge in the vagina. They have the same design and comparable dimensions and absorbencies. The differences in technological characteristics do not raise different questions of safety and effectiveness.

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9. Summary of Non-Clinical Performance Testing

Performance testing

The following performance characteristics were assessed in accordance with the 2005 FDA guidance document "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff".

Dimensions
Absorbency range
Chemical residues
Withdrawal cord strength
Fiber shedding
Tampon integrity

Biocompatibility Testing

Biocompatibility studies were performed in accordance with the 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" issued in 2016 and ISO 10993 standards as follows:

. Cytotoxicity (MEM Elution Test) per ISO 10993-5:2009
Sensitization (Guinea Pig Maximization Test) per ISO 10993-10:2010 ●
Irritation (Vaginal Irritation Test) per ISO 10993-10:2010 ●
. Acute Systemic Toxicity per ISO 10993-11:2006

These tests were performed on the subject tampons and applicators, and the results met the requirements of the ISO standards.

Microbiology Testing

Per the 2005 FDA guidance document mentioned above, microbiology testing was conducted to demonstrate that the subject devices do not:

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

10. Conclusions

The subject and predicate devices have the same intended use. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate devices.

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).