The Tempo Tampon will be offered as a traditional unscented menstrual 100% 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 absorbances: Regular and Super.

AI/ML Overview

This document is a 510(k) Premarket Notification for the "Tempo Tampon". It aims to demonstrate substantial equivalence to a legally marketed predicate device, the "Taebong CottonDay Tampon" (K182817).

Based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Acceptance Criteria	Reported Device Performance
Performance Testing (per 2005 FDA Guidance)	Dimensions	Not explicitly stated, implied to be within acceptable variance for equivalence with predicate	Pledget Length: Regular 44-48mm, Super 47-51mm; Pledget Diameter: Regular 13.5mm, Super 13.5mm; Applicator Inner Length: Regular/Super 73 ± 5%; Applicator Outer Length: Regular/Super 74.5 ± 5%; Applicator Inner Diameter: Regular/Super 11.8 ± 5%; Applicator Outer Diameter: Regular/Super 15 ± 5%. (These generally align with predicate but have some dimensional differences which are considered not to raise new questions of safety/effectiveness).
	Absorbency range (Syngyna Absorbency)	Regular: 6.0 - 9.0 gram; Super: 9.0 - 12.0 gram	Regular: 6.0 - 9.0 gram; Super: 9.0 - 12.0 gram (Matches predicate)
	Chemical residues	Not explicitly stated, implied to meet safety standards.	Not explicitly stated as a value, but testing was performed.
	Withdrawal cord strength	Not explicitly stated, implied to meet safety standards.	Not explicitly stated as a value, but testing was performed.
	Fiber shedding	Not explicitly stated, implied to meet safety standards.	Not explicitly stated as a value, but testing was performed.
	Tampon integrity	Not explicitly stated, implied to meet safety standards.	Not explicitly stated as a value, but testing was performed.
Biocompatibility Testing (per ISO 10993)	Cytotoxicity (MEM Elution Test)	Non-cytotoxic	Non-cytotoxic (for tampon and applicator)
	Sensitization (Guinea Pig Maximization Test)	Non-sensitizers	Non-sensitizers (for tampon and applicator)
	Irritation	Non-irritating	Non-irritating (for tampon and applicator)
	Acute Systemic Toxicity	Not acutely systemically toxic	Not acutely systemically toxic (for tampon)
Microbiology Testing (per 2005 FDA Guidance)	Enhance S. aureus growth	Does not enhance	Does not enhance
	Increase TSST-1 production	Does not increase	Does not increase
	Alter normal vaginal microflora	Does not alter	Does not alter

2. Sample Size Used for the Test Set and Data Provenance

Since this is a submission for a physical medical device (tampon) and not an AI/software device, the concept of "test set" in the context of AI models (e.g., training/test/validation split) does not directly apply. The "studies" described are in vitro and in vivo tests on the device itself.

Sample Size: The document does not specify the exact number of samples (e.g., individual tampons) used for each performance, biocompatibility, and microbiology test. It only states that the tests were performed.
Data Provenance: The tests are implicit to have been conducted under controlled laboratory conditions to assess the device properties. There is no mention of "country of origin of the data" in terms of patient data or "retrospective/prospective" as relevant to clinical trial data. These are laboratory studies on the manufactured product.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable to this type of device submission. The "ground truth" for the performance characteristics (e.g., absorbency, dimensions, biocompatibility) is established through standardized laboratory testing methods and accepted scientific protocols (e.g., specific FDA guidance documents, ISO standards). There isn't a "human expert" interpretation of images or symptoms involved in establishing these facts.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or interpretation of complex data that would require an adjudication process. The tests performed yield objective, measurable results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No. An MRMC study is relevant for AI or diagnostic imaging devices where human readers interpret medical images. This submission is for a menstrual tampon, and no such study was conducted or is required.

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

No. This concept is relevant for AI algorithms. The "device" here is a physical product (tampon), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by:

Standardized Test Methods: Adherence to established FDA guidance documents ("Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff") for performance characteristics.
International Standards (ISO): Compliance with specific ISO 10993 standards for biocompatibility testing.
Predicate Device Comparison: Direct comparison of key performance metrics (like absorbency) against the legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device submission. The device is manufactured, and its properties are tested.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set in the AI/ML sense.

Summary

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April 21, 2022

Dong-A Pharmaceutical Co., Ltd. % Joyce Kwon President Provision Consulting Group, Inc. 100 N. Barranca St. Suite 700 West Covina, CA 91791

Re: K212277

Trade/Device Name: Tempo Tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: March 18, 2022 Received: March 22, 2022

Dear Joyce Kwon:

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) K212277

Device Name Tempo Tampon

Indications for Use (Describe)

The Tempo 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 - K212277

Submitter

Hyunjeong Jang Dong-A Pharmaceutical Co., Ltd. 64 Cheonho-daero, Dongdaemun-gu, Seoul, 02587 Republic of Korea +82-2-920-8289

Official Correspondent

Joyce Kwon Provision Consulting Group, Inc. 100 N. Barranca St. Suite 700 West Covina, CA 91791 +1-909-493-3276 joyce@provisionfda.com

Date Prepared

April 15, 2022

Device Information

Trade Name: Tempo Tampon Common Name: Unscented Menstrual Tampon Classification Number: 21 CFR 884.5470 Classification Name: Unscented Menstrual Tampon Product Code: HEB (Tampon, Menstrual, Unscented) Regulatory Class: Class II

Predicate Devices

Taebong CottonDay Tampon (K182817)

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

Indication for Use

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

Device Description

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Substantial Equivalent Comparison Chart

		Subject Device	Predicate Device
Product Name		Tempo Tampon	Taebong CottonDay Tampon
510(k) Number		K212277	K182817
ClassificationRegulation		884.5470	884.5470
Product Code		HEB	HEB
Indications for Use		The Tempo Tampon isintended for insertion into thevagina for theabsorption ofmenstrual or other vaginaldischarge.	The CottonDay Tampon isintended for insertion into thevagina for theabsorption ofmenstrual or other vaginaldischarge.
Sterile?		No	No
Design		Tampon with cylindrical shapeand bullet-like tip. Applicatorwith smooth, rounded tip.	Tampon with cylindrical shapeand bullet-like tip. Applicatorwith smooth, rounded tip.
Syngyna Absorbency(gram)	Regular	6.0 - 9.0	Regular	6.0 - 9.0
	Super	9.0 - 12.0	Super	9.0 - 12.0
Pledget Length (mm)	Regular	44-48	Regular	38
	Super	47-51	Super	47
Pledget Diameter (mm)	Regular	13.5	Regular	12
	Super	13.5	Super	12
Applicator Inner Length(mm)	Regular	73 ± 5%	Regular	73 ± 5%
	Super	73 ± 5%	Super	73 ± 5%
Applicator Outer Length(mm)	Regular	74.5 ± 5%	Regular	76.5 ± 5%
	Super	74.5 ± 5%	Super	76.5 ± 5%
Applicator InnerDiameter (mm)	Regular	11.8 ± 5%	Regular	11.8 ± 5%
	Super	11.8 ± 5%	Super	11.8 ± 5%
Applicator OuterDiameter (mm)	Regular	15 ± 5%	Regular	14.1 ± 5%
	Super	15 ± 5%	Super	14.1 ± 5%
Materials	Pledget	100% Cotton		100% Organic Cotton
	Applicator	Polyethylene		Polyethylene

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The subject device and predicate device have the same design, tampon absorbencies, and applicator material. The subject and predicate device have different pledget and applicator sizes. The predicate device used organic cotton while the subject device does not. The intended use of the subject and predicate devices are identical - absorption of menstrual or other vaginal discharge. The dimensional and material differences between the subject device and predicate device do not raise different questions of safety and effectiveness.

Non-Clinical Test Data

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 2020 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 per ISO 10993-10:2010
· Acute Systemic Toxicity per ISO 10993-11:2017

Cytotoxicity, sensitization, and irritation testing were performed on the subject applicator and all the above biocompatibility testing was performed on the subject tampons. The results demonstrated the tampon and applicator were non-cytotoxic, non-sensitizers, non-irritating, and that the tampon was not acutely systemically toxic.

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K212277 Page 4 of 4

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

Conclusions

The results of performance testing demonstrate that the Tempo Tampon is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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).