The Tempo Natural 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. It will be offered in two absorbances: Regular and Super.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a menstrual tampon. It does not describe an AI/machine learning medical device, nor does it contain information about expert-level ground truth, multi-reader multi-case studies, or the performance of an algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set specifics, as this information is not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving novel performance against specific acceptance criteria for an AI model.

Here's an overview of what is provided:

Device: Tempo Natural Tampon
Regulatory Class: Class II, Product Code HEB
Indication for Use: "The Tempo Natural Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge."

Acceptance Criteria & Device Performance (Based on Substantial Equivalence to Predicate):

The "acceptance criteria" for this device are effectively demonstrating that it is as safe and effective as a legally marketed predicate device (Taebong CottonDay Tampon K182817) by meeting a set of similar specifications and passing specific non-clinical tests.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from Predicate Equivalence & Testing)	Reported Device Performance (as presented in the 510(k) Summary)
Intended Use	Same as predicate device	"The Tempo Natural Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge." (Identical to predicate)
Sterility	Non-sterile (same as predicate)	No (Non-sterile)
Design	Cylindrical shape, bullet-like tip, standard applicator with smooth, rounded tip (same as predicate)	Cylindrical shape, bullet-like tip, applicator with smooth, rounded tip (Identical to predicate)
Syngyna Absorbency (gram)	Regular: 6.0 – 9.0; Super: 9.0 – 12.0 (same as predicate)	Regular: 6.0 – 9.0; Super: 9.0 – 12.0 (Identical to predicate)
Pledget Length (mm)	Regular: 38; Super: 47 (same as predicate)	Regular: 38; Super: 47 (Identical to predicate)
Pledget Diameter (mm)	Regular: 12; Super: 12 (same as predicate)	Regular: 12; Super: 12 (Identical to predicate)
Applicator Inner Length (mm)	Regular: 73 ± 5%; Super: 73 ± 5% (same as predicate)	Regular: 73 ± 5%; Super: 73 ± 5% (Identical to predicate)
Applicator Outer Length (mm)	Regular: 76.5 ± 5%; Super: 76.5 ± 5% (same as predicate)	Regular: 76.5 ± 5%; Super: 76.5 ± 5% (Identical to predicate)
Applicator Inner Diameter (mm)	Regular: 11.8 ± 5%; Super: 11.8 ± 5% (same as predicate)	Regular: 11.8 ± 5%; Super: 11.8 ± 5% (Identical to predicate)
Applicator Outer Diameter (mm)	Regular: 14.1 ± 5%; Super: 14.1 ± 5% (same as predicate)	Regular: 14.1 ± 5%; Super: 14.1 ± 5% (Identical to predicate)
Materials	Pledget: 100% Organic Cotton; Applicator: Polyethylene (same as predicate)	Pledget: 100% Organic Cotton; Applicator: Polyethylene (Identical to predicate)
Performance Testing (per FDA guidance)	Meet standards for: Dimensions, Absorbency range, Chemical residues, Withdrawal cord strength, Fiber shedding, Tampon integrity.	"The following performance characteristics were assessed... and results demonstrate substantial equivalence." (Specific values not provided, only compliance stated)
Biocompatibility Testing (per ISO 10993)	Meet standards for: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity.	"The results satisfied the ISO standards requirements."
Microbiology Testing (per FDA guidance)	Not enhance S. aureus growth, not increase TSST-1 production, not alter normal vaginal microflora.	"Microbiology testing was conducted to demonstrate that the subject devices do not: [list of criteria]..." (Compliance stated)

Regarding the other requested information:

Sample size used for the test set and the data provenance: Not applicable in the context of a medical device (tampon) performance testing for 510(k). The tests are typically conducted per recognized standards on representative samples of the product. The data provenance would be laboratory testing results.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for medical device performance (e.g., absorbency, strength) is based on objective laboratory measurements against established standards, not expert consensus interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Objective laboratory measurements and adherence to specified material and dimensional characteristics based on recognized standards (e.g., ISO, FDA guidance).
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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September 17, 2021

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

Re: K212272

Trade/Device Name: Tempo Natural Tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: July 16, 2021 Received: July 20, 2021

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 (OS) 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,

Jason Roberts -S

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) K212272

Device Name Tempo Natural Tampon

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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K212272 Page 1 of 3

510(k) Summary - K212272

Submitter

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

Official Correspondent

Joyce Kwon Provision Consulting Group, Inc. 100 N. Barranca St. Suite 700 West Covina, CA 91791

Date Prepared

Sept 15, 2021

Device Information

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

Predicate Devices

Taebong CottonDay Tampon (K182817)

The predicate device has not been subject to any design-related recalls.

Indication for Use

The Tempo Natural 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 (K182817)
Product Name	Tempo Natural Tampon	Taebong CottonDay Tampon
ClassificationRegulation	884.5470	884.5470
Product Code	HEB	HEB
Indications for Use	The device is intended forinsertion into the vagina for theabsorption of menstrual orother vaginal discharge.	The device is intended forinsertion into the vagina for theabsorption of menstrual orother vaginal discharge.
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 38	Regular 38
	Super 47	Super 47
Pledget Diameter (mm)	Regular 12	Regular 12
	Super 12	Super 12
Applicator Inner Length(mm)	Regular 73 ± 5%	Regular 73 ± 5%
	Super 73 ± 5%	Super 73 ± 5%
Applicator Outer Length(mm)	Regular 76.5 ± 5%	Regular 76.5 ± 5%
	Super 76.5 ± 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 14.1 ± 5%	Regular 14.1 ± 5%
	Super 14.1 ± 5%	Super 14.1 ± 5%
Materials	Pledget 100% Organic Cotton	Pledget 100% Organic Cotton
	Applicator Polyethylene	Applicator Polyethylene

Substantial Equivalent Comparison Chart

Basis for Substantial Equivalence

The subject device is identical to the predicate device with the same material composition and dimensional characteristics. The subject and predicate device have the same intended use.

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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 2016 and ISO 10993 standards as follows:

Cytotoxicity per ISO 10993-5:2009 ●
Sensitization per ISO 10993-10:2010 ●
Irritation 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 satisfied the ISO standards requirements.

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 Natural 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).