Tempo Natural Tampon

K212272 · Dong-A Pharmaceutical Co., Ltd. · HEB · Sep 17, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K212272
• Device Name: Tempo Natural Tampon
• Applicant: Dong-A Pharmaceutical Co., Ltd.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Sep 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

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

Device Story

Tempo Natural Tampon is an unscented, 100% organic cotton menstrual tampon; consists of absorbent pledget, withdrawal cord, and polyethylene applicator. Designed for vaginal insertion to absorb menstrual or vaginal discharge. Offered in Regular and Super absorbency levels. Intended for over-the-counter use by individuals during menstruation. Device functions via passive absorption of fluids. No electronic or software components.

Clinical Evidence

Bench testing only. Performance assessed per 2005 FDA guidance for menstrual tampons, including dimensions, absorbency range, withdrawal cord strength, fiber shedding, and tampon integrity. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute systemic toxicity). Microbiology testing confirmed no enhancement of Staphylococcus aureus growth, no increase in TSST-1 production, and no alteration of normal vaginal microflora.

Technological Characteristics

Pledget: 100% organic cotton. Applicator: Polyethylene. Design: Cylindrical pledget with bullet-like tip; applicator with rounded tip. Absorbency: Regular (6.0–9.0g), Super (9.0–12.0g). Non-sterile. No energy source. No software.

Indications for Use

Indicated for individuals requiring vaginal absorption of menstrual or other vaginal discharge.

Regulatory Classification

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.

Predicate Devices

• Taebong CottonDay Tampon (K182817)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

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

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.

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| Substantial Equivalent Comparison Chart | | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device (K182817) |
| Product Name | Tempo Natural Tampon | Taebong CottonDay Tampon |
| Classification<br>Regulation | 884.5470 | 884.5470 |
| Product Code | HEB | HEB |
| Indications for Use | The device is intended for<br>insertion into the vagina for the<br>absorption of menstrual or<br>other vaginal discharge. | The device is intended for<br>insertion into the vagina for the<br>absorption of menstrual or<br>other vaginal discharge. |
| Sterile? | No | No |
| Design | Tampon with cylindrical shape<br>and bullet-like tip. Applicator<br>with smooth, rounded tip. | Tampon with cylindrical shape<br>and bullet-like tip. Applicator<br>with smooth, rounded tip. |
| Syngyna Absorbency<br>(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<br>(mm) | Regular 73 ± 5% | Regular 73 ± 5% |
| | Super 73 ± 5% | Super 73 ± 5% |
| Applicator Outer Length<br>(mm) | Regular 76.5 ± 5% | Regular 76.5 ± 5% |
| | Super 76.5 ± 5% | Super 76.5 ± 5% |
| Applicator Inner<br>Diameter (mm) | Regular 11.8 ± 5% | Regular 11.8 ± 5% |
| | Super 11.8 ± 5% | Super 11.8 ± 5% |
| Applicator Outer<br>Diameter (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.