Unscented Menstrual Tampon

K190218 · Qingdao Youjia Hygiene Technology Co., Ltd. · HEB · May 9, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K190218
• Device Name: Unscented Menstrual Tampon
• Applicant: Qingdao Youjia Hygiene Technology Co., Ltd.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: May 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

The BiuBiu tampon is inserted into the vagina and used to absorb menstrual and other vaginal discharge.

Device Story

BiuBiu Tampon is an unscented menstrual tampon consisting of an absorbent pledget, withdrawal cord, and applicator. The device is inserted into the vagina by the user to absorb menstrual and other vaginal discharge. The pledget is made of 100% organic cotton; the applicator is made of polyethylene and polypropylene. The device is provided non-sterile for single-use. It is available in three versions (regular, super, super plus) with color-coded applicators. The applicator features a smooth, rounded tip and a no-slip grip barrel to facilitate insertion. The device functions as a passive absorbent barrier.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility testing (cytotoxicity, vaginal irritation, skin sensitization) performed per ISO 10993-1, ISO 10993-5, and ISO 10993-10. Physical performance testing included appearance, dimensions, compatibility, integrity, and expulsion force, all meeting predefined acceptance criteria.

Technological Characteristics

Pledget/cord: 100% organic cotton. Applicator: Polyethylene and Polypropylene. Design: Cylindrical pledget with bullet-like tip; applicator with smooth, rounded tip and no-slip grip. Non-sterile, single-use. Dimensions vary by absorbency (Regular, Super, Super Plus). Biocompatibility per ISO 10993-1, -5, -10.

Indications for Use

Indicated for use by individuals to absorb menstrual and 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

• Ontex Tampon (Unscented) (K090819)

Submission Summary (Full Text)

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May 9, 2019

Oingdao Youjia Hygiene Technology Co., Ltd % Jessie You Official Correspondent Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, Guangdong 755 China

K190218 Trade/Device Name: BiuBiu Tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: January 26, 2019 Received: February 4, 2019

Dear Jessie You:

Re:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for 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) K190218

Device Name BiuBiu Tampon

Indications for Use (Describe)

The BiuBiu tampon is inserted into the vagina and used to absorb menstrual and 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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# K190218 - 510(k) Summary

## 1. Submission Sponsor

| Applicant Name | Qingdao Youjia Hygiene Technology Co., Ltd |
|----------------|--------------------------------------------------------|
| Address | No. 778 Mingyue Road, Huangdao Zone, Qingdao,<br>China |
| Phone No. | [phone] |
| Contact Person | Ms. Huiying Zhao |
| Email | [e-mail] |
| Date Prepared | May 8, 2019 |

## 2. Submission correspondent

| Name | Shenzhen Joyantech Consulting Co., Ltd |
|----------------|----------------------------------------------------------------------------------------------------|
| Address | Room 1122, No.55 Shizhou Middle Road, Nanshan<br>District,<br>Shenzhen,<br>Guangdong,<br>P.R.China |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Mr. Field Fu; Ms. Jessie You; Ms. Elly Xu |
| Email | [e-mail]; [e-mail] |

## 3. Device Identification

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| Trade name | BiuBiu Tampon |
|-----------------------|------------------------------------|
| Device versions | Regular, Super, and Super Plus |
| Common name | Unscented Menstrual Tampon |
| Device Class | II |
| Classification Number | 21 CFR 884.5470 |
| Classification Name | Unscented menstrual tampon |
| Product code | HEB (Tampon, Menstrual, Unscented) |

# 4. Predicate Device Information

| Trade name | Ontex Tampon (Unscented) |
|---------------|--------------------------|
| 510(k) number | K090819 |

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

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# 5. Device Description

The BiuBiu tampon is composed of an absorbent pledget (tampon), a withdrawal cord, and an applicator. The pledgets (cleared under K090819) have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. The barrel of the applicator has a no-slip grip design to help hold the tampon tightly. Each tampon is individually wrapped and packaged. There are three versions of the BiuBiu tampon with different absorbencies: regular, super and super plus. Each version has a different color applicator. The BiuBiu tampon is provided non-sterile and for single use only.

## 6. Indications for Use Statement

The BiuBiu tampon is inserted into the vagina and used to absorb menstrual and other vaginal discharge.

## 7. Substantial Equivalence Discussion

| ltem | Subject Device<br>(K190218):<br>BiuBiu Tampon | Predicate Device<br>(K090819):<br>Ontex Tampon<br>(Unscented) | Comments |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Qingdao Youjia<br>Hygiene Technology<br>Co., Ltd | Ontex International | None |
| Common<br>name | Unscented Menstrual<br>Tampon | Unscented Menstrual<br>Tampon | Same |
| Indications for<br>use | The BiuBiu tampon is<br>inserted into the<br>vagina and used to<br>absorb menstrual and<br>other vaginal<br>discharge. | Ontex Tampon is a<br>tampon that is inserted<br>into the vagina and<br>used to absorb<br>menstrual fluid. The<br>intended use of the<br>organic cotton tampon<br>is the same as all other<br>products that are<br>legally marketed. | Similar |
| Design | Tampon with<br>cylindrical shape and<br>bullet-like tip.<br>Applicator with<br>smooth and rounded<br>tip. | Tampon with cylindrical<br>shape and bullet-like<br>tip. Applicator with<br>smooth and rounded<br>tip. | Similar |
| Components | | | |
| The BiuBiu tampon is composed of an absorbent pledget and an applicator. | The Ontex Tampon consists of an absorbent pledget, with and without an applicator. | Similar. The predicate device comes without an applicator. However, both the subject and predicate device include tampons with applicators. | |
| Specifications | Regular, super, and super plus | Regular, super, and super plus | Same |
| Overwrap | Individual wrapping | Individual wrapping | Same |
| Pledget dimensions | Regular | Regular | Identical |
| | Length (mm):<br>42-46<br>Diameter (mm):<br>11.8-12.2<br>Withdrawal cord (mm):<br>130-160<br>Syngina absorption (g):<br>6.0-9.0 | Length (mm):<br>42-46<br>Diameter (mm):<br>11.8-12.2<br>Withdrawal cord (mm):<br>130-160<br>Syngina absorption (g):<br>6.0-9.0 | |
| | Super | Super | Identical |
| | Length (mm):<br>46-50<br>Diameter (mm):<br>12.8-13.2<br>Withdrawal cord (mm):<br>130-160<br>Syngina absorption (g):<br>9.0-12.0 | Length (mm):<br>46-50<br>Diameter (mm):<br>12.8-13.2<br>Withdrawal cord (mm):<br>130-160<br>Syngina absorption (g):<br>9.0-12.0 | |
| | Super plus | Super plus | Identical |
| | Diameter (mm): | Diameter (mm): | |
| | 14.8–15.2 | 14.8–15.2 | |
| | Withdrawal cord (mm): | Withdrawal cord (mm): | |
| | 130-160 | 130-160 | |
| | Syngina absorption (g): | Syngina absorption (g): | |
| | 12.0-15.0 | 12.0-15.0 | |
| Materials | -Pledget: 100% organic cotton<br>-Withdrawal cord:<br>100% organic cotton<br>-Applicator:<br>Polyethylene and Polypropylene | -Pledget: 100% organic cotton<br>-Withdrawal cord:<br>100% organic cotton<br>-Applicator:<br>Cardboard | Different.<br>The pledget and cord are identical. However, the subject device utilizes a different material in the applicator. |
| Applicator<br>Dimensions | Inner tube length (mm) X Diameter (mm):<br>Regular: 41.60 $\pm$ 0.20 x 9.75 $\pm$ 0.15<br>Super: 41.60 $\pm$ 0.20 x 9.75 $\pm$ 0.15<br>Super plus: 41.60 $\pm$ 0.20 x 9.75 $\pm$ 0.15<br><br>Outer tube length (mm) X Diameter (mm):<br>Regular: 76.8 $\pm$ 0.9 x 14.35 $\pm$ 0.15<br>Super: 77.6 $\pm$ 0.9 x 17.15 $\pm$ 0.15<br>Super plus: 77.6 $\pm$ 0.9 x 17.15 $\pm$ 0.15 | Length with applicator:<br>120 – 125 mm<br><br>Diameter with applicator:<br>15.9 – 16.1 mm | Different.<br>The subject and predicate device have different dimensions. |

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K190218 Page 3 of 5

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The subject and predicate device have similar indications for use statements and have the same intended use. The technological characteristics of the subject device are different the subject device contains different applicator materials and dimensions. The different technological characteristics of the subject device do not raise different types of safety

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and effectiveness questions.

## 8. Non-Clinical Performance Data

The pledget components of the BiuBiu tampon were cleared under K090819, and remain unchanged. Therefore, data on the performance of the pledgets, consistent with the FDA guidance document: Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s), was leveraged from K090819 to support the performance of the BiuBiu Tampon pledgets.

The following non-clinical performance tests were performed on the applicator component of the BiuBiu tampon:

### Biocompatibility

Biocompatibility testing per ISO 10993-1:2009 and 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."

- Cytotoxicity (ISO 10993-5:2009) .
- Vaginal Irritation (ISO 10993-10:2010)
- Skin Sensitization (ISO 10993-10:2010) .

The applicator was demonstrated to be non-cytotoxic, non-irritating, and non-sensitizing.

#### Physical performance testing

The following physical assessments were performed on the BiuBiu tampon applicator per in house methods with predefined acceptance criteria:

- Appearance
- Dimensions ●
- Compatibility of tampon and applicator ●
- Applicator integrity .
- Applicator expulsion force ●

## 9. Conclusion

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