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.

AI/ML Overview

This is a 510(k) summary for a medical device (BiuBiu Tampon), which establishes substantial equivalence to a predicate device. It does not describe a clinical study comparing the device to acceptance criteria in the way a clinical trial for a novel AI or diagnostic device would.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable or not provided in this document as they pertain to clinical studies typically conducted for new diagnostic or AI devices.

However, I can extract information related to the device's non-clinical performance and acceptance criteria based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are "predefined" but the specific numerical criteria are not detailed in this summary. The summary states that the tests were performed and the results demonstrate safety and effectiveness.

Test Type	Acceptance Criteria (Not explicitly quantified in summary)	Reported Device Performance
Biocompatibility	Non-cytotoxic, non-irritating, non-sensitizing	The applicator was demonstrated to be non-cytotoxic, non-irritating, and non-sensitizing.
Cytotoxicity (ISO 10993-5)	Non-cytotoxic	Non-cytotoxic
Vaginal Irritation (ISO 10993-10)	Non-irritating	Non-irritating
Skin Sensitization (ISO 10993-10)	Non-sensitizing	Non-sensitizing
Physical Performance	Conformed to predefined acceptance criteria (details not provided)	Tests performed per in-house methods with predefined acceptance criteria. Results demonstrate safety and effectiveness.
Appearance	Conforms to visual specifications	Tested (details not provided)
Dimensions	Conforms to dimensional specifications	Tested (details not provided)
Compatibility of tampon and applicator	Proper fit and function	Tested (details not provided)
Applicator integrity	Maintains structural integrity	Tested (details not provided)
Applicator expulsion force	Within specified force range for proper tampon expulsion	Tested (details not provided)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified for any of the non-clinical tests.
Data Provenance: The document does not specify the country of origin for the non-clinical test data. It refers to "in house methods," suggesting internal testing by the manufacturer (Qingdao Youjia Hygiene Technology Co., Ltd, China). The data is generated prospectively as part of product development and submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. These are non-clinical, laboratory-based tests. No experts are used to establish ground truth in the context of clinical interpretation.

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

Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

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

Not applicable. This device is a menstrual tampon, not an AI or diagnostic device that involves human readers or AI assistance.

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

Not applicable. This device is a menstrual tampon, not an algorithm.

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

For the non-clinical performance tests, the "ground truth" (or reference standard) is typically defined by:

Biocompatibility: Established scientific standards and protocols outlined in ISO 10993 series and FDA guidance, ensuring materials do not cause adverse biological reactions.
Physical Performance: Predefined engineering and design specifications for the device's physical attributes and functionality.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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,China
Phone No.	+86-532-86613616
Contact Person	Ms. Huiying Zhao
Email	youjia_zhaohy@sina.com
Date Prepared	May 8, 2019

2. Submission correspondent

Name	Shenzhen Joyantech Consulting Co., Ltd
Address	Room 1122, No.55 Shizhou Middle Road, NanshanDistrict,Shenzhen,Guangdong,P.R.China
Post Code	518000
Phone No.	86-755-86069197
Contact Person	Mr. Field Fu; Ms. Jessie You; Ms. Elly Xu
Email	Jessie@cefda.com; elly@cefda.com

3. Device Identification

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

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(K190218):BiuBiu Tampon	Predicate Device(K090819):Ontex Tampon(Unscented)	Comments
Manufacturer	Qingdao YoujiaHygiene TechnologyCo., Ltd	Ontex International	None
Commonname	Unscented MenstrualTampon	Unscented MenstrualTampon	Same
Indications foruse	The BiuBiu tampon isinserted into thevagina and used toabsorb menstrual andother vaginaldischarge.	Ontex Tampon is atampon that is insertedinto the vagina andused to absorbmenstrual fluid. Theintended use of theorganic cotton tamponis the same as all otherproducts that arelegally marketed.	Similar
Design	Tampon withcylindrical shape andbullet-like tip.Applicator withsmooth and roundedtip.	Tampon with cylindricalshape and bullet-liketip. Applicator withsmooth and roundedtip.	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):42-46Diameter (mm):11.8-12.2Withdrawal cord (mm):130-160Syngina absorption (g):6.0-9.0	Length (mm):42-46Diameter (mm):11.8-12.2Withdrawal cord (mm):130-160Syngina absorption (g):6.0-9.0
	Super	Super	Identical
	Length (mm):46-50Diameter (mm):12.8-13.2Withdrawal cord (mm):130-160Syngina absorption (g):9.0-12.0	Length (mm):46-50Diameter (mm):12.8-13.2Withdrawal cord (mm):130-160Syngina absorption (g):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-Withdrawal cord:100% organic cotton-Applicator:Polyethylene and Polypropylene	-Pledget: 100% organic cotton-Withdrawal cord:100% organic cotton-Applicator:Cardboard	Different.The pledget and cord are identical. However, the subject device utilizes a different material in the applicator.
ApplicatorDimensions	Inner tube length (mm) X Diameter (mm):Regular: 41.60 $\pm$ 0.20 x 9.75 $\pm$ 0.15Super: 41.60 $\pm$ 0.20 x 9.75 $\pm$ 0.15Super plus: 41.60 $\pm$ 0.20 x 9.75 $\pm$ 0.15Outer tube length (mm) X Diameter (mm):Regular: 76.8 $\pm$ 0.9 x 14.35 $\pm$ 0.15Super: 77.6 $\pm$ 0.9 x 17.15 $\pm$ 0.15Super plus: 77.6 $\pm$ 0.9 x 17.15 $\pm$ 0.15	Length with applicator:120 – 125 mmDiameter with applicator:15.9 – 16.1 mm	Different.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.

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).