Youjia unscented tampon with plastic applicators are composed of an absorbent pledget (tampon), a withdrawal cord and an applicator. The pledgets have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. These tampons are provided in three absorbencies: regular (6-9g), super, (9-12g), and super plus (12-15g). Each tampon is individually wrapped and packaged. The Youjia unscented tampon with plastic applicators are provided non-sterile and for single use only.

AI/ML Overview

This document describes the FDA 510(k) clearance for the Youjia unscented tampon with plastic applicators. However, it does not contain the specific detailed acceptance criteria and study results in the format requested for an AI/device performance study. The document focuses on the substantial equivalence of tampons, which are physical medical devices, not AI software.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, how training ground truth was established) are not applicable or not provided in the context of this device because it's a physical product, not an AI algorithm.

Below, I will extract the information that is present and indicate where requested information is not applicable or not provided in this document.

1. A table of acceptance criteria and the reported device performance

The document states that "The sponsor completed performance testing consistent with the FDA guidance document: Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) issued on July 27, 2005." It also mentions "pre-defined acceptance criteria" for physical performance testing, but the actual specific criteria values and the reported device performance values are not detailed in this summary.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility
Cytotoxicity	Met (demonstrated as biocompatible)
Sensitization	Met (demonstrated as biocompatible)
Irritation	Met (demonstrated as biocompatible)
Acute Systemic Toxicity	Met (demonstrated as biocompatible)
Extraction testing (USP <661>) for colorants	Completed and supports safety
Physical Performance Testing (in-house methods)
Appearance	Meets pre-defined acceptance criteria (specifics not given)
Dimensions	Meets pre-defined acceptance criteria (specifics not given)
Compatibility of tampon and applicator	Meets pre-defined acceptance criteria (specifics not given)
Applicator integrity	Meets pre-defined acceptance criteria (specifics not given)
Applicator expulsion force	Meets pre-defined acceptance criteria (specifics not given)

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

This information is not provided. The document mentions "performance testing," but does not specify sample sizes or data provenance for these tests. It does state that the subject tampon is identical to tampons cleared under K122603, and the sponsor leveraged testing from that previous clearance, as well as biocompatibility data from K190218.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical device, not an AI algorithm requiring expert ground truth for image/data interpretation.

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

Not applicable. This is a physical device.

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 is a physical device, not an AI algorithm.

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

Not applicable. This is a physical device.

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

For biocompatibility, the ground truth is established by standard biological assays (cytotoxicity, sensitization, irritation, systemic toxicity) and chemical extraction tests. For physical performance, the ground truth is against pre-defined physical specifications/criteria.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm.

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

Not applicable. This is a physical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 13, 2020

Qingdao Youjia Hygiene Technology Co., Ltd % Emma Xing Official Correspondent Suzhou Jiuzhen Consulting Company Ltd. North Building, A1, 218, Xinghu Str., Suzhou Industrial Park Suzhou, Jiangsu 15123 CHINA

Re: K192557

Trade/Device Name: Youjia unscented tampon with plastic applicators Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: January 9, 2020 Received: January 16, 2020

Dear Emma Xing:

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.

{1}------------------------------------------------

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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.

Monica D. Garcia, Ph.D. Acting 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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192557

Device Name

Youjia unscented tampon with plastic applicators

Indications for Use (Describe)

The Youjia unscented tampon with plastic applicators are 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)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary – K192557

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared:	February 12, 2020
Manufacturer:	Qingdao Youjia Hygiene Technology Co., Ltd.No. 778 Mingyue Road, Huangdao Zone, Qingdao, China
ContactPerson:	Ms. Huiying ZhaoMinister of Quality Department Phone: +86-532-86613616E-mail: youjia_zhaohy@sina.com
SubmissionCorrespondent:	Suzhou Jiuzhen Consulting Company Ltd.North Building, A1, 218, Xinghu Str., Suzhou Industrial Park,China.Ms. Emma XingPhone: +86-512-85665107E-mail: Jiuzhenservice@163.com
Trade Name:	Youjia unscented tampon with plastic applicators
CommonName:	Unscented Menstrual Tampon

Classification Name: Classification Regulation: Classification Panel:

Device Class: Classification Product Code:

Unscented menstrual tampon 21 CFR 884.5470 Obstetrics/Gynecology

Class II HEB (Tampon, Menstrual, Unscented)

{4}------------------------------------------------

Predicate Device:

Trade Name:	BiuBiu Tampon
Manufacturer:	Qingdao Youjia Hygiene Technology Co., Ltd.
510(k) Clearance:	K190218 (May 9, 2019)

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

Device Description:

The Youjia unscented tampon with plastic applicators are provided non-sterile and for single use only.

Indications for Use Statement:

The Youjia unscented tampon with plastic applicators are inserted into the vagina and used to absorb menstrual and other vaginal discharge.

Substantial Equivalence Discussion:

	Currently MarketedPredicate BiuBiu Tampon(K190218)	Proposed Youjiaunscented tampon withplasticapplicators	Comment
Manufacturer	Qingdao Youjia HygieneTechnology Co.,Ltd.	Qingdao Youjia HygieneTechnology Co.,Ltd.	-
Regulationname	Unscented menstrual tampon	Unscented menstrualtampon	No difference
Indicationsfor use	The BiuBiu tampon isinserted into the vagina andused to absorb menstrual andother vaginal discharge.	The Youjia unscentedtampon with plasticapplicators are insertedinto the vagina and used toabsorb menstrual andother vaginal discharge.	No difference
Design	Tampon with cylindricalshape and bullet-like tip.Applicator with smooth androunded tip.	Tampon with cylindricalshape and bullet-like tip.Applicator with smoothand rounded tip.	No difference
Components	The BiuBiu tampon iscomposed of an absorbentpledget and an applicator.	The tampon is composedof an absorbent pledgetand an applicator.	No difference
Materials	-Pledget: 100% organiccotton.-Withdrawal cord: 100%organic cotton-Applicator with telescope:Polyethylene andPolypropylene	-Pledget: 100% Rayon.-Withdrawal cord: 67%polyester and 33% cotton.-Applicator withtelescope: Polyethyleneand Polypropylene-Applicator withoutTelescope:Polyethylene	Different
Applicatorcolor	Orange, Green, Yellow	Applicator with telescope:Green, Red, BlueApplicator withouttelescope: white	Different
Specifications	Regular, super, and superplus	Regular, super and superplus.	No difference
Applicator Dimensions
Applicator Dimensions	Length with applicator: 120 – 125 mmDiameter with applicator:14.2 – 17.9 mm	Applicator with telescope:Length:120 – 125 mmDiameter:14.2 – 17.3 mmApplicator withouttelescope: Length:113 – 120 mmDiameter: 14.05 – 17.15mm	Different

{5}------------------------------------------------

{6}------------------------------------------------

The Youjia unscented tampon with plastic applicators and predicate devices have similar indications for use statements and have the same intended use. The differences in technological characteristics between the Youjia unscented tampon with plastic applicators and predicate devices do not raise different safety and effectiveness questions.

Summary of Performance Testing:

The sponsor completed performance testing consistent with the FDA guidance document: Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) issued on July 27, 2005. As the subject tampon is identical to the tampons cleared under K122603 (Ontex International), the sponsor leveraged testing on the K122603 tampons to support the performance of the proposed Youjia unscented tampon with plastic applicators.

Biocompatibility

Biocompatibility studies were performed in accordance with the FDA guidance "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 the ISO 10993 standards, as follows:

Cytotoxicity
Sensitization ●
Irritation ●
Acute Systemic Toxicity ●

The results of these studies demonstrated that the subject device is biocompatible. In addition, biocompatibility data from K190218 was leveraged to support the subject applicator. Extraction testing per USP <661> was completed to evaluate the safety of the colorants used in the applicator.

Physical performance testing

The following physical assessments were performed on the applicators per in house

{7}------------------------------------------------

methods with predefined acceptance criteria:

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

The results of these tests demonstrated that the subject device meets its pre-defined acceptance criteria.

Conclusion:

The Youjia unscented tampon with plastic applicators are substantially equivalent to the proposed predicate device.

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).