The Unscented Menstrual Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 4 absorbencies, light (≤ 6 grams absorbency), regular (6-9 grams), super (9-12 grams) and super plus (12-15 grams). These tampons include a pledget made from viscose and cotton as well as a polyester and polypropylene overwrap. The removal string is made of polypropylene yarn and cotton yarn. The applicator tubes are made of low density polyethylene (LDPE). The assembled tampon with applicator is wrapped in a printed polyethylene wrapper.

AI/ML Overview

This document describes the premarket notification for an "Unscented Menstrual Tampon" (K232598) and states its substantial equivalence to a predicate device. It is important to note that this document is for a medical device (menstrual tampons), not an AI/ML powered device, so the requested information about AI model performance, multi-reader multi-case studies, and ground truth establishment from experts or pathology will not be present.

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance:

The document explicitly states: "The performance tests were conducted to demonstrate the effectiveness of the subject device; all samples met the predefined acceptance criteria."

However, the specific numerical acceptance criteria for each test and the reported device performance are not explicitly detailed in a table format with specific values within this document. Instead, it lists the types of performance characteristics assessed and implies that the device met the criteria.

Here's a breakdown of the requested information based on the provided document, with explanations for what is not applicable or not explicitly stated:

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

While the document states that all acceptance criteria were met, it does not provide a table with specific numerical acceptance criteria and the corresponding reported values for the subject device. It only lists the types of tests performed.

Performance Characteristic	Acceptance Criteria (Stated)	Reported Device Performance (Stated)
Dimensional information	Predefined Acceptance Criteria (Implied numerical ranges based on predicate difference table)	Met predefined acceptance criteria (Implied: Total length (in ready to push position): 106-122.2 mm; Outside diameter (outer tube): 14.5-16.2 mm)
Absorbency range (Syngyna method per 21 CFR 801.430)	Predefined Acceptance Criteria (Implied: ≤6g, 6-9g, 9-12g, 12-15g)	Met predefined acceptance criteria
Chemical residues	Predefined Acceptance Criteria	Met predefined acceptance criteria
Withdrawal cord strength	Predefined Acceptance Criteria	Met predefined acceptance criteria
Fiber shedding	<1mg (Explicitly stated in comparison table as 'Same' for both subject and predicate)	<1mg (Explicitly stated in comparison table)
Tampon integrity	Predefined Acceptance Criteria	Met predefined acceptance criteria
Expulsion Force	<7.0N (Explicitly stated in comparison table as a difference from predicate's <6N, implying this is the subject device's target)	<7.0N (Likely achieved as stated in comparison table)

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size used for the performance tests. It states "all samples met the predefined acceptance criteria," but the number of samples is not provided.

Data Provenance: The document does not specify the country of origin for the test data or whether the studies were retrospective or prospective. Given the manufacturer is Chinese (Unibeauty (Hubei) Technology Co.,Ltd.), the testing was likely conducted in China or by a contracted lab.

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

This information is not applicable as the device is a menstrual tampon, not an AI/ML powered medical device. The "ground truth" for the performance characteristics of a tampon (e.g., absorbency, dimensions, fiber shedding) is established through standardized physical and chemical testing methods, not by expert consensus or interpretations.

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

This is not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) where there can be disagreement among experts. Here, the tests are objective, laboratory-based measurements.

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

This is not applicable as the device is a menstrual tampon and not an AI-powered system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted or is relevant.

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

This is not applicable as the device is a physical product (menstrual tampon), not an algorithm or AI system.

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

The "ground truth" for the performance characteristics of this device is established through:

Standardized Physical and Chemical Testing Methods:
- Syngyna method (for absorbency)
- Measurement of dimensions and weight
- Chemical analysis for residues
- Mechanical testing (e.g., withdrawal cord strength, expulsion force)
- Microbiological testing (e.g., growth of S. aureus, TSST-1 production, vaginal microflora alteration)
- Biocompatibility testing (in vitro cytotoxicity, sensitization, irritation, acute systemic toxicity).

This is based on objective measurements rather than subjective expert consensus, pathology, or patient outcomes for device performance.

8. The sample size for the training set

This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning model development. This is a manufactured product tested for its physical and biological properties.

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

This is not applicable for the same reasons as point 8.

Summary

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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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

December 15, 2023

Unibeauty (Hubei) Technology Co.,Ltd. % Helen Nan Official Correpondent New Risen Enterprise Management Consulting Co., Ltd. Room 302, Building 3, Hangqian Mansion, Hangqian Street Lucheng District Wenzhou, Zhejiang 325000 China

Re: K232598

Trade/Device Name: Unscented Menstrual Tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: November 13, 2023 Received: November 13, 2023

Dear Helen Nan:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Reginald K. Avery -S

for 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) K232598

Device Name Unscented Menstrual Tampon

Indications for Use (Describe)

The Unscented Menstrual Tampon is inserted into the vagina to absorb menstrual 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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Image /page/4/Picture/0 description: The image shows a logo for a company called UNI BEAUTY, along with the website address www.unibty.com. The image also contains the text "Page 1 of 6" and the code "K232598". There are Chinese characters below the logo, which translate to "beauty has you, and beauty".

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1.0 Submitter Information

· Company: Unibeauty (Hubei) Technology Co.,Ltd.
· Address: Building A8, nonwoven small and medium-sized enterprise Industrial Park, PENGCHANG Town, Xiantao City, Hubei Province
Phone: 086-728-8220088
Contact: Mr. Lin Fongshun, General Manager
Date Prepared: December 5, 2023

2.0 Device Information

Trade/Device Name: Unscented Menstrual Tampon Common Name: Unscented Menstrual Tampon Classification Name: Tampon, Menstrual, Unscented Classification Regulation: 21 CFR 884.5470 Product Code: HEB (Tampon, Menstrual, Unscented) Device Class: II

3.0 Predicate Device Information

The predicate device is Ontex Unscented Tampons with Colored Plastic Applicator manufactured by ONTEX BVBA.

510K Number: K142786

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

4.0 Device Description

The Unscented Menstrual Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 4 absorbencies,

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Image /page/5/Picture/0 description: The image shows the logo for UNI BEAUTY, along with the website address www.unibty.com. The image also contains the text "Page 2 of 6" and the code "K232598". There are also Chinese characters that translate to "You, Li, Mei, You, Ni, Er, Mei".

light (≤ 6 grams absorbency), regular (6-9 grams), super (9-12 grams) and super plus (12-15 grams). These tampons include a pledget made from viscose and cotton as well as a polyester and polypropylene overwrap. The removal string is made of polypropylene yarn and cotton yarn. The applicator tubes are made of low density polyethylene (LDPE). The assembled tampon with applicator is wrapped in a printed polyethylene wrapper.

5.0 Indications for Use

The Unscented Menstrual Tampon is inserted into the vagina to absorb menstrual discharge.

6.0 Comparison of Technological Characteristics with the Predicate Device

The following table compares the Unscented Menstrual Tampon to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

6.1 Comparison Table of Technological Characteristic with the
Predicate Device

Characteristics	Subject Device	Predicate Device(K142786)	SignificantDifferences
Device Name	Unscented MenstrualTampon	Ontex UnscentedTampons with ColoredPlastic Applicators	N/A
RegulationName	Unscented MenstrualTampon	Unscented MenstrualTampon	Same
Manufacturer	Unibeauty (Hubei)Technology Co.,Ltd.	ONTEX	N/A
Product Code	HEB	HEB	Same
RegulationNumber	21 CFR 884.5470	21 CFR 884.5470	Same
Classification	Class II	Class II	Same
Indications forUse	The UnscentedMenstrual Tamponsare inserted into thevagina to absorbmenstrual discharge.	The Ontex UnscentedTampons with ColoredPlastic Applicators areinserted into the vagina toabsorb menstrualdischarge.	Same
Overall Design	W wadding tamponwith plastic applicatorsof full size (long)	W wadding tampon withplastic applicators of fullsize (long) and compactsize	Different, nocompact size
Unscented/Scented	Unscented	Unscented	Same
DimensionsSpecifications(mm)	Total length (in readyto push position): 106-122.2Outside diameter(outer tube): 14.5- 16.2	Total length (in ready topush position): 110 - 135Outside diameter (outertube): 13.5 - 18.2	Different
WeightSpecifications (g)(single wrapper)	4.55-6.45 (without	3.6-8.1	Different
AbsorbentPledget	Viscose and Cotton	Viscose	Different
Withdrawal Cord	Cotton andPolypropylene	Cotton polyester	Different
Applicator	Plastic -polyethyleneincluding pigments	Plastic -polyethyleneincluding pigments	Same
Absorbencies	≤6g, 6-9g, 9-12g, 12-15g	<6g, 6-9g, 9-12g, 12-15g	Similar
Expulsion Force	<7.0N	<6N	Different

Fiber Shedding	<1mg	<1mg	Same
Packaging	Primary packaging:individual polymericwrapperSecondary packaging:cardboard box	Primary packaging:individual polymericwrapperSecondary packaging:cardboard box	Same
Sterile	no	no	Same
Single-Use	yes	yes	Same
The subject device has the similar indication for use as the predicate device as

E-mail: Uni@uni-beauty.com

Add.: 湖北省仙桃市彭场镇非织造布中小企业产业园 A8 栋

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Image /page/6/Picture/0 description: The image shows a logo for "UNI BEAUTY". The logo consists of a stylized butterfly figure on the left and the text "优立美" above "UNI BEAUTY" on the right. The butterfly figure is composed of curved lines and a circle at the top, resembling a person with wings. The text is in a simple, sans-serif font.

美你有 កិ 优立美

全国服务热线:400-0048-698

E-mail: Uni@uni-beauty.com

Add.: 湖北省仙桃市彭场镇非织造布中小企业产业园 A8 栋

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Image /page/7/Picture/1 description: The image contains a logo for "UNI BEAUTY". The logo consists of a stylized figure with wing-like shapes extending from its sides, resembling a person with wings. To the right of the figure, there are Chinese characters, followed by the English text "UNI BEAUTY" in a smaller font size.

立美有你世美

well as comparable technological characteristics. The differences include the material composition and dimensions; however, the differences do not raise different questions of safety and effectiveness.

7.Performance Testing – Bench

The following performance characteristics were assessed in accordance with the 2005 FDA quidance document "Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)"

Dimensional information ●
Absorbency range, tested using the Syngyna method (per 21 ● CFR 801.430)
Chemical residues ●
Withdrawal cord strength ●
Fiber shedding
Tampon integrity

The performance tests were conducted to demonstrate the effectiveness of the subject device; all samples met the predefined acceptance criteria.

8.Biocompatibility Testing

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Image /page/8/Picture/0 description: The image shows the logo for UNI BEAUTY, along with the website address www.unibty.com. The image also contains the text "Page 5 of 6" and the code "K232598". Below the logo are several Chinese characters. The characters are arranged horizontally.

Biocompatibility studies were performed in accordance with the FDA quidance document "Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO 10993-1,

'Biological Evaluation of Medical Devices - Part 1:Evaluation and testing within a risk management process" issued on September 4, 2020 as follows:

In vitro cytotoxicity test per ISO 10993-5:2009 (tampon and . applicator)
Sensitization test per ISO 10993-10:2021 (tampon and applicator) .
Vaginal irritation test per ISO 10993-23:2021 (tampon and . applicator)
Acute systemic toxicity test per ISO 10993-11:2017 (tampon only) ●

All tests were performed on the tampon and applicator separately. The results demonstrated that the subject device is non-cytotoxic, nonirritating, non-sensitizing, and non-systemically toxic.

9.Microbiology Testing

Per the FDA quidance document "Guidance for Industry and FDA Staff – Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)" issued on July 27, 2005, microbiology testing was conducted on the final, finished form of the subject device, and the test results showed that the subject device does 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. ●

10.Clinical Testing

No clinical study is included in this submission.

11. Conclusions

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Image /page/9/Picture/0 description: The image shows the logo for UNI BEAUTY, along with the website address www.unibty.com. The image also contains the text "Page 6 of 6" and the code "K232598". The Chinese characters "优立美有你而美" are also present in the image.

The nonclinical tests demonstrate that the subject device, Unscented Menstrual Tampon, is as safe and effective, as the legally marketed predicate device (K142786). Therefore, the subject device is substantially equivalent to the 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).