The proposed device is a traditional unscented menstrual tampon, and it has two types (i.e. digital tampon and applicator tampon). Each device consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by overwap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. The proposed device is provided in 4 absorbencies: light (≤6g), regular (6~~9g), super (9~~12g) and super plus (12~15g). Each device is individually wrapped and packaged in sealed multi-unit containers for retail sale. And it is provided non-sterile and for single use only.

AI/ML Overview

The provided text describes the 510(k) premarket notification for an Unscented Menstrual Tampon (K222046). It outlines the device's characteristics, its comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document references established guidance documents for menstrual tampons and pads for its performance characteristics. While specific numerical acceptance criteria are not explicitly listed in a consolidated table within the provided text, it states that "All samples met the predefined acceptance criteria" for performance testing.

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Performance Testing	Dimensions	Met predefined acceptance criteria
	Absorbency	Met predefined acceptance criteria
	Removal string strength	Met predefined acceptance criteria
	Fiber shedding	Met predefined acceptance criteria
	Tampon integrity	Met predefined acceptance criteria
	Chemical residues	Met predefined acceptance criteria
Biocompatibility Testing	In vitro cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic
	Skin sensitization (ISO 10993-10:2010)	Non-sensitizing
	Vaginal irritation (ISO 10993-10:2010)	Non-irritating
	Acute systemic toxicity (ISO 10993-11:2017) (tampon only)	Non-systemically toxic
Microbiology Testing	Enhancement of Staphylococcus aureus growth	Does not enhance growth
	Increase of Toxic Shock Syndrome Toxin-1 (TSST-1) production	Does not increase production
	Alteration of normal vaginal microflora growth	Does not alter growth

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test in the performance, biocompatibility, or microbiology testing. It only mentions "All samples met the predefined acceptance criteria."

The data provenance is from non-clinical testing performed by Suzhou Borage Medical Technology Co., Ltd. in China, or by their designated testing facilities. This is retrospective in the sense that the testing was conducted on manufactured devices for the purpose of the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the described study is a non-clinical device performance and safety evaluation for a menstrual tampon. It does not involve establishing ground truth from expert interpretation of data like images or patient outcomes. The "ground truth" here is the objective measurement of physical, chemical, and biological properties according to established standards.

4. Adjudication Method for the Test Set

This is not applicable as the described study is a non-clinical device performance and safety evaluation. Adjudication methods like 2+1 or 3+1 are typically used for expert review of clinical data, not for objective laboratory testing.

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. The submission is for a physical medical device (unscented menstrual tampon) and does not involve AI or human readers for diagnostic interpretation.

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

This is not applicable. The submission is for a physical medical device (unscented menstrual tampon) and does not involve any algorithm or AI performance.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on objective measurements and laboratory testing conforming to international standards (ISO 10993 series) and FDA guidance documents specific to menstrual tampons. This includes:

Physical measurements: Dimensions, absorbency, removal string strength, fiber shedding, tampon integrity.
Chemical analysis: Chemical residues.
Biological testing: In vitro cytotoxicity, skin sensitization, vaginal irritation, acute systemic toxicity, and specific microbiological tests for Staphylococcus aureus growth, TSST-1 production, and impact on vaginal microflora.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a physical device evaluation, not an algorithm or AI development.

9. How the Ground Truth for the Training Set Was Established

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

Summary

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September 30, 2022

Suzhou Borage Medical Technology Co., Ltd. % Grace Liu Consultant Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China

Re: K222046

Trade/Device Name: Unscented Menstrual Tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: June 13, 2022 Received: July 11, 2022

Dear Grace Liu:

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/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 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,

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222046

Device Name Unscented Menstrual Tampon

Indications for Use (Describe)

The unscented menstrual tampon is intended for insertion into 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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510(k) Summary - K222046

1. Contact Details

1.1 Applicant information

Applicant Name	Suzhou Borage Medical Technology Co., Ltd.
Address	No.9 Shiheshan Road, Dongshan Town, Wuzhong District,Suzhou City, Jiangsu Province, 215107, China
Contact person	Zhou Nana
Phone No.	+86-512-66280008
E-mail	znn@borage.com.cn
Date Prepared	2022-09-27

1.2 Submission Correspondent

Image: Logo	Shenzhen Joyantech Consulting Co., Ltd
	1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan
卓远天成	District, Shenzhen, Guangdong Province, China
Phone No.	+86-755-86069197
Contact person	Grace Liu; Field Fu;
Contact person's e-mail	grace@cefda.com; field@cefda.com
Website	http://www.cefda.com

2. Device Information

Trade name	Unscented Menstrual Tampon
Common name	Unscented Menstrual Tampon
Classification	II
Classification name	Tampon, Menstrual, Unscented
Product code	HEB
Regulation No.	21 CFR 884.5470

3. Legally Marketed Predicate Device

Trade Name	Tosama 100% Organic Cotton Menstrual Tampon
510(k) Number	K15117
Product Code	HEB
Manufacturer	TOSAMA, d.o.o.

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

4. Device Description

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has a smooth, rounded tip to ease insertion.

The proposed device is provided in 4 absorbencies: light (≤6g), regular (6~~9g), super (9~~12g) and super plus (12~15g). Each device is individually wrapped and packaged in sealed multi-unit containers for retail sale. And it is provided non-sterile and for single use only.

5. Intended Use/Indication for Use

The unscented menstrual tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

6. Technological Characteristics Comparison

	Comparison item	Proposed Device(K222046)	Predicate Device(K15117)	Comment
	Manufacturer	Suzhou Borage MedicalTechnology Co., Ltd.	TOSAMA, d.o.o.	None
	Product Name	Unscented MenstrualTampons	Tosama 100% OrganicCotton Menstrual Tampon	None
	Product Code	HEB	HEB	Same
	Regulation Number	21 CFR § 884.5470	21 CFR § 884.5470	Same
	Classification	Class II	Class II	Same
	Intended Use/ Indications for Use	The unscented menstrualtampon is intended forinsertion into the vagina fortheabsorptionofmenstrual or other vaginaldischarge.	The Tosama 100% OrganicCotton Menstrual Tampon isintended for insertion intothevaginafortheabsorption of menstrual orother vaginal discharge.	Same
	Single Use	Yes	Yes	Same
	Sterility	Non-sterile	Non-sterile	Same
	Design	Tampon with cylindricalshape and bullet-like tip.Applicator withsmooth,rounded tip.	Tampon with cylindricalshape and bullet-like tip.Applicator withsmooth,rounded tip.	Same
Absorbency
	Light	≤6g	N/A
Regular		6~9g	6~9g	Different
Super		9~12g	9~12g
	Super plus	12~15g	12~15g
Product dimensions
Digital tampon
LightPledget length		(40~50) mm	N/A	Different

	Pledget diameter	(9.5~12.5) mm
	Removal stringlength	(125~165) mm
	Pledget length	(40~50) mm	(43.0~46.0) mm
Regular	Pledget diameter	(10.5~13.5) mm	(11.0~12.0) mm
	Removal stringlength	(125~165) mm	(130~160) mm
	Pledget length	(45~55) mm	(48.0~51.0) mm
Super	Pledget diameter	(11.5~14.5) mm	(12.0~13.0) mm
	Removal stringlength	(125~165) mm	(130~160) mm
	Pledget length	(45~55) mm	(48.0~51.0) mm
Super plus	Pledget diameter	(13.3~16.3) mm	(14.0~15.0) mm
	Removal stringlength	(125~165) mm	(130~160) mm
Applicator tampon
	Pledget length	(40~50) mm
	Pledget diameter	(9.5~12.5) mm
Light	Removal stringlength	(125~165) mm	N/A
	Applicator length	125 mm
	Applicator diameter	15 mm
	Pledget length	(40~50) mm	(43.0~46.0) mm
	Pledget diameter	(10.5~13.5) mm	(11.0~12.0) mm
Regular	Removal stringlength	(125~165) mm	(130~160) mm
	Applicator length	125 mm	120 mm
	Applicator diameter	15 mm	13 mm
	Pledget length	(45~55) mm	(43.0~46.0) mm
	Pledget diameter	(11.5~14.5) mm	(12.0~13.0) mm
Super	Removal stringlength	(125~165) mm	(130~160) mm
	Applicator length	126 mm	120 mm
	Applicator diameter	16.5 mm	16 mm
Super plus	Pledget length	(45~55) mm	(43.0~46.0) mm
	Pledget diameter	(13.3~16.3) mm	(14.0~15.0) mm
	Removal stringlength	(125~165) mm	(130~160) mm
	Applicator length	126 mm	120 mm
	Applicator diameter	16.5 mm	18 mm
Component	Pledget	100% Viscose	100% Organic Cotton	Different
Materials	Overwap	Polyethylene andPolyethyleneterephthalate	100% Organic Cotton
	Removal string	Polyester and Viscose	100% Organic Cotton
	Applicator	Polyethylene andPolypropylene	TPO
AdditivesandFinishingAgents	Anti-wicking agentof removal string	Paraffin-based resin	Paraffin-based resin	Same
	Finishing agent ofpledget	Polyoxyethylene stearate	Not available	Different
Complies with ISO 10993-1		Yes	Yes	Same
Compliance with microbiologyrequirements of FDA Guidance forTampons		Yes	Yes	Same
Labeling		Complied with 21 CFR part801	Complied with 21 CFR part801	Same

Table 1 Technological Characteristics Comparison Table

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The proposed device has the similar indication for use as the predicate device as well as comparable technical characteristics, and the differences don't raise any additional questions for safety and effectiveness. Therefore, the subject device has the same intended use as the predicate.

7. Summary of Non-clinical Testing

Non-clinical testing was conducted to verify that the proposed device can meet all design specifications and perform similarly to the predicate device. The following tests were conducted.

Performance Testing

The following performance characteristics were assessed in accordance with the FDA guidance document "Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)" issued on July 27, 2005.

Dimensions
Absorbency
Removal string strength
Fiber shedding
Tampon integrity
Chemical residues

All samples met the predefined acceptance criteria.

Biocompatibility Testing

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Biocompatibility studies were performed in accordance with the FDA guidance 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
Skin sensitization test per ISO 10993-10:2010
Vaginal irritation test per ISO 10993-10:2010
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 proposed device is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.

Microbiology Testing

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

8. Clinical Testing

No clinical study is included in this submission.

9. Conclusions

The nonclinical tests demonstrate that the proposed device is as safe and effective, as the legally marketed device (K15117). Therefore, the subject device is substantially equivalent to the predicate.

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).