Predicate Devices

K15117

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and biological compatibility of a traditional menstrual tampon, with no mention of AI or ML.

Therapeutic

No
The device is described as a menstrual tampon intended for absorption of menstrual or other vaginal discharge, which is a hygienic function and not a therapeutic purpose (e.g., treating a disease or disorder).

Diagnostic

No
The device is a menstrual tampon intended for absorption of menstrual or other vaginal discharge, not for diagnosing any condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical product (tampon with absorbent core, overwap, removal string, and optional applicator) and details performance studies related to its physical properties and biological interactions, not software functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the absorption of menstrual or other vaginal discharge. This is a physical function, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
Device Description: The device is a traditional menstrual tampon. Its components and function are related to absorption, not analysis of biological samples.
Performance Studies: The performance studies focus on physical properties (dimensions, absorbency, strength, integrity), biocompatibility, and microbiological impact (growth enhancement, toxin production, microflora alteration). These are relevant to the safety and performance of a menstrual product, not a diagnostic test.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information.

In summary, the device's purpose is to absorb bodily fluids, which is a therapeutic or hygienic function, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

HEB

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Vagina

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
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.

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K15117

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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 and 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 ADMINISTRATION" in blue text.

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

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

4

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 Medical
Technology Co., Ltd. | TOSAMA, d.o.o. | None | |
| | Product Name | Unscented Menstrual
Tampons | Tosama 100% Organic
Cotton 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 menstrual
tampon is intended for
insertion into the vagina for
the
absorption
of
menstrual or other vaginal
discharge. | The Tosama 100% Organic
Cotton Menstrual Tampon is
intended for insertion into
the
vagina
for
the
absorption of menstrual or
other vaginal discharge. | Same | |
| | Single Use | Yes | Yes | Same | |
| | Sterility | Non-sterile | Non-sterile | Same | |
| | Design | Tampon with cylindrical
shape and bullet-like tip.
Applicator with
smooth,
rounded tip. | Tampon with cylindrical
shape and bullet-like tip.
Applicator with
smooth,
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 | | | | | |
| Light
Pledget length | | (4050) mm | N/A | Different | |
| | | | | | |
| | Pledget diameter | (9.512.5) mm | | | |
| | Removal string
length | (125165) mm | | | |
| | Pledget length | (4050) mm | (43.046.0) mm | | |
| Regular | Pledget diameter | (10.513.5) mm | (11.012.0) mm | | |
| | Removal string
length | (125165) mm | (130160) mm | | |
| | Pledget length | (4555) mm | (48.051.0) mm | | |
| Super | Pledget diameter | (11.514.5) mm | (12.013.0) mm | | |
| | Removal string
length | (125165) mm | (130160) mm | | |
| | Pledget length | (4555) mm | (48.051.0) mm | | |
| Super plus | Pledget diameter | (13.316.3) mm | (14.015.0) mm | | |
| | Removal string
length | (125165) mm | (130160) mm | | |
| Applicator tampon | | | | | |
| | Pledget length | (4050) mm | | | |
| | Pledget diameter | (9.512.5) mm | | | |
| Light | Removal string
length | (125165) 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 string
length | (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 string
length | (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 string
length | (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 and
Polyethyleneterephthalate | 100% Organic Cotton | | |
| | Removal string | Polyester and Viscose | 100% Organic Cotton | | |
| | Applicator | Polyethylene and
Polypropylene | TPO | | |
| Additives
and
Finishing
Agents | Anti-wicking agent
of removal string | Paraffin-based resin | Paraffin-based resin | Same | |
| | Finishing agent of
pledget | Polyoxyethylene stearate | Not available | Different | |
| Complies with ISO 10993-1 | | Yes | Yes | Same | |
| Compliance with microbiology
requirements of FDA Guidance for
Tampons | | Yes | Yes | Same | |
| Labeling | | Complied with 21 CFR part
801 | Complied with 21 CFR part
801 | Same | |

Table 1 Technological Characteristics Comparison Table

5

6

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

7

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.