Unscented Menstrual Tampon

K222046 · Suzhou Borage Medical Technology Co., Ltd. · HEB · Sep 30, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K222046
• Device Name: Unscented Menstrual Tampon
• Applicant: Suzhou Borage Medical Technology Co., Ltd.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Sep 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

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

Device Story

Unscented menstrual tampon; available as digital or applicator-based versions. Device comprises absorbent viscose pledget, polyethylene/polyethyleneterephthalate overwrap, polyester/viscose removal string, and polyethylene/polypropylene applicator. Available in four absorbency levels (light, regular, super, super plus). Intended for single-use, non-sterile, over-the-counter vaginal insertion. User inserts tampon to absorb menstrual flow; removal via withdrawal cord. Device functions as passive absorbent barrier. Benefits include menstrual hygiene management.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included dimensions, absorbency, removal string strength, fiber shedding, tampon integrity, and chemical residues. Biocompatibility testing included cytotoxicity, skin sensitization, vaginal irritation, and acute systemic toxicity. Microbiology testing confirmed no enhancement of S. aureus growth, no increase in TSST-1 production, and no alteration of normal vaginal microflora.

Technological Characteristics

Materials: Viscose pledget, PE/PET overwrap, polyester/viscose string, PE/PP applicator. Design: Cylindrical, bullet-like shape. Absorbency: 6g to 15g. Non-sterile, single-use. Complies with ISO 10993-1 and FDA guidance for menstrual tampons.

Indications for Use

Indicated for individuals requiring absorption of menstrual or other vaginal discharge.

Regulatory Classification

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.

Predicate Devices

• Tosama 100% Organic Cotton Menstrual Tampon (K15117)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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,<br>Suzhou City, Jiangsu Province, 215107, China |
| Contact person | Zhou Nana |
| Phone No. | [phone] |
| E-mail | [e-mail] |
| 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. | [phone] |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | [e-mail]; [e-mail] |
| 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

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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<br>(K222046) | Predicate Device<br>(K15117) | Comment | |
|-----------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--|
| | Manufacturer | Suzhou Borage Medical<br>Technology Co., Ltd. | TOSAMA, d.o.o. | None | |
| | Product Name | Unscented Menstrual<br>Tampons | Tosama 100% Organic<br>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<br>tampon is intended for<br>insertion into the vagina for<br>the<br>absorption<br>of<br>menstrual or other vaginal<br>discharge. | The Tosama 100% Organic<br>Cotton Menstrual Tampon is<br>intended for insertion into<br>the<br>vagina<br>for<br>the<br>absorption of menstrual or<br>other vaginal discharge. | Same | |
| | Single Use | Yes | Yes | Same | |
| | Sterility | Non-sterile | Non-sterile | Same | |
| | Design | Tampon with cylindrical<br>shape and bullet-like tip.<br>Applicator with<br>smooth,<br>rounded tip. | Tampon with cylindrical<br>shape and bullet-like tip.<br>Applicator with<br>smooth,<br>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<br>Pledget length | | (40~50) mm | N/A | Different | |
| | | | | | |
| | Pledget diameter | (9.5~12.5) mm | | | |
| | Removal string<br>length | (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 string<br>length | (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 string<br>length | (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 string<br>length | (125~165) mm | (130~160) mm | | |
| Applicator tampon | | | | | |
| | Pledget length | (40~50) mm | | | |
| | Pledget diameter | (9.5~12.5) mm | | | |
| Light | Removal string<br>length | (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 string<br>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<br>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<br>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<br>Polyethyleneterephthalate | 100% Organic Cotton | | |
| | Removal string | Polyester and Viscose | 100% Organic Cotton | | |
| | Applicator | Polyethylene and<br>Polypropylene | TPO | | |
| Additives<br>and<br>Finishing<br>Agents | Anti-wicking agent<br>of removal string | Paraffin-based resin | Paraffin-based resin | Same | |
| | Finishing agent of<br>pledget | Polyoxyethylene stearate | Not available | Different | |
| Complies with ISO 10993-1 | | Yes | Yes | Same | |
| Compliance with microbiology<br>requirements of FDA Guidance for<br>Tampons | | Yes | Yes | Same | |
| Labeling | | Complied with 21 CFR part<br>801 | Complied with 21 CFR part<br>801 | 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.