FEMME Applicator Tampon

K182142 · Jiangsu Yoai Technology Co., Ltd. · HEB · Aug 28, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K182142
• Device Name: FEMME Applicator Tampon
• Applicant: Jiangsu Yoai Technology Co., Ltd.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Aug 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

The FEMME Applicator Tampon is an unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the tampon correctly into the vagina.

Device Story

FEMME Applicator Tampon is an unscented, menstrual tampon designed for intravaginal absorption of menstrual or vaginal discharge. Device consists of an absorbent viscose pledget, overwrap, removal string, and a three-part plastic applicator (barrel, grip, plunger). Applicator features a rounded, mushroom-shaped tip to facilitate insertion. Available in Regular, Super, and Super plus absorbency levels. Used by women for personal hygiene; OTC availability. Device functions by physical absorption of fluids; applicator serves as a mechanical aid for correct placement. Benefits include ease of use and effective fluid management. No electronic or software components.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-5, -10, -11), microbiological safety (bioburden, effect on vaginal microflora, S. aureus growth, and TSST-1 production), chemical residue analysis (PCDD/Fs per EPA 1613B, pesticides per EN 15662), and physical performance (Syngyna absorbency per 21 CFR 801.430, removal string strength per AS/NZS 2869, fiber shedding, and integrity).

Technological Characteristics

Materials: Viscose pledget, polyester/polyethylene overwrap, cotton/polyester removal string, LDPE/thermoplastic elastomer applicator. Design: Compact, mushroom-shaped tip, straight grooves. Absorbency: 6.0-15.0g (Regular to Super plus). Standards: ISO 10993 (biocompatibility), ISO 11737-1 (bioburden), 21 CFR 801.430 (absorbency), AS/NZS 2869 (string strength). Non-sterile. No software or energy source.

Indications for Use

Indicated for women for personal hygiene, specifically for the intravaginal 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

• Opal by Femtex and Private Label Unscented Compact Applicator Tampon (K151470)

Submission Summary (Full Text)

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August 28, 2019

Jiangsu YOAI Technology Co., Ltd. c/o Field Fu Official Correspondent Shenzhen Joyantech Consulting Co., Ltd. Room 1122, No. 55 Shizhou Middle Road, Nanshan District Shenzhen, GD755 Guangdong CHINA

Re: K182142

Trade/Device Name: FEMME Applicator Tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: July 10, 2019 Received: July 29, 2019

Dear Field Fu:

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-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Sharon Andrews Assistant Division 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) K182142

Device Name FEMME Applicator Tampon

Indications for Use (Describe)

The FEMME Applicator Tampon is an unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the tampon correctly into the vagina.

| 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

### 1. Submission Sponsor

-

| Applicant Name | Jiangsu Yoai Technology Co., Ltd. |
|----------------|------------------------------------------------------------------------------------|
| Address | Building No.3, No.33 Jing You Road, Jiangning<br>District, Nanjing, Jiangsu, China |
| Phone No. | 86-025-69620808 |
| Contact Person | Ms. Huan Wang |
| Email | [e-mail] |
| Date Prepared | August 22, 2019 |

### 2. Submission correspondent

| Name | Shenzhen Joyantech Consulting Co., Ltd |
|----------------|----------------------------------------------------------------------------------------------------|
| Address | Room 1122, No.55 Shizhou Middle Road, Nanshan<br>District,<br>Shenzhen,<br>Guangdong,<br>P.R.China |
| Image: [logo] | |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Mr. Field Fu; Ms. Jessie You; Ms. Elly Xu |
| Email | [e-mail]; [e-mail] |

## 3. Device Identification

| Trade name | FEMME Applicator Tampon |
|---------------------|-------------------------------|
| Common name | Unscented Menstrual Tampon |
| Specifications | Regular, Super and Super plus |
| Classification | II |
| Classification name | Tampon, Menstrual, Unscented |
| Product code | HEB |
| Regulation Number | 21 CFR 884.5470 |

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Subject device: FEMME Applicator Tampon

### 4. Predicate Device Information

Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented (K151470). The predicate device has not been subject to a design-related recall.

## 5. Device Description

The FEMME Applicator Tampon is an unscented, menstrual tampon. The tampon is comprised of an absorbent viscose pledget, an overwrap, a removal string, and an applicator. The applicator contains 3 parts: a barrel, grip, and plunger. The tampon was designed as a compact tampon with a mushroom-shaped tip. The pledget is of the traditional cylindrical bullet-like shape and is covered with a thin layer of overwrap. The applicator has a standard rounded and smooth tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit container for retail sale. There are 3 specifications of tampon with different absorbencies: Regular, Super and Super plus. Each absorbency specification has a different color removal string and applicator.

## 6. Indications for Use Statement

The FEMME Applicator Tampon is an unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina.

#### 7. Substantial Equivalence Discussion

| | Subject Device | Predicate Device |
|---------------|----------------------------|----------------------------------------------------------------------------|
| | FEMME Applicator<br>Tampon | Opal by Femtex and Private<br>Label Unscented Compact<br>Applicator Tampon |
| 510(k) number | K182142 | K151470 |

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## Subject device: FEMME Applicator Tampon

| Regulation | | | | |
|---------------------|----------------------------|------------------------|----------------------------------|---------------|
| Product Code | HEB | | HEB | |
| Indications for use | The FEMME Applicator | | Unscented tampon for | |
| | | Tampon is an unscented | women's personal hygiene with | |
| | tampon for women's | | respect to intra vaginal | |
| | personal hygiene with | | absorption of menstrual or | |
| | respect to intra vaginal | | other vaginal discharge. The | |
| | absorption of menstrual or | | plastic applicator is for easing | |
| | other vaginal discharge. | | the placement of the tampon | |
| | The plastic applicator is | | correctly into the vagina. | |
| | for easing the placement | | | |
| | of the tampon correctly | | | |
| | into the vagina. | | | |
| Components | The FEMME Applicator | | The Unscented Compact | |
| | Tampon is comprised of | | Applicator Tampon is | |
| | an absorbent pledget and | | comprised of an absorbent | |
| | an applicator. | | pledget and an applicator. | |
| Sterile? | No | | No | |
| Design | Compact tampon with | | Compact tampon with | |
| | mushroom-shaped tip and | | mushroom-shaped tip and | |
| | straight grooves. | | straight grooves. | |
| Syngyna Absorbency, | N/A | | Light | < 6.0 |
| grams | Regular | 6.0 - 9.0 | Regular | 6.0 - 9.0 |
| | Super | 9.0 - 12.0 | Super | 9.0 - 12.0 |
| | Super plus<br>12.0 - 15.0 | | Super plus | 12.0 - 15.0 |
| Pledget length (mm) | N/A | | Light | 40.0 - 45.0 |
| | Regular | 42.0 - 52.0 | Regular | 40.0 - 45.0 |
| | Super | 47.0 - 52.0 | Super | 43.0 - 46.0 |
| | Super plus | 47.0 - 52.0 | Super plus | 43.0 - 46.0 |
| Pledget diameter | | N/A | Light | 8.7 – 9.7 |
| | Regular | 10.6 – 12.6 | Regular | 8.7 – 9.7 |
| | Super | 12.0 - 14.0 | Super | 11.0 - 13.0 |
| | Super plus | 14.0 - 16.0 | Super plus | 13.0 - 15.0 |
| | N/A | | Light | 66.0 — 68.0 x |
| | | | | 10.5 - 11.5 |
| Applicator length x | Regular | 78.5 — 79.5 x | Regular | 66.0 — 68.0 x |
| diameter (mm, Inner | | 6.4 - 6.5 | | 10.5 — 11.5 |

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#### Subject device: FEMME Applicator Tampon

| tube-plunger) | | Super | $78.5 - 79.5 x$<br>$6.4 - 6.5$ | Super | $64.0 - 66.0 x$<br>$13.5 - 14.5$ |
|-----------------------------------------------------|-----------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| | | Super plus | $78.5 - 79.5 x$<br>$6.4 - 6.5$ | Super plus | $65.5 - 68.5 x$<br>$15.5 - 16.5$ |
| Applicator length x<br>diameter (mm, Outer<br>tube) | | N/A | | Light | $58.0 - 60.0 x$<br>$13.0 - 14.0$ |
| | | Regular | $77.0 - 78.0 x$<br>$14.5 - 15.0$ | Regular | $58.0 - 60.0 x$<br>$13.0 - 14.0$ |
| | | Super | $77.0 - 78.0 x$<br>$14.5 - 15.0$ | Super | $59.0 - 61.0 x$<br>$15.0 - 16.0$ |
| | | Super plus | $77.5 - 78.5 x$<br>$16.5 - 17.0$ | Super plus | $60.0 - 62.0 x$<br>$17.0 - 18.0$ |
| Removal String | | Cotton, Polyester<br>Violet, green, and blue<br>colorants with the<br>following characteristics:<br>• 21 CFR 178.3297<br>compliant | | 100% Hydrophobic Cotton | |
| Pledget | | Viscose | | Viscose | |
| Overwrap | | Polyester, Polyethylene | | Polyethylene/Polyethylene<br>terephthalate | |
| Wrapper (Primary<br>Packaging) | | Polyethylene | | Polypropylene | |
| Applicator | Plastic<br>Tube | Low Density Polyethylene<br>(LDPE), Thermoplastic<br>elastomer | | Low Density Polyethylene | |
| | Colorant | Purple, green, and blue<br>colorants with the<br>following characteristics: | | Green, Pink, Blue, and Pearl<br>White colorants with the<br>following characteristics:<br>• Meets Toxics Substance<br>Control Act Inventory (TSCA)<br>• 21 CFR 178.3297 and/or EU<br>Resolution (89)1 compliant<br>• Extractables testing<br>confirmed that no harmful<br>compounds are<br>bioavailable | |

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Subject device: FEMME Applicator Tampon

| | | 178 |
|--|--------------------------|-----------------------------------------------------------------------|
| | Mold<br>Release<br>Agent | N/A<br>Food grade mold release agent—conforms with 21 CFR 177 – 178 |
| | Antistatic<br>Agent | N/A<br>Food grade antistatic agent—<br>conforms with 21 CFR 177 – 178 |

### 8. Non-Clinical Performance Data

The evaluation is in accordance with FDA guidance: Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s).

#### 8.1 Biocompatibility testing

Biocompatibility assessments for the FEMME Applicator Tampon were conducted in accordance with FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Biocompatibility testing was selected for a surface contacting device having "limited contact" (i.e., < 24 hrs) with intact skin and mucous membranes. The battery of testing included the following tests:

- A. FEMME Applicator Tampon - applicator
- In Vitro Cytotoxicity (ISO 10993-5: 2009) 1)
- 2) Intracutaneous study (ISO 10993-10: 2010)
- 3) Guinea pig maximization sensitization study (ISO 10993-10: 2010)
- FEMME Applicator Tampon pledget B.
- 1) Cytotoxicity study (ISO 10993-5: 2009)
- 2) Vaginal irritation study (ISO 10993-10: 2010)
- 3) Guinea pig maximization sensitization study (ISO 10993-10: 2010)
- Systemic toxicity study (ISO 10993-11: 2017) 4)

#### 8.2 Performance testing - Bench

The performance tests were conducted to demonstrate the effectiveness of device:

- A. Microbiological testing:
- 1) Bioburden (ISO 11737-1: 2006): the bioburden of the subject device was 5.6 CFU/tampon:

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Subject device: FEMME Applicator Tampon

- 2) The effect of tampon on growth of normal vaginal microflora (USP 71): the subject device does not alter the growth of normal vaginal microflora;
- 3) The effect of tampon on growth of Staphylococcus aureus (USP 71): The subject device does not enhance the growth of Staphylococcus aureus (S. aureus) compared to an S. aureus control;
- 4) The effect of tampon on production of S. aureus TSST-1: the subject device did not increase production of Toxic Shock Syndrome Toxin-1 (TSST-1) compared to an S. aureus control.
- B. Chemical residue testing:
- Polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans 1) residues (PCDD/Fs) testing was performed on the subject device per EPA 1613B:1997: PCDD/Fs concentrations were N.D. (not detectable).
- 2) Pesticide and CI residue testing was performed on the subject device per EN 15662: 2008: Pesticides and Cl residue concentrations were N.D. (not detectable).
- C. Physical performance testing:
- Absorbency testing for the FEMME Tampon Applicator was performed per 1) the 21 CFR 801.430 Syngyna absorbency protocol. The absorbency ranges for all specifications met the requirements of 21 CFR 801.430.
- 2) Removal string strength for the subject device was performed per AS/NZS 2869: 1998. Each tampon tested for every absorbency level met the Standard's minimum attachment strength requirement of 22.4 Newtons (N). Each absorbency data set met an average value of ≥ 28 N, which is the standard's requirement for each production lot.
- Fiber shedding testing was evaluated using internal protocols, since no 3) recognized standard is available. The subject device does not exhibit the potential to shed more than the predicate fiber.
- 4) Tampon integrity was evaluated using internal protocols, since no recognized standard is available. The subject device meets the visual and observational requirements set for an acceptable subject device.

#### 9. Conclusion

The FEMME Applicator Tampon characteristics and comparisons detailed above demonstrate that the subject device has the same fundamental design, Indications for Use, technology, and performance specifications as the predicate device. Non-Clinical Performance Testing demonstrates that the new device meets the absorbency

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#### Subject device: FEMME Applicator Tampon

requirements defined by 21 CFR 801.430, which confirms the device's effectiveness for the Indications for Use. Biocompatibility testing, microbiology testing, and physical performance testing demonstrate that the new device has a safe biocompatibility profile, does not increase the potential to promote TSS relative to the predicate device, and has a tampon integrity profile that is equivalent to the predicate device. The data support the conclusion that the FEMME Applicator Tampon by Jiangsu Yoai Technology Co., Ltd. is substantially equivalent to the predicate device and is safe and effective for its Indications for Use.