K Number

Device Name

FEMME Applicator Tampon

Manufacturer

Jiangsu YOAI Technology co., Ltd.

Date Cleared

2019-08-28

(386 days)

Product Code

HEB

Regulation Number

884.5470

Intended 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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K151470

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.
The device is described as an "unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge," which indicates it is for hygiene and absorption, not for treating or preventing disease.

Diagnostic

The device is described as an "unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge," and its intended use is for "easing the tampon correctly into the vagina." It is designed to manage menstrual flow and does not perform any diagnostic function such as detecting, monitoring, or diagnosing a medical condition. Performance studies focus on absorbency and safety, not diagnostic accuracy.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components (absorbent pledget, overwrap, removal string, applicator) and the performance studies focus on physical, chemical, and biological properties of these components, not software functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, the FEMME Applicator Tampon is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge." This is a physical function within the body, not a diagnostic test performed on a sample outside the body.
Device Description: The description details a physical device for absorption, not a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information.
Performance Studies: The performance studies focus on physical properties (absorbency, strength, integrity), biocompatibility, and microbiological effects within the vaginal environment, not on diagnostic accuracy or analytical performance.

IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. The FEMME Applicator Tampon is a personal hygiene product for managing menstrual flow.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

HEB

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

intra vaginal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

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 Performance Data:

8.1 Biocompatibility testing:

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

8.2 Performance testing - Bench:

A. Microbiological testing:
- Bioburden (ISO 11737-1: 2006): 5.6 CFU/tampon.
- The effect of tampon on growth of normal vaginal microflora (USP 71): does not alter growth.
- The effect of tampon on growth of Staphylococcus aureus (USP 71): does not enhance growth.
- The effect of tampon on production of S. aureus TSST-1: did not increase production.
B. Chemical residue testing:
- Polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans (PCDD/Fs) residues (EPA 1613B:1997): N.D. (not detectable).
- Pesticide and CI residue testing (EN 15662: 2008): N.D. (not detectable).
C. Physical performance testing:
- Absorbency testing (21 CFR 801.430 Syngyna absorbency protocol): All specifications met requirements.
- Removal string strength (AS/NZS 2869: 1998): Each tampon met minimum attachment strength of 22.4 Newtons (N), and average value for each absorbency data set was >= 28 N.
- Fiber shedding testing (internal protocols): Does not exhibit potential to shed more than predicate fiber.
- Tampon integrity (internal protocols): Meets visual and observational requirements.

Key Results: The device is effective and safe, meeting absorbency requirements, demonstrating a safe biocompatibility profile, not increasing the potential to promote TSS, and having equivalent tampon integrity to the predicate device.

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

See "Summary of Performance Studies" for quantitative metrics from bench testing (e.g., bioburden, absorbency, tensile strength, chemical residues).

Predicate Device(s)

K151470

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Indications for Use

510(k) Number (if known) K182142

Device Name FEMME Applicator Tampon

Indications for Use (Describe)

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
District, Nanjing, Jiangsu, China
Phone No.	86-025-69620808
Contact Person	Ms. Huan Wang
Email	huan.wang@yoai.com
Date Prepared	August 22, 2019

2. Submission correspondent

Name	Shenzhen Joyantech Consulting Co., Ltd
Address	Room 1122, No.55 Shizhou Middle Road, Nanshan
District,
Shenzhen,
Guangdong,
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	Jessie@cefda.com; elly@cefda.com

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

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

6. Indications for Use Statement

7. Substantial Equivalence Discussion

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

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