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.

AI/ML Overview

The provided text describes the FEMME Applicator Tampon and its substantial equivalence to a predicate device, focusing on non-clinical performance data and biocompatibility. However, it does not include information about a study involving AI, human readers, or the establishment of ground truth in the context of device performance in a clinical or diagnostic setting. Therefore, many of the requested categories for AI-related studies cannot be filled from the provided text.

Here's the information that can be extracted from the provided text regarding acceptance criteria and device performance:

Acceptance Criteria and Device Performance (FEMME Applicator Tampon)

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Standard / Protocol)	Reported Device Performance
Biocompatibility
Applicator	In Vitro Cytotoxicity (ISO 10993-5: 2009)	Not explicitly stated as "passed" or "failed" for individual tests, but the conclusion states "The data support the conclusion that the FEMME Applicator Tampon... is substantially equivalent to the predicate device and is safe and effective for its Indications for Use," implying all biocompatibility tests were met.
	Intracutaneous study (ISO 10993-10: 2010)	(See above)
	Guinea pig maximization sensitization study (ISO 10993-10: 2010)	(See above)
Pledget	Cytotoxicity study (ISO 10993-5: 2009)	(See above)
	Vaginal irritation study (ISO 10993-10: 2010)	(See above)
	Guinea pig maximization sensitization study (ISO 10993-10: 2010)	(See above)
	Systemic toxicity study (ISO 10993-11: 2017)	(See above)
Microbiological
Bioburden	ISO 11737-1: 2006	5.6 CFU/tampon
Effect on vaginal microflora	USP 71	Does not alter the growth of normal vaginal microflora
Effect on S. aureus growth	USP 71	Does not enhance the growth of Staphylococcus aureus (S. aureus) compared to an S. aureus control
Effect on S. aureus TSST-1 production	No increase in TSST-1 production compared to an S. aureus control	Did not increase production of Toxic Shock Syndrome Toxin-1 (TSST-1) compared to an S. aureus control
Chemical Residue
PCDD/Fs residues	EPA 1613B:1997	N.D. (not detectable)
Pesticide and Cl residue	EN 15662: 2008	N.D. (not detectable)
Physical Performance
Absorbency	21 CFR 801.430 Syngyna absorbency protocol (Regular: 6.0-9.0 g, Super: 9.0-12.0 g, Super Plus: 12.0-15.0 g)	The absorbency ranges for all specifications met the requirements of 21 CFR 801.430. Specific values for each type were: Regular: 6.0 - 9.0; Super: 9.0 - 12.0; Super plus: 12.0 - 15.0 grams.
Removal String Strength	AS/NZS 2869: 1998 (Minimum attachment strength: ≥ 22.4 Newtons (N); Average value for production lot: ≥ 28 N)	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.
Fiber Shedding	Internal protocols	Does not exhibit the potential to shed more than the predicate fiber.
Tampon Integrity	Internal protocols	Meets the visual and observational requirements set for an acceptable subject device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The document does not specify the exact sample sizes (e.g., number of tampons tested) for each specific test. It refers to "each tampon tested for every absorbency level" for the removal string strength and "the subject device" for other tests.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The applicant is Jiangsu Yoai Technology Co., Ltd. from China, suggesting the testing may have been conducted in China or by a contracted lab. The tests refer to international standards (ISO, USP, EPA, EN, AS/NZS) and FDA guidance, indicating adherence to globally recognized methodologies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a medical product (tampon) and the studies conducted are non-clinical (biocompatibility, performance, chemical residue). The "ground truth" here is objective measurements against established physical, chemical, and biological standards, not expert consensus on interpretations of images or clinical diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication is relevant for studies involving human interpretation or clinical outcomes, which is not the case for the non-clinical tests performed on the tampon.

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

Not applicable. There is no mention of AI or human readers in the context of this device.

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

Not applicable. There is no mention of an algorithm or AI in the context of this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the tests described are typically:

Biocompatibility: Established biological reactions and tissue compatibility as defined by ISO standards.
Microbiological: Quantifiable measures of microbial growth or toxin production.
Chemical Residue: Quantifiable measures of specific chemical compounds according to EPA and EN standards.
Physical Performance: Objective physical measurements (e.g., mass absorbed in grams, force in Newtons), visual inspections, and comparisons to predicate device shedding.

These are objective, measurable outcomes, not subjective expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is a physical medical device, not an AI or algorithm.

9. How the ground truth for the training set was established

Not applicable. There is no training set mentioned.

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: 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.

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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 (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

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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)
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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, JiangningDistrict, 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, NanshanDistrict,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

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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

6. Indications for Use Statement

7. Substantial Equivalence Discussion

	Subject Device	Predicate Device
	FEMME ApplicatorTampon	Opal by Femtex and PrivateLabel Unscented CompactApplicator 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 plus12.0 - 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$$6.4 - 6.5$	Super	$64.0 - 66.0 x$$13.5 - 14.5$
		Super plus	$78.5 - 79.5 x$$6.4 - 6.5$	Super plus	$65.5 - 68.5 x$$15.5 - 16.5$
Applicator length xdiameter (mm, Outertube)		N/A		Light	$58.0 - 60.0 x$$13.0 - 14.0$
		Regular	$77.0 - 78.0 x$$14.5 - 15.0$	Regular	$58.0 - 60.0 x$$13.0 - 14.0$
		Super	$77.0 - 78.0 x$$14.5 - 15.0$	Super	$59.0 - 61.0 x$$15.0 - 16.0$
		Super plus	$77.5 - 78.5 x$$16.5 - 17.0$	Super plus	$60.0 - 62.0 x$$17.0 - 18.0$
Removal String		Cotton, PolyesterViolet, green, and bluecolorants with thefollowing characteristics:• 21 CFR 178.3297compliant		100% Hydrophobic Cotton
Pledget		Viscose		Viscose
Overwrap		Polyester, Polyethylene		Polyethylene/Polyethyleneterephthalate
Wrapper (PrimaryPackaging)		Polyethylene		Polypropylene
Applicator	PlasticTube	Low Density Polyethylene(LDPE), Thermoplasticelastomer		Low Density Polyethylene
	Colorant	Purple, green, and bluecolorants with thefollowing characteristics:		Green, Pink, Blue, and PearlWhite colorants with thefollowing characteristics:• Meets Toxics SubstanceControl Act Inventory (TSCA)• 21 CFR 178.3297 and/or EUResolution (89)1 compliant• Extractables testingconfirmed that no harmfulcompounds arebioavailable

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Subject device: FEMME Applicator Tampon

		178
	MoldReleaseAgent	N/AFood grade mold release agent—conforms with 21 CFR 177 – 178
	AntistaticAgent	N/AFood grade antistatic agent—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)
- 1. Intracutaneous study (ISO 10993-10: 2010)
- 1. Guinea pig maximization sensitization study (ISO 10993-10: 2010)
FEMME Applicator Tampon pledget B.
- 1. Cytotoxicity study (ISO 10993-5: 2009)
- 1. Vaginal irritation study (ISO 10993-10: 2010)
- 1. 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

1. The effect of tampon on growth of normal vaginal microflora (USP 71): the subject device does not alter the growth of normal vaginal microflora;
1. 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;
1. 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).
- 1. 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.
- 1. 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.
- 1. 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.

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).