The Unscented Tampons are traditional unscented menstrual tampons. Except for the raw materials, they share the same design. The Unscented Tampons are provided with a cardboard applicator tampon. Each device consists of a tampon, including an absorbent 100% organic cotton or 100% viscose pledget , a 100% organic cotton or polyester and cotton removal string ("withdrawal cord"), and a cardboard applicator . The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. The Unscented Tampons are provided in 4 absorbencies: light (less than or equal to 6g), regular (6~~9g), super (9~~12g) and super plus (12~15g). Each device is individually wrapped. It is provided non-sterile and for single use only.

AI/ML Overview

The provided text describes the 510(k) premarket notification for an "Unscented Tampon." As such, the acceptance criteria and performance study details relate to the safety and performance of a medical device (a tampon), not an AI/algorithm-based device or a diagnostic tool.

Therefore, I cannot extract information related to:

A table of AI acceptance criteria and reported device performance.
Sample sizes for a test set or data provenance for AI.
Number of experts, their qualifications, or adjudication methods for ground truth in AI.
Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
Stand-alone (algorithm-only) performance.
Training set sample sizes or ground truth establishment for AI.

The document discusses "acceptance criteria" and "study" in the context of non-clinical testing for a physical medical device (tampon) to demonstrate its substantial equivalence to a predicate device.

Here's a summary of the non-clinical testing performed for the Unscented Tampon, which serves as the "study that proves the device meets the acceptance criteria" for this type of medical device:

1. Acceptance Criteria and Reported Device Performance (Non-AI Device)

The "acceptance criteria" for this device are established by meeting relevant FDA guidance documents and standards, demonstrating safety and performance comparable to a predicate device. The document states that "Non-clinical testing was conducted to verify that the subject devices meet all design and performance specifications similarly to the predicate device."

Here's a table summarizing the tests (which are the "acceptance criteria" for a tampon) and the reported performance:

Acceptance Criteria (Test Performed)	Reported Device Performance
Biocompatibility Testing:	Results: The subject device is non-cytotoxic, non-sensitizing, and non-systemically toxic. (Specific quantitative results like cytotoxicity index, irritation scores, etc., are not provided in this summary, but implied by "non-cytotoxic," "non-sensitizing," and "non-systemically toxic.")
- In vitro cytotoxicity test (ISO 10993-5:2009)
- Skin sensitization test (ISO 10993-10:2021)
- Vaginal irritation test (ISO 10993-23:2021)
- Acute systemic toxicity test (ISO 10993-11:2017)
Microbiology Testing:	Results: The subject devices do not: enhance the growth of Staphylococcus aureus, increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1), and do not alter the growth of normal vaginal microflora.
- Growth of Staphylococcus aureus
- Production of Toxic Shock Syndrome Toxin-1 (TSST-1)
- Alteration of normal vaginal microflora
Performance Testing:	Results: Assessed according to FDA guidance. Implied to meet specifications similar to the predicate device. (Specific quantitative results for dimension ranges, strength values, absorbency values, expulsion forces, etc., are not provided in this summary, but are part of the underlying test reports.)
- Dimensions	Specific dimensions vary by absorbency level; shown in comparison table for Light, Regular, Super, and Super Plus.
- String strength	Performance confirmed.
- Absorbency per Syngyna Testing (21 CFR 801.430)	Absorbency levels confirmed as: Light (≤6g), Regular (6~~9g), Super (9~~12g), Super plus (12~15g).
- Applicator expulsion force	Performance confirmed.
- Appearance	Performance confirmed.
- Applicator and tampon integrity	Performance confirmed.
- Fiber shedding	Performance confirmed.
- Chemical residues	Performance confirmed.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact number of tampons tested for each non-clinical test (e.g., how many tampons were subjected to biocompatibility testing, how many for dimension checks, etc.). It only mentions "the organic cotton tampon and the viscose tampon" being tested.
Data Provenance: The tests are described as non-clinical laboratory tests performed to demonstrate substantial equivalence. The country of origin of the data is not explicitly stated in the summary, but the applicant company is SHANDONG INTCO HYGIENE PRODUCTS CO., LTD. in China. The data would be prospective, as it's generated specifically for this submission.

3. Number of Experts Used and Their Qualifications

This is not applicable as the study described is non-clinical laboratory testing of a physical product (tampon), not an AI/diagnostic software. No experts are mentioned as establishing "ground truth" in the diagnostic sense. The "ground truth" for these tests is defined by established laboratory testing standards and methods (e.g., ISO standards, 21 CFR 801.430).

4. Adjudication Method for the Test Set

Not applicable as this is a non-clinical laboratory test of a physical product, not an AI/diagnostic software requiring expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/diagnostic device. The comparison is between the proposed physical tampon and a predicate physical tampon based on measured attributes and safety profiles.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by validated laboratory testing methods and industry standards (e.g., ISO 10993 series, 21 CFR 801.430, and FDA guidance documents for menstrual tampons). These methods define what constitutes acceptable dimensions, absorbency, biocompatibility, etc.

8. The Sample Size for the Training Set

Not applicable. As this is a non-clinical submission for a physical device, there is no "training set" in the context of an AI/machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for a physical medical device.

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 & 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.

January 10, 2025

Shandong Intco Hygiene Products Co., Ltd. Max Li 0A Workshop C3, No. 29, Zhangliu Road, Fangzhen Town Zhangdian DistrictZibo. Shandong 255000 China

Re: K241064

Trade/Device Name: Unscented Tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: December 13, 2024 Received: December 13, 2024

Dear Max Li:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about mediation-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,

Reginald K. Avery -S

for 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241064

Device Name

Unscented Tampon

Indications for Use (Describe)

The Unscented Tampon is intended for insertion into the vagina for 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Image /page/4/Picture/0 description: The image shows the logo for INTCO Medical. The logo features the word "INTCO" in a bold, sans-serif font, with the letters in blue. Above the word "INTCO" is a stylized graphic resembling a flower or sunburst, also in blue. Below the word "INTCO" are Chinese characters, also in blue, which likely represent the company's name in Chinese.

510(k) Summary

(As requirement by 21 CFR 807.92)

Date prepared: January 9, 2025

A. Applicant:

Name: SHANDONG INTCO HYGIENE PRODUCTS CO., LTD. Address: Workshop C3, No. 29, Zhangliu Road, Fangzhen Town Zhangdian District Zibo,Shandong Province,China Contact: Ms. Jia shuangshuang Title: QA Tel: +86-533-6298778 Email: jiashuangshuang@intco.com

Submission Correspondent: Primary contact: Maxli SHANDONG INTCO HYGIENE PRODUCTS CO., LTD. Workshop C3, No. 29, Zhangliu Road, Fangzhen Town Zhangdian District Zibo, Shandong Province, China Tel: +86-533-6298778 Email: maxli@intco.com Secondary contact: Jia shuangshuang Workshop C3, No. 29, Zhangliu Road, Fangzhen Town Zhangdian District Zibo, Shandong Province, China Tel: +86-533-6298778 Email: jiashuangshuang@intco.com

B. Device:

Trade Name: Unscented Tampon Common Name: Unscented Menstrual Tampon

Regulatory Information Classification Name: Tampon, Menstrual, Unscented Classification: Class II Product code: HEB Regulation Number: 21 CFR 884.5470 Review Panel: Obstetrics/Gynecology

C. Predicate device:

K231341

Organic cotton tampon, Viscose tampon Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. The predicate device has not been subject to a design-related recall.

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Image /page/5/Picture/0 description: The image contains the logo for INTCO Medical. The logo features the word "INTCO" in a bold, sans-serif font, with the letters in blue. Above the word "INTCO" is a stylized graphic of a blue flower or sunburst with multiple petals or rays emanating from a central point. Below the word "INTCO" are the Chinese characters "英科医疗" which translates to "INTCO Medical".

D. Indications for use of the device:

The Unscented Tampon is intended for insertion into the absorption of menstrual or other vaginal discharge.

E. Device Description:

The Unscented Tampons are provided in 4 absorbencies: light (≤6g), regular (6~~9g), super (9~~12g) and super plus (12~15g). Each device is individually wrapped. It is provided non-sterile and for single use only.

F. Summary of Technological Characteristics

The Unscented Tampons are compared with the predicate device in terms of intended use, design, material, specifications, and performance.

The following table shows similarities and differences of use, design, and material between the proposed device and the predicate device.

Device	Proposed Device	Predicate Device	Result
510K #	--	K231341	--
Manufacturer	SHANDONG INTCO HYGIENEPRODUCTS CO., LTD.	Zhejiang Tianqing ManufacturingTechnology Group Co., Ltd.	--
Product Name	Unscented Tampon	Organic cotton tampon / Viscose tampon	--
Product Code	HEB	HEB	Same
RegulationNumber	21 CFR 884.5470	21 CFR 884.5470	Same
Classification	Class II	Class II	Same
Indications for use	The Unscented Tampon is intended forinsertion into the vagina for theabsorption of menstrual or other vaginaldischarge.	The tampon is intended for insertioninto the vagina for the absorption ofmenstrual or other vaginal discharge.	Same
Single use	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Same
Design feature	Tampon with cylindrical shape andbullet-like tip.Applicator with smooth,rounded tip.	Tampon with cylindrical shape andbullet-like tip.Applicator with smooth,rounded tip.	Same
Absorbency	Light: $\leq$ 6gRegular: 6~~9gSuper: 9~~12gSuper plus: 12~15g	Light: $\leq$ 6gRegular: 6~~9gSuper: 9~~12gSuper plus: 12~15g	Same

Table 1 General Comparison of Proposed and Predicate Devices

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Image /page/6/Picture/0 description: The image contains the logo for INTCO Medical. The logo features the word "INTCO" in a bold, sans-serif font, with the letters arranged horizontally. Below the word "INTCO" are two Chinese characters, followed by the word "Medical". Above the word "INTCO" is a stylized graphic consisting of several blue, petal-like shapes arranged in a circular pattern around a central blue dot. The overall impression is that of a modern and professional medical company.

Product dimensions
Applicator tampon
Light		Pledget lengthPledget diameterRemoval string lengthApplicator lengthApplicator diameter	$45 - 50 mm$$12.2 - 13.7 mm$$115 -175 mm$$120 - 125 mm$$13.8 - 14.2 mm$	Pledget lengthPledget diameterRemoval string lengthApplicator lengthApplicator diameter	$43~~49 mm$$9.5~~12.5 mm$$120~160 mm$$130.1 mm$$15.2 mm$	different
Regular		Pledget lengthPledget diameterRemoval string lengthApplicator lengthApplicator diameter	$45 - 50 mm$$12.2 - 13.7 mm$$115 -175 mm$$120 - 125 mm$$13.8 - 14.2 mm$	Pledget lengthPledget diameterRemoval string lengthApplicator lengthApplicator diameter	$44~~50 mm$$10.5~~13.5 mm$$120~160 mm$$130.1 mm$$15.2 mm$	different
Super		Pledget lengthPledget diameterRemoval string lengthApplicator lengthApplicator diameter	$45 - 50 mm$$14.2 - 15.7 mm$$115 -175 mm$$120 - 125 mm$$15.8 - 16.2 mm$	Pledget lengthPledget diameterRemoval string lengthApplicator lengthApplicator diameter	$45~~51 mm$$11.5~~14.5 mm$$120~160 mm$$131.0 mm$$16.7 mm$	different
Super plus		Pledget lengthPledget diameterRemoval string lengthApplicator lengthApplicator diameter	$45 - 50 mm$$14.2 - 15.7 mm$$115 -175 mm$$120 - 125 mm$$15.8 - 16.2 mm$	Pledget lengthPledget diameterRemoval string lengthApplicator lengthApplicator diameter	$45~~51 mm$$12.5~~15.5 mm$$120~160 mm$$131.0 mm$$16.7 mm$	different
ComponentMaterials		Pledget	100% Organic Cotton / 100%Viscose	Pledget	100% Organic Cotton / 100%Viscose	different
		Overwrap	Polyethylene andPolyethylene terephthalate	Overwrap	Polyethylene andPolyethylene terephthalate
		Removalstring	100% Organic Cotton /Polyester And Cotton	Removalstring	100% Organic Cotton /Polyester And Cotton
		Applicator	Cardboard	Applicator	Polyethylene andPolypropylene
AdditivesandFinishingAgents	removalstring		Paraffin-based resin		Repellan T	different
	pledget	Polyoxyethylene stearate			Fiber finishes

Analysis: The subject devices have the same indication for use as the predicate device; the subject device has the same intended use as the predicate device. The differences in technological characteristics between the subject and predicate devices, outlined in Table 1, do not raise different questions for safety and effectiveness.

G. Summary of Non-Clinical Testing

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Image /page/7/Picture/0 description: The image shows the logo for INTCO Medical. The logo features the company name in blue, with a stylized graphic above it that resembles a flower or sunburst, also in blue. Below the company name, there are Chinese characters, also in blue, which likely represent the company's name or a related phrase in Chinese.

Non-clinical testing was conducted to verify that the subject devices meet all design and performance specifications similarly to the predicate device. The following tests were conducted.

> Biocompatibility

Biocompatibility studies were performed on the organic cotton tampon and the viscose tampon 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 10993-10:2021
· Vaginal irritation test per ISO 10993-23:2021
· Acute systemic toxicity test per ISO 10993-11:2017(tampon only)

All the above tests were performed on the applicator, except acute systemic toxicity. The results demonstrated that the subject device is non-cytotoxic, non-sensitizing, and non-systemically toxic.

A 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 highest absorbency of the finished form of the subject devices (i.e., the organic cotton tampon and the viscose tampon), and the test results showed that the subject devices do not:

enhance the growth of Staphylococcus aureus;
increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1); and do not
alter the growth of normal vaginal microflora.

A Performance Testing

The following performance characteristics were assessed on the organic cotton tampon and the viscose tampon 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
String strength
· Absorbency per Syngyna Testing (21 CFR 801.430)
Applicator expulsion force
· Appearance
· Applicator and tampon integrity
· Fiber shedding
· Chemical residues

H. Clinical Test Conclusion

No clinical study is included in this submission.

l. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(K) submission, the Unscented Tampons are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K231341.

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).