Rael Tampon will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.

AI/ML Overview

The provided text is a 510(k) Summary for the Rael Tampon. Since this is a submission for a medical device (tampon), the "device" in question is not an AI/ML imaging device, but rather a physical product. Therefore, many of the requested points related to AI/ML device studies (such as MRMC studies, training set details, and expert adjudication of ground truth for AI performance) are not applicable.

However, I can extract the relevant information regarding acceptance criteria and performance testing for the Rael Tampon as a physical medical device.

Acceptance Criteria and Device Performance for Rael Tampon

The Rael Tampon is being submitted for substantial equivalence to a predicate device (Tosama 100% Organic Cotton Menstrual Tampon, K151170). The acceptance criteria are based on meeting established standards and guidance documents for menstrual tampons. The study confirming these criteria is a non-clinical performance testing and biocompatibility testing program.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the results "met the requirements" or demonstrate "comparable" characteristics, but does not provide specific numerical outcomes for every test beyond the absorbency ranges and dimensions presented in the comparison table.

Acceptance Criteria Category	Specific Acceptance Criteria (based on FDA Guidance / ISO Standards)	Device Performance (Rael Tampon)
Physical Dimensions	Dimensions within acceptable ranges (e.g., comparable to predicate).	- Regular Pledget Length: 38 mm- Super Pledget Length: 47 mm- Regular Pledget Diameter: 12 mm- Super Pledget Diameter: 12 mm- Regular Applicator Inner Length: 73 ± 5% mm- Super Applicator Inner Length: 73 ± 5% mm- Regular Applicator Outer Length: 76.5 ± 5% mm- Super Applicator Outer Length: 76.5 ± 5% mm- Regular Applicator Inner Diameter: 11.8 ± 5% mm- Super Applicator Inner Diameter: 11.8 ± 5% mm- Regular Applicator Outer Diameter: 14.1 ± 5% mm- Super Applicator Outer Diameter: 14.1 ± 5% mm (All comparable to predicate)
Absorbency Range (Syngyna Test)	Absorbency within specified ranges for "Regular" and "Super" categories.	- Regular: 6.0 - 9.0 grams- Super: 9.0 - 12.0 grams (Comparable to predicate)
Chemical Residues	Levels of chemical residues within acceptable safety limits.	Met the requirements of "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff".
Withdrawal Cord Strength	Cord strength sufficient for safe removal.	Met the requirements of "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff".
Fiber Shedding	Minimal fiber shedding to ensure safety and integrity.	Met the requirements of "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff".
Tampon Integrity	Tampon maintains structural integrity during use.	Met the requirements of "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff".
Biocompatibility (ISO 10993)	- Absence of cytotoxicity (ISO 10993-5)- No sensitization (ISO 10993-10)- No vaginal irritation (ISO 10993-10)- Absence of acute systemic toxicity (ISO 10993-11)	Results met the requirements of the ISO standards for all categories.
Microbiology Testing (FDA Guidance)	- No enhancement of Staphylococcus aureus growth- No increase in Toxic Shock Syndrome Toxin-1 (TSST-1) production- No alteration of normal vaginal microflora growth	Demonstrated to meet these criteria as per the 2005 FDA guidance document.

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

The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of tampons tested for absorbency, strength, etc.). However, it indicates that "the subject tampons and applicators" were used, implying a representative sample was tested.

Data Provenance: The tests were conducted specifically for the Rael Tampon as part of its premarket notification. The location of the testing laboratories is not specified in this summary, but it would be expected to adhere to international standards (e.g., ISO, FDA guidance) which are generally applied globally. The studies are prospective in the sense that they were performed specifically for this submission to demonstrate compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. For a physical medical device like a tampon, ground truth is established by objective laboratory testing against defined physical, chemical, and biological endpoints (e.g., weight, length, absorbed volume, chemical concentration, microbial growth in cultures). It does not involve expert interpretation or consensus in the way AI/ML diagnostic tools do.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are for human interpretation of data, typically in diagnostic assessments. For laboratory testing of a physical product, the results are typically quantitative measurements or qualitative observations directly tied to predefined pass/fail criteria, not subject to human expert adjudication in the same manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. MRMC studies are specific to AI/ML diagnostic tools where multiple human readers interpret cases, often with and without AI assistance, to assess the impact of the AI on human performance. This is not relevant for a physical device like a tampon.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This question pertains to the performance of an AI algorithm in isolation. The Rael Tampon is a physical product, not an algorithm. The performance testing conducted was "standalone" in the sense that it measured the inherent properties and safety of the tampon itself, independent of human interaction beyond normal use.

7. The Type of Ground Truth Used

The ground truth for the Rael Tampon's performance is based on objective measurements, standardized test protocols, and established safety limits defined by:

Physical specifications (e.g., dimensions, absorbency ranges).
Chemical safety standards (e.g., residue limits).
Biocompatibility standards (e.g., ISO 10993 for cytotoxicity, sensitization, irritation, systemic toxicity).
Microbiological safety criteria (e.g., impact on S. aureus growth, TSST-1 production, vaginal microflora).

These "ground truths" are derived from scientific and regulatory consensus on what constitutes a safe and effective menstrual tampon.

8. The Sample Size for the Training Set

Not Applicable. The concept of a "training set" applies to machine learning algorithms. The Rael Tampon is a manufactured product; it does not have a training set in this context. The manufacturing process is guided by design specifications and quality control, not by training data.

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

Not Applicable. As there is no training set for this physical device, there is no ground truth needing to be established for it.

Summary

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July 15, 2019

Rael, Inc. % Joyce Kwun President Provision Consulting Group, Inc. 3350 Shelby St. Ste 200 Ontario, CA 91764

Re: K182814

Trade/Device Name: Rael Tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Received: June 12, 2019 Dated: June 10, 2019

Dear Joyce Kwun:

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

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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)

K182814

Device Name Rael Tampon

Indications for Use (Describe)

The Rael 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 - K182814

1. Submitter Information

Applicant:	Rael, Inc.
Contact:	Binna Won
Address:	6940 Beach Blvd D-608 &609 Buena Park, CA 90621

2. Correspondent Information

Contact:	Joyce KwunProvision Consulting Group, Inc.
Address:	3350 Shelby St. Ste 200, Ontario, CA 91764
Phone:	+1-909-493-3276 (O)+1-909-680-8562 (M)
Email:	info@provisionfda.com

3. Date Prepared: July 12, 2019

4. Device Information

Device Name:	Rael Tampon
Common Name:	Unscented Menstrual Tampon
Regulation Number:	21 CFR 884.5470
Regulation Name:	Tampon, Menstrual, Unscented
Regulatory Class:	Class II
Product Code:	HEB

5. Predicate Device Information

Tosama 100% Organic Cotton Menstrual Tampon (K151170). This predicate device has not been subject to a design-related recall.

6. Device Description

7. Indications for Use

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

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		Subject Device (K182814)	Predicate Device (K151170)
	Product Name	Rael Tampon	Tosama 100% Organic CottonMenstrual Tampon
	ClassificationRegulation	884.5470	884.5470
	Product Code	HEB	HEB
	Intended Use	The device is intended forinsertion into the vaginafor the absorption ofmenstrual or other vaginaldischarge.	The device isintended for insertioninto the vagina for theabsorption ofmenstrual or othervaginal discharge.
	Sterile?	No	No
	Design	Tampon with cylindricalshape and bullet-like tip.Applicator with smooth,rounded tip.	Tampon withcylindrical shape andbullet-like tip.Applicator withsmooth, rounded tip.
	Syngyna Absorbency(gram)	Regular	6.0 - 9.0
		Super	9.0 - 12.0
	Pledget Length (mm)	Regular	38
		Super	47
	Pledget Diameter(mm)	Regular	12
		Super	12
	Applicator InnerLength (mm)	Regular	73 ± 5%
		Super	73 ± 5%
	Applicator OuterLength (mm)	Regular	76.5 ± 5%
		Super	76.5 ± 5%
	Applicator InnerDiameter (mm)	Regular	11.8 ± 5%
		Super	11.8 ± 5%
	Applicator OuterDiameter (mm)	Regular	14.1 ± 5%
		Super	14.1 ± 5%
Materials	Pledget		100% Organic Cotton
	Applicator		Polyethylene
			100% Organic Cotton
			TPO

Comparison of Intended Use and Technological Characteristics with the Predicate Device 8.

The subject and predicate devices have the same intended use - to absorb menstrual or other discharge in the vagina. They have the same design and comparable dimensions and absorbencies. The differences in technological characteristics do not raise different questions of safety and effectiveness.

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9. Summary of Non-Clinical Performance Testing

Performance testing

The following performance characteristics were assessedin accordance with the 2005 FDA guidance document "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff".

Dimensions
Absorbency range
Chemical residues
Withdrawal cord strength
Fiber shedding
Tampon integrity

Biocompatibility Testing

Biocompatibility studies were performed in accordance with the 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" issued in 2016 and ISO 10993 standardsas follows:

. Cytotoxicity (MEM Elution Test) per ISO 10993-5:2009
Sensitization (Guinea Pig Maximization Test) per ISO 10993-10:2010 ●
Irritation (Vaginal Irritation Test) per ISO 10993-10:2010 ●
. Acute Systemic Toxicity per ISO 10993-11:2006

These tests were performed on the subject tampons and applicators, and the results met the requirements of the ISO standards.

Microbiology Testing

Per the 2005 FDA guidance document mentioned above, microbiology testing was conducted to demonstrate that the subject devices do 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

10. Conclusions

The subject and predicate devices have the same intended use. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate devices.

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).