The Lil-lets tampons (both types) are unscented tampons 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 (only the Lil-lets Silk Comfort Compact Plastic Applicator Tampon).

Device Description

Lil-lets tampons are used to absorb menstrual fluid. Lil-lets series tampons come with a plastic applicator and without a plastic applicator in sizes: Lite, Regular, Super, Super plus and Ultra. Lil-lets tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.

AI/ML Overview

The provided 510(k) summary (K120481) for the Lil-lets Silk Comfort Compact Plastic Applicator Tampon & Lil-lets Non-Applicator Tampon describes pre-clinical testing to demonstrate substantial equivalence to a predicate device, MAXIM Plastic Applicator and Non Applicator Tampons (K080775). However, it does not contain a comprehensive study proving that the device meets specific acceptance criteria in the manner typically described for clinical studies of new medical devices with defined performance metrics, patient populations, and statistical analysis.

Instead, the summary focuses on non-clinical tests to ensure safety and equivalence based on existing standards and knowledge of the predicate device. The "acceptance criteria" are implied by adherence to these standards and by demonstrating that the Lil-lets tampons do not present new questions of safety or effectiveness.

Here's a breakdown of the information based on the provided text, using the requested format where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria (Standard)	Reported Device Performance (Summary)
Biocompatibility	Substantial equivalence to predicate's materials (MAXIM Plastic Applicator and Non Applicator Tampons, K080775).	"No additional testing was necessary because the materials of Lil-lets tampons are substantially equivalent to MAXIM Plastic Applicator and Non Applicator Tampons, K080775."
Microbiology Tests	- Enhance the growth of Staphylococcus aureus (Zone of inhibition)- Alter the growth of normal vaginal microflora (Zone of inhibition)- Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1)	(Not explicitly stated as "met" or specific results, but the submission implies these were assessed and deemed acceptable for substantial equivalence. The overall conclusion states substantial equivalence.)
Syngyna Testing	Adherence to 21 CFR 801.430(f)(2) to verify absorbency ranges as specified in the regulation. Tampons must be labeled in accordance with required ranges.	"Syngyna testing was conducted in accordance to 21 CFR 801.430(f)(2) to verify that the subject tampons met absorbency ranges as specified in the regulation. The tampons are labeled in accordance to required ranges." (This directly states the criteria were met.)
Physical and Chemical Tests	Internal methods for:- Fibre loss test- Stability of digital tampons- Withdrawal cord attachment test- Expulsion force of applicator tampons	(Not explicitly stated as "met" or specific results, but the submission implies these were assessed and deemed acceptable for substantial equivalence. The overall conclusion states substantial equivalence.)
Technological Characteristics	No differences from the technical characteristics of the substantially equivalent predicate devices (MAXIM tampons under K080775), differing only in dimensions across sizes (Lite, Regular, Super, Super plus, Ultra). The tampons contain commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.	"There are no differences between the technical characteristics of the Lil-lets tampons and the predicate characteristics of the substantially equivalent devices MAXIM tampons under K080775. All sizes... have the same characteristics; they differ only in dimensions."

Detailed Study Information:

This document is a 510(k) summary focused on demonstrating substantial equivalence for tampons, not a report of a traditional clinical performance study for a novel device. Therefore, many of the requested points do not apply or are not explicitly detailed in the provided text, as the regulatory pathway chosen (510(k)) relies heavily on comparing technical and safety characteristics to a legally marketed predicate device.

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

The document does not specify general "test set" sample sizes or data provenance in the context of a clinical study.
For Syngyna testing, it states "Syngyna testing was conducted," but does not provide the number of tampons tested. This is a bench test performed in a lab, not on human subjects.
For Microbiology and Physical/Chemical tests, no sample sizes are provided for individual tests.
Data provenance for these non-clinical tests would likely be the manufacturing site or a contract lab performing the tests, which is in Slovenia, given the submitter's address.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable in this context. "Ground truth" in the sense of expert consensus for diagnostic performance is not relevant to non-clinical tests of tampon safety and absorbency. Expertise is implied by adherence to regulatory standards and testing methodologies by competent personnel.

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

Not applicable. This concept is for clinical studies involving human interpretation or challenging outcomes.

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. This device is a tampon, not an AI-assisted diagnostic tool or an imaging device.

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

Not applicable. This device is a physical product (tampon), not an algorithm.

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

The "ground truth" for these non-clinical tests would be the established regulatory standards and validated test methodologies themselves (e.g., 21 CFR 801.430(f)(2) for absorbency, specific microbiological assays, internal physical testing protocols).
For biocompatibility, the ground truth is the accepted safety profile of the predicate device's materials.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of such a device and its regulatory submission.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the word "TOSAMA" in a bold, sans-serif font. The letters are outlined in black, with a white fill. To the left of the word is a symbol that looks like a stylized plus sign or cross. The overall impression is of a clean, modern logo or brand name.

510(k) Summary of Safety and Effectiveness

As required by 21 CFR 807.92

JUL. 1 3 2012

Submitter's name:

Tosama D.O.O.

Phone: +386 (0)1 7290 370 . FAX: +386 (0)1 7293 084 e-mail: marjetka kralj-kuncic@tosama.si

Address:

Contact person:

Date Prepared:

Device name:

Trade names:

i ii

Common name:

Classification name:

Predicate Devices:

Device description:

Tovarna sanitetnega materiala d.o.o. Vir, Šaranovičeva cesta 35, SI 1230 Domžale, Slovenia

Marjetka Kralj Kunčič, PhD Quality Control Manager

July 10, 2012

Applicator tampon Non applicator tampon

Lil-lets Silk Comfort Compact, Plastic Applicator; Lite, Regular, Super, Super plus and Ultra · Lil-lets Non Applicator; Regular, Super; Super plus and Ultra

Unscented Tampon

Unscented menstrual tampons (21 CFR 884.5470)

MAXIM Plastic Applicator and Non Applicator Tampons K080775

Intended use:

Lil-lets unscented menstrual tampon are intended for intravaginal absorption of menstrual or other vaginal discharge. This is the same intended use as current commercial tampons.

Technological characteristics:

There are no differences between the technical characteristics of the Lil-lets tampons and the predicate characteristics of the substantially equivalent devices MAXIM tampons under K080775. All sizes of Lil-lets tampons without plastic applicator and all sizes of Lil-lets tampons with plastic applicator: Lite, Regular, Super , Super plus and Ultra have the same characteristics; they differ only in dimensions.

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Non-Clinical Tests

Biocompatibility:

No additional testing was necessary because the materials of Lil-lets tampons are substantially equivalent to MAXIM Plastic Applicator and Non Applicator Tampons, K080775.

TOSAMA

Characteristics	Standard
PreclinicalMicrobiology Tests	- Enhance the growth of Staphylococcus aureus (Zone of inhibition)- Alter the growth of normal vaginal microflora (Zone of inhibition)- Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1)
Syngyna Testing	Syngyna testing was conducted in accordance to 21 CFR 801.430(f)(2) to verify that the subject tampons met absorbency ranges as specified in the regulation.The tampons are labeled in accordance to required ranges.
Physical andchemical tests	Internal method:- Fibre loss test- Stability of digital tampons- Withdrawal cord attachment test- Expulsion force of applicator tampons

Conclusion:

.....

The Lil-lets Silk Comfort Compact Plastic Applicator Tampons and Lil-lets Non Applicator Tampons are substantially equivalent to MAXIM Plastic Applicator Tampons and MAXIM Non Applicator Tampons approved for market under K080775. . :

Signed by Quality Control Manager . . . . . Marjetka Kralj Kunčič, PhD . . . . . . . .

Fraiz Lilicic

. .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Marjetka Kralj Kunčič, Ph.D. Ouality Control Manager TOSAMA d.o.o. Šaranovičeva cesta 035 VIR DOMŽALE 1230 SLOVENIA

JUL 1 3 2012

K120481 Re:

Trade/Device Name: Lil-lets Comfort Compact Plastic Applicator Tampon & Lil-lets Non-Applicator Tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: June 20, 2012 Received: June 20, 2012

Dear Dr. Kunčič:

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 for use suated in the enactment date of 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, de neces that have over require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general voltaren profitsturing 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 r lease of actived that I D I was in that your device complies with other requirements of the Act that I DA has made a avoid regulations administered by other Federal agencies. You must of any I cueral statuteb and reaguinements, including, but not limited to: registration and listing Comply with an the Pre-Prefections) : medical device reporting (reporting (reporting of medical

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Page 2-.

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1107.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the I ou inay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Evans

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510K Number (if known):

K120481

Device Name:

Lil-lets Silk Comfort Compact Plastic Applicator Tampon & Lil-lets Non-Applicator Tampon

Indications for Use:

The Lil-lets tampons (both types) are unscented tampons 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 (only the Lil-lets Silk Comfort Compact Plastic Applicator Tampon).

AND/OR Over-The Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use

(Part 21CFR 801 Subpart C) (Optional Format 1-

2- 96)

(Part 21 CFR 801 Subpart O)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helene Siewer

tive. Gastro-Renal, and

Page 1 of 1

Exhibit 117 006

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).