LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,

K120481 · Tosama, D.O.O. · HEB · Jul 13, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K120481
• Device Name: LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
• Applicant: Tosama, D.O.O.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Jul 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for 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.

Device Story

Lil-lets tampons are unscented menstrual hygiene products designed for intravaginal absorption of menstrual or vaginal discharge. Available in two configurations: non-applicator and plastic applicator (Silk Comfort Compact). Sizes include Lite, Regular, Super, Super plus, and Ultra. Constructed from cotton and rayon fibers with a polyethylene/polyester cover and cotton or rayon withdrawal string. Used by women for personal hygiene; intended for over-the-counter use. The plastic applicator facilitates correct vaginal insertion. The device functions by absorbing fluid; performance is verified through Syngyna testing to ensure compliance with absorbency ranges per 21 CFR 801.430(f)(2).

Clinical Evidence

Bench testing only. No clinical data provided. Testing included Syngyna absorbency testing per 21 CFR 801.430(f)(2), microbiology testing (Staphylococcus aureus growth, vaginal microflora impact, TSST-1 production), and physical/chemical tests (fibre loss, stability, withdrawal cord attachment, and applicator expulsion force).

Technological Characteristics

Materials: cotton, rayon, polyethylene/polyester cover, cotton/rayon string. Design: applicator and non-applicator variants in multiple sizes (Lite to Ultra). Principle: passive absorption of vaginal fluid. Testing standards: 21 CFR 801.430(f)(2) for absorbency. No electronic or software components.

Indications for Use

Indicated for women for personal hygiene, specifically the intravaginal absorption of menstrual or other vaginal discharge. The plastic applicator version is indicated to assist in the correct placement of the tampon into the vagina.

Regulatory Classification

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.

Predicate Devices

• MAXIM Plastic Applicator and Non Applicator Tampons (K080775)

Submission Summary (Full Text)

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### 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: [phone] . FAX: [phone] e-mail: marjetka [e-mail]

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

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.

### 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 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preclinical<br>Microbiology Tests | - Enhance the growth of Staphylococcus aureus (Zone of inhibition)<br>- Alter the growth of normal vaginal microflora (Zone of inhibition)<br>- 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.<br>The tampons are labeled in accordance to required ranges. |
| Physical and<br>chemical tests | Internal method:<br>- Fibre loss test<br>- Stability of digital tampons<br>- Withdrawal cord attachment test<br>- 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Helene Siewer

tive. Gastro-Renal, and

Page 1 of 1

### Exhibit 117 006