Tosama 100% Organic Cotton Menstrual Tampon

K151170 · Tosama, D.O.O. · HEB · Jul 2, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K151170
• Device Name: Tosama 100% Organic Cotton Menstrual Tampon
• Applicant: Tosama, D.O.O.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Jul 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The Tosama 100% Organic Cotton Menstrual Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

Device Story

Device is an unscented menstrual tampon consisting of an absorbent 100% organic cotton pledget, a withdrawal cord, and a thermoplastic olefin (TPO) applicator. Designed for vaginal insertion to absorb menstrual or vaginal discharge. Available in Regular, Super, and Super Plus absorbencies. Intended for over-the-counter use by patients. Operates via passive absorption of fluid. Withdrawal cord treated with Sevophob (paraffin-based resin) to prevent wicking. Safety and efficacy established through non-clinical bench testing, including biocompatibility (ISO 10993), microbiological testing, and Syngina absorbency testing per 21 CFR 801.430(f)(2).

Clinical Evidence

Bench testing only. No clinical data. Testing included chemical analysis (pesticides, dioxins, phthalates, PCBs), microbiological testing (Ph. Eur. 2.6.12/2.6.13, TSST-1, S. aureus growth), biocompatibility (ISO 10993-5, -10, -11), and efficacy testing (Syngina absorbency, fiber loss, pull-out resistance, tampon integrity).

Technological Characteristics

Pledget/cord: 100% organic cotton. Applicator: Thermoplastic olefin (TPO). Wrapping: Polypropylene. Withdrawal cord treated with paraffin-based resin (Sevophob). Dimensions: 43-51mm length, 11-15mm diameter. Syngina absorbency: 6.0g-15.0g. Sterilization method not specified.

Indications for Use

Indicated for females requiring absorption of menstrual or other vaginal discharge.

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

• Naturalena 100% Cotton Tampon (K130609)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure in profile, with three faces overlapping to symbolize health, human services, and the relationship between them. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

July 2, 2015

TOSAMA, d.o.o. % Dave Yungvirt CEO Third Party Review Group, LLC 45 Rockefeller Plaza. Suite 2000 New York, NY 10111

Re: K151170

> Trade/Device Name: Tosama 100% Organic Cotton Menstrual Tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: June 16, 2015 Received: June 18, 2015

Dear Dave Yungvirt,

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. 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 statutes and regulations administered by other Federal agencies.

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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 (reporting of medical 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for

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

510(k) Number (if known) K151170

Device Name

Tosama 100% Organic Cotton Menstrual Tampon

Indications for Use (Describe)

The Tosama 100% Organic Cotton Menstrual 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)

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# 510(k) Summary

DATE OF PREPARATION: July 1, 2015

| COMPANY/OWNER: | TOSAMA, d.o.o.<br>Saranoviceva cesta 35, Vir<br>SI-1230 Domzale<br>SLOVENIA, EU |
|----------------|---------------------------------------------------------------------------------|
| CONTACT: | Marjetka Kralj Kuncic, PhD<br>Head of Quality Control |
| TELEPHONE: | 00386 1 7290370 |
| FAX: | 00386 1 7291244 |
| EMAIL: | [e-mail] |

Tosama 100% Organic Cotton Menstrual Tampon DEVICE TRADE NAME: Unscented Menstrual Tampon COMMON NAME: Tampon, Menstrual, Unscented CLASSIFICATION NAME: REGULATION NUMBER: 21 CFR §884.5470 PRODUCT CODE: HEB DEVICE CLASS: =

PREDICATE DEVICE: Naturalena 100% Cotton Tampon (K130609)

DEVICE DESCRIPTION: The device 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 three absorbencies: Regular, Super, and Super Plus.

INDICATION FOR USE: The Tosama 100% Organic Cotton Menstrual Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The Tosama 100% Orqanic Cotton Menstrual Tampon demonstrates substantial equivalence to the Naturalena 100% Cotton Tampon (K130609). Table 5-1 summarizes the key technological characteristics and features of both the predicates and the new device.

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| Feature | Tosama 100%<br>Organic Cotton<br>Menstrual<br>Tampon | Predicate<br>Naturalena<br>100% Cotton<br>Tampon |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K130609 |
| Intended Use | The device is<br>intended for insertion<br>into the vagina for the<br>absorption of<br>menstrual or other<br>vaginal discharge. | The device is<br>intended for insertion<br>into the vagina for the<br>absorption of<br>menstrual or other<br>vaginal discharge. |
| Design | Tampon with<br>cylindrical shape and<br>bullet-like tip.<br>Applicator with<br>smooth, rounded tip. | Tampon with<br>cylindrical shape and<br>bullet-like tip.<br>Applicator with<br>smooth, rounded tip. |
| Dimensions &<br>Weights | Digital Tampons | Digital Tampons |
| Description: | Regular Digital | Regular Digital |
| Length: | 43.0mm – 46.0mm | 43.0mm – 46.0mm |
| Diameter: | 11.0mm – 12.0mm | 11.0mm – 12.0mm |
| Mass: | 2.30g – 2.70g | 2.30g – 2.70g |
| Withdrawal Cord: | 130mm – 160mm | 130mm – 160mm |
| Syngina Absorbency: | 6.0g – 9.0g | 6.0g – 9.0g |
| Description: | Super Digital | Super Digital |
| Length: | 48.0mm – 51.0mm | 48.0mm – 51.0mm |
| Diameter: | 12.0mm – 13.0mm | 12.0mm – 13.0mm |
| Mass: | 2.70g – 3.10g | 2.70g – 3.10g |
| Withdrawal Cord: | 130mm – 160mm | 130mm – 160mm |
| Syngina Absorbency: | 9.0g – 12.0g | 9.0g – 12.0g |
| Description: | Super Plus Digital | Super Plus Digital |
| Length: | 48.0mm – 51.0mm | 48.0mm – 51.0mm |
| Diameter: | 14.0mm – 15.0mm | 14.0mm – 15.0mm |
| Mass: | 3.30g – 3.80g | 3.30g – 3.80g |
| Withdrawal Cord: | 130mm – 160mm | 130mm – 160mm |
| Syngina Absorbency: | 12.0g – 15.0g | 12.0g – 15.0g |
| Dimensions &<br>Weights | Applicator<br>Tampons | Applicator<br>Tampons |
| Description: | Regular Applicator | Regular Applicator |
| Tampon Length: | 43.0mm – 46.0mm | 43.0mm – 46.0mm |
| Applicator Length: | 120mm ± 5% | 120mm ± 5% |
| Tampon Diameter: | 11.0mm – 12.0mm | 11.0mm – 13.0mm |
| Applicator Diameter: | 13mm | 16mm |
| Tampon Mass: | 2.00g – 2.30g | 2.00g – 2.30g |
| Applicator Mass: | 3.40g – 3.60g | 3.40g – 3.60g |
| Total Mass: | 5.40g – 5.90g | 5.40g – 5.90g |
| Withdrawal Cord: | 130mm – 160mm | 130mm – 160mm |
| Feature | Tosama 100%<br>Organic Cotton<br>Menstrual<br>Tampon | Predicate<br>Naturalena<br>100% Cotton<br>Tampon |
| Syngina Absorbency: | 6.0g - 9.0g | 6.0g - 9.0g |
| Description: | Super Applicator | Super Applicator |
| Tampon Length: | 43.0mm - 46.0mm | 48.0mm - 51.0mm |
| Applicator Length: | 120mm ± 5% | 120mm ± 5% |
| Tampon Diameter: | 12.0mm - 13.0mm | 13.0mm - 15.0mm |
| Applicator Diameter: | 16mm | 19mm |
| Tampon Mass: | 2.60g - 3.00g | 2.60g - 3.00g |
| Applicator Mass: | 4.10g - 4.30g | 4.20g - 4.40g |
| Total Mass: | 6.70g - 7.30g | 6.80g - 7.40g |
| Withdrawal Cord: | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency: | 9.0g - 12.0g | 9.0g - 12.0g |
| Description: | Super Plus Applicator | Super Plus Applicator<br>Not included in<br>submission. |
| Tampon Length: | 43.0mm - 46.0mm | |
| Applicator Length: | 120mm ± 5% | |
| Tampon Diameter: | 14.0mm - 15.0mm | |
| Applicator Diameter: | 18mm | |
| Tampon Mass: | 3.00g - 3.50g | |
| Applicator Mass: | 4.20g - 4.40g | |
| Total Mass: | 7.20g - 7.90g | |
| Withdrawal Cord: | 130mm - 160mm | |
| Syngina Absorbency: | 12.0g - 15.0g | |
| Materials | All Products | All Products |
| Pledget: | 100% Organic Cotton | 100% Cotton |
| Withdrawal Cord: | 100% Organic Cotton | 100% Cotton |
| Applicator: | TPO | Polyethylene |
| Individual Wrapping: | Polypropylene | Polypropylene |
| Additives &<br>Finishing<br>Agents | Hydrophobic<br>withdrawal cord. | Hydrophobic coating<br>on withdrawal cord. |

Table 5-1: Comparison of Proposed Device with Predicate Devices

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The proposed Tosama 100% Organic Cotton Menstrual Tampon and the Naturalena predicate device have the following two differences:

- Naturalena uses Repellan T anti-wicking agent in its withdrawal cord, while the 1. proposed device uses Sevophob. Both are a paraffin-based resin used to ensure the cord does not wick menstrual fluid out of the vaqina.
- 2. Naturalena uses a polyethylene plastic for the applicator material, while the proposed device uses a thermoplastic olefin plastic for the applicator material.

The proposed device is essentially identical to the Naturalena predicate device other than the differences listed above. It has been demonstrated through biocompatibility and performance testing that neither of the two differences have an impact on the safety and effectiveness of the device. Although the addition of the wicking agent to the withdrawal cord could potentially impact the safety (biocompatibility) of the

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device, it has been confirmed as safe through appropriate biocompatibility testing. SUMMARY OF NON-CLINICAL DATA:

All materials used in the construction of Tosama 100% Organic Cotton Menstrual Tampons as well as complete devices have been subjected to the following tests in accordance with recommended requirements and proper consideration of its intended use:

- · Chemical analysis for pesticide, dioxin, phthalate, and PCB residues;
- Microbiological testing for enumeration per Ph. Eur. 2.6.12/2.6.13. Toxic Shock Syndrome Toxin-1 production, vaginal microflora growth alteration, and S. aureus growth enhancement:
- · Biocompatibility testing of the pledget as follows:
- o ISO 10993-5:2009: Tests for in vitro cytotoxicity;
- ISO 10993-10:2010: Tests for irritation and skin sensitization;
- o ISO 10993-11:2006: Tests for systemic toxicity;
- · Biocompatibility testing of the applicator as follows:
- o ISO 10993-5:2009: Tests for in vitro cytotoxicity;
- o ISO 10993-10:2010: Tests for irritation and skin sensitization:
- Efficacy testing according to the FDA Guidance on Menstrual Tampons and Pads:
- Syngina absorbency according to 21 CFR 801.430(f)(2); o
- fiber loss: o
- withdrawal cord pull-out resistance; o
- o tampon integrity.

The results of these tests support the conclusion that the proposed device is safe for its intended use.

## CONCLUSIONS:

The intended use and indications for use, as well as the safety and effectiveness, of Tosama 100% Organic Cotton Menstrual Tampons and that of the Naturalena predicate device as unscented menstrual tampons are identical. Chemical, biocompatibility, microbiological, and efficacy testing show this to be verifiable. Thus, the Tosama 100% Organic Cotton Menstrual Tampon is substantially equivalent to the legally marketed predicate device Naturalena 100% Cotton Tampon (K130609).