Tosama Biobased Applicator Tube Menstrual Tampon

K172504 · Tosama, D.O.O. · HEB · Feb 9, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K172504
• Device Name: Tosama Biobased Applicator Tube Menstrual Tampon
• Applicant: Tosama, D.O.O.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Feb 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

The Tosama Biobased Applicator Tube 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 biobased LDPE plastic applicator. Used by patients for menstrual hygiene; inserted into the vagina to absorb discharge. Applicator features a rounded tip to facilitate insertion. Available in Regular, Super, and Super Plus absorbencies. Device is non-sterile, single-use, and over-the-counter. No electronic components or algorithms.

Clinical Evidence

Bench testing only. Testing included ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization) for the applicator. Microbiological testing confirmed absence of pathogens. Performance testing per FDA guidance included Syngina absorbency, dimensional analysis, mass, withdrawal cord pull-out strength, fiber loss, and tampon integrity. All results met pre-defined acceptance criteria.

Technological Characteristics

Pledget/cord: 100% organic cotton. Applicator: Biobased LDPE. Dimensions: 43-48mm length, 11-16mm diameter. Energy source: None (mechanical). Connectivity: None. Sterilization: Not stated. Software: None.

Indications for Use

Indicated for use by individuals 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

• Tosama 100% Organic Cotton Menstrual Tampon (K151170)

Submission Summary (Full Text)

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February 9, 2018

TOSAMA, d.o.o. Janez Obreza Head of Regulatory Affairs Saranoviceva cesta 35 Vir, SI 1230 Domzale Slovenia

Re: K172504

> Trade/Device Name: Tosama Biobased Applicator Tube Menstrual Tampon Regulation Number: 21 CFR\$ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: January 5, 2018 Received: January 11, 2018

Dear Janez Obreza:

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 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.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Joyce M. Whang -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) K172504

#### Device Name

Tosama Biobased Applicator Tube Menstrual Tampon

Indications for Use (Describe)

The Tosama Biobased Applicator Tube Menstrual 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)

区 | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary – K172504

| DATE OF PREPARATION: | February 9, 2018 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| COMPANY/OWNER: | TOSAMA, d.o.o.<br>Saranoviceva cesta 35, Vir<br>SI-1230 Domzale<br>SLOVENIA, EU |
| CONTACT: | Janez Obreza<br>Head of Regulatory Affairs |
| TELEPHONE: | 00386 1 7290370 |
| FAX: | 00386 1 7291244 |
| EMAIL: | [e-mail] |
| DEVICE TRADE NAME: | Tosama Biobased Applicator Tube Menstrual<br>Tampon |
| COMMON NAME: | Unscented Menstrual Tampon |
| CLASSIFICATION NAME: | Tampon, Menstrual, Unscented |
| REGULATION NUMBER: | 21 CFR §884.5470 |
| PRODUCT CODE: | HEB (tampon, menstrual, unscented) |
| DEVICE CLASS: | II |
| PREDICATE DEVICE: | Tosama 100% Organic Cotton Menstrual Tampon<br>(K151170)<br>The predicate device has not been subject to a<br>design-related recall. |
| DEVICE DESCRIPTION: | The device will be offered as a traditional unscented<br>menstrual tampon consisting of an absorbent<br>pledget, a withdrawal cord, and an applicator<br>comprised of biobased plastic. The pledget is of the<br>traditional cylindrical, bullet-like shape and the<br>applicator has a standard rounded tip to ease<br>insertion.<br>Each tampon is individually wrapped and packaged<br>in multi-unit containers for retail sale. It will be offered<br>in three absorbencies: Regular, Super, and Super<br>Plus. |
| INDICATION FOR USE: | The Tosama Biobased Applicator Tube Menstrual<br>Tampon is intended for insertion into the vagina for<br>the absorption of menstrual or other vaginal<br>discharge. |

## SUBSTANTIAL EQUIVALENCE DISCUSSION:

The Tosama Biobased Applicator Tube Menstrual Tampon demonstrates substantial equivalence to the Tosama 100% Organic Cotton Menstrual Tampon (K151170).

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The table below summarizes the key technological characteristics and features of both the predicate and subject devices.

| Feature | Tosama<br>Biobased<br>Applicator Tube<br>Menstrual<br>Tampon | PREDICATE:<br>Tosama 100%<br>Organic Cotton<br>Tampon |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K172504 | K151170 |
| Indication for Use | The Tosama Biobased<br>Applicator Tube Menstrual<br>Tampon is intended for<br>insertion into the vagina<br>for the absorption of<br>menstrual or other vaginal<br>discharge. | The Tosama 100%<br>Organic Menstrual<br>Tampon is intended for<br>insertion into the vagina<br>for the absorption of<br>menstrual or other vaginal<br>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 | Applicator<br>Tampons | Applicator<br>Tampons |
| Description: | Regular Applicator | Regular Applicator |
| Tampon Length: | 43.0mm – 48.0mm | 43.0mm - 46.0mm |
| Applicator Length: | 120mm ± 5% | 120mm ± 5% |
| Tampon Diameter: | 11.0mm – 14.0mm | 11.0mm - 12.0mm |
| Applicator Diameter: | 16mm | 13mm |
| Tampon Mass: | 1.50g - 2.30g | 2.00g - 2.30g |
| Applicator Mass: | 3.00g - 3.40g | 3.40g - 3.60g |
| Total Mass: | 4.50g - 5.70g | 5.40g - 5.90g |
| Withdrawal Cord: | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency: | 6.0g – 9.0g | 6.0g - 9.0g |
| Description: | Super Applicator | Super Applicator |
| Tampon Length: | 43.0mm – 48.0mm | 43.0mm - 46.0mm |
| Applicator Length: | 120mm ± 5% | 120mm ± 5% |
| Tampon Diameter: | 13.0mm – 16.0mm | 12.0mm - 13.0mm |
| Applicator Diameter: | 18mm | 16mm |
| Tampon Mass: | 2.10g - 3.00g | 2.60g - 3.00g |
| Applicator Mass: | 3.80g - 4.00g | 4.10g - 4.30g |
| Total Mass: | 5.90g - 7.00g | 6.70g - 7.30g |
| Withdrawal Cord: | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency: | 9.0g – 12.0g | 9.0g - 12.0g |
| Description: | Super Plus Applicator | Super Plus Applicator |
| Tampon Length: | 43.0mm – 48.0mm | 43.0mm - 46.0mm |
| Applicator Length: | 120mm ± 5% | 120mm ± 5% |
| Tampon Diameter: | 13.0mm – 16.0mm | 14.0mm - 15.0mm |
| Applicator Diameter: | 18mm | 18mm |
| Tampon Mass: | 3.00g - 4.00g | 3.00g - 3.50g |
| Applicator Mass: | 3.80g - 4.00g | 4.20g - 4.40g |
| Total Mass: | 6.80g - 8.00g | 7.20g - 7.90g |
| Withdrawal Cord: | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency: | 12.0g - 15.0g | 12.0g - 15.0g |
| Materials | All Products | All Products |
| Pledget: | 100% Organic Cotton | 100% Organic Cotton |
| Withdrawal Cord: | 100% Organic Cotton | 100% Organic Cotton |
| Applicator: | Biobased LDPE | TPO |
| Individual Wrapping: | Polypropylene | Polypropylene |
| Additives &<br>Finishing<br>Agents | Hydrophobic<br>withdrawal cord | Hydrophobic<br>withdrawal cord |

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The subject and predicate device have the same intended use.

The subject and predicate device have different technological characteristics, namely in dimensions and materials. The material and dimensional changes do not raise different questions of safety or effectiveness.

## SUMMARY OF NON-CLINICAL DATA:

All materials used in the construction of Tosama Biobased Applicator Tube 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:

- . The proposed device uses identical materials, processes, and equipment for the cotton/pledget and only proposes to change the applicator material component of the device. As such, the testing conducted on the cotton/pledget to support the predicate submission is applicable to the proposed device (e.g., chemical residues, production of toxic shock syndrome toxin, vaginal microflora, and Staphylococcus aureus growth enhancement).
- 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 sensitization;
- Microbiological testing on the complete finished device for total aerobic ● microbial count, total yeast and mold count, and absence of pathogenic organisms (C. albicans, S. aureus, and P. Aeruginosa)
- . Testing on each absorbency level of the complete finished device according to the FDA Guidance on Menstrual Tampons and Pads:
- o Syngina absorbency according to 21 CFR 801.430(f)(2):
- o dimensional analysis and mass
- o withdrawal cord pull-out strength;
- o fiber loss;
- o tampon integrity.

The results of these tests met pre-defined acceptance criteria as applicable and are acceptable.

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## CONCLUSIONS:

The Tosama Biobased Applicator Tube Menstrual Tampon is substantially equivalent to the legally marketed predicate device Tosama 100% Organic Cotton Menstrual Tampon (K151170).