(175 days)
No
The device description and performance studies focus on the physical properties, materials, and absorbency of a menstrual tampon, with no mention of AI or ML technology.
No
The device is described as a menstrual tampon, intended for absorbency of discharge, which is a supportive function rather than a direct therapeutic intervention for a disease or condition.
No
The device is a menstrual tampon, intended for absorption of menstrual or vaginal discharge. Its functions are entirely related to absorption and containment, not to diagnosing any medical condition or disease.
No
The device description clearly states it is a physical menstrual tampon with an applicator, withdrawal cord, and absorbent pledget. It also details material testing and physical performance studies, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the absorption of menstrual or other vaginal discharge. This is a physical function, not a diagnostic test performed in vitro (outside the body) on a sample to diagnose a condition or provide information about a physiological state.
- Device Description: The description details a physical product for absorption, not a test kit or instrument for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
- Testing: The performance studies focus on physical properties (absorbency, strength, integrity), biocompatibility, and microbiological safety, which are relevant for a medical device intended for physical use, not for an IVD.
IVDs are devices used to examine specimens from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, prevention, or treatment of disease or to assess health. This menstrual tampon does not fit that description.
N/A
Intended Use / 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.
Product codes
HEB
Device Description
The device will be offered as a traditional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator comprised of biobased plastic. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Syngina absorbency according to 21 CFR 801.430(f)(2):
- dimensional analysis and mass
- withdrawal cord pull-out strength;
- fiber loss;
- tampon integrity.
The results of these tests met pre-defined acceptance criteria as applicable and are acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) Summary – K172504
| DATE OF PREPARATION: | February 9, 2018 |
|---|---|
| COMPANY/OWNER: | TOSAMA, d.o.o. |
| Saranoviceva cesta 35, Vir | |
| SI-1230 Domzale | |
| SLOVENIA, EU | |
| CONTACT: | Janez Obreza |
| Head of Regulatory Affairs | |
| TELEPHONE: | 00386 1 7290370 |
| FAX: | 00386 1 7291244 |
| EMAIL: | janez.obreza@tosama.si |
| DEVICE TRADE NAME: | Tosama Biobased Applicator Tube Menstrual |
| 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 |
| (K151170) | |
| The predicate device has not been subject to a | |
| design-related recall. | |
| DEVICE DESCRIPTION: | The device will be offered as a traditional unscented |
| menstrual tampon consisting of an absorbent | |
| pledget, a withdrawal cord, and an applicator | |
| comprised of biobased plastic. 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 Biobased Applicator Tube Menstrual |
| Tampon is intended for insertion into the vagina for | |
| the absorption of menstrual or other vaginal | |
| discharge. |
SUBSTANTIAL EQUIVALENCE DISCUSSION:
The Tosama Biobased Applicator Tube Menstrual Tampon demonstrates substantial equivalence to the Tosama 100% Organic Cotton Menstrual Tampon (K151170).
4
The table below summarizes the key technological characteristics and features of both the predicate and subject devices.
| Feature | Tosama
Biobased
Applicator Tube
Menstrual
Tampon | PREDICATE:
Tosama 100%
Organic Cotton
Tampon |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K172504 | K151170 |
| Indication 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. | The Tosama 100%
Organic Menstrual
Tampon is intended for
insertion into the vagina
for the absorption of
menstrual or other vaginal
discharge. |
| Design | Tampon with
cylindrical shape and
bullet-like tip.
Applicator with
smooth, rounded tip. | Tampon with
cylindrical shape and
bullet-like tip.
Applicator with
smooth, rounded tip. |
| Dimensions &
Weights | Applicator
Tampons | Applicator
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 &
Finishing
Agents | Hydrophobic
withdrawal cord | Hydrophobic
withdrawal cord |
5
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.
6
CONCLUSIONS:
The Tosama Biobased Applicator Tube Menstrual Tampon is substantially equivalent to the legally marketed predicate device Tosama 100% Organic Cotton Menstrual Tampon (K151170).