(62 days)
Not Found
No
The device description and performance studies focus on the physical properties, materials, and absorbency of a traditional menstrual tampon, with no mention of AI or ML.
No.
The device's intended use is for absorption of menstrual or other vaginal discharge, which is not a therapeutic function.
No
The device is a menstrual tampon, intended for absorbing menstrual or other vaginal discharge. Its purpose is absorption, not diagnosis of a medical condition.
No
The device description clearly indicates a physical product (tampon with applicator and cord) and the performance studies focus on material properties, biocompatibility, and physical performance, not software functionality.
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 one.
- Device Description: The description details a physical product for absorption, not a test or reagent used to examine specimens from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing information about a disease or condition.
- Performance Studies: The performance studies focus on physical properties (absorbency, integrity, fiber loss) and biocompatibility, not diagnostic accuracy (sensitivity, specificity, etc.).
- Predicate Device: The predicate device is another menstrual tampon, reinforcing its classification as a physical absorbent product.
IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This tampon does not fit that definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HEB
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.
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 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:
- ISO 10993-5:2009: Tests for in vitro cytotoxicity;
- ISO 10993-10:2010: Tests for irritation and skin sensitization;
- ISO 10993-11:2006: Tests for systemic toxicity;
- Biocompatibility testing of the applicator as follows:
- ISO 10993-5:2009: Tests for in vitro cytotoxicity;
- 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);
- fiber loss:
- withdrawal cord pull-out resistance;
- tampon integrity.
The results of these tests support the conclusion that the proposed device is safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Naturalena 100% Cotton Tampon (K130609)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/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.
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 (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
510(k) Summary
DATE OF PREPARATION: July 1, 2015
| COMPANY/OWNER: | TOSAMA, d.o.o.
Saranoviceva cesta 35, Vir
SI-1230 Domzale
SLOVENIA, EU |
|----------------|---------------------------------------------------------------------------------|
| CONTACT: | Marjetka Kralj Kuncic, PhD
Head of Quality Control |
| TELEPHONE: | 00386 1 7290370 |
| FAX: | 00386 1 7291244 |
| EMAIL: | marjetka.kralj-kuncic@tosama.si |
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.
4
| Feature | Tosama 100%
Organic Cotton
Menstrual
Tampon | Predicate
Naturalena
100% Cotton
Tampon |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K130609 |
| Intended Use | The device is
intended for insertion
into the vagina for the
absorption of
menstrual or other
vaginal discharge. | The device 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 | 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 &
Weights | Applicator
Tampons | Applicator
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%
Organic Cotton
Menstrual
Tampon | Predicate
Naturalena
100% Cotton
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
Not included in
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 &
Finishing
Agents | Hydrophobic
withdrawal cord. | Hydrophobic coating
on withdrawal cord. |
Table 5-1: Comparison of Proposed Device with Predicate Devices
5
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.
-
- 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
6
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).