(18 days)
No
The device description and performance studies focus on the physical properties and safety of a traditional tampon, with no mention of AI or ML.
No
The device is described as a traditional menstrual tampon intended for absorption of menstrual or other vaginal discharge, not to treat or prevent a disease or condition.
No
This device, a tampon, is intended for absorption of menstrual or other vaginal discharge, not for diagnosing any medical condition. Its performance studies focus on safety and absorbency, not diagnostic capabilities.
No
The device description clearly states it is a physical tampon with an absorbent pledget, withdrawal cord, and applicator, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Tosama 100% Cotton Tampon is a physical device intended for absorption of menstrual or other vaginal discharge. It does not perform any diagnostic testing on a sample.
- Intended Use: The intended use clearly states "for insertion into the vagina for absorption of menstrual or other vaginal discharge." This is a physical function, not a diagnostic one.
- Device Description: The description details the physical components and form of the tampon, not any diagnostic capabilities.
- Performance Studies: The performance studies focus on the safety and efficacy of the tampon's physical properties (absorbency, integrity, biocompatibility), not on the accuracy of a diagnostic test.
Therefore, based on the provided information, the Tosama 100% Cotton Tampon is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Tosama 100% Cotton Tampon is intended for insertion into the vagina for absorption of menstrual or other vaginal discharge.
Product codes
HEB
Device Description
The device will be offered as a traditional unscented menstrual 100% 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% 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, heavy metal, phthalate, and PCB residues;
- Microbiological testing for enumeration per USP /, Toxic Shock Syndrome Toxin-1 production, vaginal microflora growth alteration, and S. aureus growth enhancement;
- Biocompatibility testing for in vitro cytotoxicity, intracutaneous and vaginal irritation, sensitization, and acute systemic toxicity;
- Efficacy testing for Syngina absorbency, fiber loss, withdrawal cord pull-out resistance, and 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)
Naturalena 100% Cotton Tampon (K130609), Cottons 100% Natural Cotton Tampon (K080733)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2015
Tosama D.O.O. % Dave Yungvirt CEO Third Party Review Group, LLC 45 Rockerfeller Plaza, Suite 2000 New York, NY 10111
Re: K150897
Trade/Device Name: Tosama 100% Cotton Menstrual Tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: April 14, 2015 Received: April 15, 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. 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
1
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/ResourcesforYou/Industry/default.htm. 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.
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)
Device Name
Tosama 100% Cotton Menstrual Tampon
Indications for Use (Describe)
The Tosama 100% Cotton 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)
|×| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Section 5: 510(k) Summary
DATE OF PREPARATION: April 20th, 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 |
DEVICE TRADE NAME: Tosama 100% Cotton Menstrual Tampon Unscented Menstrual Tampon COMMON NAME: CLASSIFICATION NAME: Tampon, Menstrual, Unscented REGULATION NUMBER: 21 CFR §884.5470 PRODUCT CODE: HEB DEVICE CLASS: =
PREDICATE DEVICES: Naturalena 100% Cotton Tampon (K130609) Cottons 100% Natural Cotton Tampon (K080733)
The device will be offered as a traditional unscented DEVICE DESCRIPTION: menstrual 100% 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.
INDICATIONS FOR USE: The Tosama 100% Cotton Tampon is intended for insertion into the vagina for absorption of menstrual or other vaginal discharge.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE: The Tosama 100% Cotton Tampon demonstrates substantial equivalence to both the Naturalena 100% Cotton Tampon (K130609) and the Cottons 100% Natural Cotton Tampon (K080733). Table 5-1 summarizes the key technological characteristics and features of both the predicates and the new device.
4
| Predicates | ||||
|---|---|---|---|---|
| Feature | Tosama 100% | |||
| Cotton Tampon | Naturalena | |||
| 100% Cotton | ||||
| Tampon | Cottons 100% | |||
| Natural Cotton | ||||
| Tampon | ||||
| 510(k) Number | K130609 | K080733 | ||
| Indications for | ||||
| 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. | 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. | Tampon with | |||
| cylindrical shape and | ||||
| bullet-like tip. | ||||
| Applicator with | ||||
| smooth, rounded tip. | ||||
| Dimensions & | ||||
| Weights | Digital Tampons | Digital Tampons | Digital Tampons | |
| Description: | Regular Digital | Regular Digital | Regular Digital | |
| Length: | 43.0mm – 46.0mm | 43.0mm – 46.0mm | 43.0mm – 46.0mm | |
| Diameter: | 11.0mm – 12.0mm | 11.0mm – 12.0mm | 11.0mm – 12.0mm | |
| Mass: | 2.30g – 2.70g | 2.30g – 2.70g | 2.30g – 2.70g | |
| Withdrawal Cord: | 130mm – 160mm | 130mm – 160mm | 130mm - 160mm | |
| Syngina Absorbency: | 6.0g - 9.0g | 6.0g - 9.0g | 6.0g - 9.0g | |
| Description: | Super Digital | Super Digital | Super Digital | |
| Length: | 48.0mm – 51.0mm | 48.0mm – 51.0mm | 48.0mm - 51.0mm | |
| Diameter: | 12.0mm – 13.0mm | 12.0mm – 13.0mm | 12.0mm - 13.0mm | |
| Mass: | 2.70g – 3.10g | 2.70g – 3.10g | 2.70g - 3.10g | |
| Withdrawal Cord: | 130mm - 160mm | 130mm - 160mm | 130mm - 160mm | |
| Syngina Absorbency: | 9.0g - 12.0g | 9.0g - 12.0g | 9.0g - 12.0g | |
| Description: | Super Plus Digital | Super Plus Digital | Super Plus Digital | |
| Length: | 48.0mm - 51.0mm | 48.0mm - 51.0mm | 48.0mm - 51.0mm | |
| Diameter: | 14.0mm - 15.0mm | 14.0mm - 15.0mm | 14.0mm - 15.0mm | |
| Mass: | 3.30g – 3.80g | 3.30g – 3.80g | 3.30g - 3.80g | |
| Withdrawal Cord: | 130mm - 160mm | 130mm - 160mm | 130mm - 160mm | |
| Syngina Absorbency: | 12.0g – 15.0g | 12.0g – 15.0g | 12.0g - 15.0g | |
| Dimensions & | ||||
| Weights | Applicator | |||
| Tampons | Applicator | |||
| Tampons | Applicator | |||
| Tampons | ||||
| Description: | Regular Applicator | Regular Applicator | Regular Applicator | |
| Tampon Length: | 43.0mm – 46.0mm | 43.0mm – 46.0mm | 43.0mm - 46.0mm | |
| Applicator Length: | 120mm ± 5% | 120mm ± 5% | 120mm ± 5% | |
| Tampon Diameter: | 11.0mm – 12.0mm | 11.0mm – 12.0mm | 11.0mm - 12.0mm | |
| Applicator Diameter: | 13mm | 13mm | 13mm | |
| Tampon Mass: | 2.00g - 2.30g | 2.00g - 2.30g | 2.00g - 2.30g | |
| Applicator Mass: | 3.40g - 3.60g | 3.40g - 3.60g | 3.40g - 3.60g | |
| Total Mass: | 5.40g - 5.90g | 5.40g - 5.90g | 5.40g - 5.90g | |
| Withdrawal Cord: | 130mm - 160mm | 130mm – 160mm | 130mm - 160mm | |
| Syngina Absorbency: | 6.0g - 9.0g | 6.0g - 9.0g | 6.0g - 9.0g | |
| Feature | Tosama 100% Cotton Tampon | Predicates | ||
| Naturalena 100% Cotton Tampon | Cottons 100% Natural Cotton Tampon | |||
| Description: | Super Applicator | Super Applicator | Super Applicator | |
| Tampon Length: | $43.0mm - 46.0mm$ | $43.0mm - 46.0mm$ | $43.0mm - 46.0mm$ | |
| Applicator Length: | $120mm \pm 5%$ | $120mm \pm 5%$ | $120mm \pm 5%$ | |
| Tampon Diameter: | $12.0mm - 13.0mm$ | $12.0mm - 13.0mm$ | $12.0mm - 13.0mm$ | |
| Applicator Diameter: | $16mm$ | $16mm$ | $16mm$ | |
| Tampon Mass: | $2.60g - 3.00g$ | $2.60g - 3.00g$ | $2.60g - 3.00g$ | |
| Applicator Mass: | $4.10g - 4.30g$ | $4.10g - 4.30g$ | $4.10g - 4.30g$ | |
| Total Mass: | $6.70g - 7.30g$ | $6.70g - 7.30g$ | $6.70g - 7.30g$ | |
| Withdrawal Cord: | $130mm - 160mm$ | $130mm - 160mm$ | $130mm - 160mm$ | |
| Syngina Absorbency: | $9.0g - 12.0g$ | $9.0g - 12.0g$ | $9.0g - 12.0g$ | |
| Description: | Super Plus Applicator | Super Plus Applicator | Super Plus Applicator | |
| Tampon Length: | $43.0mm - 46.0mm$ | $43.0mm - 46.0mm$ | $43.0mm - 46.0mm$ | |
| Applicator Length: | $120mm \pm 5%$ | $120mm \pm 5%$ | $120mm \pm 5%$ | |
| Tampon Diameter: | $14.0mm - 15.0mm$ | $14.0mm - 15.0mm$ | $14.0mm - 15.0mm$ | |
| Applicator Diameter: | $18mm$ | $18mm$ | $18mm$ | |
| Tampon Mass: | $3.00g - 3.50g$ | $3.00g - 3.50g$ | $3.00g - 3.50g$ | |
| Applicator Mass: | $4.20g - 4.40g$ | $4.20g - 4.40g$ | $4.20g - 4.40g$ | |
| Total Mass: | $7.20g - 7.90g$ | $7.20g - 7.90g$ | $7.20g - 7.90g$ | |
| Withdrawal Cord: | $130mm - 160mm$ | $130mm - 160mm$ | $130mm - 160mm$ | |
| Syngina Absorbency: | $12.0g - 15.0g$ | $12.0g - 15.0g$ | $12.0g - 15.0g$ | |
| Materials | All Products | All Products | All Products | |
| Pledget: | 100% Cotton | 100% Cotton | 100% Cotton | |
| Withdrawal Cord: | 100% Cotton | 100% Cotton | 100% Cotton | |
| Applicator: | Polyethylene | Polyethylene | Polyethylene | |
| Individual Wrapping: | Polypropylene | Polypropylene | Cellophane | |
| Additives & Finishing Agents | Hydrophobic coating on withdrawal cord. | Hydrophobic coating on withdrawal cord. | None. |
Table 5-1: Comparison of Proposed Device with Predicate Devices
5
SUMMARY OF NON-CLINICAL DATA:
All materials used in the construction of Tosama 100% 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, heavy metal, phthalate, and PCB residues;
- Microbiological testing for enumeration per USP /, Toxic Shock Syndrome Toxin-1 production, vaginal microflora growth alteration, and S. aureus growth enhancement;
- · Biocompatibility testing for in vitro cytotoxicity, intracutaneous and vaginal irritation, sensitization, and acute systemic toxicity;
- · Efficacy testing for Syngina absorbency, fiber loss, withdrawal cord pull-out resistance, and tampon integrity.
The results of these tests support the conclusion that the proposed device is safe for its intended use.
6
CONCLUSIONS:
The intended use and indications for use, as well as the safety and effectiveness, of Tosama 100% Cotton Tampons and that of Naturalena and Cottons predicate devices as unscented menstrual tampons are identical. Chemical, biocompatibility, microbiological, and efficacy testing show this to be verifiable. Thus, the Tosama 100% Cotton Tampon is substantially equivalent to the legally marketed predicate devices, Naturalena 100% Cotton Tampon (K130609) and Cottons 100% Natural Cotton Tampon (K080733).