(18 days)
The Tosama 100% Cotton Tampon is intended for insertion into the vagina for absorption of menstrual or other vaginal discharge.
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.
The provided document describes a medical device (Tosama 100% Cotton Menstrual Tampon) and its substantial equivalence to predicate devices, rather than an AI-powered diagnostic tool. Therefore, many of the requested categories for acceptance criteria and study design (such as Number of experts used to establish the ground truth, Adjudication method, MRMC comparative effectiveness study, Standalone performance, Type of ground truth, and Sample size for the training set and Ground truth for training set) are not applicable.
However, I can extract information related to the device's performance, the tests conducted, and the basis for its equivalence.
Here's the information derived from the provided text, adapted to the closest relevant categories:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" but lists various physical and functional specifications for the tampon, along with reported values for the Tosama 100% Cotton Menstrual Tampon and the predicate devices. The study objective was to demonstrate substantial equivalence, meaning the Tosama device performs within the same established ranges as the predicates.
| Feature / Acceptance Criteria (Implied) | Reported Device Performance (Tosama 100% Cotton Menstrual Tampon) | Predicate Performance (Naturalena / Cottons 100% Natural Cotton Tampon) |
|---|---|---|
| Indications for Use | Intended for insertion into the vagina for absorption of menstrual or other vaginal discharge. | Same |
| Design | Tampon with cylindrical shape and bullet-like tip. Applicator with smooth, rounded tip. | Same |
| Pledget Material | 100% Cotton | 100% Cotton |
| Withdrawal Cord Material | 100% Cotton | 100% Cotton |
| Applicator Material | Polyethylene | Polyethylene |
| Individual Wrapping Material | Polypropylene | Polypropylene (Naturalena), Cellophane (Cottons) |
| Additives & Finishing Agents | Hydrophobic coating on withdrawal cord. | Hydrophobic coating on withdrawal cord (Naturalena), None (Cottons) |
| Digital Regular Tampon | ||
| 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 Length | 130mm – 160mm | 130mm – 160mm |
| Syngina Absorbency | 6.0g - 9.0g | 6.0g - 9.0g |
| Digital Super Tampon | ||
| 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 Length | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency | 9.0g - 12.0g | 9.0g - 12.0g |
| Digital Super Plus Tampon | ||
| 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 Length | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency | 12.0g – 15.0g | 12.0g – 15.0g |
| Applicator Regular Tampon | ||
| Tampon Length | 43.0mm – 46.0mm | 43.0mm - 46.0mm |
| Applicator Length | 120mm ± 5% | 120mm ± 5% |
| Tampon Diameter | 11.0mm – 12.0mm | 11.0mm - 12.0mm |
| Applicator Diameter | 13mm | 13mm |
| 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 Length | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency | 6.0g - 9.0g | 6.0g - 9.0g |
| Applicator Super Tampon | ||
| Tampon Length | 43.0mm - 46.0mm | 43.0mm - 46.0mm |
| Applicator Length | 120mm ± 5% | 120mm ± 5% |
| Tampon Diameter | 12.0mm - 13.0mm | 12.0mm - 13.0mm |
| Applicator Diameter | 16mm | 16mm |
| Tampon Mass | 2.60g - 3.00g | 2.60g - 3.00g |
| Applicator Mass | 4.10g - 4.30g | 4.10g - 4.30g |
| Total Mass | 6.70g - 7.30g | 6.70g - 7.30g |
| Withdrawal Cord Length | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency | 9.0g - 12.0g | 9.0g - 12.0g |
| Applicator Super Plus Tampon | ||
| Tampon Length | 43.0mm - 46.0mm | 43.0mm - 46.0mm |
| Applicator Length | 120mm ± 5% | 120mm ± 5% |
| Tampon Diameter | 14.0mm - 15.0mm | 14.0mm - 15.0mm |
| Applicator Diameter | 18mm | 18mm |
| Tampon Mass | 3.00g - 3.50g | 3.00g - 3.50g |
| Applicator Mass | 4.20g - 4.40g | 4.20g - 4.40g |
| Total Mass | 7.20g - 7.90g | 7.20g - 7.90g |
| Withdrawal Cord Length | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency | 12.0g - 15.0g | 12.0g - 15.0g |
The "study that proves the device meets the acceptance criteria" is described as a non-clinical data summary. This non-clinical data was used for substantial equivalence determination to predicate devices already on the market.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test, but it is implied that representative samples of the Tosama 100% Cotton Menstrual Tampon and its components were tested.
- Data Provenance: The manufacturer is TOSAMA, d.o.o. from Slovenia, EU. The testing appears to have been conducted by or for the manufacturer. The data is likely prospective, as it relates to testing the specific device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a physical and chemical testing study for a medical device, not an AI-powered diagnostic tool requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical and chemical testing study, not based on human review/adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device. The device itself is a standalone medical product.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to established test methodologies and results for similar predicate devices, and the physical, chemical, and microbiological properties of the materials and finished product. Testing followed "recommended requirements."
- Chemical Analysis: Tests for pesticide, dioxin, heavy metal, phthalate, and PCB residues.
- Microbiological Testing: Enumeration per USP <61>/<62>, Toxic Shock Syndrome Toxin-1 production, vaginal microflora growth alteration, and S. aureus growth enhancement.
- Biocompatibility Testing: In vitro cytotoxicity, intracutaneous and vaginal irritation, sensitization, and acute systemic toxicity.
- Efficacy Testing: Syngina absorbency, fiber loss, withdrawal cord pull-out resistance, and tampon integrity.
- Physical Characteristics: Length, diameter, mass, withdrawal cord length, applicator dimensions.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set as it is not an AI device.
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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 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
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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)
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Section 5: 510(k) Summary
DATE OF PREPARATION: April 20th, 2015
| COMPANY/OWNER: | TOSAMA, d.o.o.Saranoviceva cesta 35, VirSI-1230 DomzaleSLOVENIA, EU |
|---|---|
| CONTACT: | Marjetka Kralj Kuncic, PhDHead 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.
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| Predicates | ||||
|---|---|---|---|---|
| Feature | Tosama 100%Cotton Tampon | Naturalena100% CottonTampon | Cottons 100%Natural CottonTampon | |
| 510(k) Number | K130609 | K080733 | ||
| Indications forUse | The device isintended for insertioninto the vagina for theabsorption ofmenstrual or othervaginal discharge. | The device isintended for insertioninto the vagina for theabsorption ofmenstrual or othervaginal discharge. | The device isintended for insertioninto the vagina for theabsorption ofmenstrual or othervaginal discharge. | |
| Design | Tampon withcylindrical shape andbullet-like tip.Applicator withsmooth, rounded tip. | Tampon withcylindrical shape andbullet-like tip.Applicator withsmooth, rounded tip. | Tampon withcylindrical shape andbullet-like tip.Applicator withsmooth, 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 | ApplicatorTampons | ApplicatorTampons | ApplicatorTampons | |
| 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
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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 <61>/<62>, 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.
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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).
§ 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).