(175 days)
The Tosama Biobased Applicator Tube Menstrual Tampon is intended for insertion into the absorption of menstrual or other vaginal discharge.
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.
This document is a 510(k) premarket notification for a medical device (a menstrual tampon) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of a novel AI/software-as-a-medical-device (SaMD) or diagnostic device that would typically involve acceptance criteria related to accuracy, sensitivity, and specificity, and the elements of an MRMC study.
Therefore, the requested information regarding AI/SaMD performance metrics (such as a table of acceptance criteria for device performance, ground truth establishment, expert adjudication, MRMC studies, training/test set details, etc.) is not applicable to this document.
However, the document does contain "acceptance criteria" in the context of non-clinical testing for the physical and biological properties of the tampon. I can extract that information.
Here's a breakdown of the information that is available in the provided text, adapted to the closest relevant sections of your request:
Study on Device Meeting Acceptance Criteria (Non-Clinical)
1. A table of acceptance criteria and the reported device performance:
The document states: "The results of these tests met pre-defined acceptance criteria as applicable and are acceptable." It does not provide the specific numerical acceptance criteria or the numerical results for each test. However, it lists the types of tests performed.
| Test Type | Acceptance Criteria (Stated) | Device Performance (Stated) |
|---|---|---|
| Biocompatibility (ISO 10993-5:2009: Tests for in vitro cytotoxicity) | Acceptable (pre-defined criteria) | Met pre-defined acceptance criteria |
| Biocompatibility (ISO 10993-10:2010: Tests for irritation and sensitization) | Acceptable (pre-defined criteria) | Met pre-defined acceptance criteria |
| Microbiological testing (total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms C. albicans, S. aureus, P. Aeruginosa) | Acceptable (pre-defined criteria) | Met pre-defined acceptance criteria |
| Syngina absorbency (according to 21 CFR 801.430(f)(2)) | Acceptable (pre-defined criteria) | Met pre-defined acceptance criteria |
| Dimensional analysis and mass | Acceptable (pre-defined criteria) | Met pre-defined acceptance criteria |
| Withdrawal cord pull-out strength | Acceptable (pre-defined criteria) | Met pre-defined acceptance criteria |
| Fiber loss | Acceptable (pre-defined criteria) | Met pre-defined acceptance criteria |
| Tampon integrity | Acceptable (pre-defined criteria) | Met pre-defined acceptance criteria |
| Chemical residues (re-use of predicate data) | Acceptable (re-use of predicate data) | Deemed applicable from predicate data |
| Production of toxic shock syndrome toxin (re-use of predicate data) | Acceptable (re-use of predicate data) | Deemed applicable from predicate data |
| Vaginal microflora (re-use of predicate data) | Acceptable (re-use of predicate data) | Deemed applicable from predicate data |
| Staphylococcus aureus growth enhancement (re-use of predicate data) | Acceptable (re-use of predicate data) | Deemed applicable from predicate data |
Note: The specific numerical "pre-defined acceptance criteria" for each test (e.g., minimum pull-out strength, maximum microbial counts) are not provided in this document.
2. Sample sized 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. The testing was conducted on "All materials used in the construction of Tosama Biobased Applicator Tube Menstrual Tampons as well as complete devices" and "each absorbency level of the complete finished device." This implies a sufficient number of samples were tested to demonstrate compliance, but the exact number isn't quantified.
- Data Provenance: Not explicitly stated, but given the company (Tosama, d.o.o.) is based in Slovenia, EU, it's highly probable the testing was conducted in Europe. The data refers to non-clinical lab testing. These would be prospective experimental tests conducted for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as this is a physical/biological product validation, not a diagnostic device involving expert human interpretation for "ground truth." The ground truth for these tests is established by quantifiable physical, chemical, and biological measurements following established standards (e.g., ISO, FDA guidance).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for non-clinical lab testing. The results are based on objective measurements against pre-defined standards.
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/SaMD device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/SaMD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is established by objective laboratory measurements against recognized international standards and FDA guidance. Examples include:
- Quantifiable values from biocompatibility assays (e.g., cell viability).
- Microbial counts from culture methods.
- Measured absorbency in grams.
- Physical dimensions in millimeters/grams.
- Measured force for withdrawal cord pull-out strength.
8. The sample size for the training set
- Not applicable. This is not an AI/SaMD device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/SaMD device requiring a training set.
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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.
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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 (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
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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.Saranoviceva cesta 35, VirSI-1230 DomzaleSLOVENIA, EU |
| CONTACT: | Janez ObrezaHead of Regulatory Affairs |
| TELEPHONE: | 00386 1 7290370 |
| FAX: | 00386 1 7291244 |
| EMAIL: | janez.obreza@tosama.si |
| DEVICE TRADE NAME: | Tosama Biobased Applicator Tube MenstrualTampon |
| 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 adesign-related recall. |
| DEVICE DESCRIPTION: | The device will be offered as a traditional unscentedmenstrual tampon consisting of an absorbentpledget, a withdrawal cord, and an applicatorcomprised of biobased plastic. The pledget is of thetraditional cylindrical, bullet-like shape and theapplicator has a standard rounded tip to easeinsertion.Each tampon is individually wrapped and packagedin multi-unit containers for retail sale. It will be offeredin three absorbencies: Regular, Super, and SuperPlus. |
| INDICATION FOR USE: | The Tosama Biobased Applicator Tube MenstrualTampon is intended for insertion into the vagina forthe absorption of menstrual or other vaginaldischarge. |
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 | TosamaBiobasedApplicator TubeMenstrualTampon | PREDICATE:Tosama 100%Organic CottonTampon |
|---|---|---|
| 510(k) Number | K172504 | K151170 |
| Indication for Use | The Tosama BiobasedApplicator Tube MenstrualTampon is intended forinsertion into the vaginafor the absorption ofmenstrual or other vaginaldischarge. | The Tosama 100%Organic MenstrualTampon is intended forinsertion into the vaginafor the absorption ofmenstrual or other vaginaldischarge. |
| Design | Tampon withcylindrical shape andbullet-like tip.Applicator withsmooth, rounded tip. | Tampon withcylindrical shape andbullet-like tip.Applicator withsmooth, rounded tip. |
| Dimensions &Weights | ApplicatorTampons | ApplicatorTampons |
| 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 &FinishingAgents | Hydrophobicwithdrawal cord | Hydrophobicwithdrawal 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).
§ 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).