(276 days)
Not Found
No
The device description and performance studies focus on mechanical function, material properties, and biocompatibility. There is no mention of AI or ML in the text.
No
The device is intended to assist in the insertion of a menstrual tampon into the vagina, which is a supportive function and not a direct therapeutic action to treat or prevent a disease or condition.
No
Explanation: The device is intended to assist in the insertion of a menstrual tampon into the vagina. It does not perform any diagnostic function such as detecting, monitoring, or diagnosing a medical condition.
No
The device description clearly outlines physical components made of thermoplastic elastomer and polystyrene, and the performance studies focus on biocompatibility and bench testing of these physical properties. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "insert a digital (no applicator) menstrual tampon into the vagina." This is a physical action for delivering a product (a tampon) into the body.
- Device Description: The description details a mechanical device for insertion. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Measurement of analytes
- Diagnostic claims or interpretation of results
- Use in a laboratory setting
The device is clearly described as a reusable medical device for the physical insertion of a tampon.
N/A
Intended Use / Indications for Use
The TOSAMA Reusable Applicator is intended to be used to insert a digital (no applicator) menstrual tampon into the vagina.
Product codes
HEB, HIL
Device Description
The TOSAMA Reusable Applicator is a non-sterile, single user, reusable medical device. It is intended to be sold in three different packaging configurations: Applicator with prepackaged tampons (regular, super and super plus absorbency versions) and Applicator with loose tampons of super and regular absorbency. The device is comprised of a tampon holder and pusher made of thermoplastic elastomer and a lipstick-style cap to protect the applicator, which is made of polystyrene. The tampon holder and pusher are connected at the hinged base of the holder, which opens to load a tampon and closes to allow the pusher to eject a tampon. The holder and pusher are designed to stay connected and not separate during use, storage, or cleaning. The TOSAMA Reusable Applicator requires the user to load the applicator with a legally marketed menstrual tampon. The use-life of the subject TOSAMA Reusable Applicator is 2 years. The device requires the user to clean (holder and pusher) and disinfect (lipstick cap) before initial use, before long term storage and at the end of the menstrual cycle, as well as to clean the device after each use. The applicator is available in one size for all sizes of tampon absorbencies (Light, Regular, Super and Super Plus) and accommodates a maximal tampon diameter of 15 mm. The holder inner diameter is 8.2 + 0.25/- 0.10 mm, pusher length is 83.7 ±0.5 mm and total length and diameter of the applicator (without the lipstick cap) is 70.8 ± 1.0 mm and 19.6 ±0.05 mm respectively.
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)
- Biocompatibility:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (Delayed Hypersensitivity) (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-23:2021)
- Results: The results showed that the subject device was non-cytotoxic, non-irritating, and a non-sensitizer.
- Bench Testing:
- Device weight
- Physical dimensions
- Functional evaluation, including:
- Ejection force of tampon
- Force required to pull plunger from applicator.
- Pusher Stability
- Hinge durability over use life
- Lipstick cap compatibility over use life
- Use-life testing
- Results: The results of the non-clinical performance data were acceptable and met the established acceptance criteria.
- Reprocessing, Cleaning, and Disinfecting:
- Cleaning instructions were developed per the recommendations in the 2015 FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- The TOSAMA Reusable Applicator (Holder and Pusher) should be washed with warm water and mild soap after every use and boiled and disinfected before the first use and at the end of each menstrual cycle.
- The applicator Lipstick Cap should be disinfected with alcohol (ethanol or isopropyl alcohol) after every menstrual cycle.
- The TOSAMA Reusable Applicator is not provided sterile and is not intended to be sterilized by users.
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2024
Tosama, d.o.o. Janez Obreza Regulatory Affairs Manager Vir. Saranoviceva cesta 35 Domžale, Slovenia 1230 SLOVENIA
Re: K232060
Trade/Device Name: TOSAMA Reusable Applicator Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB, HIL Dated: July 10, 2023 Received: March 12, 2024
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Reginald K. Avery -S
for Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232060
Device Name TOSAMA Reusable Applicator
Indications for Use (Describe)
The TOSAMA Reusable Applicator is intended to be used to insert a digital (no applicator) menstrual tampon into the vagina.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for TOSAMA. The logo consists of a blue medical cross symbol on the left, followed by the text "TOSAMA" in blue, sans-serif font. Below the text "TOSAMA" is the text "Since 1923" in a smaller, gray, sans-serif font.
510(k) Summary
K232060
1. Contact Details
Applicant Name: Tosama, d.o.o. Applicant Address: Vir, Šaranovičeva cesta 35, Domžale 1230, Slovenia Applicant Contact Telephone: 386-1-7290155 Applicant Contact: Janez Obreza Applicant Contact Email: janez.obreza@tosama.si Summary Preparation Date: April 12, 2024
2. Device Name
Device Trade Name: TOSAMA Reusable Applicator Common Name: Reusable Tampon Applicator Regulation Name: Unscented Menstrual Tampon Regulation Number: 21 CFR 884.5470 Product Code: HEB (Tampon, Menstrual, Unscented), HIL (Tampon, Menstrual, Scented, Deodorized) Regulatory Class: II
3. Legally Marketed Predicate Devices
Predicate 510(k) Number: K212479 Predicate Trade Name: COHITECH Reusable Tampon Applicator Company Name: Cotton High Tech S.L.
The predicate device has not been subject to a design-related recall.
4. Device Description
The TOSAMA Reusable Applicator is a non-sterile, single user, reusable medical device. It is intended to be sold in three different packaging configurations: Applicator with prepackaged tampons (regular, super and super plus absorbency versions) and Applicator with loose tampons of super and regular absorbency. The device is comprised of a tampon holder and pusher made of thermoplastic elastomer and a lipstick-style cap to protect the applicator, which is made of polystyrene. The tampon holder and pusher are connected at the hinged base of the holder, which opens to load a tampon and closes to allow the pusher to eject a tampon. The holder and pusher are designed to stay connected and not separate during use, storage, or cleaning. The TOSAMA Reusable Applicator requires the user to load the applicator with a legally marketed menstrual tampon. The use-life of the subject TOSAMA Reusable Applicator is 2 years. The device requires the user to clean (holder and pusher) and disinfect (lipstick cap) before initial use, before long term storage and at the end of the menstrual cycle, as well as to clean the device after each use. The applicator is available in one size for all sizes of tampon absorbencies (Light, Regular, Super and Super Plus) and accommodates a maximal tampon diameter of 15 mm. The holder inner diameter is 8.2 + 0.25/- 0.10 mm, pusher length is 83.7 ±0.5 mm and total length and
4
Image /page/4/Picture/0 description: The image shows the logo for TOSAMA. The logo consists of a blue medical cross symbol on the left, followed by the word "TOSAMA" in blue, sans-serif font. Below the word "TOSAMA" are the words "Since 1923" in a smaller, gray, sans-serif font.
diameter of the applicator (without the lipstick cap) is 70.8 ± 1.0 mm and 19.6 ±0.05 mm respectively.
5. Indications for Use
The TOSAMA Reusable Applicator is intended to be used to insert a digital (no applicator) menstrual tampon into the vagina.
| Description | Subject Device | Predicate Device |
|---|---|---|
| Device name | TOSAMA Reusable | |
| Applicator | COHITECH Reusable | |
| Tampon Applicator | ||
| Manufacturer/Applicant | Tosama, d.o.o | Cotton High Tech, S.L. |
| 510(K) Number | K232060 | K212479 |
| Product code | HEB, HIL | HEB, HIL |
| Regulation Number | 884.5470 | 884.5470 |
| Material Composition | Polystyrene, thermoplastic | |
| elastomer | Polyethylene, polypropylene | |
| Indications for use | The TOSAMA Reusable | |
| Applicator is intended to be | ||
| used to insert a digital (no | ||
| applicator) menstrual | ||
| tampon into the vagina. | COHITECH Reusable | |
| Tampon Applicator is | ||
| intended to be used to insert a | ||
| digital menstrual tampon into | ||
| the vagina. | ||
| Usability | Reusable | Reusable |
| Use- Life | 2 years | 4 years |
| Tampon Compatibility | Digital tampons of various | |
| sizes (regular, super, and | ||
| super plus) | Digital tampons of various | |
| sizes (regular, super, and | ||
| super plus) | ||
| Device Design | Holder, pusher, and a | |
| Lipstick cap for holder. | ||
| Holder has hinged cap to | ||
| facilitate tampon loading | Outer tampon housing and | |
| inner pusher and storage case |
6. Comparison of Technological Characteristics and Indications for Use
The subject and predicate device have the same intended use - to deliver digital menstrual tampons into the vagina. The subject device differs from the predicate device in technological characteristics. The subject device has a different device design, use-life, and material composition. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.
7. Summary Discussion of Non-Clinical Performance Testing
Biocompatibility:
The following biocompatibility studies were performed on the Subject device in accordance with the requirements of ISO 10993-1:2018 "Biological evaluation of medical devices – Part 1:
5
Image /page/5/Picture/0 description: The image shows the logo for TOSAMA. The logo consists of a blue medical cross symbol on the left, followed by the text "TOSAMA" in a larger blue font. Below the text "TOSAMA" is the text "Since 1923" in a smaller, gray font.
Evaluation and testing within a risk management process, ISO 14971:2019 Medical devices-Application of risk management to medical devices, and the 2023 FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
- Cytotoxicity (ISO 10993-5:2009) O
- O Sensitization (Delayed Hypersensitivity) (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-23:2021) O
The results showed that the subject device was non-cytotoxic, non-irritating, and a non-sensitizer.
Bench Testing:
The following performance characteristics were assessed to demonstrate that the proposed subject device met applicable design and performance requirements:
- Device weight ●
- Physical dimensions ●
- Functional evaluation, including: ●
- Ejection force of tampon о
- Force required to pull plunger from applicator. O
- Pusher Stability o
- Hinge durability over use life O
- Lipstick cap compatibility over use life O
- . Use-life testing
The results of the non-clinical performance data were acceptable and met the established acceptance criteria.
Reprocessing, Cleaning, and Disinfecting
The cleaning instructions were developed per the recommendations in the 2015 FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." The TOSAMA Reusable Applicator (Holder and Pusher) should be washed with warm water and mild soap after every use and boiled and disinfected before the first use and at the end of each menstrual cycle. The applicator Lipstick Cap should be disinfected with alcohol (ethanol or isopropyl alcohol) after every menstrual cycle.
The TOSAMA Reusable Applicator is not provided sterile and is not intended to be sterilized by users.
8. Conclusion:
The subject and predicate device have the same intended use and the technological differences do not raise different questions of safety or effectiveness. The results of the nonclinical testing described above demonstrate that TOSAMA Reusable Applicator is substantially equivalent to the predicate device.