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.

AI/ML Overview

The provided text describes the regulatory clearance of the "TOSAMA Reusable Applicator" (K232060) and includes some information about its testing. However, it does not contain a detailed study report that proves the device meets specific acceptance criteria in the format requested.

The text generally states that "The results of the non-clinical performance data were acceptable and met the established acceptance criteria." but does not provide the specific "acceptance criteria" themselves or the detailed "reported device performance" against those criteria in a table. It also lacks significant details regarding the study design, sample sizes for test sets, data provenance, ground truth establishment, or multi-reader studies as typically found in comprehensive medical device performance reports.

Based on the provided text, here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred/General)	Reported Device Performance (General Statement)
Non-cytotoxic	The subject device was non-cytotoxic.
Non-sensitizing	The subject device was a non-sensitizer.
Non-irritating (vaginal)	The subject device was non-irritating.
Met applicable design and performance requirements for device weight	Acceptable and met established acceptance criteria.
Met applicable design and performance requirements for physical dimensions	Acceptable and met established acceptance criteria.
Met applicable design and performance requirements for functional evaluation (e.g., ejection force, plunger pull force, pusher stability, hinge durability, lipstick cap compatibility)	Acceptable and met established acceptance criteria.
Met applicable design and performance requirements for use-life testing	Acceptable and met established acceptance criteria.
Met reprocessing, cleaning, and disinfecting requirements	Cleaning instructions developed per FDA guidance; validated processes for washing, boiling, and alcohol disinfection.

Missing specific acceptance values and corresponding performance results.

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 for Test Set: Not specified for any of the tests (biocompatibility, bench testing, reprocessing).
Data Provenance: Not specified. It's a regulatory submission from a Slovenian company (Tosama, d.o.o., Domžale, Slovenia). The testing would likely have been conducted by or for this company. Whether the data is retrospective or prospective is not mentioned.

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)

This type of study (e.g., biocompatibility and functional bench testing for a reusable tampon applicator) would not typically involve human experts establishing "ground truth" in the way an AI diagnostic device would. Instead, the ground truth is based on standardized biochemical assays (for biocompatibility) or engineering measurements against design specifications (for bench testing). Therefore, this question is not directly applicable in the context of this device's testing according to the provided information.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for the types of tests described (biocompatibility, bench testing). Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, not for objective laboratory or engineering tests.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use AI as an aid. The TOSAMA Reusable Applicator is a physical medical device (tampon applicator), not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is not an algorithm or AI. The testing described focuses on the physical and biological safety and performance of the applicator itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For Biocompatibility: The ground truth is based on established biological and toxicological standards and test methods (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation) and their defined pass/fail criteria.
For Bench Testing: The ground truth is established by engineering design specifications and performance requirements (e.g., specific force values for ejection, dimensional tolerances, durability cycles).
For Reprocessing: The ground truth is based on micro-biological testing (e.g., reduction of bioburden) and visual inspection to ensure cleanliness and disinfection efficacy, validated against pre-defined criteria.

8. The sample size for the training set

Not applicable. This device is not an AI model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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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

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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

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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)

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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

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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 ReusableApplicator	COHITECH ReusableTampon 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, thermoplasticelastomer	Polyethylene, polypropylene
Indications for use	The TOSAMA ReusableApplicator is intended to beused to insert a digital (noapplicator) menstrualtampon into the vagina.	COHITECH ReusableTampon Applicator isintended to be used to insert adigital menstrual tampon intothe vagina.
Usability	Reusable	Reusable
Use- Life	2 years	4 years
Tampon Compatibility	Digital tampons of varioussizes (regular, super, andsuper plus)	Digital tampons of varioussizes (regular, super, andsuper plus)
Device Design	Holder, pusher, and aLipstick cap for holder.Holder has hinged cap tofacilitate tampon loading	Outer tampon housing andinner 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:

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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.

Regulation Number and Section

§ 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).