The re.t.a.™ Reusable Tampon Applicator is a non-sterile, single user reusable device. It is intended to be sold on its own, without a pre-loaded tampon. The applicator requires the user to insert a legally-marketed digital/non-applicator menstrual tampon into the applicator at the time of use. The use-life of the subject applicator is two years.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the re.t.a.™ Reusable Tampon Applicator.

It's important to note that the provided 510(k) summary is for a physical medical device (a tampon applicator), not an AI/software medical device. Therefore, many of the typical questions for AI/software (like human reader improvement, standalone algorithm performance, number of experts, adjudication methods, training set details) are not applicable to this submission. The acceptance criteria and testing focus on mechanical, functional, and biological safety aspects of the device.

Acceptance Criteria and Device Performance Study for re.t.a.™ Reusable Tampon Applicator

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Functional Evaluation	Weight	Assessed (Specific values not provided in summary, but implied to meet requirements for proper function).
	Physical dimensions	Assessed (Specific values not provided, but implied to meet requirements for proper function and compatibility).
	Outer cover uncap-force (Ease of removing the outer cover)	Assessed (Specific force not provided, but implied to meet usability requirements).
	Tampon compatibility testing (Ability to be used with various digital tampons)	Assessed (Implied to be compatible with "Digital tampons of various sizes").
	Ejection force (Ease of pushing the tampon out)	Assessed (Specific force not provided, but implied to meet usability requirements).
Durability/Use-life	Use-life testing (Ability to function for the stated lifespan of 2 years)	Assessed (Device is stated to have a "2 years" use-life, and testing implicitly confirms this).
Biocompatibility	Cytotoxicity (Assessment of potential cell damage)	Assessed (Indicates no unacceptable cytotoxicity).
	Vaginal irritation (Assessment of potential irritation to vaginal tissue)	Assessed (Indicates no unacceptable vaginal irritation).
	Sensitization (Assessment of potential allergic reactions)	Assessed (Indicates no unacceptable sensitization).
Hygiene/Maintenance	Cleaning Validation (Effectiveness of cleaning procedures for reuse)	Assessed (Implied that cleaning procedures are validated to be effective, supporting its "Reusable" classification).
Substantial Equivalence	Comparison to Predicate Device (K091749) regarding safety and effectiveness	The device was found to be "substantially equivalent" to the predicate, meaning its differences "do not raise different questions of safety or effectiveness." This overarching criterion implies all individual performance tests support this conclusion.
Intended Use	The re.t.a.™ reusable tampon applicator is intended to be used to insert a digital menstrual tampon into the vagina.	The device's design and functional tests demonstrate it fulfills this intended use. It is an accessory to a Class II tampon device, aligning its intended use with the general function of a tampon applicator.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify the sample sizes used for any of the performance tests (functional, use-life, biocompatibility, cleaning validation). It also does not provide details on the data provenance in terms of country of origin or whether the studies were retrospective or prospective, as these are typically not relevant for the type of bench and lab testing described for this physical device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This summary is for a physical device, not an AI/software device that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for this device would be established by objective measurements against engineering specifications, biological safety standards, and validated test methods.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in image analysis or diagnostic studies where there's variability in human interpretation. For a physical device undergoing functional, mechanical, and biocompatibility testing, these methods are not used. Results are usually determined by passing or failing predefined metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is relevant for diagnostic devices (especially AI/imaging) to assess the impact of a device on human reader performance. This device is a physical, reusable tampon applicator, so an MRMC study is not appropriate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This concept applies to AI algorithms. The re.t.a.™ is a physical medical device; thus, no "standalone algorithm performance" assessment was performed or is relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance studies would be based on:

Engineering Specifications: Pre-defined physical dimensions, force tolerances (e.g., for uncap-force, ejection force), weight limits.
Performance Standards: Industry or internal standards for functional reliability over time (use-life).
Biocompatibility Standards: Established ISO standards (e.g., ISO 10993 series) for cytotoxicity, irritation, and sensitization, determined through laboratory tests.
Microbiological Standards: Standards for cleaning effectiveness (e.g., reduction of microbial load).
Reference Tampon Specifications: Compatibility with legally marketed digital menstrual tampons, requiring measurement against their standardized dimensions and features.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical device, not an AI/machine learning model. Therefore, there is no "training set" in the computational sense. The device's design and manufacturing processes are refined through engineering, testing, and validation, not through machine learning training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI model, there is no ground truth established for a training set.

Summary

{0}------------------------------------------------

510(k) Summary

Submitter:	THINX INC601 W 26th St, Suite 515New York, NY 10001
Contact Person:	John Gillespie (Consultant) Clover Medical LLC79 Haven St.Dover, MA 02030Phone: 1-774-567-0277Email: jgillespie@clovermedical.com

Date of Preparation: August 17, 2018

Device Trade Name: re.t.a™ Reusable Tampon Applicator

Common Name: Reusable Tampon Applicator

Classification: Class: Il Panel: Obstetrics/Gynecology Requlation: 884.5470, Unscented Menstrual Tampon Product Code: HEB (Unscented Menstrual Tampon) and HIL (Scented-Deodorized Menstrual Tampon)

Predicate Device: K091749, U by Kotex® Click® Unscented Menstrual Tampons

The predicate device has not been subject to a design-related recall.

Device Description:

Indications for Use Statement:

The re.t.a.™ reusable tampon applicator in intended to be used to insert a digital menstrual tampon into the vagina.

{1}------------------------------------------------

Comparison of Technological Characteristics and Indication for Use:

The following table compares the indications for use statement of the subject and predicate device.

Device & Predicate Device(s):	K180850	K091749
Indication for Use	The re.t.a.TM reusabletampon applicator inintended to be used toinsert a digitalmenstrual tampon intothe vagina	Kimberly-clark U by Kotexis an unscented menstrualtampon inserted into thevagina to absorbmenstrual fluid
Usability	Reusable	Single use
Use-life	2 years	N/A
Tampon compatibility	Digital tampons ofvarious sizes	Kotex Click (applicatorspecific tampon)
Device Design	Sleeve with slit,pusher, and outercover	Sleeve with compressedtampon, pusher and outercover

The Indications for Use statement for the subject device is different from the predicate device. However, they have the same intended use because the subject applicator is an accessory to a class II tampon device.

The subject device differs from the predicate device in technological characteristics. The predicate device is a tampon with applicator whereas the subject device is used for the placement of digital tampons. The subject device is similar in its operating principle (applicator portion of the predicate device). On the other hand, there are several design, usability, and tampon compatibility differences between the subject device and predicate device.

These differences do not raise different questions of safety or effectiveness.

{2}------------------------------------------------

Performance Data

The following tests demonstrate that the proposed subject devices met the applicable design and performance requirements:

Functional evaluation, including assessment of:
- o Weight
- o Physical dimensions
- o Outer cover uncap-force
- o Tampon compatibility testing
- o Ejection force
Use-life testing
Biocompatibility including cytotoxicity, vaginal irritation, and sensitization ● testing
o Cleaning Validation

Conclusion

The subject device is substantially equivalent to the predicate device.

{3}------------------------------------------------

Please wait...

If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.

You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.

For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.

Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.

{4}------------------------------------------------

August 20, 2018

THINX, Inc. % John Gillespie Consultant Clover Medical, LLC 79 Haven St. Dover, MA 02030

Re: K180850

Trade/Device Name: re.t.a™ Reuseable Tampon Applicator Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB, HIL Dated: July 17, 2018 Received: July 18, 2018

Dear John Gillespie:

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. 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 located 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.

{5}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

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

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).