re.t.a Reuseable Tampon Applicator

K180850 · Thinx, Inc. · HEB · Aug 20, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K180850
• Device Name: re.t.a Reuseable Tampon Applicator
• Applicant: Thinx, Inc.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Aug 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

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

Device Story

re.t.a™ is a non-sterile, reusable applicator for digital menstrual tampons; intended for single-user, multi-use over a two-year lifespan. User manually loads a legally-marketed digital tampon into the device sleeve; device functions as a mechanical delivery tool to facilitate vaginal insertion. Operates similarly to the applicator component of standard disposable tampon products. Used by the patient in a home setting. Benefits include reduced waste compared to single-use applicators and assistance for users preferring digital tampons but requiring an insertion aid.

Clinical Evidence

Bench testing only. Performance evaluation included weight, physical dimensions, outer cover uncap-force, tampon compatibility, ejection force, and use-life testing. Biocompatibility testing included cytotoxicity, vaginal irritation, and sensitization. Cleaning validation was performed to support the reusable nature of the device.

Technological Characteristics

Non-sterile, reusable sleeve with slit, pusher, and outer cover. Designed for two-year use-life. Compatible with various digital tampon sizes. Mechanical operation; no energy source or software.

Indications for Use

Indicated for use by individuals requiring assistance with the insertion of digital menstrual tampons into the vagina.

Regulatory Classification

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.

Predicate Devices

• U by Kotex® Click® Unscented Menstrual Tampons (K091749)

Submission Summary (Full Text)

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# 510(k) Summary

| Submitter: | THINX INC<br>601 W 26th St, Suite 515<br>New York, NY 10001 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Gillespie (Consultant) Clover Medical LLC<br>79 Haven St.<br>Dover, MA 02030<br>Phone: [phone]<br>Email: [e-mail] |

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:

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.

#### 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.

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### 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 reusable<br>tampon applicator in<br>intended to be used to<br>insert a digital<br>menstrual tampon into<br>the vagina | Kimberly-clark U by Kotex<br>is an unscented menstrual<br>tampon inserted into the<br>vagina to absorb<br>menstrual fluid |
| Usability | Reusable | Single use |
| Use-life | 2 years | N/A |
| Tampon compatibility | Digital tampons of<br>various sizes | Kotex Click (applicator<br>specific tampon) |
| Device Design | Sleeve with slit,<br>pusher, and outer<br>cover | Sleeve with compressed<br>tampon, pusher and outer<br>cover |

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.

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#### 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.

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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.

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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 ([e-mail]) or phone [phone] 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