Every Cycle Reusable Tampon Applicator

K211519 · Cycle, LLC · HEB · Aug 13, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K211519
• Device Name: Every Cycle Reusable Tampon Applicator
• Applicant: Cycle, LLC
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Aug 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

Every Cycle™ Reusable Tampon Applicator is intended to be used to insert a digital menstrual tampon into the vagina.

Device Story

Reusable, non-sterile manual applicator for digital menstrual tampons; intended for over-the-counter use by individuals. Device consists of barrel with slit, plunger, large outer cap, storage compartment, and small cap. User manually loads digital tampon into applicator, inserts into vagina, and uses plunger to deploy tampon. Device is reusable for up to two years; requires cleaning with unscented soap after each use and sanitization in boiling water after each cycle. Provides a mechanical aid for tampon insertion; does not include tampon. Benefits include reusable alternative to single-use applicators.

Clinical Evidence

Bench testing only. Testing included use-life, device weight, dimensions, and functional evaluations (tampon compatibility, ejection force, uncapping force). Biocompatibility testing performed per ISO 10993-1, including cytotoxicity (ISO 10993-5), vaginal irritation (ISO 10993-10), and guinea pig maximization (ISO 10993-10).

Technological Characteristics

Manual, non-sterile, reusable applicator. Components: barrel, plunger, caps, storage compartment. Materials evaluated for biocompatibility per ISO 10993-1. Cleaning/sanitization per FDA reprocessing guidance. Two-year use-life. No electronic components 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

• re.t.a™ Reusable Tampon Applicator (K180850)

Submission Summary (Full Text)

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August 13, 2021

Cycle, LLC % Gabriela McCoole Quality and Regulatory Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129

Re: K211519

> Trade/Device Name: Every Cycle™ Reusable Tampon Applicator Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB, HIL Dated: May 13, 2021 Received: May 17, 2021

Dear Gabriela McCoole:

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.

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 and Part 809); 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Monica D. Garcia, 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

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## Indications for Use

510(k) Number (if known)

#### K211519

Device Name Every Cycle™ Reusable Tampon Applicator

Indications for Use (Describe)

Every Cycle™ Reusable Tampon Applicator is intended to be used to insert a digital menstrual tampon into the vagina.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

| Sponsor: | Cycle, LLC<br>1927 Washington Avenue<br>Santa Monica, Ca 90403 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gabriela McCoole<br>Consultant<br>NJK & Associates, Inc.<br>13721 Via Tres Vista<br>San Diego, CA 92129 USA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

Date Prepared: August 11, 2021

#### DEVICE INFORMATION:

| Proprietary Name: | Every Cycle™ Reusable Tampon Applicator |
|--------------------|------------------------------------------------------|
| Regulation Number: | 21 CFR 884.5470 |
| Regulation Name: | Unscented menstrual tampon |
| Regulatory Class: | II |
| Product Codes: | HEB (tampon, menstrual, unscented) |
| | HIL (scented or scented deodorized menstrual tampon) |

### PRODUCT DESCRIPTION:

The Every Cycle™ 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 load the applicator with a legally-marketed digital/non-applicator menstrual tampon. The use-life of the subject device is two years.

The applicator is comprised of a barrel with a slit, plunger, large (outer) cap, storage compartment, and a small cap.

### INDICATIONS FOR USE:

Every Cycle™ Reusable Tampon Applicator is intended to insert a digital menstrual tampon into the vagina.

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## PREDICATE DEVICE:

The selected predicate device, the re.t.a™ Reusable Tampon Applicator was cleared on August 20, 2018. Thinx Inc, is the owner of the predicate 510(k), K180850.

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

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# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

Table 1 is a detailed comparison of the Every Cycle ™ Reusable Tampon Applicator with its predicate device.

| Characteristic | Subject Device | Predicate Device (K180850) | Comparison<br>Evaluation |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Every CycleTM Reusable Tampon Applicator | re.t.aTM Reusable Tampon Applicator | N/A |
| Manufacturer | Cycle LLC | Thinx Inc | N/A |
| Product Code | HEB (Unscented Menstrual Tampon) and HIL<br>(Scented or Scented Deodorized Menstrual<br>Tampon) | HEB (Unscented Menstrual Tampon) and HIL<br>(Scented or Scented Deodorized Menstrual<br>Tampon) | Same |
| Intended Use/<br>Indications for Use | The Every CycleTM Reusable Tampon applicator is<br>intended to be used to insert a digital menstrual<br>tampon into the vagina. | The re.t.aTM reusable tampon applicator is intended<br>to be used to insert a digital menstrual tampon into<br>the vagina. | Same, other than product<br>name |
| Design | Barrel with slit, plunger, large (outer) cap, storage<br>compartment, and small cap.<br>Applicator only, does not include tampon. | Sleeve with slit, pusher, and outer cover.<br>Applicator only, does not include tampon. | Different. Subject and<br>predicate device barrel and<br>sleeve design differs.<br>Predicate does not have a<br>storage compartment. This<br>difference is minor and<br>does not raise different<br>issues of safety or<br>effectiveness. |
| Reuse life | 2 years | 2 years | Identical. |
| Tampon Compatibility | Compatible with Super Plus, Super, Regular, and<br>Light absorbency digital tampons. Not for use with<br>Ultra absorbency digital tampons. | Compatible with most digital tampons. | Similar; the subject device<br>is not compatible with the<br>largest size. |
| Usability | Reusable | Reusable | Identical |

| | | | Table 1 Comparison of the Every Cycle ™ Reusable Tampon Applicator and its predicate | | | | |
|--|--|--|--------------------------------------------------------------------------------------|--|--|--|--|
| | | | | | | | |

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## K211519 Page 4 of 4

#### PERFORMANCE DATA

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

- Use-life testing
- Device weight ●
- Dimensions
- Functional evaluation, including: ●
- Tampon compatibility о
- Ejection force о
- o Uncapping force
- Biocompatibility per the 2020 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""
- o Cytotoxicity per ISO 10993-5: 2009/(R)2014
- o Vaginal irritation per ISO 10993-10:2010
- o Guinea pig maximization per ISO 10993-10:2010

### STERILIZATION & SHELF LIFE TESTING

The cleaning instructions provided for the Every Cycle™ Reusable Tampon Applicator were developed per the recommendations in the 2015 FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." The Every Cycle™ Reusable Tampon Applicator should be washed with unscented soap after every use and sanitized in boiling water after every cycle.

The Every Cycle™ Reusable Tampon Applicator is not provided sterile and is not intended to be sterilized by users. The Every Cycle™ Reusable Tampon Applicator was tested in its expected shipping conditions and verified that the device and its packaging can tolerate the expected shipping stress.

### CONCLUSION

The subject and predicate devices have the same intended use and the technological differences do not raise different questions of safety or effectiveness. The performance data provided demonstrate the subject device is substantially equivalent to the predicate device.