(88 days)
Not Found
No
The device description and performance studies focus on mechanical function, biocompatibility, and cleaning, with no mention of AI or ML.
No
The device is intended to assist in the insertion of a tampon, not to treat or cure a disease or condition.
No
The device's stated intended use is to insert a tampon, which is a functional purpose, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions.
No
The device description clearly outlines a physical, reusable tampon applicator with various components (barrel, plunger, caps, storage compartment). The performance studies focus on physical characteristics, functional evaluation, biocompatibility, and cleaning instructions, all related to a hardware device. There is no mention of software in the description or testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Every Cycle™ Reusable Tampon Applicator is designed to physically insert a menstrual tampon into the vagina. It does not involve the collection, preparation, or examination of any bodily specimens for diagnostic purposes.
- Intended Use: The stated intended use is "to be used to insert a digital menstrual tampon into the vagina." This is a mechanical function, not a diagnostic one.
The information provided clearly describes a device for a physical process related to menstrual hygiene, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Every Cycle™ Reusable Tampon Applicator is intended to be used to insert a digital menstrual tampon into the vagina.
Product codes (comma separated list FDA assigned to the subject device)
HEB, HIL
Device 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.
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
Over-The-Counter Use
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)
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
- Ejection force
- 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""
- Cytotoxicity per ISO 10993-5: 2009/(R)2014
- Vaginal irritation per ISO 10993-10:2010
- Guinea pig maximization per ISO 10993-10:2010
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) Summary
| Sponsor: | Cycle, LLC
1927 Washington Avenue
Santa Monica, Ca 90403 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gabriela McCoole
Consultant
NJK & Associates, Inc.
13721 Via Tres Vista
San Diego, CA 92129 USA
Phone: (619) 322-7535
Fax: (858) 764-9739
Email: GMcCoole@njkconsulting.com |
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.
4
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.
5
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
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
(Scented or Scented Deodorized Menstrual
Tampon) | HEB (Unscented Menstrual Tampon) and HIL
(Scented or Scented Deodorized Menstrual
Tampon) | Same |
| Intended Use/
Indications for Use | The Every CycleTM Reusable Tampon applicator is
intended to be used to insert a digital menstrual
tampon into the vagina. | The re.t.aTM reusable tampon applicator is intended
to be used to insert a digital menstrual tampon into
the vagina. | Same, other than product
name |
| Design | Barrel with slit, plunger, large (outer) cap, storage
compartment, and small cap.
Applicator only, does not include tampon. | Sleeve with slit, pusher, and outer cover.
Applicator only, does not include tampon. | Different. Subject and
predicate device barrel and
sleeve design differs.
Predicate does not have a
storage compartment. This
difference is minor and
does not raise different
issues of safety or
effectiveness. |
| Reuse life | 2 years | 2 years | Identical. |
| Tampon Compatibility | Compatible with Super Plus, Super, Regular, and
Light absorbency digital tampons. Not for use with
Ultra absorbency digital tampons. | Compatible with most digital tampons. | Similar; the subject device
is not compatible with the
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.