(266 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a menstrual cup and applicator, with no mention of software, data processing, or AI/ML algorithms.
No
The device is designed to collect menstrual fluid, which is a collection function, not a therapeutic one that treats or prevents a condition.
No
The device description clearly states its purpose is to collect menstrual fluid. It does not mention any function for diagnosing conditions or diseases.
No
The device description clearly outlines physical components made of silicone, nylon, and thermoplastic polyurethane, and the performance studies focus on mechanical properties, biocompatibility, and reprocessing validation of these physical components. There is no mention of any software component.
Based on the provided information, the Sunny Cup and Applicator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "collect blood and cellular debris that is exuded from the uterus via the cervix during menstruation." This describes a collection device for bodily fluids, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics and function of a menstrual cup and applicator for collection and insertion. There is no mention of any components or processes related to analyzing or testing the collected fluid.
- Lack of Diagnostic Function: The device's purpose is solely to contain menstrual fluid within the body. It does not perform any analysis, measurement, or testing of the collected fluid to provide diagnostic information about a patient's health or condition.
- Performance Studies: The performance studies described focus on the physical properties of the device (strength, volume, folding), biocompatibility, and reprocessing. There are no studies related to the accuracy or reliability of any diagnostic measurements.
In summary, the Sunny Cup and Applicator is a medical device for collecting menstrual fluid in vivo (within the body). It does not perform any diagnostic tests on the collected fluid, which is the defining characteristic of an IVD.
N/A
''
Intended Use / Indications for Use
The Sunny Cup and Applicator is a receptacle placed in the vagina to collect blood and cellular debris that is exuded from the uterus via the cervix during menstruation.
Product codes
HHE
Device Description
The Sunny Cup and Applicator is an over the counter (OTC) medical device consisting of a reusable silicone menstrual cup with a lubricious coating and a reusable applicator with a nylon body and a thermoplastic polyurethane (TPU) tip with a lubricious coating. The Sunny Cup is a soft receptacle designed for placement within the vaginal canal to hold up to 25 mL of menstrual fluid and can remain within the body for up to 12 hours. The Sunny Cup is also designed with grip lines and a stem on the distal end to allow for easy location and manipulation of the Sunny Cup during removal.
The Applicator component enables the insertion process for the user and consists of a barrel, a pusher, and a pusher base, functioning similarly to a tampon applicator. For the insertion process, the Sunny Cup is folded and placed in the Applicator barrel. The pusher component is then used to deploy the Cup through the Applicator. The Sunny Cup then unfolds upon deployment to create a seal in the vaginal canal and collect menstrual fluid. After 12 hours, the Sunny Cup is removed manually by squeezing the grip lines to break the seal and pulling the Cup out by the grip lines along the base of the Cup. The Cup component should be cleaned via boiling at the start of each menstrual cycle, and the Cup and Applicator components should be cleaned with warm water and mild, fragrance-free soap between uses. The Sunny Cup and Applicator may be reused by a single patient for up to a vear or until discoloration or damage is evident.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, uterus, cervix
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
Bench performance testing verified that the Sunny Cup and Applicator met the prespecified requirements to demonstrate the Cup and Applicator can withstand anticipated applied forces during cup deployment, and that the Cup met the 25 mL volume capacity and folding requirements throughout its use-life.
Biocompatibility studies were performed in accordance with the FDA guidance document "Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO 10993-1. 'Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" issued September 2023 as follows:
- Cytotoxicity test per ISO 10993-5:2009 (cup and applicator)
- Sensitization test per ISO 10993-10:2021 (cup and applicator)
- Vaginal irritation test per ISO 10993-23:2021 (cup only)
- Intracutaneous (intradermal) reactivity test per ISO 10993-23:2021 (applicator only)
- Acute systemic toxicity test per ISO 10993-11:2017 (cup only)
All tests were performed on the cup and applicator separately. The results demonstrated that the subject device is non-cytotoxic, nonirritating, non-sensitizing, and non-systemically toxic.
Reprocessing validation testing demonstrated acceptability of the Cup and Applicator cleaning procedures as included in the Instructions for Use and validated the ability of the Cup and Applicator to withstand repeated reprocessing.
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
''
§ 884.5400 Menstrual cup.
(a)
Identification. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 21, 2024
Menstrual Mates Cindy Belardo CEO 16192 Coastal Highway Lewes, Delaware 19958
Re: K233361
Trade/Device Name: Sunny Cup and Applicator Regulation Number: 21 CFR 884.5400 Regulation Name: Menstrual Cup Regulatory Class: II Product Code: HHE Dated: May 14, 2024 Received: May 16, 2024
Dear Cindy Belardo:
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 (QS) 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 medical devices and radiation-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
2
Indications for Use
510(k) Number (if known) K233361
Device Name Sunny Cup and Applicator
Indications for Use (Describe)
The Sunny Cup and Applicator is a receptacle placed in the vagina to collular debris that is extruded from the uterus via the cervix during menstruation.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 92.
| 1. Submitter Information | |
|---|---|
| Manufacturer: | Menstrual Mates Inc. |
| 16192 Coastal Highway | |
| Lewes, DE 19958 | |
| Contact: | Cindy Belardo |
| Telephone: +1-405-679-7593 | |
| E-mail: cindy@sunnyperiod.com | |
| Regulatory Consultant: | Mehdi Kazemzadeh-Narbat, PhD, PMP |
| Director, Regulatory Affairs | |
| MCRA, LLC | |
| 803 7th Street NW, Floor 3 | |
| Washington, DC 20001 | |
| Phone:202-552-6011 | |
| Email: mkazemzadeh@mcra.com | |
| Date Prepared: | 11 June 2024 |
| Device Trade Name: | Sunny Cup and Applicator |
| 2. Device Information | |
| Common Name: | Menstrual Cup |
| Classification Name: | Menstrual Cup |
| Classification Number: | 21 CFR 884.5400 |
| Device Class: | II |
| Product Code: | HHE (Cup, Menstrual) |
4
3. Predicate Device Information
Predicate:
SckoonCup (K120107)
The predicate device has not been subject to any design-related recall.
4. Device Description
The Sunny Cup and Applicator is an over the counter (OTC) medical device consisting of a reusable silicone menstrual cup with a lubricious coating and a reusable applicator with a nylon body and a thermoplastic polyurethane (TPU) tip with a lubricious coating. The Sunny Cup is a soft receptacle designed for placement within the vaginal canal to hold up to 25 mL of menstrual fluid and can remain within the body for up to 12 hours. The Sunny Cup is also designed with grip lines and a stem on the distal end to allow for easy location and manipulation of the Sunny Cup during removal.
The Applicator component enables the insertion process for the user and consists of a barrel, a pusher, and a pusher base, functioning similarly to a tampon applicator. For the insertion process, the Sunny Cup is folded and placed in the Applicator barrel. The pusher component is then used to deploy the Cup through the Applicator. The Sunny Cup then unfolds upon deployment to create a seal in the vaginal canal and collect menstrual fluid. After 12 hours, the Sunny Cup is removed manually by squeezing the grip lines to break the seal and pulling the Cup out by the grip lines along the base of the Cup. The Cup component should be cleaned via boiling at the start of each menstrual cycle, and the Cup and Applicator components should be cleaned with warm water and mild, fragrance-free soap between uses. The Sunny Cup and Applicator may be reused by a single patient for up to a vear or until discoloration or damage is evident.
5. Indications for Use
The Sunny Cup and Applicator is a receptacle placed in the vagina to collect blood and cellular debris that is exuded from the uterus via the cervix during menstruation.
6. Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of the Sunny Cup and Applicator are substantially equivalent to the technological characteristics of the predicate device. Both the Sunny Cup and the predicate device are similarly shaped menstrual cups that have the same overall cup length. Additionally, both cups are composed of a soft silicone elastomer material and are supplied non-sterile. Apart from cup insertion, the subject device and the predicate device also have identical principles of operation, including duration of use (i.e., up to 12 hours), reusability, cleaning / reprocessing requirements, and method of cup removal. During insertion, however, the Sunny Cup is manually folded and placed in the Applicator, a component unique to the Sunny device, which is then inserted into the vagina where the Cup is deployed. The predicate device is similarly manually folded but then inserted into the vagina without an applicator. The Sunny Cup and Applicator also have different patientcontacting materials than the predicate device, including a
5
lubricious coating on the Sunny Cup and Applicator to aid in the insertion process and the nylon and TPU materials of the Applicator. Further, the Sunny Cup diameter and stem length dimensions and volume capacity differ slightly from the predicate device. Comparatively, the Sunny Cup has a slightly larger diameter than Size 2 of the predicate device, and the Sunny Cup volume falls within the volumes listed for Size 1 and Size 2 of the predicate device. These differences in the technological characteristics between the Sunny Cup and Applicator and the predicate device do not raise different questions of safety and effectiveness.
The following table compares the subject device to the predicate device with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
| Characteristics | Subject Device | Predicate Device | Significant
Differences |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Device Name | Sunny Cup and
Applicator | SCKOONCUP (K120107) | N/A |
| Regulation Name | Menstrual Cup | Menstrual Cup | Same |
| Manufacturer | Menstrual Mates Inc. | Sckoon Inc. | N/A |
| Product Code | HHE | HHE | Same |
| Regulation Number | 21 CFR 884.5400 | 21 CFR 884.5400 | Same |
| Classification | Class II | Class II | Same |
| Indications for Use | The Sunny Cup and
Applicator is a
receptacle placed in the
vagina to collect blood
and cellular debris that
is exuded from the
uterus via the cervix
during menstruation. | SckoonCup is a
receptacle placed
in the vagina to
collect blood and
cellular debris
that is extruded
from the uterus via
the cervix during
menstruation. | Same |
| Overall design | Menstrual cup manually
folded into reusable
applicator which is then
used to insert into the
vagina | Menstrual cup manually
inserted into vagina | Different;
reusable
applicator
for the
subject
device only |
| Unscented/Scented | Unscented | Unscented | Same |
6
| Dimensions of
menstrual cup | 70.75 mm (total length
from rim to stem of
menstrual cup size 1) x
48.85 mm (total diameter
of menstrual cup cup size
-
| 70 mm (total length from
rim to stem of menstrual
cup)x 40 mm and 45 mm
(total diameter of
menstrual cup) | Different | | |
|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------|--|--|
| Materials of cup | Silicone elastomer with
lubricous coating | Silicone elastomer | Different | | |
| Volume of Fluid | Menstrual cup holds 25
mL | Menstrual cup holds 23
mL | Different | | |
| Applicator
dimensions | Barrel Max Diameter:
26.97 mm
Barrel Length: 73.75 mm
Barrel Base Diameter:
27.7 mm
Pusher Max Diameter:
22.72 mm
Pusher Length: 75 mm
Pusher Base Diameter:
30.39 mm | N/A | Different | | |
| Applicator Materials | Nylon, thermoplastic
polyurethane with
lubricious coating, and
polypropylene | N/A | Different | | |
| Duration of use (per
use) | 12 hours | 12 hours | Same | | |
| Sterile | No | No | Same | | |
| Single-Use | No | No | Same | | |
| The subject device has the same indications for use as the predicate device as well as | | | | | |
similar technological characteristics. The differences include the use of an applicator, material composition and dimensions; however, the differences do not raise different questions of safety and effectiveness.
7. Performance Testing - Bench
Bench performance testing verified that the Sunny Cup and Applicator met the prespecified requirements to demonstrate the Cup and Applicator can withstand anticipated applied forces during cup deployment, and that the Cup met the 25 mL volume capacity
7
and folding requirements throughout its use-life.
8. Biocompatibility Testing
Biocompatibility studies were performed in accordance with the FDA guidance document "Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO 10993-1. 'Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" issued September 2023 as follows:
- Cytotoxicity test per ISO 10993-5:2009 (cup and applicator) ●
- Sensitization test per ISO 10993-10:2021 (cup and applicator) ●
- Vaginal irritation test per ISO 10993-23:2021 (cup only) ●
- Intracutaneous (intradermal) reactivity test per ISO 10993-23:2021 (applicator only) ●
- Acute systemic toxicity test per ISO 10993-11:2017 (cup only) ●
All tests were performed on the cup and applicator separately. The results demonstrated that the subject device is non-cytotoxic, nonirritating, non-sensitizing, and non-systemically toxic.
9. Reprocessing and Cleaning Validation:
The Sunny Cup and Applicator is not provided sterile. Reprocessing validation testing demonstrated acceptability of the Cup and Applicator cleaning procedures as included in the Instructions for Use and validated the ability of the Cup and Applicator to withstand repeated reprocessing.
10. Clinical Testing
No clinical study is included in this submission.
11. Conclusion:
In conclusion, the Sunny Cup and Applicator is demonstrated to be as safe and as effective as the SckoonCup. The Sunny Cup and Applicator has the same intended use, principles of operation, and similar technological characteristics as the identified predicate device. The provided performance testing and labeling demonstrate the subject device is as safe and effective as the predicate device. Thus, the Sunny Cup and Applicator is substantially equivalent to the predicate device.