(301 days)
No
The description focuses on the physical design, material, and intended use of a menstrual cup, with no mention of AI or ML capabilities.
No
The device is described as a receptacle for collecting menstrual fluid and cellular debris, which is not a therapeutic function. Therapeutic devices are generally intended to treat, cure, mitigate, or prevent disease.
No
The device is described as a receptacle for collecting blood and cellular debris during menstruation. Its intended use is purely collection, not analysis or diagnosis of any condition.
No
The device description clearly states it is a physical menstrual cup made of silicone elastomer, which is a hardware component.
Based on the provided information, the Rhea Cup is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation." This is a collection device for menstrual fluid, not a device used to perform tests on biological samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical characteristics and function of the cup as a receptacle for menstrual fluid. There is no mention of any components or processes for analyzing or testing the collected fluid.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Performing tests on biological samples.
- Providing diagnostic information.
- Using reagents or analytical methods.
- Measuring specific analytes or biomarkers.
The Rhea Cup is a medical device, specifically a menstrual cup, intended for the collection of menstrual fluid within the body. It falls under the category of devices used for managing menstruation, not for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Rhea Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Product codes
HHE
Device Description
The Rhea Cup is a reusable menstrual cup placed in the vagina to collect blood and cervical debris that is extruded from the uterus via the cervix during menstruation. The Rhea Cup will be made in two model sizes to allow for the variability of the female vagina and menstrual flow due to normal differences between women as well as the effects of childbirth. Model 1 holds approximately 25ml of fluid and is for women who have never given birth vaginally. Model 2 holds approximately 30ml of fluid and is for women who have given birth vaginally.
The Rhea Cup is made of a flexible silicone elastomer which allows for easy insertion and a comfortable fit in the body. This material is durable and allows the cup to be used during many menstrual cycles. The Rhea Cup is comprised of a body, which acts as a receptacle for fluid and a ribbed tail attached at the base of the body, providing support when removing the cup from the vagina.
The Rhea Cup is made of a silicone elastomer, which has been cleared by the FDA for use in the BelleCup (K092985) predicate device.
No applicable mandatory performance standards or special controls exist for this device.
The Rhea Cup is not supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, cervix, uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(k) Premarket Notification - Rhea Cup
Ki.12165
MAY 2 4 2012
510(k) Summary
Date Submission Prepared: July 26, 2011 Revision B Prepared: May 16, 2012
Submitter:
Apex Medical Technologies, Inc. 10064 Mesa Ridge Court, Suite 202 San Diego, CA 92121 USA Phone: (858) 535-0012 Fax: (858) 535-9715 Establishment Registration Number 2025773
Contact: Scott Herrick Title: Senior Development Engineer
New Device:
| Trade Name: | Rhea Cup |
|---|---|
| Common Name: | Menstrual cup |
| Classification Name: | Cup, Menstrual |
| Review Panel: | Obstetrics/Gynecology |
| Product Code: | HHE |
| Regulation Number: | 21 CFR 884.5400 |
| Device Class: | II |
Predicate Devices:
| Trade Name: | Tassaway | Trade Name: | BelleCup |
|---|---|---|---|
| 510(k) number: | K803250 | 510(k) number: | K092985 |
| Product Code: | HHE | Product Code: | HHE |
| Trade Name: | |||
| 510(k) number: | |||
| Product Code: | Lunette | ||
| K091754 | |||
| HHE |
1
Device Description:
The Rhea Cup is a reusable menstrual cup placed in the vagina to collect blood and cervical debris that is extruded from the uterus via the cervix during menstruation. The Rhea Cup will be made in two model sizes to allow for the variability of the female vagina and menstrual flow due to normal differences between women as well as the effects of childbirth. Model 1 holds approximately 25ml of fluid and is for women who have never given birth vaginally. Model 2 holds approximately 30ml of fluid and is for women who have given birth vaginally.
The Rhea Cup is made of a flexible silicone elastomer which allows for easy insertion and a comfortable fit in the body. This material is durable and allows the cup to be used during many menstrual cycles. The Rhea Cup is comprised of a body, which acts as a receptacle for fluid and a ribbed tail attached at the base of the body, providing support when removing the cup from the vagina.
The Rhea Cup is made of a silicone elastomer, which has been cleared by the FDA for use in the BelleCup (K092985) predicate device.
No applicable mandatory performance standards or special controls exist for this device.
The Rhea Cup is not supplied sterile.
Intended Use:
The Rhea Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Comparison to Predicate Device:
The Rhea Cup and BelleCup menstrual cups are both made of the same silicone elastomer, LIM 6040-D2 and the two devices are substantially equivalent in material, technological characteristics and intended use.
The Rhea Cup is substantially equivalent to the Lunette menstrual cup in dimensions, technological characteristics and intended use. The lunette is made from a similar silicone elastomer material.
The Rhea Cup has the same intended use and similar characteristics as all of the predicate devices including methods for insertion and removal, fluid holding capacity and wear time.
Any differences between the Rhea Cup and the predicate devices do not affect the intended use or alter the technology of the device. No new questions of safety or effectiveness are raised by differences in technology or materials.
:: . .........................................................................................................................................................................
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Scott Herrick Senior Development Engineer Apex Medical Technologies, Inc. 10064 Mesa Ridge Court, Suite #202 SAN DIEGO CA 92121
MAY 2 4 2012 .
K112165 Trade/Device Name: Rhea Cup Regulation Number: 21 CFR§ 884.5400 Regulation Name: Menstrual cup Regulatory Class: II Product Code: HHE Dated: May 16, 2012 Received: May 17, 2012
Dear Mr. Herrick:
Re:
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. The I ou make your 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 r loase be act novel a determination that your device complies with other requirements of the Act that I Drival statutes and regulations administered by other Federal agencies. You must or any I vacturer and the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Twitchell
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
4
Indications for Use
510(k) Number (if known): K112165
Device Name: Rhea Cup
Indications for Use:
The Rhea Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helent lemen
... .
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number. K112165
. . .