(413 days)
Not Found
No
The summary describes a physical menstrual cup and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device's intended use is to collect menstrual flow, which is a physiological process, not to treat or prevent a disease, or to affect the structure or any function of the body as a therapeutic medical device would.
No
The device is a menstrual cup, which collects fluid and does not perform any diagnostic function. Its intended use is to collect menstrual blood, not to diagnose medical conditions.
No
The device description clearly describes a physical, reusable silicone menstrual cup, which is a hardware device. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside the body (in vitro).
- MoonCup Function: The MoonCup is a device that is placed inside the body (in vivo) to collect menstrual fluid. It does not perform any diagnostic testing on the collected fluid. Its purpose is collection, not analysis for diagnostic purposes.
The description clearly states its function is to "collect blood and cellular debris" and "holds monthly menstrual flow." There is no mention of any testing or analysis of this fluid for diagnostic purposes.
N/A
Intended Use / Indications for Use
The MoonCup® 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 (comma separated list FDA assigned to the subject device)
HHE
Device Description
General. The MoonCup® menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available in two sizes:
- . Style A - After childbirth;
- Style B Before childbirth and/or C-section. .
The cup remains entirely within the vagina and does not touch the cervix but the stem remains outside the body to ensure retrieval of the cup. See the instruction brochure for information about how to use and care for the MoonCup® menstrual cup.
Material. The MoonCup® menstrual cup is manufactured from a soft silicone elastomer. The properties of the silicone are described in a master file at FDA. The Materials Data Safe Sheet (MDSS) and the Product Specifications Sheet for the silicone were submitted. The master file and the MDSS provides data on all of the biocompatibility or toxicity testing required according to FDA's memorandum to guidance G95-1. The silicone elastomer is well characterized chemically and physically and has a long history of safe use as a medical device in long-term contact with the human body.
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
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): 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
§ 884.5400 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
Premarket Notification [510(k)] Summary
[As required by section 807.92(c)]
Submitter: Morris Waxler, Ph.D.
FDA Regulatory Affairs Specialist LaFollette, Godfrey & Kahn One East Main Street Madison, WI 53701-2719 TEL: 608-284-2638 FAX: 608-257-0609
New device:
Trade or proprietary name: MoonCup® Common or usual name: Menstrual Cup Classification name of the device: 21 CFR §884.5400
Predicates: DivaCup™ - Menstrual Solution (K021356) The Keeper® (K870803) Tassaway (K803250)
Description of the Device:
General. The MoonCup® menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available in two sizes:
- . Style A - After childbirth;
- Style B Before childbirth and/or C-section. .
The cup remains entirely within the vagina and does not touch the cervix but the stem remains outside the body to ensure retrieval of the cup. See the instruction brochure for information about how to use and care for the MoonCup® menstrual cup.
Material. The MoonCup® menstrual cup is manufactured from a soft silicone elastomer. The properties of the silicone are described in a master file at FDA. The Materials Data Safe Sheet (MDSS) and the Product Specifications Sheet for the silicone were submitted. The master file and the MDSS provides data on all of the biocompatibility or toxicity testing required according to FDA's memorandum to guidance G95-1. The silicone elastomer is well characterized chemically and physically and has a long history of safe use as a medical device in long-term contact with the human body.
Intended Use/Indication for Use: The MoonCup® is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation. The MoonCup® is placed low enough in the vagina to be retrieved readily and, at the same time, to prevent it's touching the cervix or interfering with menstrual flow through it.
1
Substantial Equivalence
The MoonCup® is substantially equivalent to the DivaCup™ (K021356), The Keeper® (K870803), and the Tassaway (K803250) in materials, dimensions, intended use, and indication for use. The MoonCup® is made of silicone similar to the DivaCup™. The MoonCup® can hold approximately one ounce of menstrual fluid is inserted into the vagina with a stem slightly protruding to aid removal.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows a circular seal with an eagle-like bird in the center. The bird is facing left and has three lines above it, possibly representing feathers or motion. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle, following its curvature. The seal appears to be a logo or emblem, possibly associated with a government agency.
MAR 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MoonCup, LLC c/o Morris Waxler, Ph.D. FDA Regulatory Affairs Specialist LaFollette, Godfrey & Kahn One East Main Street P.O. Box 2719 MADISON WI 53701-2719
Re: K040335
Trade/Device Name: MoonCup® Menstrual Cup, Styles A and B Regulation Number: 21 CFR §884.5400 Regulation Name: Menstrual cup Regulatory Class: II Product Code: HHE Dated: March 7, 2005 Received: March 9, 2005
Dear Dr. Waxler:
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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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. 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); good manufacturing practice requirements as set forth in the quality systems (05) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hanteeing your
premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket notification: "The PDA mailing of oation for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific advice for your de restled wing numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entired, cornation on your responsibilities under the Act from the 807.97). Tou may ootain outer gollerial missistance at its toll-free number (800) DIVISION of Sillan Manufacturers, Internet address http://www.fda.gov/cdrl/dsmadsmam.html
Sincercly yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): 长 040335
Device Name: MoonCup® ________________________________________________________________________________________________________________________________________________________
.
Indications for Use: The MoonCup® is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Over-The-Counter Use _ V Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broador
DIVISION SIGN-OFF
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040335