(121 days)
Not Found
No
The device description and performance studies focus on the material properties, size variations, and biocompatibility of a physical menstrual cup, with no mention of AI or ML technology.
No
A therapeutic device is one that treats, cures, or prevents disease. The MeLuna Menstrual Cup is used for collecting menstrual flow and does not perform a therapeutic function.
No
The device collects menstrual blood and cellular debris; it does not analyze or interpret these to diagnose a medical condition.
No
The device description clearly states it is a physical menstrual cup made of TPE, which is a hardware component, not software.
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).
- MeLuna Menstrual Cup Function: The MeLuna Menstrual Cup is a physical receptacle placed inside the body (in vivo) to collect menstrual fluid. It does not perform any testing or analysis of the collected fluid to provide diagnostic information. Its purpose is purely for collection and containment.
The description clearly states its function is to "collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation." This is a mechanical function, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The MeLuna Menstrual 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 (comma separated list FDA assigned to the subject device)
HHE
Device Description
The MeLuna Menstrual Cup is a soft small TPE (Thermoplastic elastomer) menstrual cup that is placed internally in the vagina. The MeLuna is reusable and holds menstrual flow instead of absorbing it. It is available in two size classifications: Standard and Shorty, with cup diameters the same for both Shorty and Regular, but cup capacity and cup length varying between the two classifications.
The cups are available in two different firmness levels referred to as Classic or Sport. The Classic material has a shore rating of 40; the firmer Sport model has a shore rating of 50.
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
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)
NON-CLINICAL PERFORMANCE DATA BIOCOMPATIBILITY
The MeLuna Menstrual Cup was tested in accordance with the testing requirements of ISO-10993-1:2009 (R2013), "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for cytotoxicity, sensitization, and acute systemic toxicity testing. In addition, a use-life testing supported a three-years use-life, and cleaning/disinfection validation testing demonstrated acceptability of cleaning and disinfection procedures included in the Instructions for Use.
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
JUL 1 0 2014
510(k) Summary
510 (K) Number K140626
| SPONSOR | |||||
|---|---|---|---|---|---|
| Company Name: | MeLuna | ||||
| Company Address | Industriestr 7 | ||||
| Gunzenhausen, GERMANY 91710 | |||||
| Telephone: | 210.391.8558 | ||||
| Contact Person: | Karin Baker | ||||
| Summary Preparation Date: July 8, 2014 | |||||
| DEVICE NAME | |||||
| Trade Name: | MeLuna Menstrual Cup (Models Classic and Sport) | ||||
| Common/Usual Name: | Menstrual Cup | ||||
| Classification Name: | Menstrual Cup | ||||
| Regulation Number: | 21 CFR 884.5400 | ||||
| HHE | |||||
| Product Code: | |||||
| Device Class: | Class II . | ||||
| PREDICATE DEVICE | |||||
| Company | Product | 510(k) # |
| Company | Product | 510(K) # |
|---|---|---|
| Diva International, Inc. | Diva Cup | K021356 |
DEVICE DESCRIPTION
The MeLuna Menstrual Cup is a soft small TPE (Thermoplastic elastomer) menstrual cup that is placed internally in the vagina. The MeLuna is reusable and holds menstrual flow instead of absorbing it. It is available in two size classifications: Standard and Shorty, with cup diameters the same for both Shorty and Regular, but cup capacity and cup length varying between the two classifications.
| Capacity | Diameter | Cup Length | ||
|---|---|---|---|---|
| Shorty- | Regular | Shorty/Regular | Shorty | Regular |
| S - 10ml | S - 15 ml | Small - 39 mm | S - 35 mm | S - 46 mm |
| M - 12ml | M - 20ml L | Medium- 42 mm | M- 38 mm | M - 50mm |
| - 15ml | L - 24 ml XL | Large - 45 mm | L - 41 mm | L - 53mm |
| - 18ml | XL - 30 ml | X Large - 48 mm | XL - 43 mm | XL - 57mm |
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The cups are available in two different firmness levels referred to as Classic or Sport. The Classic material has a shore rating of 40; the firmer Sport model has a shore rating of 50.
INDICATIONS FOR USE
The MeLuna Menstrual 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 OF PREDICATE PRODUCT TECHNICAL CHARACTERISTICS
The MeLuna Menstrual Cup is similar to the predicate device in indications for use, operating principle, and device design. The MeLuna differs from the predicate device in material, and in slight differences in dimensions and capacity. These differences do not raise new types of safety or effectiveness questions.
NON-CLINICAL PERFORMANCE DATA BIOCOMPATIBILITY
The MeLuna Menstrual Cup was tested in accordance with the testing requirements of ISO-10993-1:2009 (R2013), "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for cytotoxicity, sensitization, and acute systemic toxicity testing. In addition, a use-life testing supported a three-years use-life, and cleaning/disinfection validation testing demonstrated acceptability of cleaning and disinfection procedures included in the Instructions for Use.
CONCLUSION
The MeLuna Menstrual Cup is similar to the predicate products in indications for use, operating principle, and device design. The differences in material, dimensions and capacity do not introduce new issues in terms of safety and efficacy, and MeLuna concludes that the MeLuna Menstrual Cup is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an eagle-like symbol with three tail feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 10. 2014
Meluna % Yolanda Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, MD 21114
K140626 Re:
Trade/Device Name: MeLuna Menstrual Cup (Models Classic and Sport) Regulation Number: 21 CFR§ 884.5400 Regulation Name: Menstrual Cup Regulatory Class: Class II Product Code: HHE Dated: June 3, 2014 Received: June 5, 2014
Dear Yolanda Smith,
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 ffor 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. Please note: CDRH does not cvaluate 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Yolanda Smith
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Glenn B. Bell -S
for
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) KI40626
Device Name
MeLuna Menstrual Cup (Models Classic and Sport)
Indications for Use (Describe)
The MeLuna Menstrual Cup 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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【アート】【送料無料】【送料無料】【】【FOR FOATUSE ONLY MP】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 】【 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Glenn ByBell -S for BRF
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FORM FDA 3881 (1/14)
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