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.

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.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria related to device performance (e.g., sensitivity, specificity, accuracy) for the MeLuna Menstrual Cup, nor does it describe a study to prove the device meets such criteria in the context of typical AI/medical device performance evaluation.

This document is a 510(k) summary for a menstrual cup, which is a relatively low-risk medical device. The focus of the regulatory approval process for such devices is primarily on safety and substantial equivalence to a predicate device, rather than on complex performance metrics like those for diagnostic AI systems.

However, I can extract the information related to the non-clinical performance data and the overall conclusion of substantial equivalence, which serves as the "acceptance criteria" and "proof" in this context.

Summary of Acceptance Criteria and Study Findings (based on the provided text):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	The MeLuna Menstrual Cup was tested in accordance with ISO-10993-1:2009 (R2013) for:
Cytotoxicity	Passed
Sensitization	Passed
Acute Systemic Toxicity	Passed
Use-Life Testing	Supported a three-year use-life.
Cleaning/Disinfection Validation	Demonstrated acceptability of cleaning and disinfection procedures included in the Instructions for Use.
Substantial Equivalence (Overall Acceptance)	Device is similar to the predicate device (Diva Cup K021356) in indications for use, operating principle, and device design. Differences in material, dimensions, and capacity do not introduce new issues in terms of safety and efficacy.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. The provided document describes non-clinical laboratory testing (biocompatibility, use-life, cleaning validation) and a comparison to a predicate device. It does not involve a "test set" of patient data or typical clinical validation with sample sizes as would be seen for AI algorithms.
The data provenance is from laboratory testing performed according to ISO standards, not patient data from a specific country or retrospective/prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This type of information is not relevant to the non-clinical testing described. Laboratory tests have established protocols and endpoints, not expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Not Applicable. No adjudication method was used, as described above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a menstrual cup, a physical medical device. It is not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For biocompatibility: ISO-10993-1:2009 (R2013) standards and their defined endpoints for cytotoxicity, sensitization, and acute systemic toxicity.
For use-life: Presumably, established accelerated aging or physical stress test protocols to simulate 3 years of use.
For cleaning/disinfection: Microbial reduction or other established disinfection efficacy standards.
For substantial equivalence: Comparison against the technical characteristics and regulatory profile of the predicate device (Diva Cup).

8. The Sample Size for the Training Set

Not Applicable. This is not an AI device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary

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JUL 1 0 2014

510(k) Summary

510 (K) Number K140626

SPONSOR
Company Name:	MeLuna
Company Address	Industriestr 7Gunzenhausen, 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
HHEProduct Code:
Device Class:	Class II .
PREDICATE DEVICE
Company	Product	510(k) #

Company	Product	510(K) #
Diva International, Inc.	Diva Cup	K021356

DEVICE DESCRIPTION

	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.

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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

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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

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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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Glenn ByBell -S for BRF

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FORM FDA 3881 (1/14)

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Regulation Number and Section

§ 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.