Allow needle-free withdrawal, reconstitution and transfer of Bravelle® (urofolitropin for injection, purified) and/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration on a single patient during a single procedure.

Device Description

The device is a needless transfer device which enables reconstitution of one diluent vial and up to five vials of the fertility drugs Bravelle®, or Menopur® manufactured by Ferring using one MP Vial Adapter 13 mm.

The device is a single use sterile device which will be included into Ferring Pharmaceutical's Bravelle® and/or Menopur® drug kits to assist in the reconstitution of these lyophilized drugs for injection using one reconstitution diluent vial.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided text is a Traditional 510(k) Summary for a medical device called the "MP Vial Adapter 13mm." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive standalone clinical trials with predefined acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

Therefore, the document does not contain a table of acceptance criteria for device performance with corresponding reported values in the typical sense of diagnostic or AI-driven devices. Instead, the "acceptance criteria" are implied by the demonstration of equivalence to predicate devices and successful completion of "bench testing."

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Implied)	Reported Device Performance
Technological Characteristics	The MP Vial Adapter 13mm's material of construction and design is identical to the vial adapter subcomponent of the previously cleared Medimop Mixject with spray head (K122023).
Performance (Functional Equivalence)	The proposed device's performance, packaging, and sterilization are the same as that of a previously cleared Medimop 13mm Dispensing Pin (K963583).
Indication for Use Equivalence	The device's updated indication for use with Ferring Pharmaceutical's fertility drugs Bravelle® and/or Menopur® is equivalent to that of the previously cleared Q-Cap (K043304).
Bench Testing	"Bench testing was performed to demonstrate the ability of the proposed MP Vial Adapter 13mm to effectively reconstitute and transfer Bravelle® and/or Menopur® fertility drugs." (The specific results or metrics of this bench testing are not provided in this summary.)

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

This information is not provided in the 510(k) summary. Given it's a bench testing study for a physical device, the "test set" would refer to the number of devices or vials tested. The provenance of "data" (e.g., country of origin, retrospective/prospective) is typically associated with clinical studies involving human or patient data, which is not the case here.

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

This information is not applicable/provided. The "ground truth" for this type of device (a vial adapter) would be its physical functionality and ability to perform the intended actions (reconstitution, transfer). This is assessed through engineering and bench testing, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers in interpreting clinical data, which is not relevant for the bench testing of this device.

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

There was no MRMC comparative effectiveness study and this question is not applicable. This device is a manual medical device, not an AI-driven system that would involve human readers or AI assistance.

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

This question is not applicable. The device is not an algorithm seeking standalone performance evaluation. Its "standalone" performance refers to its ability to function as designed when used by a human user, which was assessed via bench testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation was functional performance established through bench testing, likely against engineering specifications and industry standards for fluid transfer and reconstitution. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is not an AI algorithm that requires a "training set."

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

This information is not applicable/provided. As explained, there is no training set for this type of device.

Summary

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Confidential

Name:

Traditional 510(k)

510(k) Summary 1. Submitter Information Medimop Medical Projects Ltd . ..

Address:	17 Hatidhar StRa'anana 4366519Israel
Telephone Number:	972-9-7778666
Fax Number:	972-9-7485916

AUG 0 8 2013

Contact person:	Ilanit Goldgraber
	Director of RA
Telephone Number:	972-9-7778666 Extension 219
Fax Number:	972-9-7485916
E-mail:	ilanit.goldgraber@westpharma.com

Deborah M. Thomas US Agent: West Pharmaceutical Services, Inc. 530 Herman O. West Drive Address: Exton, PA 19341-1147

Telephone Number:	(610) 594-3105
Fax Number:	(610) 594-3004
Email:	debbie.thomas@westpharma.com
Date Prepared:	23 January 2013

2. Device Name

Device Trade Name:	MP Vial Adapter 13mm
Common Name:	MP Vial Adapter 13mm
Classification name:	IV Administration Set

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3. Classification

Product Code:	LHI
Regulation No.:	880.5440
Class:	II
Panel identification:	General Hospital Panel

4. Predicate Devices

Mixiect with Spray Head (K122023) .
Mixject Dispensing Pin 13mm (K963583) .
Q-Cap needle-Free Reconstitution 13mm Vial Adapter (K043304) .

5. Device description

6. Indications for use

7. Technological Characteristics and Substantial Equivalence

The MP Vial Adapter 13mm material of construction and design is the vial adapter subcomponent of the previously cleared Medimop Mixject with spray head (K122023). The proposed devices performance, packaging and sterilization are the same to that of a previously cleared Medimop 13mm Dispensing Pin (Vial Adapter - K963583). The only

CONFIDENTIAL

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change to the proposed device is the indication for use which is being updated for use with the Ferring Pharmaceutical's fertility drugs Bravelle® and/or Menopur® and is equivalent to that of the previously cleared Q-Cap (K043304) and is therefore substantially equivalent to the predicate devices.

8. Nonclinical Testing

Bench testing was performed to demonstrate the ability of the proposed MP Vial Adapter 13mm to effectively reconstitute and transfer Bravelle® and/or Menopur® fertility drugs.

9. Conclusion

Comparative analysis of technological characteristics between proposed and predicate devices and results of verification testing performed demonstrate that the subject device is substantially equivalent to the legally marketed predicate devices. Any differences between the proposed and predicate devices do not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

August 08, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medimop Medical Projects, Limited Mr. Hanit Goldgraber Director of Regulatory Affairs 17 Hatidhar Street RA'ANANA ISRAEL 4366519

Re: K130179

Trade/Device Name: MP Vial Adapter 13 mm Regulation Number: 21 CFR 880.5440 Regulation Name: Set, I.V. Fluid Transfer Regulatory Class: II Product Code: LHI Dated: June 12, 2013 Received: July 11, 2013

Dear Mr. Goldgraber:

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 10 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 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.

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Page 2 - Mr. Goldgraber

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 (reporting of medical 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/About/DA/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/McdicalDcyices/Safety/ReportaProblem/dcfault.hum 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,

Kwame O. Ulmer -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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MP Vial Adapter 13mm

Confidential

Indications for Use

510(k) Number (if known): K130179

Device Name: MP Vial Adapter 13 mm

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

.. . .

. . . . . .

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign-Off)Division of Anesthesiology, General HospitalInfection Control, Dental Devices	Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number:	K130179
	Richard C. Chapman
	2013.08.06
	11:50:18 -04'00'
	Page 1 of 1

23 January 2013 CONFIDENTIAL Page 21 of 147

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.