The proposed device, Vial Connector 13 mm Closed Collar, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The proposed device consists of two integrated parts, the first part is the 13mm vial connector body intended to be attached to a standard 13 mm drug vial neck and a male luer connection. The vial connector body contains the single lumen piercing spike and an assembled 5μm fluid path filter (Versapor® Hydrophilic membrane on a HDPE disc). The second part of the device is the closed collar which restricts the connection of the vial connector to standard 13 mm vials with a body diameter of up to 15 mm. The two integrated parts are injection molded as one single device. The proposed device does not contain any medicinal substances.

AI/ML Overview

This looks like a 510(k) summary for a medical device. Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is a common pathway for medical device clearance in the US. This type of submission relies on demonstrating that the new device has the same indications for use and principle of operation as a legally marketed device, rather than requiring new clinical trials or performance studies against predefined acceptance criteria for a novel device.

Here's why each point in your request cannot be fulfilled based on the provided text:

A table of acceptance criteria and the reported device performance: This information is not present. The document describes the device, its intended use, and argues for its similarity to a predicate. It does not contain performance metrics or acceptance criteria as would be found in a study report.
Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned because no performance study for this specific device is referenced.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no test set or ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication process is mentioned.
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 mechanical "Vial Connector," not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a non-AI, mechanical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth is established for this type of device submission.
The sample size for the training set: Not applicable, as this is a mechanical device and does not involve AI model training.
How the ground truth for the training set was established: Not applicable, same reason as above.

In summary, the provided text is a 510(k) summary demonstrating substantial equivalence for a medical device, which typically does not include detailed performance studies with acceptance criteria in the way a novel technology or an AI/software device often would. The clearance is based on its similarity to an already approved predicate device.

Summary

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8. 510(K) SUMMARY

Vial Connector 13 mm Closed Collar Device:

Company Name:

Medimop Medical Projects Ltd 17 Hatidhar St Ra'anana 4366519 Israel Phone: 972-9-7778666 Fax: 972-9-7485916

Contact Person:

Ilanit Goldgraber Director of RA Phone: 972-9-7778666-219 Fax: 972-9-7485916 E-mail: ilanit.goldgraber@westpharma.com

US Agent:

Deborah M. Thomas West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, PA 19341-1147 Phone: (610) 594-3105 Fax: (610) 594-3004 Email: debbie.thomas@westpharma.com

25 June 2013 Preparation date:

Classification:

Classification Name:	IV Administration Set
Trade Name:	Vial Connector 13 mm Closed Collar
Common/Usual Name:	Vial Connector 13 mm Closed Collar
Product Code:	LHI
Regulation No.:	880.5440
Class:	II
Panel Identification:	General Hospital Panel

Predicate Devices:

Mixject Dispensing Pin from Medimop Medical Projects, Ltd, cleared by 510(k) number K963583 and K001293

Special 510 (k)

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Device Description:

The proposed device consists of two integrated parts, the first part is the 13mm vial connector body intended to be attached to a standard 13 mm drug vial neck and a male luer connection. The vial connector body contains the single lumen piercing spike and an assembled 5μm fluid path filter (Versapor® Hydrophilic membrane on a HDPE disc). The second part of the device is the closed collar which restricts the connection of the vial connector to standard 13 mm vials with a body diameter of up to 15 mm. The two integrated parts are injection molded as one single device. The proposed device does not contain any medicinal substances.

Indications for use:

The proposed device is indicated for the transfer and mixing of drugs contained in a vial.

Substantial equivalence

The proposed device, Vial Connector 13 mm Closed Collar, has the same indications for use and principle of operation as the predicate device, Mixject Dispensing Pin, from Medical Projects, Ltd, cleared by 510(k) number K963583 and K001293, and is therefore substantially equivalent to the predicate device.

Conclusion

The evaluation of the proposed device, Vial Connector 13 mm Closed Collar, does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device, Mixject Dispensing Pin, 510(k) K963583 and K001293.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

July 31, 2013

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

Re: K132040

Trade/Device Name: Vial Connector 13mm Closed Collar Regulation Number: 21 CFR 880.5440 Regulation Name: Set, I.V. Fluid Transfer Regulatory Class: II Product Code: LHI Dated: June 25, 2013 Received: July 5, 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 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 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 (OS) 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,

Mary S. Runner -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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7. INDICATIONS FOR USE

510(k) Number (if known): _ K 32040

Device Name: Vial Connector 13 mm Closed Collar

Indications for Use:

The proposed device is indicated for the transfer and mixing of drugs contained in a vial.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K132040

Page 1_ of 1_ Richard C. Chapman 2013.07.30 15:55:07 -04'00'

25 June 2013

Page 36 of 207

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.