The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.

Device Description

The proposed device, Vial2Bag" Direct Connect, consists of the Vial2Bag" piercing spike and cover, the twist-off connector and an integrated Vial Adapter for access to the drug/solution vial. It does not contain any medicinal substances and can be used with standard drug vials. It is intended for use in healthcare facilities or in home environment by a care-giver to aid and support prescribed treatment and therapy.

AI/ML Overview

The provided text describes the 510(k) summary for the Vial2Bag™ Direct Connect device, focusing on its substantial equivalence to predicate devices based on performance testing and biocompatibility assessments. Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All bench testing was performed following double EtO sterilization to ensure that the sterilization process does not have a detrimental effect on the proposed device, Vial2Bag™ Direct Connect performance. The following tests were completed and all of them passed the established acceptance criteria." However, it does not explicitly list the specific quantitative acceptance criteria for each test. It simply states that they "passed."

Acceptance Criteria (Not explicitly quantified in text)	Reported Device Performance
Air leakage test: Established acceptance criteria	Passed
Vial adapter detachment force from Vial2Bag™ body: Established acceptance criteria	Passed
Vial adapter breaking torque: Established acceptance criteria	Passed
Vial adapter total vial penetration force: Established acceptance criteria	Passed
Vial adapter detachment force from vial: Established acceptance criteria	Passed
Vial adapter spike damage: Established acceptance criteria	Passed
Cytotoxicity (MEM Elution - ISO): Established acceptance criteria	Passed
Sensitization (ISO Guinea Pig Maximization Sensitization Test): Established acceptance criteria	Passed
Irritation / Intracutaneous (ISO Intracutaneous Study in Rabbits): Established acceptance criteria	Passed
Hemocompatibility (In Vitro Hemolysis Study Extraction Method): Established acceptance criteria	Passed
Acute Systemic Toxicity (ISO Systemic Toxicity Study in Mice): Established acceptance criteria	Passed
Material Mediated Pyrogenicity (USP Rabbit Pyrogen Extraction Method): Established acceptance criteria	Passed
Bacterial Pyrogenicity (LAL Test Method): Established acceptance criteria	Passed

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

The document does not specify the sample sizes used for each of the performance and biocompatibility tests. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective), but it can be inferred that the testing was conducted by or on behalf of Medimop Medical Projects Ltd. in Israel, as they are the company proposing the device. These tests are typically prospective, meaning they are designed and executed specifically for regulatory submission.

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 and not provided in the context of device performance and biocompatibility testing for this type of medical device (IV administration set). "Ground truth" and expert consensus typically apply to diagnostic or AI-driven devices where human interpretation or a gold standard diagnosis is compared against the device's output. Here, the tests are objective, laboratory-based measurements against pre-defined engineering and biological safety standards.

4. Adjudication Method for the Test Set

This information is not applicable for this type of device testing. Adjudication methods like 2+1 or 3+1 typically relate to conflicting expert opinions in diagnostic studies, which is not relevant here. The evaluation of test results against acceptance criteria is usually a straightforward pass/fail assessment.

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

An MRMC study is not applicable and was not performed or mentioned for the Vial2Bag™ Direct Connect device. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images or data, often in conjunction with AI. The Vial2Bag™ Direct Connect is an IV administration set and does not involve "readers" or AI assistance in this context.

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

This is not applicable. The Vial2Bag™ Direct Connect is a physical medical device, not an algorithm or software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance tests, the "ground truth" is defined by established engineering specifications and physical properties that the device must meet, often based on recognized standards (e.g., ISO for biocompatibility). For biocompatibility, the ground truth is the biological response observed in standardized in vitro and in vivo animal models compared against internationally recognized safety thresholds. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the way it would be for a diagnostic tool.

8. The Sample Size for the Training Set

This is not applicable. The Vial2Bag™ Direct Connect is a physical medical device. It does not employ machine learning or AI, and therefore does not have a "training set" in the computational sense.

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

This is not applicable, as there is no training set for this device.

Summary

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510(K) SUMMARY 5

Vial2Bag™ Direct Connect 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 Regulatory Phone: 972-9-7778666 Fax: 972-9-7485916 E-mail: ilanit.goldgraber@westpharma.com

US Agent:

Kevin Lentz Director of Regulatory/PDS group West Pharmaceutical Services, Inc 530 Herman O. West Drive Exton, PA 19341 Phone: (610) 594-4353 E-mail: kevin.lentz@westpharma.com

....

Preparation date: March 17, 2014

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Classification:

Classification name: IV Administration Set Trade name: Vial2Bag™ Direct Connect Common/usual name: Vial2Bag" Direct Connect Product Code: LHI Regulation No.: 880.5440 Class: II Panel identification: General Hospital Panel

Predicate Devices:

Vial2Bag" from Medimop Medical Projects, Ltd, cleared by 510(k) number K072759

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

Device Description:

Indications for use:

The proposed device, Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV bag and an external IV line. The integrated vial adapter is used to reconstitute and admix drugs from a vial into the infusion solution.

Substantial equivalence

The proposed device. Vial2Bag™ Direct Connect has the same intended use, materials of construction and principle of operation as the predicate devices. Vial2Bag™ device (K072759) and the Mixject Dispensing Pin (Vial Adapter) (K001293) manufactured by Medimop Medical Projects Ltd. Therefore, the Vial2Bag™ Direct Connect is substantially equivalent to the predicate devices.

17 March 2014

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Vial2Bag™ Direct Connect

Performance Testing

Bench testing was performed to verify design requirements and to mitigate any potential risks. All bench testing was performed following double EtO sterilization to ensure that the sterilization process does not have a detrimental effect on the proposed device, Vial2Bag™ Direct Connect performance. The following tests were completed and all of them passed the established acceptance criteria.

Air leakage test ●
Vial adapter detachment force from Vial2Bag™ body .
Vial adapter breaking torque �
Vial adapter total vial penetration force .
Vial adapter detachment force from vial �
Vial adapter spike damage

Biocompatibility Tests

The proposed device. Vial2Bag™ Direct Connect, is classified as an external communicating device with prolonged indirect blood contact (24 hours to 30 days). The following tests were performed. All the tests passed the established acceptance criteria.

Cytotoxicity (MEM Elution -ISO) .
Sensitization (ISO Guinea Pig Maximization Sensitization Test) .
. Irritation / Intracutaneous (ISO Intracutaneous Study in Rabbits)
Hemocompatibility (In Vitro Hemolysis Study Extraction Method) .
Acute Systemic Toxicity (ISO Systemic Toxicity Study in Mice) ●
· Material Mediated Pyrogenicity (USP Rabbit Pyrogen Extraction Method)
Bacterial Pyrogenicity (LAL Test Method) .

Conclusion

ﺭ

Evaluation of the proposed device. Vial2Bag™ Direct Connect does not raise any additional concerns regarding safety and effectiveness. Therefore, it is considered substantially equivalent to the predicate devices, the Vial2Bag" device (K072759) and the Mixject Dispensing Pin (Vial Adapter) (K001293).

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Public Health Service

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

June 12, 2014

Medimop Medical Projects Limited Mr. Ilanit Goldgraber 17 Hatidhar Street Ra'anana 4366519 ISRAEL

Re: K140730

Trade/Device Name: Vial2Bag Direct™ Connect Regulation Number: 21 CFR 880.5440 Regulation Name: Vial2Bag Direct™ Connect Regulatory Class: II Product Code: LHI Dated: March 17, 2014 Received: March 24, 2014

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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 (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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary-S.Runner-S

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140730

Device Name

-Vial2Bag™ Direct Connect-

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman -S Date: 2014.06.12 14:06:42 -04'00'

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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.