The proposed device, Vented Vial Adapter Transfer Device - 13mm, 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 13mm vial adapter body intended to be attached to a standard 13 mm drug vial. The other end is intended to be connected to a Female Luer connection. The vial adapter body contains the dual lumen piercing spike and the second part of the device is an assembled 0.2um hydrophobic air path filter (100% expanded PTFE membrane over Non-woven polyester membrane support). This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/ released air through 0.2um air filter. The proposed device does not contain any medicinal substances.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Vented Vial Adapter Transfer Device - 13mm". The document focuses on demonstrating substantial equivalence to a predicate device (Vented Vial Adapter Transfer Device, K062482) through design comparisons and performance testing.

Here's an analysis of the acceptance criteria and the study as described in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that all testing met the required acceptance criteria, but it does not explicitly list specific numerical or qualitative acceptance criteria for each test. Instead, it lists the types of tests performed and generally states that the results met internal performance standards.

Test Name	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Product Functionality Performance test according to IFU	"Required acceptance criteria" (Internal standards)	Met "internal performance standards"
Filter Bursting Pressure	"Required acceptance criteria" (Internal standards)	Met "internal performance standards"
Flow Rate Testing	"Required acceptance criteria" (Internal standards)	Met "internal performance standards"
Cap/valve-housing detachment from body Test	"Required acceptance criteria" (Internal standards)	Met "internal performance standards"
Internal stress level for assembled product	"Required acceptance criteria" (Internal standards)	Met "internal performance standards"
Biocompatibility	Harmonized standard (ISO 10993-1)	Met "required acceptance criteria" (Tested per ISO 10993-1)

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

The document does not specify the sample sizes used for any of the performance tests. It also does not provide information on the data provenance (e.g., country of origin of the data, retrospective or prospective); it's implied the testing was conducted internally by Medimop Medical Projects Ltd. as part of their design control.

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

This information is not applicable to this type of device and study. The testing described is strictly focused on the physical and functional performance of a medical device (vial adapter), not on clinical diagnostic accuracy or interpretation by experts. Ground truth, in this context, refers to objective measurements and adherence to engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert reviews or clinical outcomes where there might be disagreements in interpretation. The performance tests for this device involve objective measurements against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to assess diagnostic performance. The device here is a physical product for drug transfer, not an AI-powered diagnostic tool.

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

This information is not applicable as the device is a physical, mechanical medical device and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used for the performance testing is based on internal performance standards and harmonized international standards (e.g., ISO 10993-1 for biocompatibility). For physical and functional tests, the ground truth would be precise measurements and observations confirming adherence to specified design parameters and functional requirements. For biocompatibility, the ground truth is conformance to the criteria outlined in ISO 10993-1.

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires training data.

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

This information is not applicable. As stated above, the device does not involve a training set.

Summary

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

May 4, 2016

Medimop Medical Projects Ltd. Ilanit Goldgraber Director of Regulatory Affairs 17 Hatidhar Street Ra'anana. 4366519 ISRAEL

Re: K160503

Trade/Device Name: Vented Vial Adapter Transfer Device - 13mm Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: April 1, 2016 Received: April 4, 2016

Dear Ilanit 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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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 devicerelated 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 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" (21 CFR 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 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,

Tina Kiang
-S

for 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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Indications for Use

510(k) Number (if known) K160503

Device Name

Vented Vial Adapter Transfer Device - 13mm

Indications for Use (Describe)

The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in a vial.

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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Vented Vial Adapter Transfer Device - 13mm

510(K) SUMMARY

Device: Vented Vial Adapter Transfer Device - 13mm

Company Name:

Medimop Medical Projects Ltd 17 Hatidhar St Ra'anana 4366519 Israel Phone: 972-9-7757122 Fax: 972-9-7485916

Contact Person:

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

US Agent:

Kevin Lentz Sr. Director RA West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, PA 19341 Phone: (610) 594-4353 Email: kevin.lentz@westpharma.com

Preparation date: 5/4/2016

Classification:

Classification Name:	Intravascular Administration Set
Trade Name:	Vented Vial Adapter Transfer Device - 13mm
Common/Usual Name:	Vented Vial Adapter 13mm
Product Code:	LHI
Regulation No.:	880.5440
Class:	II
Panel Identification:	General Hospital Panel
Predicate Devices:	Vented Vial Adapter Transfer Device, cleared by 510(K) K062482

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Vented Vial Adapter Transfer Device - 13mm

Device Description:

The proposed device consists of two integrated parts, the 13mm vial adapter body intended to be attached to a standard 13 mm drug vial. The other end is intended to be connected to a Female Luer connection. The vial adapter body contains the dual lumen piercing spike and the second part of the device is an assembled 0.2um hydrophobic air path filter (100% expanded PTFE membrane over Non-woven polyester membrane support). This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/ released air through 0.2um air filter. The proposed device does not contain any medicinal substances.

Indications for use:

The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in a vial.

Substantial Equivalence

The proposed device, Vented Vial Adapter Transfer Device - 13mm, has the same indications for use and principle of operation as the predicate device, Vented Vial Adapter Transfer Device, from Medimop Medical Projects, Ltd, cleared by 510(k) number K062482.

The following modifications have been made to the Vented Vial Adapter Transfer Device originally cleared by 510(K) K062482:

o Dimension of body connection modified to fit a 13mm vial
Air Filter Reversal in order to avoid clogging of the filter if the diluent is injected in ● upright position and, by that, to improve the usability of the device. The hydrophobic side of the filter is now facing the vent path.
The vial adapter body was redesigned to include "tight grip" feature to improve adherence of the vial adapter to the 13mm vial. Subsequently the geometry of the individual blister package was modified to adapt the "tight grip" modification (larger internal diameter)
The cap is attached to the body by ultrasonic welding instead of a snap fit ●

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Vented Vial Adapter Transfer Device – 13mm

Technological Characteristics and Substantial Equivalence:

The Medimop Vented Vial Adapter Transfer Device - K062482 has been cleared for the transfer and mixing of drugs contained in vials and is being selected as the predicate device for this proposed device. The predicate and proposed devices are designed and manufactured by the same organization and share the same materials and function. The proposed device expands the dimensional and functional attributes of the predicate 20mm vial adapter for use with smaller 13mm vials.

The predicate and proposed devices share the same principle of operation and fundamental technology when utilizing the Vented Vial Adapter device. The Vented Vial Adapter allows the connection of any standard accessory with a Luer connection to be connected to a vial. Once mixing of the diluent and the drug is complete, the drug solution can be transferred using the vial adapter. The determination that the drug solution is ready for use is based on drug manufacturer recommendations. The vial adapter is a single use device and should be disposed of after use.

Areas forcomparison	Claimed SubstantiallyEquivalent ProductVented Vial AdapterK062482	Proposed DeviceVented Vial Adapter –13mmK160503	Comparison
Indication forUse	Intended for the transferand mixing of drugscontained in vials	Intended for the transferand mixing of drugscontained in vials	Identical
SterilizationMethod	Gamma	Gamma	Identical
SterilityAssurance Level	SAL 10⁻⁶	SAL 10⁻⁶	Identical
Single use	Yes	Yes	Identical
Material	Polycarbonate	Polycarbonate	Identical
Expiration Date	5 years	3 years	Modified
Body Diameter	30.4mm to fit 20mm VialsImage: Vented Vial Adapter	18.5mm to fit 13mm VialsImage: Vented Vial Adapter	Modified

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Vented Vial Adapter Transfer Device - 13mm

Areas forcomparison	Claimed SubstantiallyEquivalent ProductVented Vial AdapterK062482	Proposed DeviceVented Vial Adapter -13mmK160503	Comparison
Air Filtration	0.2 micron hydrophobicFilterOval centered hole	0.2 micron hydrophobicFilterRound centered holeReversed direction of flow	Modified
Cap Assembly	Assembly AttachedMechanically	Assembly AttachedUltrasonically	Modified
Vial Adapter Fit(Vial Side)	Snap Fit to Vial	Snap Fit to VialReduced Diameter toimprove grip of 13mmVials (i.e. "Tight Grip"Feature)	Modified
Piercing Spike	Plastic - Dual Lumen	Plastic - Dual Lumen	Identical

Performance Testing:

The modifications to the proposed device were evaluated within the Medimop design control system. A risk assessment was performed to ensure that the proposed device modifications did not introduce any new potential risks. The following tests (Product functionality according to IFU, Total penetration force, detachment force from drug vial, filter bursting pressure, wet filter test, cap detachment from body, internal stress level, system leakage and biocompatibility) were performed on the proposed device, Vented Vial Adapter Transfer Device 13 mm, as a result of the risk assessment to ensure the all potential risks associated with the device modifications were mitigated to acceptable levels.

Dimension change to 13mm
o Addition of 'Tight Grip' feature
Reverse air filter direction ●
Use ultrasonic welding for cap attachment to body ●

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Vented Vial Adapter Transfer Device – 13mm

Performance Testing Summary
Test Name	Testing Standard
Product Functionality Performancetest according to IFU	Tested to internal performance standards
Filter Bursting Pressure	Tested to internal performance standards
Flow Rate Testing	Tested to internal performance standards
Cap/valve-housing detachmentfrom body Test	Tested to internal performance standards
Internal stress level forassembled product	Tested to internal performance standards
Biocompatibility	Tested per ISO 10993-1

All testing met the required acceptance criteria.

Conclusion

The evaluation of the proposed device, Vented Vial Adapter Transfer Device - 13mm, does not raise any additional concerns regarding safety and effectiveness and is considered to be substantially equivalent to the predicate device, Vented Vial Adapter Transfer Device, 510(k) K062482.

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.