The Vial2Bag Advanced® 13mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL V bag, vial with 13mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. Indicated for adolescent and adult patients only.

Device Description

The Vial2Bag Advanced® 13mm Admixture Device is a single use, fluid transfer device that allows for reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, nonpyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 13mm and an elastomeric stopper. The Vial2Bag Advanced® 13mm device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV infusion set. Users should not attach a Vial2Bag Advanced device to another Vial2Bag Advanced Device. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced 13mm Device for the device to meet its intended purpose.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device (Vial2Bag Advanced® 13mm Admixture Device) and does not describe an AI/ML powered device. Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone (algorithm only) performance," are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, chemical tests, biocompatibility testing, sterilization validation, and a human factors study.

Here's the breakdown of the information provided in the document based on your request, with a clear indication of what is not applicable due to the nature of the device:

Device Reviewed: Vial2Bag Advanced® 13mm Admixture Device

Overall Conclusion: The device is deemed substantially equivalent to a predicate device (Vial2Bag Advanced 20mm Admixture Device, K201415), based on non-clinical performance data, chemical tests, biocompatibility tests, sterilization, and human factors study results. It is not an AI/ML device, thus direct AI-specific performance metrics are not available.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct "acceptance criteria" table with performance results in a single, concise format for each test. Instead, it lists the types of tests performed and states that the device "met the applicable design and performance requirements." For each test, the acceptance criteria are implicitly those defined by the referenced standards (e.g., ISO-8536-4, USP <788>, EN ISO 8536-2, ISO 10993 series) or the in-house test methods mentioned. The performance is reported as meeting these requirements.

Here's a summary of the types of tests and the general reported performance:

Test Type	Test Method/Standard	Reported Device Performance
Performance Testing	In-house test methods for various parameters (e.g., Dose Concentration of Delivery Profile, Twist Off Opening Torque, Vial Adaptor Tensile Detachment Force, Vial Adapter Torque Test, Vial Adapter to Vial Penetration Force, Detachment Force of Vial Adapter from Vial, Visual Inspection for Product Damage, 1m Drop Durability, IV Spike to IV Port Attachment Force, Leakage test (IV spike to IV port), IV Spike from IV Port Detachment Force, IV Spike Dimensions, Flow rate, IV Spike Protector Detachment Force, Visual Inspection of Device, Finger Flange Break Force, Short Circuit Test Method, IV Spike Lumen Dimensions, Mass Transfer, Residual Volume). ISO 8536-4 (Leakage, IV Port Tensile Strength), USP <788> (Particulate), EN ISO 8536-2 & 7864 (Fragmentation, Coring).	"Met the applicable design and performance requirements." "Satisfies the product requirements for performance, safety, and effectiveness." "Support a determination of substantial equivalence."
Chemical Tests	ISO 8536-4: 2019 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed; Annex B.	"The test results provide evidence that the device meets the requirements listed in ISO 8536-4:2019, Annex B Chemical Tests."
Biocompatibility Testing	ISO 10993-1: 2018 series (Parts 4, 5, 10, 11) and ASTM F756-17.	"Successfully conducted." "Materials... are considered biocompatible." "Does not raise any additional concerns regarding risk, safety, and effectiveness."
Sterilization	ISO 11135:2014/AMD1:2018 (Ethylene Oxide sterilization).	Achieved a Sterility Assurance Level (SAL) of 10-6.
Human Factors Validation	Simulated use sessions with intended users.	"No repeatable patterns of use-related errors." "Validated that recruited nurses, physicians, and pharmacists can operate the subject device safely and effectively."

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

Sample Size for Test Set: The document explicitly mentions:
- For Fragmentation and Coring tests: "sample size based on EN ISO 7864, Annex B. Section B.4." (Specific number not provided in this document, but directed to the standard).
- For other performance tests, chemical tests, and biocompatibility, specific sample sizes are not detailed in this summary, but would be part of the underlying test reports.
- For the Human Factors Validation Study: "recruited nurses, physicians, and pharmacists". The specific number of participants is not provided in this summary.
Data Provenance: The studies are conducted by West Pharma. Services IL, Ltd. (Israel-based manufacturer). These are prospective tests performed on the manufactured device, not retrospective data analysis. The data is generated from laboratory testing and simulated use, not from clinical patient data from specific countries.

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

Not Applicable (N/A) for AI/ML device ground truth. This device is a mechanical fluid transfer device. Ground truth is established through adherence to recognized international standards and in-house validated test methods, rather than expert annotation of data.
For the Human Factors Validation Study, the "experts" are the intended users of the device (nurses, physicians, and pharmacists). Their "qualification" is their professional role and ability to use the device safely and effectively in a simulated environment. The number of such participants is not specified.

4. Adjudication Method for the Test Set

N/A for AI/ML device adjudication. There is no "adjudication" in the context of human expert review of AI outputs for this type of device. The verification processes involve engineering testing and quality control.

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

N/A. This is not an AI-powered diagnostic/assistance device, so no MRMC study or AI assistance evaluation was performed.

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

N/A. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

N/A in the AI/ML sense. For this device, "ground truth" equates to:
- Validated engineering specifications and performance benchmarks: Established by international standards (e.g., ISO, USP, EN ISO) and the manufacturer's own design control processes.
- Biocompatibility standards: ISO 10993 series.
- Sterility standards: ISO 11135.
- Human Factors validation: Demonstrated safe and effective use by intended users in a simulated setting.

8. The Sample Size for the Training Set

N/A. There is no "training set" as this is not an AI/ML device.

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

N/A. There is no "training set" and thus no ground truth establishment for such a set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

December 1, 2023

West Pharma Services IL, Ltd. % Lynn Lundy Sr. Director, Regulatory Affairs West Pharmaceutical Services, Inc. 530 Hermon O. West Drive Exton, Pennsylvania 19341

Re: K230988

Trade/Device Name: Vial2Bag Advanced® 13mm Admixture Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: November 3, 2023 Received: November 3, 2023

Dear Lynn Lundy:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices.

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and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K230988

Device Name

Vial2Bag Advanced® 13mm Admixture Device

Indications for Use (Describe)

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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K230988 - 510(K) SUMMARY

SUBMITTER 1

Applicant:

West Pharma. Services IL, Ltd. 4 Hasheizaf St. Ra'anana, Israel 4366411 Facility Establishment Registration Number: 3000223297

Manufacturer:

West Pharma. Services IL, Ltd. 4 Hasheizaf St. Ra'anana, Israel 4366411 Facility Establishment Registration Number: 3000223297

Contact Person:

Lynn Lundy Sr Director, Regulatory Affairs Phone: 484-885-3298 Fax: 610-717-0668 E-mail: lynn.lundy@westpharma.com

Date Prepared: 06 April 2023

2 DEVICE

Trade Name:	Vial2Bag Advanced® 13mm Admixture Device
Common/Usual Name:	I.V. Fluid Transfer Set
Regulation Name:	Intravascular administration set
Product Code:	LHI
Regulation No.:	880.5440
Class:	II
Panel Identification:	General Hospital Panel

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3 PREDICATE DEVICE

Vial2Bag Advanced 20mm Admixture Device; K201415 This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

DEVICE DESCRIPTION 4

4.1 Device Design and Operation

The subject Vial2Bag Advanced® 13mm Admixture Device is being developed as a new offering to the market.

4.2 Principle of Operation

The Vial2Bag Advanced® 13mm Admixture Device is operated by manual process. The Vial Adapter is first attached to the drug vial, and after removing the Protector, the IV spike is then connected to the administration port of the IV bag. Fluid is transferred from the IV bag to the drug vial to reconstitute/dilute the drug prior to being transferred back to the IV bag. The IV administration set is then connected to the device's IV Port followed by administration to the patient.

INDICATIONS FOR USE 5

The Vial2Bag Advanced® 13mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 13mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. Indicated for adolescent and adult patients only.

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL 6 EQUIVALAENCE

Both the subject and predicate devices have the similar intended uses for the reconstitution and transfer of drug content from the vial into the IV bag. Both devices are intended for use in healthcare environments by clinically trained healthcare professional providers to aid and support prescribed treatment and therapy. The predicate device is indicated for general use with a vial with 20mm closure and the subject device is indicated to be used with a vial with a 13mm closure for adolescent and adult patients only. Human Factors, Performance and Biocompatibility testing confirmed the subject device accommodating a smaller 13mm drug vial size and the adolescent and adult patient population do not raise new or additional concerns regarding device safety profile or clinical effectiveness.

A summary comparing the subject device and the predicate device are provided below:

Areas forComparison	Subject DeviceVial2Bag Advanced® 13mmAdmixture Device	Predicate Device(K201415):Vial2Bag Advanced® 20mmAdmixture Device	Comparison
General Information
Indications for Use	To serve as a connectionbetween a 50, 100, or 250ml IVbag, vial with 13mm closure,and an external IVadministration set. Theintegrated Vial Adapter makes itpossible to reconstitute and/oradmix drugs. Indicated foradolescent and adult patientsonly.	To serve as a connectionbetween a 50, 100, or 250mlIV bag, vial with 20mmclosure, and an external IVadministration set. Theintegrated Vial Adaptermakes it possible toreconstitute and/or admixdrugs.	Difference #1 - HumanFactors, Performance andBiocompatibility testingconfirmed the subjectdevice accommodating asmaller 13mm drug vialsize and the adolescent andadult patient population donot raise new or additionalconcerns regarding devicesafety profile or clinicaleffectiveness.
Contraindications	None known	None known	Identical
Intended UserPopulation	Intended for use by HealthcareProfessionals (HCPs)	Intended for use byHealthcare Professionals(HCPs)	Identical
Intended UseEnvironment	Intended for use in hospitals,outpatient nursing units andother suitable clinicalenvironments	Intended for use in hospitals,outpatient nursing units andother suitable clinicalenvironments	Identical
Device ProductCode. Class &Classification Name	LHI, Class II, I.V. Fluid TransferSet	LHI, Class II, I.V. FluidTransfer Set	Identical
Regulation Number/ Name	21CFR 880.5440Intravascular Administration Set	21CFR 880.5440	Identical
Areas forComparison	Subject DeviceVial2Bag Advanced® 13mmAdmixture Device	Predicate Device(K201415):Vial2Bag Advanced® 20mmAdmixture Device	Comparison
		Intravascular AdministrationSet
Prescription Use	Yes	Yes	Identical
Single Use	Yes	Yes	Identical
Design
Operation Principle	Manual	Manual	Identical
Design	Made of plastic material,featuring a 13mm Vial Adaptorto access the drug content in the13mm vial, an IV Spikeintegrated for the connection tothe IV bag, and a twist off whichafter removal opens the IV portfor connection to the IVadministration set.	Made of plastic materialfeaturing a 20mm VialAdaptor to access the drugcontent in the 20mm vial, anIV Spike integrated for theconnection to the IV bag, anda twist off which afterremoval opens the IV port forconnection to the IVadministration set.	Difference #2–Performance, chemical andbiocompatibility testingconfirmed material andvial adapter size do notimpact device intendeduse, clinical effectiveness,or safety profile.
Materials ofConstruction	• 13mm Vial Adapter:Polycarbonate (PC) + Orangecolorant masterbatch	• 20mm Vial Adapter: PC +Blue colorant masterbatch	Difference #3 –Performance, chemical andbiocompatibility testingconfirmed differences incolorant do not impactdevice intended use,clinical effectiveness, orsafety profile.
	• IV Port Twist Off: PC +Polyvinyl Chloride (PVC)3224	• IV Port Twist Off: PC +Polyvinyl Chloride (PVC)3250	Difference #3 –Polycarbonate is identical,differs in PVC.Performance, chemical andbiocompatibility testingconfirmed differences inPVC grade do not impactdevice intended use,clinical effectiveness, orsafety profile.
	• Spike Protector: Low DensityPolyethylene (LDPE)	• Spike Protector: LDPE	Identical
Compatible VialSize	13mm	20mm	Difference #2–Performance testingconfirmed differencesnoted with compatible vialsize do not impact deviceintended use, clinicaleffectiveness, or safetyprofile.
Areas forComparison	Subject DeviceVial2Bag Advanced® 13mmAdmixture Device	Predicate Device(K201415):Vial2Bag Advanced® 20mmAdmixture Device	Comparison
Bag Size	50, 100, 250mL	50, 100, 250mL	Identical
Single/inlineconfiguration	Single configuration onlyDo not attach one device toanother device.	Single configuration onlyDo not attach one device toanother device.	Identical
Vial Adapter Fit	Vial first, snap fit to vial	Vial first, snap fit to vial	Identical
Performance onfluid transfer	Transfer of vial contents to theIV bag and to the administrationset was quantified to establishproduct requirement for thesubject device.	Subject device can transferequivalent vial contents tothe IV bag and administrationset compared with thepredicate device.	Identical
Biocompatibility	ISO 10993-1:2018External Communicating,Prolonged Indirect BloodContact (>24hr to 30 days)	ISO 10993-1:2018External Communicating,Prolonged Indirect BloodContact (>24hr to 30 days)	Identical
Non-pyrogenic	Yes	Yes	Identical
Sterilization
Sterility	Sterile	Sterile	Identical
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Identical
Sterility AssuranceLevel	SAL of 10-6	SAL of 10-6	Identical
Packaging
Packaging	Sterile Barrier packagematerials: PETG blister withTyvek® seal	Sterile Barrier packagematerials: PETG blister withTyvek® seal	Identical

Table 6-1: Substantial Equivalence Comparison Table

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The results of performance, biocompatibility, and human factors studies for the subject device, provided within this submission, demonstrate that the differences between the subject device and the predicate device do not raise any additional concerns regarding risk, safety, and effectiveness. See details as follows:

. Difference #1 - Human Factors (Section 8.1), Performance (Table 7-1) and Biocompatibility (Section 7.3) testing confirmed the differences in indications for use, including the subject device accommodating a smaller 13mm drug vial size and the adolescent and adult patient population do not raise new or additional concerns regarding device safety profile or clinical effectiveness.
Difference #2 Performance (Table 7-1), chemical (Section 7.2) and biocompatibility ● (Section 7.3) testing confirmed differences in design and compatible vial size do not impact device intended use, clinical effectiveness, or safety profile.

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. Difference #3 - Performance (Table 7-1), chemical (Section 7.2) and biocompatibility (Section 7.3) testing confirmed differences in materials of construction do not impact device intended use, clinical effectiveness, or safety profile.
For the reasons listed above, the Vial2Bag Advanced® 13mm Admixture Device, subject of this Traditional 510(k), is substantially equivalent in its intended use, design/construction. technology/principle of operation, materials, and performance to the predicate device, Vial2Bag Advanced 20mm Admixture Device, which is cleared under K201415.

PERFORMANCE DATA 7

The following non-clinical performance data were provided in support of the substantial equivalence determination.

7.1 Performance Testing

Performance testing was conducted to ensure that the Vial2Bag Advanced® Admixture Device met the applicable design and performance requirements throughout its shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. The table below provides a list of non-clinical bench performance tests that were completed on the device and provided within this submission.

Test	Test Method/ Standard
Dose Concentration of Delivery Profile	In-house test methods
Twist Off Opening Torque from IV Port	In-house test method
Vial Adaptor Tensile Detachment Force	In-house test method
Vial Adaptor Torque Test	In-house test method
Vial Adapter to Vial Penetration Force	In-house test method
Detachment Force of Vial Adapter from Vial	In-house test method
Visual Inspection for Product Damage	In-house test method
Leakage test (Device)	ISO-8536-4; Section 7.2
Internal Diameter of the Upper Skirt for Vial Adapter	In-house test method
1m Drop Durability	In-house test method
IV Port Tensile Strength	ISO 8536-4; Section 7.3

Table 7-1: Summary of Performance Testing

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Test	Test Method/ Standard
IV Spike to IV Port Attachment Force	In-house test method
Leakage test (IV spike to IV port)	In-house test method
IV Spike from IV Port Detachment Force	ISO 8536-4 Section 7.3
IV Spike Dimensions	ISO 8536-4:2019; Section 7.4
Flow rate	ISO 8536-4:2019; Section 7.10
IV Spike Protector Detachment Force	ISO 8536-4:2019; Section 7.13
Visual Inspection of Device	In-house test method
Finger Flange Break Force	In-house test method
Short Circuit Test Method	In-house test method
IV Spike Lumen Dimensions	In-house test method
Particulate	USP <788>
Fragmentation	Acceptance criteria based on EN ISO 8536-2,section 6.2.2 and sample size based on ENISO 7864, Annex B. Section B.4.
Mass Transfer	In- house test method
Residual Volume	In-house test method
Coring	Acceptance criteria based on EN ISO 8536-2,section 6.2.2 and sample size based on ENISO 7864, Annex B, Section B.4.

Performance testing and risk management review indicate all product design requirements are verified and the residual risk level is acceptable based on the test results. Together, the objective evidence satisfies the product requirements for performance, safety, and effectiveness and the results support a determination of substantial equivalence.

7.2 Chemical Tests

To assure the device can properly serve as a connection between IV bags and Administration Sets, Vial2Bag Advanced 13mm Admixture Devices were tested to ISO 8536-4: 2019 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed; Annex B. The test results provide evidence that the device meets the requirements listed in ISO 8536-4:2019, Annex B Chemical Tests.

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7.3 Biocompatibility Testing

In accordance with ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, the subject Vial2Bag Advanced 13mm Admixture Device is classified as an externally communicating device with prolonged contact duration (>24 hours to 30 days) and blood path indirect contact. The finished device's patient contacting parts were tested in accordance with the tests recommended in the 2023 FDA Guidance: Use of International Standard ISO 10993-1. "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. " The following biocompatibility tests have been successfully conducted on the Vial2Bag Advanced 13mm Admixture Device:

Cytotoxicity (Tested to ISO 10993-5: 2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity)

Sensitization (Tested to ISO 10993-10: 2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization)

Intracutaneous Reactivity (Tested to ISO 10993-10: 2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization)

Acute Systemic Toxicity (Tested to ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)

Material Mediated Pyrogenicity (Tested to ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)

Systemic (Subacute) Toxicity (Tested to ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)

Hemolysis (Tested to ISO 10993-4: 2017 Biological evaluation of medical devices -Part 4: Selection of tests for interactions with blood and ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials)

Based upon the results of the biocompatibility tests, the materials used to manufacture the subject device are considered biocompatibility results demonstrate the subject device does not raise any additional concerns regarding risk, safety, and effectiveness; therefore, the subject Vial2Bag Advanced 13mm Admixture Device is considered substantially equivalent to the predicate device.

7.4 Sterilization

The sterility of the subject device is assured using a sterilization method validated in accordance with ISO 11135:2014/AMD1:2018 Sterilization of Health Care Products -Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. The sterilization method provides a sterility assurance level (SAL) of 10-6.

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8 CLINICAL DATA

No clinical trial was performed for Vial2Bag Advanced 13mm Admixture Device.

8.1 Human Factors

A Human Factors Validation study was conducted to demonstrate that intended users are able to use the device safely and effectively without patterns of preventable use errors, or difficulties that could result in serious harm to the user or patient.

The subject device related IFU was validated in simulated use sessions with representatives of the intended user groups to establish safe and effective preparation for drug administration by healthcare professionals. An evaluation of the subject device Blister Pack. Carton, and associated labeling were also included.

There were no repeatable patterns of use-related errors resulting in failures, close calls, operational difficulties, or foreseeable misuse of the Vial2Bag Advanced® 13mm admixture device. This Human Factors study validated that recruited nurses, physicians, and pharmacists can operate the subject device safely and effectively per the intended use. The results of this study provided objective evidence and determined that the potential use errors identified in the use-related risk analysis that could lead to serious harm have been mitigated to acceptable levels. All risk control measures were found to be effective.

CONCLUSION 9

In summary, the Vial2Bag Advanced® 13mm Admixture Device, the subject of this Premarket Notification, is as safe, as effective, and is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicate device, Vial2Bag Advanced 20mm Admixture Device (K201415).

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.