The freetlex@+ Transfer Adapter is indicated for reconstituting a drug in a vial with a 20mm closure and the transfer of the drug into the freeflex®+ IV Bag prior to administration to the patient. The device may be used for pediatric (newborn to 21 years) and adult populations.

Device Description

The freeflex®+ Transfer Adapter is a single use, fluid transfer device that allows for the reconstitution and transfer of powdered or liquid drugs from drug vials into the freeflex + IV Bag (NDA BN070012) through the IV bag medication port. The device consists of a body, male Luer lock and a safety ring. The device is provided as a sterile, non-pyrogenicproduct. The device is intended to be used with standard drug vials with a seal diameter of 20mm. with an elastomeric membrane. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the freeflex®+ Transfer Adapter for the device to meet its intended purpose.

AI/ML Overview

The Fresenius Kabi AG freeflex®+ Transfer Adapter (K212445) is a single-use fluid transfer device intended for reconstituting drugs in a vial with a 20mm closure and transferring them into a freeflex®+ IV Bag prior to administration.

Here's an analysis of its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria & Test	Reported Device Performance
ISO 22413:2013 Transfer sets for pharmaceutical preparations	Successfully passed.
Fragmentation	Successfully passed.
USP <788> Particulate Matter in Injections Test method 1	Successfully passed.
Particulate Testing	Successfully passed.
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods	Successfully passed.
Luer Connector Leakage	Successfully passed.
Stress Cracking Resistance Testing	Successfully passed.
ISO 11607-1 (2019-02) Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems	Successfully passed.
Sterile Barrier Systems Validation	Successfully passed.
Internal device performance test methods	Successfully passed.
Visual Inspection	Successfully passed.
Penetration Force	Successfully passed.
Force to Remove Safety Ring	Successfully passed.
Separation under Tensile Force	Successfully passed.
Residual Volume in Adapter-Vial-System	Successfully passed.
Biocompatibility Testing	Successfully passed.
Hemolysis	Successfully passed.
Cytotoxicity	Successfully passed.
Irritation	Successfully passed.
Skin Sensitization	Successfully passed.
Acute Systemic Toxicity	Successfully passed.
Chemical Characterization	Successfully passed.
Material Mediated Pyrogenicity	Successfully passed.
Particulate Testing (re-listed, but part of biocompatibility section)	Successfully passed.
Sterilization Validation	Successfully passed.
Ethylene oxide sterilization (DIN EN ISO 11135:2014)	Achieved a Sterilization Assurance Level (SAL) of 10-6.

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

The document does not explicitly state the specific sample sizes for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). It generally mentions "functional performance bench testing was conducted." Without specific numbers, it's impossible to provide these details accurately.

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

Not applicable. This device is a physical medical device, not an AI/ML algorithm requiring expert human interpretation for ground truth establishment. The performance testing is based on objective, quantifiable measurements according to established international and internal standards.

4. Adjudication Method for the Test Set

Not applicable, for the same reason as point 3.

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

Not applicable. This is not an AI/ML device that involves human reader interpretation.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on the objective criteria defined by the cited international standards (e.g., ISO 22413, USP <788>, ISO 80369-20, ISO 11607-1) and internal test methods. These standards define measurable thresholds for attributes like leakage, fragmentation, particulate matter, etc. For biocompatibility, the ground truth is the absence of adverse biological reactions as defined by ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. This is a physical device and presumably does not involve a "training set" in the context of an AI/ML algorithm.

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

Not applicable, for the same reason as point 8.

Study Proving Acceptance Criteria are Met:

The study proving the device meets the acceptance criteria is a series of bench testing and biocompatibility testing as detailed in Section 9 of the 510(k) Summary.

Bench Performance Testing: The device was subjected to various functional tests based on international standards (ISO 22413, USP <788>, ISO 80369-20, ISO 11607-1) and internal test methods. These tests evaluated properties such as freedom from fragmentation, particulate matter, Luer connector leakage, stress cracking resistance, sterile barrier integrity, visual inspection, penetration force, force to remove the safety ring, separation under tensile force, and residual volume.
Biocompatibility Testing: Following FDA guidance (ISO 10993-1), a comprehensive suite of biocompatibility tests was performed, including hemolysis, cytotoxicity, irritation, skin sensitization, acute systemic toxicity, chemical characterization, material mediated pyrogenicity, and particulate testing.
Sterilization Validation: Ethylene oxide sterilization was validated to meet DIN EN ISO 11135:2014, achieving an SAL of 10-6.

All these tests were successfully conducted, and their aggregated results are deemed to demonstrate that the freeflex®+ Transfer Adapter performs as intended and supports a substantial equivalence determination to the predicate device (Vial2Bag Advanced™ 20mm Admixture Device, K201415). The conclusion explicitly states: "The freeflex®+ Transfer Adapter, has met all established acceptance criteria for performance testing and design verification testing. Results of functional performance and biocompatibility testing conducted with the freeflex + Transfer Adapter, demonstratethat the subject device supports a substantial equivalence determination to the predicate device."

Summary

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June 1, 2022

Fresenius Kabi AG % Keith Dunn Director Regulatory Affairs Fresenius Kabi LLC, USA 3 Corporate Dr Suite 300 Lake Zurich, Illinois 60047

Re: K212445

Trade/Device Name: freeflex®+ Transfer Adapter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: April 29, 2022 Received: May 2, 2022

Dear Keith Dunn:

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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 Wolloscheck For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, 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

Enclosure

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Indications for Use

510(k) Number (if known) K212445

Device Name freeflex®+ Transfer Adapter

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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K212445 - 510(k) SUMMARY

1. Submitter Information

Name:	Fresenius Kabi AG
Address:	Else-Kröner-Str. 161352 Bad Homburg
Contact Person:	Keith DunnDirector, Regulatory AffairsFresenius Kabi USA, LLCThree Corporate Drive, 2nd FloorLake Zurich, IL 60047 USA
Telephone Number:	(224) 817-2430
Fax Number:	(847) 550 2960
E-mail:	keith.dunn@fresenius-kabi.com
Date Prepared:	April 21, 2022
SecondaryContact Person:	Jason MaSr. Manager, Regulatory AffairsFresenius Kabi USA, LLCThree Corporate Drive, 2nd FloorLake Zurich, IL 60047 USA
Telephone Number:	224-817-4100
Fax Number:	847 550 2960

2. Device Name and Classification

Device Trade Name: freeflex®+ Transfer Adapter Common Name: IV Fluid Transfer Set Classification Name: 21 CFR 880.5440 Intravascular administration set Regulatory Class: II Product Code: LHI 510(k) Number: K212445

Jason.ma01@fresenius-kabi.com

3. Predicate Device

E-mail:

Device Trade Name: Vial2Bag Advanced™ 20mm Admixture Device Common Name: IV Fluid Transfer Set Classification Name: 21 CFR 880.5440 Intravascular administration set

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Regulatory Class:	II
Product Code:	LHI
510(k) Number:	K201415

4. Device Description

The device is intended to be used with standard drug vials with a seal diameter of 20mm. with an elastomeric membrane. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the freeflex®+ Transfer Adapter for the device to meet its intended purpose.

5. Principle of Operation

The freeflex®+ Transfer Adapter is operated by manual manipulation. Initially, the vial opening that the transfer adaptor will connect to is disinfected with 70% isopropyl alcohol. Next the freeflex +transfer adaptor is removed from the package. The protective cap is removed from the freeflex®+ IV bag injection port and the injection port is disinfected with 70% isopropyl alcohol. The freeflex 4transfer adaptor is connected to the injection port, then attached to the drug vial. Fluid is transferred manually from the IV bag to the drug vial to reconstitute/dilute drug powder/liquid prior to being transferred back to the IV bag. Once the drug is transferred to the IV bag the transfer adapter is removed from the IV bag and discarded. Finally, the freeflex®HV bag injection port is capped with a protective cap.

6. Indication for Use/ Intended Use

Indication for Use:

The freeflex®+ Transfer Adapter is indicated for reconstituting and/or admixing a drug in a vial with a 20mm closure and the transfer of the drug into the freeflex 9+ IV Bag prior to administration to the patient. The device may be used for pediatric (newborn to 21 years) and adult populations.

7. Substantial Equivalence

Intended Use/Indication for Use-Discussion of Differences

The subject and predicate devices have the same intended use. The indication for use of the subject and predicate device are equivalent and do not create a new intended use.

. The indication for use for the subject device is limited to vials with a 20mm Fresenius Kabi

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closure.

The subject device is only indicated for use with the freeflex + IV Bag.
The predicate device does not indicate the patient population for which it may be ● used.

Physical Characteristics

The subject and predicate devices share the following physical characteristics:

Flanges on the device provide secure attachment to the drug vial.
A spike pierces the IV bag and drug vial for fluid transfer, providing a needle-free connection.

Technological Characteristics-Discussion of Differences

1. The predicate device is designed to attach to the administration port of a standard IV bag, size 50, 100 or 250 mL while the subject device is designed to attach only to the freeflex + IV Bag sizes 50, 100, 250, 500, or 1000 mL using the medication port.
1. The predicate device allows connection of an external IV administration set using an IV port with a twist off feature while the subject device, freeflex + Transfer Adapter, does not connect to an external administration set.
1. The predicate device allows connection of the Vial2Bag Advanced™ 20mm Admixture Device directly into the administration path while the subject device connects to the medication port of the IV Bag, which is not part of the administration path.
The predicate device allows connection to 20mm device (or smaller). The proposed 4. device is designed for use with vials with 20mm opening only.
1. The main body of both devices is made of polycarbonate. The subject device has an additional component made of polypropylene (nut) that is not fluid contacting

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Conclusion on Substantial Equivalence

The freeflex®+ Transfer Adapter has the same intended use and equivalent indication for use as the predicate device. The subject device has similar technological characteristics to the predicate, and the descriptive and performance information provided within this premarket notification demonstrates that:

any differences do not raise different questions of safety and . effectiveness compared to the predicate device; and
the proposed device is at least as safe and effective as the legally . marketed predicate device.

Based on the comparison of the intended use and the technological characteristics, the subject device is substantially equivalent to the currently marketed predicate Vial2Bag Advanced™ 20mm Admixture Device.

8. Comparison of the Technological Characteristics with the Predicate Device

The technological characteristics of the subject device, freeflex®+ Transfer Adapter, are substantially equivalent to those of the predicate device, Vial2Bag Advanced™ 20mm Admixture Device, in regard to the following technological characteristics:

Principle of operation and conditions of use of the subject device are equivalent to those of the predicate device.
Material composition of the subject device is equivalent to that of the predicate device in that both devices are made from plastics used in medical devices of this type. Material composition of the proposed device does not raise new questions of safety and effectiveness, as demonstrated by performance testing and biocompatibility evaluation.
Physical specifications of the subject device are equivalent to those of the predicate ● device. The freeflex®+ Transfer Adapter does not raise new questions of safety and effectiveness, as demonstrated by performance testing.
Design features and interfaces are equivalent in that both devices connect to a drug vial and IV bag and allow for fluid transfer between the drug vial and IV bag. The subject device is limited for use with the freeflex + IV Bag only. Performance verification of the subject device does not raise new questions of safety and effectiveness.
Sterilization method and SAL level are identical between the subject andpredicate ● device.

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A comparison between the predicate device and the subject device is provided in Table 1.

Areas for Comparison	Subject DeviceK212445	Predicate DeviceK201415	Comparison
Product Code andRegulation	LHI21 CFR 880.5440	LHI21 CFR 880.5440	Same
Classification	Class II (non-exempt)	Class II (non-exempt)	Same
Review Panel	General Hospital	General Hospital	Same
Type of Use	Prescription use only	Prescription use only	Same
Conditions of Use	Single use only	Single use only	Same
Sterilization Method	Ethylene oxide	Ethylene oxide	Same
Indication for Use	The freeflex®+Transfer Adapter isindicated forreconstituting and/oradmixing a drug in avial with a 20mmclosure and the transferof the drug into thefreeflex®+ IV Bagprior to administrationto the patient. Thedevice may be used forpediatric (newborn to21 years) and adultpopulations.	The Vial2BagAdvancedTM 20mmAdmixture Device isindicated to serve as aconnection between a 50,100, or 250ml IV bag,vial with 20mm closure,and an external IVadministration set. Theintegrated Vial Adaptermakes it possible toreconstitute and/oradmix drugs prior toadministration to thepatient.	SimilarThe differences areminimal and do notimpact the risk topatient or user. Bothdevices have the sameintended use for thereconstitution andtransfer of drug contentfrom the vial into theIV bag. The predicateis indicated for usewith any standard IVbag whereas thefreeflex®+ TransferAdapter is for use onlythe freeflex®+ IVBags.
Operation Principle	Manual	Manual	Same
Areas for Comparison	Subject DeviceK212445	Predicate DeviceK201415	Comparison
Design	The freeflex®+Transfer Adapter ismade of plasticmaterials and is asingle use, sterile, non-pyrogenic transferadapter device thatconnects to a 20mmseal diameter drug vial.The spike of thetransfer device piercesthe seal of the drug vialand allows for thereconstitution/dilutionand transfer of drugs toa 50, 100, 250, 500 or1000 mL freeflex®+IV bag. Fluid istransferredfrom the IVbag to the drug vial bya manual process toreconstitute/dilute thedrug prior to beingtransferred back to theIV bag. Once the drugis transferred to the IVbag the transfer adapteris removed from the IVbag and discarded.	The Vial2BagAdvanced™ 20mmAdmixture Device is asingle use, fluid transferdevice that allows for thereconstitution andtransfer of fluids fromdrug vials into the IVbag containing infusionsolution, through the IVbag administration port.The device consists ofthe body, Protector, IVPort, and an integratedvial adapter. TheVial2Bag connects theIV bag and IV set andcreates a fluid path. TheVial2Bag Advanced 20mm Admixture Device'sintegrated vial adapterconnects to the body ofthe Vial2Bag and to a20mm (or smaller) sealdiameter drug vial. Thevial adapter spike piercesthe seal of the drug vial.Fluid from the IV bag istransferred into the drugvial by a manual processto reconstitute/dilute thedrug. Oncereconstituted/diluted thedrug solution istransferred to the IV bag.The vial adapter canremain attached to theVial2Bag during drugdelivery or alternativelybe removed anddiscarded. The deviceworks with standard 50,100, 250mL IV bags.	DifferentThe difference isminimal and does notimpact the risk topatient or user. TheVial2Bag is a systemwhich contains a vialadapter which isattached to theVial2Bag system whenreconstituting/admixingthe drug andtransferring it to the IVbag. The vial adaptercan stay attached to theVial2Bag device duringdrug delivery to thepatient or be removedfrom the Vial2Bagdevice and discarded.The freeflex®+Transfer Adapter isonly the adapter. It isattached to the IV bagand drug vial. The drugisreconstituted/admixedand then once the drughas been transferred tothe IV bag thefreeflex®+ TransferAdapter is removedfrom the IV bag anddiscarded.
Materials	Body: PolycarbonateNut: PolycarbonateSafety Ring:Polypropylene	Body: PolycarbonateOption for siliconizedspikeVented adapter has PTFE0.2 micron air filter	DifferentThe difference isminimal and does notimpact the risk to patientor user.The main body of bothdevices is made of
Areas for Comparison	Subject DeviceK212445	Predicate DeviceK201415	ComparisonPage 7 of 9
			polycarbonate. Thesubject device has anadditional componentmade of polypropylene(nut) that is not fluidcontacting
Biocompatibility	- Hemolysis- Cytotoxicity- Irritation- Skin Sensitization- Acute SystemicToxicity- ChemicalCharacterization- Pyrogenicity- Particulate Testing	- Hemolysis- Cytotoxicity- Irritation- Skin Sensitization- Acute SystemicToxicity- Sub-chronic Toxicity- Pyrogenicity- Particulate Testing	SimilarThe difference is notaffecting thedetermination of anunacceptable adversebiological response. Thesubject device hasadditional evidence inchemicalcharacterization whereasthe predicate device wastested on sub-chronictoxicity. However, thesub-chronic toxicitytesting is not requiredbecause the subjectdevice is removed fromthe IV Bag after a fewminutes and does notremain attached.
Drug Form	Powdered or liquid	Powdered or liquid	Same
Vial Size	20 mm	20 mm (or smaller)	SimilarThe difference isminimal and does notimpact the risk to patientor user. The predicatedevice may be used withsmaller size drug vials
Bag System	freeflex® + IV Bag	Standard IV Bag	DifferentThe difference isminimal and does notimpact the risk to patientor user. The predicatedevice may be used withany standard IV bagwhile the subject devicemayonly be used withthe freeflex® + IV Bag
Bag Size	50, 100, 250, 500,1000 mL	50, 100, 250mL	SimilarThe difference isminimal and does notimpact the risk to patientor user. The freeflex®+Transfer Adapter canconnect toadditional
Page 8 of 9
Areas for Comparison	Subject DeviceK212445	Predicate DeviceK201415	Comparison
Performance Testing	USP<788>ISO22413ISO80369-20ISO11607-1Internal Test Methodsfor mechanical andperformancecharacteristics.	ISO 8536-4Internal Test Methods formechanical andperformancecharacteristics.	DifferentFor particulate testingthe subject devicefollowed USP<788>versus ISO8536-4 forthe predicate. For otherperformance tests thesubject device followedFDA recognizedstandards includingISO22413, ISO80369-20, ISO11607-1, as wellas in house test methodsversus in house testmethods were followedfor the predicate device. sizes of IV bagscompared to thepredicate.

Table 1: Summary of Substantial Equivalence Comparison

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9. Performance Testing—Bench

Functional performance bench testing was conducted to demonstrate that the freeflex®+ Transfer Adapter performs as intended. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.

The following performance testing was conducted to support the substantial equivalence determination (Table 2):

ISO 22413:2013 Transfer sets for pharmaceuticalpreparations	Fragmentation
USP <788> Particulate Matter in Injections Testmethod 1	Particulate Testing
ISO 80369-20:2015 Small-bore connectors forliquids and gases in healthcare applications - Part20: Common test methods	Luer Connector LeakageStress CrackingResistance Testing
ISO 11607-1 (2019-02) Packaging for terminallysterilized medical devices - Part 1: Requirementsfor materials, sterile barrier systems	Sterile Barrier Systems Validation
Internal device performance test methods	Visual Inspection Penetration Force Force to Remove Safety Ring Separation under Tensile Force Residual Volume in Adapter-Vial-System

Table 2: Performance Testing: Subject Device

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Biocompatibility Testing 9.

Following the 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 tests selected were for prolonged externally communicating devices. The following biocompatibility tests were successfully conducted on the freeflex®+ Transfer Adapter:

Hemolysis ●
Cytotoxicity
Irritation ●
Skin Sensitization ●
Acute Systemic Toxicity ●
Chemical Characterization ●
Material Mediated Pyrogenicity ●
Particulate Testing ●

10. Sterilization Validation

Sterilization was achieved by ethylene oxide and meets the requirements of DIN EN ISO 11135:2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. The ethylene oxide sterilization method achieves a Sterilization Assurance Level (SAL) of 10-6.

11. Conclusion

The freeflex®+ Transfer Adapter, has met all established acceptance criteria for performance testing and design verification testing. Results of functional performance and biocompatibility testing conducted with the freeflex + Transfer Adapter, demonstratethat the subject device supports a substantial equivalence determination to the predicate device. Vial2Bag Advanced™ 20mm Admixture Device (K201415), as described in Section 7.

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.