freeflex+ Transfer Adapter

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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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212445 Device Name freeflex®+ Transfer Adapter Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | |----------------------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## K212445 - 510(k) SUMMARY ## 1. Submitter Information | Name: | Fresenius Kabi AG | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Address: | Else-Kröner-Str. 1<br>61352 Bad Homburg | | Contact Person: | Keith Dunn<br>Director, Regulatory Affairs<br>Fresenius Kabi USA, LLC<br>Three Corporate Drive, 2nd Floor<br>Lake 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 | | Secondary<br>Contact Person: | Jason Ma<br>Sr. Manager, Regulatory Affairs<br>Fresenius Kabi USA, LLC<br>Three Corporate Drive, 2nd Floor<br>Lake 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 {4}------------------------------------------------ | Regulatory Class: | II | |-------------------|---------| | Product Code: | LHI | | 510(k) Number: | K201415 | ## 4. 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. ## 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 {5}------------------------------------------------ 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. - 2. 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. - 3. 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. - 5. 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 {6}------------------------------------------------ #### 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. {7}------------------------------------------------ A comparison between the predicate device and the subject device is provided in Table 1. | Areas for Comparison | Subject Device<br>K212445 | Predicate Device<br>K201415 | Comparison | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code and<br>Regulation | LHI<br>21 CFR 880.5440 | LHI<br>21 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®+<br>Transfer Adapter is<br>indicated for<br>reconstituting and/or<br>admixing a drug in a<br>vial with a 20mm<br>closure and the transfer<br>of the drug into the<br>freeflex®+ IV Bag<br>prior to administration<br>to the patient. The<br>device may be used for<br>pediatric (newborn to<br>21 years) and adult<br>populations. | The Vial2Bag<br>AdvancedTM 20mm<br>Admixture Device is<br>indicated to serve as a<br>connection between a 50,<br>100, or 250ml IV bag,<br>vial with 20mm closure,<br>and an external IV<br>administration set. The<br>integrated Vial Adapter<br>makes it possible to<br>reconstitute and/or<br>admix drugs prior to<br>administration to the<br>patient. | Similar<br>The differences are<br>minimal and do not<br>impact the risk to<br>patient or user. Both<br>devices have the same<br>intended use for the<br>reconstitution and<br>transfer of drug content<br>from the vial into the<br>IV bag. The predicate<br>is indicated for use<br>with any standard IV<br>bag whereas the<br>freeflex®+ Transfer<br>Adapter is for use only<br>the freeflex®+ IV<br>Bags. | | Operation Principle | Manual | Manual | Same | | Areas for Comparison | Subject Device<br>K212445 | Predicate Device<br>K201415 | Comparison | | Design | The freeflex®+<br>Transfer Adapter is<br>made of plastic<br>materials and is a<br>single use, sterile, non-<br>pyrogenic transfer<br>adapter device that<br>connects to a 20mm<br>seal diameter drug vial.<br>The spike of the<br>transfer device pierces<br>the seal of the drug vial<br>and allows for the<br>reconstitution/dilution<br>and transfer of drugs to<br>a 50, 100, 250, 500 or<br>1000 mL freeflex®+<br>IV bag. Fluid is<br>transferredfrom the IV<br>bag to the drug vial by<br>a manual process to<br>reconstitute/dilute the<br>drug prior to being<br>transferred back to the<br>IV bag. Once the drug<br>is transferred to the IV<br>bag the transfer adapter<br>is removed from the IV<br>bag and discarded. | The Vial2Bag<br>Advanced™ 20mm<br>Admixture Device is a<br>single use, fluid transfer<br>device that allows for the<br>reconstitution and<br>transfer of fluids from<br>drug vials into the IV<br>bag containing infusion<br>solution, through the IV<br>bag administration port.<br>The device consists of<br>the body, Protector, IV<br>Port, and an integrated<br>vial adapter. The<br>Vial2Bag connects the<br>IV bag and IV set and<br>creates a fluid path. The<br>Vial2Bag Advanced 20<br>mm Admixture Device's<br>integrated vial adapter<br>connects to the body of<br>the Vial2Bag and to a<br>20mm (or smaller) seal<br>diameter drug vial. The<br>vial adapter spike pierces<br>the seal of the drug vial.<br>Fluid from the IV bag is<br>transferred into the drug<br>vial by a manual process<br>to reconstitute/dilute the<br>drug. Once<br>reconstituted/diluted the<br>drug solution is<br>transferred to the IV bag.<br>The vial adapter can<br>remain attached to the<br>Vial2Bag during drug<br>delivery or alternatively<br>be removed and<br>discarded. The device<br>works with standard 50,<br>100, 250mL IV bags. | Different<br>The difference is<br>minimal and does not<br>impact the risk to<br>patient or user. The<br>Vial2Bag is a system<br>which contains a vial<br>adapter which is<br>attached to the<br>Vial2Bag system when<br>reconstituting/admixing<br>the drug and<br>transferring it to the IV<br>bag. The vial adapter<br>can stay attached to the<br>Vial2Bag device during<br>drug delivery to the<br>patient or be removed<br>from the Vial2Bag<br>device and discarded.<br>The freeflex®+<br>Transfer Adapter is<br>only the adapter. It is<br>attached to the IV bag<br>and drug vial. The drug<br>is<br>reconstituted/admixed<br>and then once the drug<br>has been transferred to<br>the IV bag the<br>freeflex®+ Transfer<br>Adapter is removed<br>from the IV bag and<br>discarded. | | Materials | Body: Polycarbonate<br>Nut: Polycarbonate<br>Safety Ring:<br>Polypropylene | Body: Polycarbonate<br>Option for siliconized<br>spike<br>Vented adapter has PTFE<br>0.2 micron air filter | Different<br>The difference is<br>minimal and does not<br>impact the risk to patient<br>or user.<br>The main body of both<br>devices is made of | | Areas for Comparison | Subject Device<br>K212445 | Predicate Device<br>K201415 | Comparison<br>Page 7 of 9 | | | | | polycarbonate. The<br>subject device has an<br>additional component<br>made of polypropylene<br>(nut) that is not fluid<br>contacting | | Biocompatibility | - Hemolysis<br>- Cytotoxicity<br>- Irritation<br>- Skin Sensitization<br>- Acute Systemic<br>Toxicity<br>- Chemical<br>Characterization<br>- Pyrogenicity<br>- Particulate Testing | - Hemolysis<br>- Cytotoxicity<br>- Irritation<br>- Skin Sensitization<br>- Acute Systemic<br>Toxicity<br>- Sub-chronic Toxicity<br>- Pyrogenicity<br>- Particulate Testing | Similar<br>The difference is not<br>affecting the<br>determination of an<br>unacceptable adverse<br>biological response. The<br>subject device has<br>additional evidence in<br>chemical<br>characterization whereas<br>the predicate device was<br>tested on sub-chronic<br>toxicity. However, the<br>sub-chronic toxicity<br>testing is not required<br>because the subject<br>device is removed from<br>the IV Bag after a few<br>minutes and does not<br>remain attached. | | Drug Form | Powdered or liquid | Powdered or liquid | Same | | Vial Size | 20 mm | 20 mm (or smaller) | Similar<br>The difference is<br>minimal and does not<br>impact the risk to patient<br>or user. The predicate<br>device may be used with<br>smaller size drug vials | | Bag System | freeflex® + IV Bag | Standard IV Bag | Different<br>The difference is<br>minimal and does not<br>impact the risk to patient<br>or user. The predicate<br>device may be used with<br>any standard IV bag<br>while the subject device<br>mayonly be used with<br>the freeflex® + IV Bag | | Bag Size | 50, 100, 250, 500,<br>1000 mL | 50, 100, 250mL | Similar<br>The difference is<br>minimal and does not<br>impact the risk to patient<br>or user. The freeflex®+<br>Transfer Adapter can<br>connect toadditional | | Page 8 of 9 | | | | | Areas for Comparison | Subject Device<br>K212445 | Predicate Device<br>K201415 | Comparison | | Performance Testing | USP<788><br>ISO22413<br>ISO80369-20<br>ISO11607-1<br>Internal Test Methods<br>for mechanical and<br>performance<br>characteristics. | ISO 8536-4<br>Internal Test Methods for<br>mechanical and<br>performance<br>characteristics. | Different<br>For particulate testing<br>the subject device<br>followed USP<788><br>versus ISO8536-4 for<br>the predicate. For other<br>performance tests the<br>subject device followed<br>FDA recognized<br>standards including<br>ISO22413, ISO80369-<br>20, ISO11607-1, as well<br>as in house test methods<br>versus in house test<br>methods were followed<br>for the predicate device. sizes of IV bags<br>compared to the<br>predicate. | Table 1: Summary of Substantial Equivalence Comparison {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ## 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 pharmaceutical<br>preparations | Fragmentation | |-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | USP <788> Particulate Matter in Injections Test<br>method 1 | Particulate Testing | | ISO 80369-20:2015 Small-bore connectors for<br>liquids and gases in healthcare applications - Part<br>20: Common test methods | Luer Connector Leakage<br>Stress Cracking<br>Resistance Testing | | ISO 11607-1 (2019-02) Packaging for terminally<br>sterilized medical devices - Part 1: Requirements<br>for 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 {11}------------------------------------------------ #### 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.