MixJect® Transfer Device

{0}------------------------------------------------ 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". May 23, 2023 West Pharma Services IL, Ltd. % Fred Cowdery Director, Regulatory Affairs West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, Pennsylvania 19341 Re: K230464 Trade/Device Name: MixJect® Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI Dear Fred Cowdery: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 22, 2023. Specifically, FDA is updating this SE Letter to add the missing clearance date as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact David Wolloscheck, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 301-796-1480, david.wolloscheck(@fda.hhs.gov. Sincerely, Porsche Bennett Porsche Bennett For David Wolloscheck, Ph.D. 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo has a blue square with the letters FDA in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. West Pharma Services IL, Ltd. % Fred Cowdery Director, Regulatory Affairs West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, Pennsylvania 19341 Re: K230464 Trade/Device Name: MixJect® Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI Dated: February 17, 2023 Received: February 21, 2023 Dear Fred Cowdery: 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 {2}------------------------------------------------ requirements, including, but not limited to: registration and listing (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, Porsche Bennett Porsche Bennett For David Wolloscheck, Ph.D. 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 Ouality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230464 Device Name MixJect® Transfer Device | <b>Indications for Use (Describe)</b> | |-------------------------------------------------------------------------------------| | The device is intended for the transfer and injection 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) #### 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." {4}------------------------------------------------ ## K230464 - 510(k) SUMMARY #### Date Prepared: May 22, 2023 #### 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: Fred Cowdery Director, Regulatory Affairs, Medical Devices Phone: 267-205-1273 Fax: 610-717-0668 E-mail: fred.cowdery@westpharma.com ## SUBJECT DEVICE | Trade Name: | MixJect® Transfer 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 | ## PREDICATE DEVICE | Predicate Device | MixJect Dispensing Pin / with Detachable Vial Holder / with Detachable Vial<br>Holder and Preattached Needle | |-------------------|--------------------------------------------------------------------------------------------------------------| | 510(k) Number | K001293 | | Common/Usual Name | I.V. Fluid Transfer Set | | Product Code | LHI | {5}------------------------------------------------ | Regulation Name / Number / Class | Intravascular Administration Set / 21CFR880.5440 / Class II | |----------------------------------|-------------------------------------------------------------| | Panel | General Hospital | ### INDICATION FOR USE The device is intended for the transfer and injection of drugs contained in a vial. # DEVICE DESCRIPTION #### Device Overview The subject device, MixJect® Transfer Device (MXJ), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer and injection of drugs contained in a vial. The MXJ device is intended for use by Healthcare Professionals (HCPs) in a clinical, hospital, or other healthcare environment. The subject device is available by prescription use only and has no known contraindications. The MXJ device does not contain any medicinal substances and is only intended for use with drug vials having a neck diameter of 13mm. The subject device has a 3-year shelf life. The MXJ device configuration consists of four main components inclusive of a 30-gauge needle, a vial adapter including integral cannulated spike, MXJ Body, and MXJ Core. The subject device interfaces with a syringe (not supplied) that connects to the female Luer lock port located in the main body of the MXJ device. The MXJ Vial Adapter component connects to a drug vial having a neck diameter of 13mm. The Vial Adapter component contains a piercing spike and a female Luer lock connector. Puncturing of the drug vial stopper membrane is achieved by means of an integral spike located in the center of the MXJ Vial Adapter component. Once the drug vial stopper membrane is breached by the cannulated spike, fluid can travel from the drug vial into the MXJ device main body. A prefilled diluent syringe (not supplied) is then connected to MXJ female Luer lock port. The diluent is injected from the syringe into the drug vial. The reconstituted medicament is then aspirated back into the syringe. The MXJ device is then twisted in a counterclockwise direction, changing the fluid path from the syringe-vial to the syringe-needle. After reconstitution and aspiration, the drug is ready to be administered through the attached MXJ needle. The MXJ primary device package consists of a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek® lid sealed on top of the blister pack. In accordance with ISO 10993-1:2018, the subject device MixJect® Transfer Device is classified as an externally communicating device, having limited indirect contact with the patient blood path (< 24 hour). The subject device needle has transient contact (<60 minutes) with the patient body. {6}------------------------------------------------ ### Principle of Operation The MXJ is operated by a manual process. The subject device connects to a drug vial (supplied by the Drug Manufacturer) having a neck diameter of 13mm via the Vial Adapter portion of the MXJ device. The vial adapter contains an integral plastic cannulated spike located in the center of the MXJ Vial Adapter component, intended to puncture the vial stopper membrane allowing access to the vial contents. This piercing cannulated spike then facilitates the transfer of the drug between the vial and the syringe. A prefilled diluent syringe is then connected to the MXJ, interfacing to a female Luer lock port located on the MXJ body. The diluent is then injected into the drug vial. The reconstituted medicament is then aspirated back into the syringe. The MXJ body is then manually rotated in a counterclockwise direction, changing the fluid path from the syringe-vial to the syringe-needle. After reconstitution and aspiration, the drug can be administered through the attached syringe / needle. {7}------------------------------------------------ # TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE The MixJect® Transfer Device is substantially equivalent in its intended use, design/construction, technology/principle of operation, materials, and performance to the predicate device, MixJect Dispensing Pin / with Detachable Vial Holder / with Detachable Vial Holder and Preattached Needle, cleared under K001293. A summary of equivalence and differences between the subject device and the predicate device are provided in the table below. | Areas for<br>Comparison | Subject Device<br>MixJect® Transfer Device | Predicate Device<br>(K001293): | Comparison | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | General Information | | | | | Manufacturer | West Pharma. Services IL, Ltd. | Medimop Medical Projects, Ltd./West Pharma. Services IL., Ltd. | Different; Medimop acquired by West Pharmaceutical Services, Inc. | | Device Trade Name | MixJect® Transfer Device | MixJect Dispensing Pin / with Detachable Vial Holder / with Detachable Vial Holder and Preattached Needle | Similar: Changed for marketing purposes only. Change does not impact device intended use. | | Catalog Number | 970133 | 800405 | Similar: Change does not impact device intended use. | | Indications for Use | The MixJect® Transfer Device is intended for the transfer and injection of drugs contained in a vial. | Transfer, mixing, and injection of drugs contained in a vial. | Similar – Differences do not raise new or additional concerns regarding device safety profile or clinical effectiveness. | | Contraindications | None known | None known | Identical | | Intended User<br>Population | Intended for use by Healthcare Professionals (HCPs) | Intended for use by Healthcare Professionals (HCPs) | Identical | | Intended Use<br>Environment | Intended for use in hospitals, outpatient nursing units and other suitable clinical environments | Intended for use in hospitals, outpatient nursing units and other suitable clinical environments | Identical | | Device Class &<br>Classification Name | Class II, I.V. Fluid Transfer Set | Class II, I.V. Fluid Transfer Set | Identical | | Regulation Number / Name | 21CFR 880.5440<br>Intravascular Administration Set | 21CFR 880.5440<br>Intravascular Administration Set | Identical | | Areas for<br>Comparison | Subject Device<br>MixJect® Transfer Device | Predicate Device<br>(K001293):<br>MixJect Dispensing Pin /<br>with Detachable Vial Holder<br>/ with Detachable Vial<br>Holder and Preattached<br>Needle | Comparison | | Product Code | LHI | rhi | Identical | | Prescription Use | Yes | Yes | Identical | | Single Use | Yes | Yes | Identical | | Shelf life | 3 years | 3 years | Identical | | Design | | | | | Operation Principle | Manual | Manual | Identical | | Design/construction | Featuring a 13mm Vial Adaptor<br>body with tight grip hold<br>("wings"), intended to be<br>attached to a standard drug vial<br>with a neck diameter of 13mm.<br>The device contains a piercing<br>spike, a 30Ga Needle and a<br>female Luer lock fitting<br>compliant with BS EN ISO<br>80369-7:2016, for attachment to<br>a standard accessory such as a<br>syringe (not supplied). | Featuring a 13mm Vial<br>Adaptor body with tight grip<br>hold ("wings"), intended to<br>be attached to a standard drug<br>vial with a neck diameter of<br>13mm. The device contains<br>a piercing spike, a 30Ga<br>Needle and a female Luer<br>lock fitting compliant with<br>ISO 594-1 and ISO 594-2,<br>for attachment to a standard<br>accessory such as a syringe<br>(not supplied). | Similar - Differences<br>noted with ISO Luer<br>Standard compliance do<br>not alter device intended<br>use, clinical effectiveness,<br>or safety profile. | | Female Luer Lock<br>Connector | Compliant with<br>BS EN ISO 80369-7:2016 | Compliant with<br>ISO 594-1 and ISO 594-2 | Similar – Subject device<br>updated for compliance<br>with latest ISO Luer<br>standard. No change in<br>intended use. | | Compatible Vial<br>Size | 13mm | 13mm | Identical | | Body Diameter | 18.5mm to accommodate 13mm<br>standard vials. | 18.5mm to accommodate<br>13mm standard vials. | Identical | | Piercing Spike | Single lumen | Single lumen | Identical | | Vial Adapter Fit | Vial first, snap fit to vial | Vial first, snap fit to vial | Identical | | Material | MixJect Body: Polycarbonate<br>MixJect Core: High Density<br>Polyethylene<br>MixJect Vial Adapter Body:<br>Polycarbonate | MixJect Body: Polycarbonate<br>MixJect Core: High Density<br>Polyethylene<br>MixJect Vial Adapter Body:<br>Polycarbonate | Identical | | Areas for<br>Comparison | Subject Device<br>MixJect® Transfer Device | Predicate Device<br>(K001293): | Comparison | | | | MixJect Dispensing Pin /<br>with Detachable Vial Holder<br>/ with Detachable Vial<br>Holder and Preattached<br>Needle | | | Biocompatibility | ISO 10993-1:2018<br>External Communicating,<br>Transient Contact (<60 min) | ISO 10993-1 and USP<br>Biological Reactivity<br>External Communicating,<br>Transient Contact (<60 min) | Identical | | Non-pyrogenic | Yes | Yes | Identical | | Sterilization | | | | | Sterility | Sterile | Sterile | Identical | | Sterilization Method | Gamma | Gamma | Identical | | Sterility Assurance<br>Level | SAL of 10-6 | SAL of 10-6 | Identical | | Packaging | | | | | Packaging | Sterile Barrier package<br>materials: PETG blister with<br>Tyvek® seal | Sterile Barrier package<br>materials: PETG blister with<br>Tyvek® seal | Identical | | | Sterile Barrier package<br>orientation: Devices are supplied<br>in an individual blister, vial first<br>orientation. | Sterile Barrier package<br>orientation: Devices are<br>supplied in an individual<br>blister, vial first orientation. | | ### Substantial Equivalence Comparison Table {8}------------------------------------------------ {9}------------------------------------------------ # PERFORMANCE DATA The following non-clinical performance data were provided in support of the substantial equivalence determination. ### Performance Testing Performance testing was conducted to confirm the MixJect® Transfer Device meets all applicable design and performance requirements throughout its defined shelf life and 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. {10}------------------------------------------------ | Test | Test Method/ Standard | |--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Fragmentation Test | ISO 8536-2:2010 section 6.2.2 | | Particulate Testing | USP <788> | | Internal Diameter Upper Skirt | ISO 8362-6:2010 Section 4.2 | | Luer Gauging Test | ISO 594-1:1986 and ISO 594-2:1998 | | Luer Stability and compliance to ISO 80369-7 | ISO 80369-7:2021 | | Luer Stability and compliance to ISO 80369-7 | ISO 80369-20:2015, Annex B & Annex C for<br>the leakage reference connector (fluid<br>leakage) | | Luer Stability and compliance to ISO 80369-7 | ISO 80369-20:2015, Annex D & Annex C for<br>the leakage reference connector (air leakage) | | Luer Stability and compliance to ISO 80369-7 | ISO 80369-20: 2015, Annex E & Annex C for<br>the stress cracking reference connector | | Luer Stability and compliance to ISO 80369-7 | ISO 80369-20: 2015, Annex F & Annex C for<br>the axial load reference connector | | Luer Stability and compliance to ISO 80369-7 | ISO 80369-20: 2015, Annex G & Annex C for<br>the resistance separation from unscrewing<br>reference connector | | Luer Stability and compliance to ISO 80369-7 | ISO 80369-20: 2015, Annex G & Annex C for<br>the overriding reference connector | | Luer Stability and compliance to ISO 80369-7 | ISO 80369-7:2021 Table B.2 and B.5<br>(compliance to dimensions) | | Residual Volume | In-house test method | | Device Leakage | In-house test method | | Device Total Penetration Force | In-house test method | | Vial Adapter Detachment Force | In-house test method | | Product Retention in Blister | In-house test method | | Flow Rate | In-house test method | | Device Removal Force from Blister | In-house test method | | Tyvek Total Peel Test Force | In-house test method | | Test | Test Method/ Standard | | Internal Diameter Dimensional Measurements Upper Skirt | In-house test method | | Functionality according to IFU | In-house test method | | Injection Force | In-house test method | | Aspiration Force | In-house test method | | Label Legibility | In-house test method | | Impact Force | In-house test method | | Needle Protective Cap Removal Force | In-house test method | | Torque Test | In-house test method | ## Summary of Performance Testing {11}------------------------------------------------ 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, objective evidence satisfies the product requirements for performance, safety and effectiveness and the results support a determination of substantial equivalence to the predicate device. #### Biocompatibility Testing The biocompatibility evaluation for the MixJect® Transfer Device was conducted in accordance with, 2016 FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: ISO 10993-5:2009: Cytotoxicity ISO 10993-4: 2017: ASTM Hemolysis ASTM F756: Hemolysis Study ISO 10993-10:2010: Maximization and Sensitization ISO 10993-10:2010: Intracutaneous Reactivity ISO 10993-11:2017: Acute Systemic Toxicity ISO 10993-11:2017: Material Mediated Pyrogenicity {12}------------------------------------------------ ### Sterilization The subject device is terminally sterilized using a Gamma irradiation sterilization method, validated in accordance with standard BS EN ISO 11137-1:2015 & A2:2019 Sterilization of health care products – Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and BS EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, and ISO 13004 -Sterilization of health care products – Radiation – Substantiation of a selected sterilization dose: Method VDmaxD. The sterilization method of Gamma irradiation provides a sterility assurance level (SAL) of 10-6. Bacterial Endotoxin Testing by limulus amebocyte lysate (LAL) was also performed on the same batch of product used for sterility dose verification, which passed with acceptable levels, further ensuring the safety of the device. The Sterility Validation and Bacterial Endotoxin Testing are provided within this submission. ## CLINICAL DATA Clinical trials were not performed for the MixJect® Transfer Device. ## CONCLUSION The differences between the predicate and the subject devices do not raise any new or different questions of safety or effectiveness. The subject device, MixJect® Transfer Device is substantially equivalent to the predicate device, MixJect Dispensing Pin / with Detachable Vial Holder / with Detachable Vial Holder and Preattached Needle.