nextaro Transfer System, nextaro va

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below. March 15, 2019 sfm medical devices GmbH % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313 Re: K183187 Trade/Device Name: nextaro® Transfer System, nextaro® va Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI Dated: February 18, 2019 Received: February 21, 2019 Dear Mark Job: 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 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 {1}------------------------------------------------ # K183187 - Mark Job devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Sapana Patel -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183187 Device Name The nextaro® Transfer System and nextaro® va Indications for Use (Describe) The nextaro® Transfer System and nextaro® va is indicated for the transfer and mixing of drugs contained in vials. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | | | X | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ Traditional 510(k) 510k Summary # 510K SUMMARY K183187 | Submitter's Name<br>and Address | sfm medical devices GmbH<br>Brueckenstrasse 5<br>Waechtersbach Hessen<br>GERMANY 63607 | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | sfm medical devices GmbH<br>Brueckenstrasse 5<br>Waechtersbach Hessen<br>GERMANY 63607 | | Contact Person: | Phil Triolo<br>Phone: 801-699-9846<br>Facsimile: 801-328-2399 | | Date Prepared: | March 14, 2019 | | Device: | nextaro® Transfer System and nextaro® va | | FDA Product Code: | LHI | | Class: | II | | Common or Usual Name: | I.V. Fluid Transfer Set | | Regulation Description: | Intravascular Administration Set | | Regulation Number: | 21 CFR 880.5440 | | Legally Marketed Predicate: | Mix2Vial® Transfer Device (K031861)<br>West Pharmaceutical Services, Inc. | | Reason for Submission: | New Device | | Device Description: | The nextaro® Transfer System and nextaro® va is indicated for the transfer and<br>mixing of drugs contained in vials. The nextaro® Transfer System and nextaro® va is | practically one system with two variants which are to be used independently. {4}------------------------------------------------ | Technological<br>Characteristics: | The nextaro® Transfer System consists of two components already assembled<br>(screwed together) in the delivery condition. Each of the components has a plastic<br>spike which is used to perforate the seals of a solvent vial, or lyophilizated<br>pharmaceutical vial, respectively. The components have a male and female Luer<br>adapter to create an air-tight inner media-carrying system with open ends for fluid<br>transfer. Both components are equipped with a filter element to prevent particles<br>(fragments of vial seals, undissolved pharmaceutical) from being administered into<br>the patient's circulatory system. | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | To be used as intended, the spike of the blue ("upper") part of the nextaro®<br>Transfer System is used to perforate the seal of the solvent vial. The assembly is<br>flipped vertically and the spike of the white ("lower") part of the device is used to<br>perforate the seal of the pharmaceutical vial. The solvent transfer process starts<br>immediately due to the vacuum in the pharmaceutical vial. | | | After solvent transfer and reconstitution of the pharmaceutical by gentle swirling,<br>the blue component of the device is removed from the white part by unscrewing, a<br>standard syringe with a male Luer is attached to the exposed female Luer of the<br>device to aspirate the ready-to-use solution. | | | The nextaro® va is a standalone device. Basically, it is the lower part of the<br>nextaro® Transfer System, but without the thread which the latter has to connect<br>the upper part. After connecting the nextaro® va to a pharmaceutical vial by<br>pushing it downwards, a solvent can be transferred by a syringe via the female Luer.<br>After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, a<br>standard syringe with a male Luer is attached to the female Luer of the device to<br>aspirate the ready-to-use solution. | Indications for The nextaro® Transfer System and nextaro® va is indicated for the transfer and Use: mixing of drugs contained in vials. | Areas for Comparison | Predicate Device<br>Mix2Vial<br>K031861 | Proposed Device<br>nextaro®<br>Transfer System | Proposed Device<br>nextaro® va | Comparison | |-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------| | Indications for Use | | | | | | Intended use or<br>indications | Intended for<br>transferring and<br>mixing drugs<br>contained in two<br>vials | Indicated for the<br>transfer and mixing<br>of drugs contained<br>in vials | Indicated for the<br>transfer and mixing<br>of drugs contained<br>in vials | See Discussion of<br>Differences | | Regulatory Information | | | | | | Device Classification<br>Name | Set I.V. Fluid<br>Transfer | Set I.V. Fluid<br>Transfer | Set I.V. Fluid<br>Transfer | Equivalent | | Regulation Number | 880.5440 | 880.5440 | 880.5440 | Equivalent | | Regulation Description | Intravascular<br>Administration Set | Intravascular<br>Administration Set | Intravascular<br>Administration Set | Equivalent | | Product Code | LHI | LHI | LHI | Equivalent | | Areas for Comparison | Predicate Device<br>Mix2Vial<br>K031861 | Proposed Device<br>nextaro®<br>Transfer System | Proposed Device<br>nextaro® va | Comparison | | Regulatory Medical<br>Specialty | General Hospital | General Hospital | General Hospital | Equivalent | | Device Class | 2 | 2 | 2 | Equivalent | | GMP Exempt | No | No | No | Equivalent | | Design Features | | | | | | Uses vacuum pressure | Yes | Yes | No | See Discussion of<br>Differences | | Vial size the product is<br>to be used with | 20 mm /<br>14 mm | 20 mm | 20 mm | Equivalent<br>to 20 mm model | | Vial adapter / vial access<br>component | Yes | Yes | Yes | Equivalent | | In-line liquid filter | Yes | Yes | Yes | Equivalent | | Mesh opening | 15 μm | 11 μm | 11 μm | See Discussion of<br>Differences | | Open area | 9 % | 5 % | 5 % | See Discussion of<br>Differences | | Female Luer adapter for<br>connection to syringes | Yes | Yes | Yes | Equivalent | | Luer adapter and vial<br>adapter are integrated<br>in one component | Yes | Yes | Yes | Equivalent | | Needleless access to vial | Yes | Yes | Yes | Equivalent | | Sterile, biocompatible<br>fluid path | Yes | Yes | Yes | Equivalent | | Manufactured by plastic<br>injection molding | Yes | Yes | Yes | Equivalent | | Single use, sterile | Yes | Yes | Yes | Equivalent | | Sterilization | Gamma / EtO | EtO | EtO | Equivalent to one of<br>the methods (EtO) | | Sterility Assurance Level | SAL 10-6 | SAL 10-6 | SAL 10-6 | Equivalent | | Biocompatibility | Pass | Pass | Pass | Equivalent | | Shelf Life | > 3 years | 5 years | 5 years | Equivalent | | Principles of Operation | | | | | | Manually operated | Yes | Yes | Yes | Equivalent | | Mechanically connected<br>to a drug vial | Yes | Yes | Yes | Equivalent | | Transfers solvent<br>manually using a syringe<br>plunger rod | No | No | Yes | similar | | Drug reconstitution<br>through manual<br>agitation of vial while<br>connected to device | Yes | Yes | Yes | Equivalent | | Mixed drug is manually<br>aspirated into a syringe<br>barrel using the syringe<br>plunger rod | Yes | Yes | Yes | Equivalent | | Areas for Comparison | Predicate Device<br>Mix2Vial<br>K031861 | Proposed Device<br>nextaro®<br>Transfer System | Proposed Device<br>nextaro® va | Comparison | | Single Use | Yes | Yes | Yes | Equivalent | | Materials | | | | | | Transfer device | Polycarbonate | Polypropylene, TPE | Polypropylene | Similar | | In-line Filter | Polyethylene<br>terephthalate | Polyethylene<br>terephthalate | Polyethylene<br>terephthalate | Equivalent | | Packaging | Blister Pack: PETG<br>Lid: Tyvek | Blister Pack: PETG<br>Lid: Tyvek | Blister Pack: PETG<br>Lid: Tyvek | Equivalent | # Substantial Equivalence Comparison: {5}------------------------------------------------ {6}------------------------------------------------ ## Discussion of Differences - Difference in While the indications for use for the nextaro® Transfer System and nextaro® va are worded slightly different than that of the predicate device, both the subject devices Indications: and predicate device are used for the same purpose: The transfer of solvents into a drug vial / the aspiration of the ready-to-use solution of the dissolved pharmaceuticals which are contained in vials. The nextaro® Transfer System is intended to be used with two vials (solvent and pharmaceutical agent vial) just as is the predicate device, while the nextaro® va is intended to be used with one vial (pharmaceutical agent vial; the solvent transferred into pharmaceutical agent vial by a syringe with male Luer adapter filled with solvent). There is no critical difference in the intended therapeutic use of the subject and predicate devices. - Uses Vacuum The nextaro® Transfer System, the nextaro® va and the Mix2Vial all are used to Pressure: transfer solvent into a vial which contains a freeze-dried pharmaceutical agent (lyophilizate). All of the devices use pressure to transfer the solvent: In the case of the nextaro® Transfer System, the devices use the negative pressure within the pharmaceutical agent vial to transfer the solvent from the solvent vial which was connected to the device beforehand, just as is the case with the predicate device. The nextaro® va also uses pressure to transfer the solvent, but due to the design of the nextaro® va, the solvent must be applied by means of a syringe. However, the direction of the solvent flow is the same for all predicate and subject devices. There is no critical difference in the use of vacuum pressure or manual pressure (to the plunger of the syringe) to transfer the solvent. The solvent transfer methods of the subject and predicate devices can be regarded as equivalent. Filter The nextaro® Transfer System, the nextaro® va and the Mix2Vial all are equipped with Elements: filter elements, to retain fragments which could be punched out during perforation of the vial seals from being transferred or aspirated into the ready-to-use solution. The same applies for undissolved pharmaceutical agent particles. > The filter mesh used in the nextaro® and nextaro® va are capable to retain particles of ≥ 15 um size. A retention rate of > 95 % of particles sized ≥ 15 um has been confirmed by testing. The performance of the filters (retention) of the subject and predicate devices has been shown to be substantially equivalent. {7}------------------------------------------------ - Shelf life: The predicate device has a shelf-life of > 3 years while the subject devices have a shelflife of 5 years. The packaging materials are equivalent. The subject devices are substantially equivalent with regard to their shelf-life. This does not raise different questions of safety or effectiveness - Both the predicate and the nextaro® devices are made of biocompatible thermoplastic Materials: polymer materials. Although the basic materials for the manufacturing of the devices is not the same, the performance tests show that the subject devices are substantially equivalent regarding the performance of the devices. Both the subject device and predicate use the same filter material (PET). The biocompatibility tests show that the subject devices are biocompatible and can therefore be regarded as substantially equivalent in regard to biocompatibility. ## Testing The following tests were conducted to demonstrate that the nextaro® Transfer System and nextaro® va perform as intended. | Standard | Test Performed | |------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 22413 | • Fragmentation<br>• Penetration Force<br>• Piercing<br>• Verification of Design Specifications for Transfer Devices with Housing | | ISO 594-2 | • Male Conical Fitting / Luer Connector | | ISO 8536-4 | • Flow Rate of Infusion Fluid<br>• Fluid Filter (Retention Rate)<br>• Leakage (Aging/ Submersion Test)<br>• Metal Ions<br>• Particulate Contamination<br>• Penetration Force<br>• Reduction of Oxidizable Matter<br>• Residue on Evaporation<br>• Tensile Strength<br>• Titration Acidity or Alkalinity<br>• UV Absorption of Extract Solution | {8}------------------------------------------------ | Standard | Test Performed | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 11607 | • Sterile Barrier and Packaging Systems | | ASTM D3078 | • Bubble Emissions | | ASTM F 1886 | • Integrity of Seals | | ASTM F 1929-12 | • Seal Leakage | | ASTM F 1980-07 | • Accelerated Aging | | ASTM F 2054-07, EN 868-5 | • Seal Strength | | ISTA 2A | • Transport Testing | | USP <85> , USP <161> | • Bacterial Endotoxin | | N/A | • Roll Inhibition (to design specification)<br>• Transfer performance for residual volume (to design specification)<br>• Opening torque (to design specification) | # Biocompatibility Tests were conducted to show that the nextaro® Transfer System and the nextaro® va were evaluated for biocompatibility in accordance with ISO 10993-1. Filter particulate testing was also conducted (see above table). Material Mediated Pyrogenicity LAL Testing ## Sterility The sterility of the nextaro® Transfer System and nextaro® va were validated in accordance with 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 maximum levels of ethylene oxide (EtO) and ethylene chlorohydrin (ECH) residuals remaining on the products were within the guidelines for limited and tolerable contact limit devices according to ISO 10993-7:2008. ## Summary / Conclusion The evaluation of the proposed nextaro® devices has demonstrated through performance testing to be substantially equivalent to the predicate device. Based on the device type, indications, intended use, technological characteristics, physical characteristics, the nextaro® Transfer Device and nextaro® va are substantially equivalent to the predicate device.