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510(k) Data Aggregation

    K Number
    K241976
    Device Name
    nextaro® va, 15mm, 5µm
    Manufacturer
    SFM Medical Devices GmbH
    Date Cleared
    2024-09-06

    (63 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    SFM Medical Devices GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nextaro® va. 15mm, 5um is indicated for the transfer and mixing of drugs contained in vials.
    Device Description
    The nextaro® va, 15mm, 5μm is a sterile packaged vial adapter for single withdrawal of drug solutions with a single-use syringe via Luer adapter from drug vials or for one-time injection of a low-particle and sterile solution with immediate withdrawal of the prepared drug solution with a single-use syringe via Luer adapter from drug vials.
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    K Number
    K240748
    Device Name
    nextaro® v, 20/20
    Manufacturer
    sfm medical devices GmbH
    Date Cleared
    2024-04-16

    (28 days)

    Product Code
    LHI, DAT
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    sfm medical devices GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nextaro® v, 20/20 is indicated for the transfer and mixing of drugs contained in vials.
    Device Description
    The nextaro® v, 20/20 is a sterile-packaged transfer device with ventilation on solvent side with built-in particle filter (15µm nominal) installed on solvent and drug side and a female Luer-Lock adapter for the connection of a single-use syringe for a low-particle withdrawal of the prepared drug solution. The nextaro® v, 20/20 consists of two components already assembled (screwed together) in the delivery condition. Each of the components has a plastic spike which is used to perforate the seals of a solvent vial, or lyophilizated pharmaceutical vial, respectively. The components have a male and female Luer adapter to create an air-tight inner media-carrying system with open ends at the spikes. Both components are equipped with a filter element to prevent particles (fragments of vial seals, undissolved pharmaceutical) from being administered into the patient's circulatory system. To be used as intended, the spike of the blue ("upper") part of the nextaro® v, 20/20 is used to perforate the seal of the solvent vial. The assembly is flipped vertically and the spike of the white ("bottom") part of the device is used to perforate the seal of the pharmaceutical vial. The solvent transfer process starts immediately due to the vacuum in the pharmaceutical vial. The spike of the upper part has two lumen allows air to enter the solvent vial so that ventilation takes place during the transfer. The other lumen ensures that the solvent is transferred to the pharmaceutical vial. After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, the blue component of the device is removed from the white part by unscrewing, a standard syringe with a male Luer is attached to the exposed female Luer of the device to aspirate the prepared solution.
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    K Number
    K183187
    Device Name
    nextaro Transfer System, nextaro va
    Manufacturer
    SFM Medical Devices GmbH
    Date Cleared
    2019-03-15

    (116 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    SFM Medical Devices GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nextaro® Transfer System and nextaro® va is indicated for the transfer and mixing of drugs contained in vials.
    Device Description
    The nextaro® Transfer System and nextaro® va is practically one system with two variants which are to be used independently. The nextaro® Transfer System consists of two components already assembled (screwed together) in the delivery condition. Each of the components has a plastic spike which is used to perforate the seals of a solvent vial, or lyophilizated pharmaceutical vial, respectively. The components have a male and female Luer adapter to create an air-tight inner media-carrying system with open ends for fluid transfer. Both components are equipped with a filter element to prevent particles (fragments of vial seals, undissolved pharmaceutical) from being administered into the patient's circulatory system. To be used as intended, the spike of the blue ("upper") part of the nextaro® Transfer System is used to perforate the seal of the solvent vial. The assembly is flipped vertically and the spike of the white ("lower") part of the device is used to perforate the seal of the pharmaceutical vial. The solvent transfer process starts immediately due to the vacuum in the pharmaceutical vial. After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, the blue component of the device is removed from the white part by unscrewing, a standard syringe with a male Luer is attached to the exposed female Luer of the device to aspirate the ready-to-use solution. The nextaro® va is a standalone device. Basically, it is the lower part of the nextaro® Transfer System, but without the thread which the latter has to connect the upper part. After connecting the nextaro® va to a pharmaceutical vial by pushing it downwards, a solvent can be transferred by a syringe via the female Luer. After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, a standard syringe with a male Luer is attached to the female Luer of the device to aspirate the ready-to-use solution.
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