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510(k) Data Aggregation
K Number
K241976Device Name
nextaro® va, 15mm, 5µm
Manufacturer
SFM Medical Devices GmbH
Date Cleared
2024-09-06
(63 days)
Product Code
LHI
Regulation Number
880.5440Why 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
K240748Device Name
nextaro® v, 20/20
Manufacturer
sfm medical devices GmbH
Date Cleared
2024-04-16
(28 days)
Product Code
LHI, DAT
Regulation Number
880.5440Why 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
K183187Device Name
nextaro Transfer System, nextaro va
Manufacturer
SFM Medical Devices GmbH
Date Cleared
2019-03-15
(116 days)
Product Code
LHI
Regulation Number
880.5440Why 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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