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510(k) Data Aggregation

    K Number
    K191910
    Device Name
    SpaceStation MRI
    Manufacturer
    B. Braun Melsugen AG
    Date Cleared
    2020-03-12

    (239 days)

    Product Code
    MRZ,FRN
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K062699,K062700,K030323
    Why did this record match?
    Device Name :

    SpaceStation MRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SpaceStation MRI is a MRI (Magnetic Resonance Imaging) System Rack for the operation of Space Infusion Pumps during MRI examinations (MRI procedures) of adult, pediatric or neonatal patients.
    The product is intended to be used by qualified healthcare professionals.

    The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation'ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood components, Total Parenteral Nutrition (TPN), Lipids, and enteral fluids. The Perfusor® Syringe Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances).

    The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The system is intended for use on adults, pediativs, and neonates for the intermittent or continuous delivery of parenteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to colloids and cristalloids, blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. (only road ambulances).

    Device Description

    The SpaceStation MRI is a movable MRI Rack System for the operation of up to four B.Braun Space Infusions Pumps in MRI rooms (faraday cage of antimagnetic materials) during MRI examinations of patients. The SpaceStation MRI does not include the Infusion Pumps, and it does not control the operation of the user-installed Infusion Pumps. Patients are moved from nursing units to the MRI area with infusing pumps which are placed in the SpaceStation MRI for the MRI scan.

    The SpaceStation MRI is a RF-shielded housing which is mounted on the trolley. The mechanical construction of the housing makes it possible to position the system within the MRI room; it provides a shielded space and mechanical and electrical connections for up to four Space Infusion Pumps. A window in the door allows for direct viewing of the inserted infusion pumps, allowing all pump status and alarm conditions to be observed. The exterior housing provides IV line inlets and outlets, and knobs to release the infusion pumps.

    The SpaceStation MRI (Unit) includes the SpaceStation with SpaceCover comfort and Magnet Indicator Tesla Spy 2010.

    The SpaceCover comfort includes a large light display that shows the status and alarm condition of the pumps within the station as well as an audible alarm.

    The Magnet Indicator Tesla Spy 2010 allows the operator to correctly position the SpaceStation MRI within the MRI room by measurement of the magnetic flux density. An optical and audible alarm is triggered if the station is too close to the MRI, exceeding the permitted flux density. The Trolley has an IV pole and provides a mount for the Safety Tether. The SpaceStation MRI is not connected to a network.

    The Perfusor® Space Infusion Syringe Pump is a 12V DC or battery powered external, transportable, infusion syringe pump. The Perfusor® Space Infusion Syringe Pump utilizes a swivel-drive pumping mechanism and is intended to provide infusions of parenteral fluids. The Perfusor® Space Infusion Syringe Pump is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances). A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting.

    The system is intended to provide intermittent or continuous delivery of parenteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medicated for infusion as well as blood and blood products.

    The Perfusor® Space Infusion Syringe Pump uses standard, single-use, disposable syringes (with luer-lock connectors) designed for use on syringe pumps and validated on the Perfusor® Space Infusion Syringe Pump.

    The Infusomat Space Volumetric Infusion Pump is a 12V DC or battery powered external, transportable, volumetric infusion pump. The Infusomat Space Volumetric Infusion Pump utilizes a linear peristaltic pumping mechanism and is intended to provide infusions of parenteral fluids. The Infusomat Space Volumetric Infusion Pump is intended for but not limited to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances). A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting.

    The system created by using the administration sets with the Infusomat Space Volumetric Infusion Pump is intended to provide intermittent or continuous flow of parenteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medications indicated for infusion as well as blood and blood products.

    AI/ML Overview

    This document describes the SpaceStation MRI (K191910), an MRI System Rack for B. Braun Space Infusion Pumps, and modifications to the Perfusor Space Infusion Syringe Pump (K062699) and Infusomat Space Volumetric Infusion Pump (K062700) to be MRI Conditional when used with the SpaceStation MRI.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are generally described as "pre-determined acceptance criteria was met in all testing" and conformance to various national and international standards. No specific quantitative targets are provided in the document for performance metrics like flow rate accuracy or alarm thresholds.

    Acceptance Criteria CategoryReported Device Performance and Methods
    For SpaceStation MRI (Traditional 510(k))
    Software Validation (SpaceStation MRI components, SpaceCover Comfort, Magnet Indicator Tesla Spy 2010)Software documentation aligned with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Major level of concern). Software validation conducted according to FDA guidance "General Principles of Software Validation - Final Guidance for Industry and FDA Staff". (Detailed results not provided, but stated as "verified/validated")
    Electrical SafetyPassed testing in accordance with AAMI/ANSI ES 60601-1:2005/(R)2012 + A1:2012, C1:2009/(R)2012 + A2:2010/(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
    EMC (Electromagnetic Compatibility)Passed testing in accordance with IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements for basic Safety and essential performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
    MRI CompatibilityMeasurement of magnetostatic forces in accordance with intended MR conditions. Magnetic immunity in accordance with intended MR conditions. MRI immunity in accordance with intended MR conditions. Radio frequency field induced and gradient field induced heating. Field interference test in accordance with FDA recognized standard ASTM F2119: 2013 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants. Key Finding: Passed all tests for 1.5 Tesla and 3 Tesla MRI environments.
    Device Functionality/Compatibility Testing (incl. Tesla Spy 2010 and alarm systems)Verification of SpaceStation MRI – Magnetic Indicator/Tesla spy 2010 functionality and associated alarm detection system. Essential performance requirements of compatible Perfusor and Infusomat pumps verified through performance testing in accordance with their intended use and FDA Guidance "Infusion Pumps Total Product Life Cycle" (including flow rate/bolus accuracy, alarm verification, etc.), while used with SpaceStation MRI in intended MR conditions. Key Finding for Tesla Spy 2010: Functionality of the magnetic flux density indicator was verified and validated to notify the operator of a correctly positioned device. Key Finding for Alarm Systems: Functionality of alarm systems (SpaceCover comfort) verified by performance testing.
    Human FactorsHuman factors studies conducted per FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016). Studies involved intended user population, use environment, and use scenarios to simulate clinical conditions. Conducted in alignment with IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices. Key Finding: Results demonstrate validation of the device per the intended use.
    Risk ManagementRisk analysis conducted in accordance with FDA recognized standard ISO 14971: 2007 Medical devices - Application of risk management to medical devices.
    For Perfusor Space Infusion Syringe Pump (Labeling Change)
    Device performance in intended MR Conditions (when used within SpaceStation MRI)Essential performance requirements of the device verified through performance testing in accordance with intended use and FDA Guidance “Infusion Pumps Total Product Life Cycle” (including flow rate/bolus accuracy, alarm verification, etc.). Key Finding: Functionality of the Perfusor Space Infusion Syringe Pump was verified when used in the SpaceStation MRI in MR conditions. The pre-determined acceptance criteria were met.
    MRI compatibilityMR Compatibility testing described for the SpaceStation MRI (in Section C06) was completed with Perfusor Space Infusion Syringe Pumps within the SpaceStation MRI. Key Finding: Passed all MRI compatibility tests.
    For Infusomat Space Volumetric Infusion Pump (Labeling Change)
    Device performance in intended MR Conditions (when used within SpaceStation MRI)Essential performance requirements of the device verified through performance testing in accordance with intended use and FDA Guidance “Infusion Pumps Total Product Life Cycle” (including flow rate/bolus accuracy, alarm verification, etc.). Key Finding: Functionality of the Infusomat Space Volumetric Infusion Pump was verified when used in the SpaceStation MRI in MR conditions. The pre-determined acceptance criteria were met.
    MRI compatibilityMR Compatibility testing described for the SpaceStation MRI (in Section C06) was completed with Perfusor Space Infusion Syringe Pumps (a typo, likely meant Infusomat pumps here but referencing the same tests performed for Perfusor due to the bundled nature) within the SpaceStation MRI. Key Finding: Passed all MRI compatibility tests.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not specify exact sample sizes for the test sets. All testing described is non-clinical performance testing, verified to be compliant with national and international standards. The provenance of the data is from the manufacturer, B. Braun Melsungen AG, based in Germany. The studies are prospective in nature, as they involve testing the physical devices in controlled environments for substantial equivalence determination.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    No ground truth established by experts is mentioned as this is a device for infusion and an MRI rack, not an AI/diagnostic device that relies on expert interpretation of observational data. The performance is assessed against technical specifications and safety standards.

    4. Adjudication Method for the Test Set

    Not applicable. This is not a study requiring adjudication of expert interpretations. Device performance is determined by meeting pre-defined technical acceptance criteria in a laboratory setting.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

    No. This document does not mention any MRMC comparative effectiveness study. The devices are infusion pumps and an MRI system rack, not AI-powered diagnostic tools designed to improve human reader performance.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

    Not applicable. The SpaceStation MRI, Perfusor Space Infusion Syringe Pump, and Infusomat Space Volumetric Infusion Pump are physical medical devices, not algorithms. Their performance is assessed directly through non-clinical testing. The "Magnet Indicator Tesla Spy 2010" is an integrated component of the SpaceStation MRI, and its functionality was verified as part of the system.

    7. The Type of Ground Truth Used

    The "ground truth" for the performance of these devices is established by technical specifications, national and international standards, and regulatory guidance documents (e.g., FDA's "Infusion Pumps Total Product Life Cycle" and "Applying Human Factors and Usability Engineering to Medical Devices"). The devices must meet these pre-defined, measurable criteria for safety and effectiveness.

    8. The Sample Size for the Training Set

    Not applicable. There is no training set mentioned as these are hardware devices and not AI/machine learning algorithms that require training data.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no training set for these devices.

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