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 Category	Reported 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 Safety	Passed 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 Compatibility	Measurement 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 Factors	Human 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 Management	Risk 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 compatibility	MR 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 compatibility	MR 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

B. Braun Melsugen AG % Andre Kindsvater Senior Consultant RA & QA Emergo Global Consulting , LLC 2500 Bee Cave Road Austin. Texas 78746

Re: K191910

Trade/Device Name: SpaceStation MRI Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRZ, FRN Dated: January 29, 2020 Received: February 4, 2020

Dear Andre Kindsvater:

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

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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 medical devices and radiation-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,

For Nikhil Thakur 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

Enclosure

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Indications for Use

510(k) Number (if known) K191910

Device Name SpaceStation MRI

Indications for Use (Describe)

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.

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."

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Indications for Use

510(k) Number (if known) K191910

Device Name Perfusor® Space Infusion Syringe Pump

Indications for Use (Describe)

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.

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."

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Indications for Use

510(k) Number (if known) K191910

Device Name

Infusomat® Space Volumetric Infusion Pump

Indications for Use (Describe)

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.

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.

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."

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510(k) Summary - K191910

Administrative Information

01) 510(k) Sponsor

B. Braun Melsungen AG Carl-Braun-Strasse 1 Melsungen 34212 Germany Phone: +49 5661 71-1461

02) Contact Person

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Cell Phone: +41 78 843 7077 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: André Kindsvater, Senior Consultant, RA/QA Email: LST.AUS.ProjectManagement@ul.com.

03) Date Prepared

February 28, 2020

Proposed Device(s)

This is a bundled 510(k), where the summary is organized in 3 sub-sections which correspond to each device bundled within the subject 510(k):

. Section A) MRI conditional labeling changes to K062699 Perfusor Space Infusion Syringe Pump (See pages 2 - 4)
Section B) MRI conditional labeling changes to K062700 Infusomat Space Volumetric Infusion Pump (See pages 5 - 7)
Section C) Traditional 510(k) SpaceStation MRI (See pages 8 - 13)

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Section A) Perfusor Space Infusion Syringe Pump

A01) Proposed Device

Trade/Proprietary Name:	Perfusor® Space Infusion Syringe Pump
Common/Usual Name:	Infusion Syringe Pump
Regulation Number:	880.5725
Regulation Device:	Infusion Pump
Product Code:	FRN
Device Class:	Class II
Classification Panel:	General Hospital

A02) Legally Marketed Predicate Device

Perfusor® Space Infusion Syringe Pump System by B. Braun Melsungen AG - K062699

A03) Device Description

A04) Indications for Use Statement

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 fluids through clinically accepted routes of administration. These routes include, but are not limited to 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 and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Perfusor® Space Infusion 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).

A05) Substantial Equivalence Discussion

The Perfusor Space Infusion Syringe Pump design and functional characteristics are the same as those cleared under K062699. The labeling was revised to indicate that the pump is MRI Conditional when

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used within the SpaceStation MRI. The only changes to the Perfusor Syringe Pump are the following:

Characteristic	Subject DeviceK191910Perfusor Space InfusionSyringe Pump	Predicate DeviceK062699Perfusor Space InfusionSyringe Pump System	Discussion of Differences
MRICompatibility	MRI Conditional - onlywithin the SpaceStationMRI.The device is MRI Unsafeif used as a standalonedevice.	MRI Unsafe	There is no change to the subjectinfusion pump device, only thechange to the environment of usewhen the subject device is usedwithin the SpaceStation MRI.Performance in an MR environmentwas verified and validated.
	AdditionalLabeling	MRI Conditional whenused within SpaceStationMRI. Provides referenceto SpaceStation MRIlabeling.	MRI Unsafe

Table 5A - Comparison of Changed Characteristics

The subject device and the predicate device are both infusion pumps; the same in design and functional characteristics. The labeling of the subject device is being revised to indicate that the subject device is MRI Conditional when used within the SpaceStation MRI. The functionality of the Pefusor Space Infusion Syringe Pump was verified when used in the SpaceStation MRI in MR conditions by verification testing.

A06) Non-Clinical Performance Data

Testing was performed to verify the proper functioning of the Perfusor Syringe Pump in the intended Magnetic Resonance (MR) environment when used with the SpaceStation MRI. Both, the influence of the Perfusor Space Infusion Syringe Pump (within the SpaceStation MRI) on the functioning of the intended MRI Scanners and the influence of the intended MRI Scanners on the functioning of the Perfusor Space Infusion Syringe Pump (within the SpaceStation MRI) were tested.

The following functional testing/compatibility testing was completed to demonstrate substantial equivalence of the Perfusor Syringe Pump to the predicate device when used in the SpaceStation MRI in the intended MR environment. The pre-determined acceptance criteria was met in all testing.

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Device performance inintended MRConditions withSpaceStation MRI	• The essential performance requirements of the device were verified throughperformance testing in accordance with the intended use of the device and inaccordance with the FDA Guidance “Infusion Pumps Total Product Life Cycle”,Including flow rate/bolus accuracy, alarm verification, etc.
MRI compatibility	• MR Compatibility testing described in Section C06) for the SpaceStation MRIwas completed with Perfusor Space Infusion Syringe Pumps within theSpaceStation MRI

No clinical testing was completed to support substantial equivalence of the predicate device.

A07) Statement of Substantial Equivalence

Differences between the intended use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness. The performance of the device is supported by non-clinical testing and risk management activities. The Perfuson Space Infusion Syringe Pump is Substantially Equivalent (SE) to the Perfusor Syringe Pump System, cleared under K062699.

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Section B) Infusomat Space Volumetric Infusion Pump

B01) Proposed Device

Trade/Proprietary Name:	Infusomat® Space Volumetric Infusion Pump
Common/Usual Name:	Volumetric Infusion Pumps (Syringe and Volumetric Pumps)
Regulation Device:	Pump, Infusion
Regulation Number:	880.5725
Product Code:	FRN
Device Class:	Class II
Classification Panel:	General Hospital

B02) Legally Marketed Predicate Device

Infusomat® Space Volumetric Infusion Pump System by B. Braun Melsungen AG - K062700

B03) Device Description

B04) Indications for Use Statement

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, 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, irrigation, 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).

B05) Substantial Equivalence Discussion

The Infusomat Space Volumetric Infusion Pump design and functional characteristics are the same as those cleared under K062700. The labeling was revised to indicate that the pump is MRI Conditional when used within the SpaceStation MRI. The only changes to the Infusomat Space Volumetric Infusion Pump are the following:

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Characteristic	Subject DeviceK191910Infusomat® SpaceVolumetric Infusion Pump	Predicate DeviceK062700Infusomat® Space VolumetricInfusion Pump System	Discussion of Differences
MRICompatibility	MRI Conditional - onlywithin the SpaceStationMRI.The device is MRI Unsafe ifused as a standalonedevice.	MRI Unsafe	There is no change to thesubject infusion pumpdevice, only the change tothe environment of usewhen the subject device isused within theSpaceStation MRI.Performance in an MRenvironment of use wasverified and validated.
AdditionalLabeling	MRI Conditional whenused within SpaceStationMRI. Provides reference toSpaceStation MRI labeling.	MRI Unsafe	There is no change to thesubject infusion pumpdevice, only the change tothe environment of usewhen the subject device isused within theSpaceStation MRI. Theadditional labeling describethe MRI conditional use ofthe subject device

Table 5B - Comparison of Changed Characteristics

The subject device and the predicate device are both infusion pumps; the same in design and functional characteristics. The labeling of the subject device is being revised to indicate that the subject device is MRI Conditional when used within the SpaceStation MRI. The functionality of the Infusomat Space Volumetric Infusion Pump was verified when used in the SpaceStation MRI in MR conditions by verification testing.

B06) Non-Clinical Performance Data

Testing was performed to verify the proper functioning of the Infusomat Space Volumetric Infusion Pump in the intended Magnetic Resonance (MR) environment when used with the SpaceStation MRI. Both, the influence of the Infusomat Space Volumetric Infusion Pump (within the SpaceStation MRI) on the functioning of the intended MRI Scanners and the influence of the intended MRI Scanners on the functioning of the Infusomat Space Volumetric Infusion Pump (within the SpaceStation MRI) were tested.

The following functional testing/compatibility testing was completed to demonstrate substantial equivalence of the Infusomat Space Volumetric Infusion Pump to the predicate device when used in the SpaceStation MRI in the intended MR environment. The pre-determined acceptance criteria was met in all testing.

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Device performance inintended MRConditions withSpaceStation MRI	• The essential performance requirements of the device were verified throughperformance testing in accordance with the intended use of the device and inaccordance with the FDA Guidance “Infusion Pumps Total Product Life Cycle”,Including flow rate/bolus accuracy, alarm verification, etc.
MRI compatibility	• MR Compatibility testing described in Section C06) for the SpaceStation MRIwas completed with Perfusor Space Infusion Syringe Pumps within theSpaceStation MRI

No clinical testing was completed to support substantial equivalence of the predicate device.

B07) Statement of Substantial Equivalence

Differences between the intended use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness. The performance of the device is supported by non-clinical testing and risk management activities. The Infusomat Space Volumetric Infusion Pump is Substantially Equivalent (SE) to the Infusomat Space Volumetric Infusion Pump System, cleared under K062700.

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Section C) Traditional 510(k) SpaceStation MRI

C01) Proposed Device

Trade/Proprietary Name:	SpaceStation MRI	Characteristic	Subject DeviceK191910B. Braun Melsungen AGSpaceStation MRI	Predicate DeviceK030323MIPMMRI-Caddy	Discussion of Differences
Common/Usual Name:	MRI System Rack for B. Braun Space Infusion Pumps (Perfusor Syringe andInfusomat Volumetric Pumps)	RegulationNumber	880.5725	880.5725	No difference
Regulation Device:	Accessories, Pump, Infusion	RegulationDescription	Infusion pump.	Infusion pump.	No difference
Regulation Number:	880.5725	DeviceProduct Code	Accessories, Pump,Infusion MRZ	Pump, InfusionFRN	Both devices have the sameenvironment of use. Thepredicate device includesfixed infusion pumps in theMRI systems rack, whereaswith the subject device, theuser has the ability to add orremove infusion pumps.Performance of the Spacepumps within theSpaceStation MRI wasverified and validated for usein the MR environment.
Product Code:	MRZ	Indications forUse	The SpaceStation MRI isa MRI (MagneticResonance Imaging)System Rack foroperation of SpaceInfusion Pumps duringMRI examinations (MRIprocedures) of adult,pediatric or neonatalpatients.The product is intendedto be used by qualifiedhealthcareprofessionals.	The intended medicalapplication of MRI-Caddywith three 2000-Seriessyringe pumps is toproduce controlledmovement of the plungerof a syringe to inject a setamount of therapeuticfluid into a patient withina hospital setting at a setrate and at set times. TheMRI-Caddy is designed foruse in an MR-environmentat a maximum magneticfield strength of 20mT.	Both devices have the sameenvironment of use. Thepredicate device includesfixed infusion pumps in theMRI systems rack, whereaswith the subject device, theuser has the ability to add orremove infusion pumps.Performance of the Spacepumps within theSpaceStation MRI wasverified and validated for usein the MR environment.
Device Class:	Class II
Classification Panel:	General Hospital

C02) Legally Marketed Predicate Device(s)

MRI-Caddy (MIPM Mammendorfer Institut für Physik und Medizin GmbH) - K030323

C03) Device Description

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.

C04) Indications for Use Statement

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.

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C05) Substantial Equivalence Discussion

The following Table 5C compares the SpaceStation MRI to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence.

Table 5C – Comparison of Characteristics- SpaceStation MRI

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Characteristic	Subject DeviceK191910B. Braun Melsungen AGSpaceStation MRI	Predicate DeviceK030323MIPMMRI-Caddy	Discussion of Differences
Type of unit	MRI system rack,including SpaceStation,SpaceCover comfort(housing up to 4 B.Braun Infusomat SpaceVolumetric and PerfusorSpace Syringe infusionpumps)	MRI systems rack,designed for using Medex2010 pumps (fixed in theMRI-Caddy housing, up to3 pumps)	Both devices are MRI systemracks that allow infusionpumps to be used within theMR environment. Thedifference is the physicalpump that the MRI systemrack was designed to contain.Performance of the B. BraunSpace pumps within theSpaceStation MRI wasverified and validated in theMR environment
IncludesInfusion Pumpsas a part of510(k)clearance	No	Yes	The predicate device includesfixed infusion pumps in theMRI systems rack. With thesubject device, the user hasthe ability to add or removeSpace Infusion Pumps.Performance of the Spacepumps within theSpaceStation MRI wasverified and validated for usein the MR environment.
Includes Statusand Alarmdisplay	Yes	Yes(Central alarm)	No difference
IncludesMagnetic fluxdensityindicator (TeslaSpy 2010)	Yes	No	The predicate deviceinstructions state to positionthe device at a certainlocation within the MRenvironment. The subjectdevice instructions state thesame but the device also usesa magnetic flux densityindicator to notify theoperator of a correctlypositioned device.Performance of the magneticflux density indicator wasverified and validated.
MRIConditional	Yes	Yes	No difference
Mode ofoperation	Continuous	Continuous	No difference
Characteristic	Subject DeviceK191910B. Braun Melsungen AGSpaceStation MRI	Predicate DeviceK030323MIPMMRI-Caddy	Discussion of Differences
AC Powered	100 to 240 VAC, 50/60 Hz	100 to 240 VAC, 50/60 Hz	No difference
NetworkConnection	No	No	No difference
Sterile	No	No	No difference
Single-Use	No	No	No difference
Latex Free	Yes	Yes	No difference
MRI Safety andCompatibilitytests	Yes1.5 Tesla and 3 Tesla	Yes1.5 Tesla and 3 Tesla	No difference

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The subject and the predicate devices are both mobile infusion pump management systems to accommodate dedicated infusion pumps. The SpaceStation MRI and the predicate MRI-Caddy both have a faraday cage of antimagnetic materials, which allows them to operate within specification in a MR environment up to 20mT.

The SpaceStation MRI differs from the predicate by having a magnetic flux density indicator (Tesla Spy 2010), which helps the user to correctly position the subject device within the MRI room by measuring the magnetic flux density. The functionality of the Tesla Spy 2010 with the SpaceStation MRI system is verified by performance testing.

The MRI Caddy provides one red light for main alarm indication, whereas the SpaceStation MRI comes with a Status and Alarm display (SpaceCover comfort), all status and alarm conditions within the system as well of as of the pumps themselves are signalized. The functionality of these alarm systems were verified by performance testing.

Based on the information described within this section, the subject device does not raise of safety or effectiveness based on the similarities to the predicate device.

C06) Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of SpaceStation MRI and in showing substantial equivalence to the predicate device. B. Braun Melsungen AG completed a number of non-clinical performance tests.

The SpaceStation MRI passed all testing in accordance with internal requirements, national standards, and international standards shown above to support substantial equivalence of the subject device:

Extensive tests were performed to verify the proper functioning of the SpaceStation MRI in the intended Magnetic Resonance (MR) environment. Both, the influence of the SpaceStation MRI on the functioning of the intended MRI Scanners and the influence of the intended MRI Scanners on the functioning of the SpaceStation MRI were tested. Human factors testing of the SpaceStation MRI was completed to validate safe and proper use of the device.

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A summary of the performance data/non-clinical testing that was provided in support of the substantial equivalence determination for the SpaceStation MRI is provided below:

Software	Software of SpaceStation MRI components, SpaceCover Comfort and MagnetIndicator Tesla Spy 2010 were verified/validated in the following ways:Software documentation is included according to FDA's Guidance forthe Content of Premarket Submissions for Software Contained inMedical Devices for Major level of concern for the software embeddedin the SpaceStation MRI System. Software validation was conducted according to FDA guidancedocument General Principles of Software Validation - Final Guidance forIndustry and FDA Staff.
Electrical Safety	AAMI/ANSI ES 60601-1:2005/(R)2012 + A1:2012, C1:2009/(R)2012 +A2:2010/(R) 2012 Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance
EMC	IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: GeneralRequirements for basic Safety and essential performance - CollateralStandard: Electromagnetic Disturbances -Requirements and Tests
MRI compatibility	Measurement of magnetostatic forces in accordance with intended MRconditions 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 con Field interference test in accordance with FDA recognized standardASTM F2119: 2013 Standard Test Method for Evaluation of MR ImageArtifacts from Passive Implants
DeviceFunctionality/CompatibilityTesting	Verification of SpaceStation MRI – Magnetic Indicator/Tesla spy 2010functionality and associated alarm detection system The essential performance requirements of the compatible Perfusorand Infusomat pumps were verified through performance testing inaccordance with the intended use of the device and in accordance withthe FDA Guidance "Infusion Pumps Total Product Life Cycle", includingflow rate/bolus accuracy, alarm verification, etc., while used withSpaceStation MRI when used in accordance with intended MRconditions.
Human Factors	Human factors studies per the FDA Guidance Applying Human Factorsand Usability Engineering to Medical Devices (February 3, 2016). Thehuman factors studies were conducted with the intended userpopulation, use environment and use scenarios to simulate clinical
		conditions. Results of the human factors testing demonstrate validation of the device per the intended use. Human factors study was conducted in alignment with FDA recognized standard: IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices.
Risk Management		A risk analysis was conducted in accordance with FDA recognized standard ISO 14971: 2007 Medical devices - Application of risk management to medical devices.

Table 5D – Performance Testing Summary

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No clinical testing was completed to support substantial equivalence of the subject device to the predicate device.

C07) Statement of Substantial Equivalence

Differences between the intended use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness. The performance of the device is supported by non-clinical testing and risk management activities. The SpaceStation MRI is Substantially Equivalent (SE) to the MRI-Caddy, cleared under K030323.

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).