(239 days)
Not Found
No
The device description and intended use focus on the mechanical and electrical aspects of housing and operating infusion pumps in an MRI environment. There is no mention of AI or ML in the text.
No
The SpaceStation MRI is described as an MRI System Rack supporting the operation of infusion pumps during MRI examinations. It does not directly provide therapy, but rather facilitates the use of other devices (infusion pumps) that deliver therapeutic agents.
No
The description explicitly states that the SpaceStation MRI is "a MRI (Magnetic Resonance Imaging) System Rack for the operation of Space Infusion Pumps during MRI examinations" and "does not include the Infusion Pumps, and it does not control the operation of the user-installed Infusion Pumps." The other devices mentioned, such as the Perfusor® Space Infusion Syringe Pump and Infusomat® Space Volumetric Infusion Pump, are infusion pumps used for delivering fluids and medications. None of these devices are described as being used to diagnose conditions or diseases.
No
The device description clearly outlines a physical rack system (SpaceStation MRI) with mechanical and electrical components, including a shielded housing, trolley, window, IV line inlets/outlets, knobs, light display, audible alarm, and a magnetic indicator. While it interacts with software-controlled infusion pumps, the device itself is a hardware system.
Based on the provided information, the SpaceStation MRI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Intended Use of SpaceStation MRI: The SpaceStation MRI is a rack system designed to hold and operate infusion pumps during MRI procedures. Its purpose is to facilitate the delivery of fluids and medications to patients in vivo (within the living body) during an imaging procedure. It does not analyze or test any biological specimens.
- Function of SpaceStation MRI: The device provides a shielded environment and connections for existing infusion pumps. It does not perform any diagnostic tests or analyze patient samples.
- Function of the Infusion Pumps: The infusion pumps themselves deliver fluids and medications to the patient. While the substances being delivered might be used in treatment or diagnosis, the pumps are delivery devices, not diagnostic devices.
The SpaceStation MRI is a medical device, specifically an accessory or component used in conjunction with infusion pumps during MRI procedures. Its function is related to patient care and safety during imaging, not to the analysis of biological samples for diagnostic purposes.
N/A
Intended Use / Indications for 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, 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 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).
Product codes
MRZ, FRN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric or neonatal patients
Intended User / Care Setting
qualified healthcare professionals.
healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Device performance in intended MR Conditions with SpaceStation MRI: The essential performance requirements of the device were verified through performance testing in accordance with the intended use of the device and in accordance 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 MRI was completed with Perfusor Space Infusion Syringe Pumps within the SpaceStation MRI.
No clinical testing was completed to support substantial equivalence of the predicate device.
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.
Device performance in intended MR Conditions with SpaceStation MRI: The essential performance requirements of the device were verified through performance testing in accordance with the intended use of the device and in accordance 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 MRI was completed with Perfusor Space Infusion Syringe Pumps within the SpaceStation MRI.
No clinical testing was completed to support substantial equivalence of the predicate device.
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.
Software: Software of SpaceStation MRI components, SpaceCover Comfort and Magnet Indicator Tesla Spy 2010 were verified/validated in the following ways: Software documentation is included according to FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for Major level of concern for the software embedded in the SpaceStation MRI System. Software validation was conducted according to FDA guidance document General Principles of Software Validation - Final Guidance for Industry 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: General requirements for basic safety and essential performance
EMC: 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 con Field interference test in accordance with FDA recognized standard ASTM F2119: 2013 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.
Device Functionality/Compatibility Testing: Verification of SpaceStation MRI – Magnetic Indicator/Tesla spy 2010 functionality and associated alarm detection system The essential performance requirements of the compatible Perfusor and Infusomat pumps were verified through performance testing in accordance with the intended use of the device and in accordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle", including flow rate/bolus accuracy, alarm verification, etc., while used with SpaceStation MRI when used in accordance with intended MR conditions.
Human Factors: Human factors studies per the FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016). The human factors studies were conducted with the intended user population, 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.
No clinical testing was completed to support substantial equivalence of the subject device to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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."
3
Indications for Use
510(k) Number (if known) K191910
Device Name Perfusor® Space Infusion Syringe Pump
Indications for Use (Describe)
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).
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."
4
Indications for Use
510(k) Number (if known) K191910
Device Name
Infusomat® Space Volumetric Infusion Pump
Indications for Use (Describe)
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).
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.
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."
5
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)
6
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
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.
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
7
used within the SpaceStation MRI. The only changes to the Perfusor Syringe Pump are the following:
| Characteristic | Subject Device
K191910
Perfusor Space Infusion
Syringe Pump | Predicate Device
K062699
Perfusor Space Infusion
Syringe Pump System | Discussion of Differences |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MRI
Compatibility | MRI Conditional - only
within the SpaceStation
MRI.
The device is MRI Unsafe
if used as a standalone
device. | MRI Unsafe | There is no change to the subject
infusion pump device, only the
change to the environment of use
when the subject device is used
within the SpaceStation MRI.
Performance in an MR environment
was verified and validated. |
| | Additional
Labeling | MRI Conditional when
used within SpaceStation
MRI. Provides reference
to SpaceStation MRI
labeling. | 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.
8
| Device performance in
intended MR
Conditions with
SpaceStation MRI | • The essential performance requirements of the device were verified through
performance testing in accordance with the intended use of the device and in
accordance 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 MRI
was completed with Perfusor Space Infusion Syringe Pumps within the
SpaceStation 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.
9
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
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.
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:
10
| Characteristic | Subject Device
K191910
Infusomat® Space
Volumetric Infusion Pump | Predicate Device
K062700
Infusomat® Space Volumetric
Infusion Pump System | Discussion of Differences |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MRI
Compatibility | MRI Conditional - only
within the SpaceStation
MRI.
The device is MRI Unsafe if
used as a standalone
device. | MRI Unsafe | There is no change to the
subject infusion pump
device, only the change to
the environment of use
when the subject device is
used within the
SpaceStation MRI.
Performance in an MR
environment of use was
verified and validated. |
| Additional
Labeling | MRI Conditional when
used within SpaceStation
MRI. Provides reference to
SpaceStation MRI labeling. | MRI Unsafe | There is no change to the
subject infusion pump
device, only the change to
the environment of use
when the subject device is
used within the
SpaceStation MRI. The
additional labeling describe
the MRI conditional use of
the 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.
11
| Device performance in
intended MR
Conditions with
SpaceStation MRI | • The essential performance requirements of the device were verified through
performance testing in accordance with the intended use of the device and in
accordance 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 MRI
was completed with Perfusor Space Infusion Syringe Pumps within the
SpaceStation 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 Device
K191910
B. Braun Melsungen AG
SpaceStation MRI | Predicate Device
K030323
MIPM
MRI-Caddy | Discussion of Differences |
|-------------------------|---------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | MRI System Rack for B. Braun Space Infusion Pumps (Perfusor Syringe and
Infusomat Volumetric Pumps) | Regulation
Number | 880.5725 | 880.5725 | No difference |
| Regulation Device: | Accessories, Pump, Infusion | Regulation
Description | Infusion pump. | Infusion pump. | No difference |
| Regulation Number: | 880.5725 | Device
Product Code | Accessories, Pump,
Infusion MRZ | Pump, Infusion
FRN | Both devices have the same
environment of use. The
predicate device includes
fixed infusion pumps in the
MRI systems rack, whereas
with the subject device, the
user has the ability to add or
remove infusion pumps.
Performance of the Space
pumps within the
SpaceStation MRI was
verified and validated for use
in the MR environment. |
| Product Code: | MRZ | Indications for
Use | The SpaceStation MRI is
a MRI (Magnetic
Resonance Imaging)
System Rack for
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 intended medical
application of MRI-Caddy
with three 2000-Series
syringe pumps is to
produce controlled
movement of the plunger
of a syringe to inject a set
amount of therapeutic
fluid into a patient within
a hospital setting at a set
rate and at set times. The
MRI-Caddy is designed for
use in an MR-environment
at a maximum magnetic
field strength of 20mT. | Both devices have the same
environment of use. The
predicate device includes
fixed infusion pumps in the
MRI systems rack, whereas
with the subject device, the
user has the ability to add or
remove infusion pumps.
Performance of the Space
pumps within the
SpaceStation MRI was
verified and validated for use
in 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 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.
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 Device
K191910
B. Braun Melsungen AG
SpaceStation MRI | Predicate Device
K030323
MIPM
MRI-Caddy | Discussion of Differences |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of unit | MRI system rack,
including SpaceStation,
SpaceCover comfort
(housing up to 4 B.
Braun Infusomat Space
Volumetric and Perfusor
Space Syringe infusion
pumps) | MRI systems rack,
designed for using Medex
2010 pumps (fixed in the
MRI-Caddy housing, up to
3 pumps) | Both devices are MRI system
racks that allow infusion
pumps to be used within the
MR environment. The
difference is the physical
pump that the MRI system
rack was designed to contain.
Performance of the B. Braun
Space pumps within the
SpaceStation MRI was
verified and validated in the
MR environment |
| Includes
Infusion Pumps
as a part of
510(k)
clearance | No | Yes | The predicate device includes
fixed infusion pumps in the
MRI systems rack. With the
subject device, the user has
the ability to add or remove
Space Infusion Pumps.
Performance of the Space
pumps within the
SpaceStation MRI was
verified and validated for use
in the MR environment. |
| Includes Status
and Alarm
display | Yes | Yes
(Central alarm) | No difference |
| Includes
Magnetic flux
density
indicator (Tesla
Spy 2010) | Yes | No | The predicate device
instructions state to position
the device at a certain
location within the MR
environment. The subject
device instructions state the
same but the device also uses
a magnetic flux density
indicator to notify the
operator of a correctly
positioned device.
Performance of the magnetic
flux density indicator was
verified and validated. |
| MRI
Conditional | Yes | Yes | No difference |
| Mode of
operation | Continuous | Continuous | No difference |
| Characteristic | Subject Device
K191910
B. Braun Melsungen AG
SpaceStation MRI | Predicate Device
K030323
MIPM
MRI-Caddy | Discussion of Differences |
| AC Powered | 100 to 240 VAC, 50/60 Hz | 100 to 240 VAC, 50/60 Hz | No difference |
| Network
Connection | No | No | No difference |
| Sterile | No | No | No difference |
| Single-Use | No | No | No difference |
| Latex Free | Yes | Yes | No difference |
| MRI Safety and
Compatibility
tests | Yes
1.5 Tesla and 3 Tesla | Yes
1.5 Tesla and 3 Tesla | No difference |
15
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.
16
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 Magnet
Indicator Tesla Spy 2010 were verified/validated in the following ways:
Software documentation is included according to FDA's Guidance for
the Content of Premarket Submissions for Software Contained in
Medical Devices for Major level of concern for the software embedded
in the SpaceStation MRI System. Software validation was conducted according to FDA guidance
document General Principles of Software Validation - Final Guidance for
Industry 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: General
requirements for basic safety and essential performance | |
| EMC | 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 con Field interference test in accordance with FDA recognized standard
ASTM F2119: 2013 Standard Test Method for Evaluation of MR Image
Artifacts from Passive Implants | |
| Device
Functionality/Compatibility
Testing | Verification of SpaceStation MRI – Magnetic Indicator/Tesla spy 2010
functionality and associated alarm detection system The essential performance requirements of the compatible Perfusor
and Infusomat pumps were verified through performance testing in
accordance with the intended use of the device and in accordance with
the FDA Guidance "Infusion Pumps Total Product Life Cycle", including
flow rate/bolus accuracy, alarm verification, etc., while used with
SpaceStation MRI when used in accordance with intended MR
conditions. | |
| Human Factors | Human factors studies per the FDA Guidance Applying Human Factors
and Usability Engineering to Medical Devices (February 3, 2016). The
human factors studies were conducted with the intended user
population, 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
17
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.