MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit

K143538 · Bayer Medical Care, Inc. · DXT · Aug 14, 2015 · Cardiovascular

Device Facts

• Record ID: K143538
• Device Name: MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
• Applicant: Bayer Medical Care, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Aug 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The MEDRAD® MRXperion MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.

Device Story

Automated syringe-based fluid delivery system for MR contrast media and saline; used in MRI suites. System comprises Scan Room Unit (SRU) with injector head and Control Room Unit (CRU) with All-in-One Computer (AIOC) and pod. Operator programs injection volume and flow rate via touchscreen; system performs automated filling, priming, and injection. Includes eGFR and weight-based dosing calculators; informatics compatibility. Fiber optic communication between units. Provides real-time injection progress feedback. Benefits include precise, automated delivery of contrast agents, improving workflow and consistency in diagnostic imaging. Operated by trained healthcare professionals.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via system testing (flow rates, pressures, timers, calculator accuracy), biocompatibility (ISO 10993), sterilization validation (ISO 11137), electrical safety/EMC (IEC 60601-1), and simulated use/human factors testing (ANSI/AAMI HE75, EN 62366).

Technological Characteristics

Syringe-based injector; dual-syringe system. Materials: PET (barrel), polycarbonate (plunger), polyisoprene/polybutadiene (plunger cover), silicone oil (coating), ABS (spikes), PVC (tubing). Connectivity: Fiber optic. Power: AC mains with rechargeable Li-ion battery for motors. Sterilization: E-beam. Software: Rule-based control system with integrated calculators.

Indications for Use

Indicated for delivery of contrast media and saline into the human vascular system for diagnostic MRI studies. Patient population: individuals undergoing MRI procedures with scanners between 0.7T and 3.0T. Contraindications: none stated.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Spectris Solaris EP MR Injection System (K042784)

Reference Devices

• Weight Based Dosing Calculator - Nemoto Sonic Shot GX (K091734)
• eGFR Calculator - E-Z-EM Empower MR Injection System (K062449)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, representing health and human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 14, 2015

Bayer Medical Care, Inc. Lisa Ewing Sr. Principal Regulatory Affairs Specialist 1 Bayer Drive Indianola, PA 15051

Re: K143538

Trade/Device Name: MEDRAD MRXperion MR Injection System and MR Injection System Svringe Kit Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: December 12, 2014 Received: December 15, 2014

Dear Lisa Ewing:

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. 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M. A. Hilleman

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

K143538 510(k) Number:

Device Name: MRXperion MR Injection System and MR Injection System Syringe Kit

Indications for Use:

The MEDRAD® MRXperion MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.

Prescription Use × (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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### 510(k) Summary

| Submitter: | Bayer Medical Care, Inc.<br>1 Bayer Drive<br>Indianola, PA 15051 | Bayer Medical Care Inc.<br>1 Bayer Drive<br>Indianola, PA 15051<br>U.S.A.<br>[phone]<br>www.ri.bayer.com |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa A. Ewing<br>Sr. Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Email: [e-mail] | |
| Date Prepared: | July 2, 2015 | |
| Device Trade Name: | MEDRAD MRXperion MR Injection System<br>MEDRAD MRXperion Sterile Disposable<br>MRI Kit | |
| Common Name: | Angiographic Injector and Syringe | |
| Classification Name: | Injector and Syringe, Angiographic [21 CFR 870.1650] | |
| Product Code: | DXT | |
| Classification: | Class II | |
| Predicate Device: | The subject device is equivalent to the<br>following device:<br>Spectris Solaris EP MR Injection System<br>K042784, December 10, 2004<br><br>Reference devices:<br>- Weight Based Dosing Calculator -<br>Nemoto Sonic Shot GX, K091734, May<br>21, 2010<br>- eGFR Calculator - E-Z-EM Empower<br>MR Injection System, K062449, April 13,<br>2007 | |

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### Device Description:

The MEDRAD MRXperion MR Injection System is a software-controlled medical device used for the administration of intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes and then to perform an injection with a user-programmed volume and flow rate.

The MEDRAD MRXperion MR Injector consists of two basic modules: a Scan Room Unit (SRU) and a Control Room Unit (CRU).

The SRU is comprised of an integral injector head, base assembly, pedestal, and a power supply.

- The injector head of the SRU physically performs the injection. .
- . The base assembly functions as the interface between the CRU, the injector head, and the SRU power supply.
- . The injector head and base are located on a pedestal is designed with locking casters to allow the SRU to be moved when not connected to a patient.
- . To power the base assembly, power is received from the AC mains and is converted to DC voltage by the SRU power supply.

The CRU consists of an All-in-One Computer (AlOC), pod, their dedicated power supplies, mechanical stand, and an optional hand switch.

- The AIOC provides a platform for the graphical user interface for the injector as well as ● the optional informatics applications. From the AIOC, an operator can use the touchscreen display to manage protocols, arm and disarm the injector, review injection realtime progress/feedback and history, access eGFR and patient Weight-Based Dosing calculators, and set system configuration options. The operator can also use the features of the optional informatics device from the AIOC.
- The pod provides injection start and stop functionality and contains the safety controls . for the CRU.
- . To power the AIOC and pod, each component receives AC mains power from its own dedicated off-the-shelf power supply.
- The AIOC and pod are mounted on a desk top mechanical stand.
- . An optional hand switch gives the operator an additional means to start, hold, and stop an injection from the Control Room. The hand switch contains a light that identifies the state of the injector.

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#### Indications for Use:

The MEDRAD® MRXperion MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.

#### Comparison to the Predicate Device:

The fundamental scientific technology, materials, sterilization process, manufacturing processes and risk assessment are unchanged from the predicate. The intended use and indications for use statement are unchanged from the predicate device with the exception that the MEDRAD MRXperion MR Injection System is indicated for use with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. No new or different questions of safety or effectiveness are raised with the proposed modification.

Tables 1, 2 and 3 provide a detailed comparison of the MEDRAD MRXperion MR Injection System to the predicate Spectris Solaris EP MR Injection Device:

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| Feature | MEDRAD MRXperion<br>MR Injection System<br>(Proposed) | Spectris Solaris EP<br>(K042784) | Rationale for Change | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Indications for Use<br>/ Intended Use | The MEDRAD®<br>MRXperion MR Injection<br>System is a syringe-based<br>fluid delivery system<br>indicated for delivery of<br>contrast media and saline<br>during MR applications. It<br>is intended to be used for<br>the specific purpose of<br>injecting intravenous MR<br>contrast media and saline<br>into the human vascular<br>system for diagnostic<br>studies in magnetic<br>resonance imaging (MRI)<br>applications with MRI<br>scanners that have a<br>magnetic field strength<br>between 0.7 and 3.0<br>Tesla. Only trained<br>healthcare professionals<br>are intended to operate<br>this device. | The Spectris Solaris EP<br>MR Injection System is a<br>syringe-based fluid<br>delivery system indicated<br>for delivery of contrast<br>media during MR<br>applications. It is<br>intended to be used for<br>the specific purpose of<br>injecting intravenous MR<br>contrast media and<br>common flushing<br>solutions into the human<br>vascular system for<br>diagnostic studies in<br>magnetic resonance<br>imaging (MRI)<br>procedures. Only trained<br>healthcare professionals<br>are intended to operate<br>this device. | Updates for clarification of<br>MR field strength only. | |
| Fill Volume<br>(Syringe A) | 0.5 ml to max. syringe<br>volume in:<br>* 0.1 ml increments<br>between 0.5 and 31 ml<br>* 1 ml increments for 31<br>ml and above | 0.5 ml to max. syringe<br>volume in:<br>* 0.1 ml increments<br>between 0.5 and 31 ml<br>* 1 ml increments for 31<br>ml and above | N/A. No change. | |
| Fill Volume<br>(Syringe B) | 1 ml to max. syringe<br>volume in 1 ml increments | 1 ml to max. syringe<br>volume in 1 ml increments | N/A. No change. | |
| Fill Speed<br>(low speed) | 1.0 to 10.0 ml/s in 0.5 ml/s<br>increments | 1.0 to 10.0 ml/s in 0.5 ml/s<br>increments | N/A. No change. | |
| Feature | MEDRAD MRXperion<br>MR Injection System<br>(Proposed) | Spectris Solaris EP<br>(K042784) | Rationale for Change | |
| Fill Speed<br>(high speed) | 1.0 to 10.0 ml/s | 1.0 to 10.0 ml/s | N/A. No change. | |
| Flow Rate | 0.01 to 10 ml/s | 0.01 to 10 ml/s | N/A. No change. | |
| Delay | N/A. Addressed by Pause<br>Phase. | 1 to 300 s in 1 s<br>increments | MRXP allows Pause<br>phase to be the first<br>phase of the injection. | |
| Pause Phase | 1 to 1200 s | 1 to 900 s | Longer Pause Phase<br>added for customer<br>convenience. | |
| Programmable<br>Pressure Limit<br>(PSI/kPa) | Yes | Yes | N/A. No change. | |
| Keep Vein Open<br>(KVO) | Yes | Yes | N/A. No change. | |
| Protocol Memory | 60 protocols of up to 6<br>phases each | 32 protocols of up to 6<br>phases each | Additional protocol<br>memory storage added<br>for customer<br>convenience. | |
| Injection History<br>Memory | Previous 20 successful<br>injections | Previous 20 successful<br>injections | N/A. No change. | |
| Information<br>Display<br>(Control Room) | Color LCD | Color LCD | N/A. No change. | |
| Programming<br>Keys<br>(Control Room) | Software-generated<br>via an LCD touch<br>screen | Software-generated<br>via an LCD touch<br>screen | N/A. No change. | |
| Programming<br>Keys<br>(Scan Room) | Dedicated keys on injector<br>head | Dedicated keys on injector<br>head | No change to technology.<br>Additional keys added to<br>MRXperion Injector Head<br>for increased functionality<br>in the scan room. | |
| Multi-Phase | 6 phases per injection | 6 phases per injection | N/A. No change. | |
| Feature | MEDRAD MRXperion<br>MR Injection System<br>(Proposed) | Spectris Solaris EP<br>(K042784) | Rationale for Change | |
| Safety Stop<br>Mechanism | Software stops and<br>electromechanical switch | Software stops | Additional safety stops<br>included. | |
| Syringe System | Dual Syringes | Dual Syringes | N/A. No change. | |
| Syringe Docking | Non-rotational orientation | Keyed, rotational<br>orientation | Customer convenience. | |
| Docking | Manual and Automatic | Manual only | Customer convenience. | |
| Fill Control | Manual and Automatic | Manual only | Automatic fill feature<br>added for customer<br>convenience. | |
| Prime Control | Manual and Automatic | Manual only | Automatic prime feature<br>added for customer<br>convenience. | |
| Retract Control | Manual and Automatic | Manual only | Automatic retract feature<br>added for customer<br>convenience. | |
| Check for Air<br>Confirmation | Operator visual<br>inspection; user confirmed | Operator visual<br>inspection; user confirmed | N/A. No change. | |
| Start/Stop Switch | Control Room and Scan<br>Room | Control Room | Customer convenience. | |
| Hand Switch | Control Room (optional) | Control Room | Spectris Solaris EP did<br>not have Start/Stop<br>capability without the<br>Hand Switch. The Hand<br>Switch is not needed for<br>MRXperion, as a<br>Start/Stop switch was<br>added to the MRXperion<br>Injector Head and the<br>Control Room Unit. | |
| Communication | Fiber Optic | Fiber Optic | N/A. No change. | |
| Feature | MEDRAD MRXperion<br>MR Injection System<br>(Proposed) | Spectris Solaris EP<br>(K042784) | Rationale for Change | |
| MR Compatibility | 0.7T to 3.0T | 0.2T to 3.0T | MRXperion is<br>commercially targeted for<br>scanners used in the<br>majority of the US and<br>worldwide market. | |
| eGFR Calculator | Yes | No<br>Reference Device -<br>E-Z-EM Empower MR<br>Injection System K062449 | eGFR Calculator feature<br>added for customer<br>convenience. | |
| Weight-Based<br>Dosing Calculator | Yes | No<br>Reference Device -<br>Nemoto Sonic Shot GX<br>K091734 | Weight-Based Dosing<br>Calculator feature added<br>for customer<br>convenience. | |
| Informatics<br>Compatibility | Yes | No | Informatics compatibility<br>added for customer<br>convenience. | |
| Power<br>management | The Base supplies power<br>to the Injector Head and<br>the main processor via an<br>AC/DC power supply-<br>module. A rechargeable<br>lithium ion battery is used<br>to power the motors in the<br>base during an injection. | Rechargeable lead-acid<br>battery power for the Scan<br>Room Unit. | Improved power<br>management scheme for<br>longer battery life. | |
| | Component /<br>Feature | MEDRAD MRXperion<br>MR Injection System<br>Syringes (Proposed) | Spectris Solaris EP<br>Syringes (Predicate) | Rationale for Change |
| Construction | Syringe Volume | 65 ml (contrast),<br>115 ml (saline) | 65 ml (contrast),<br>115 ml (saline) | N/A. No change. |
| | Dust Caps | Yes | Yes | N/A. No change. |
| | Tubing Set<br>Compatibility | Connects to female<br>luer on low pressure<br>connector tubing | Connects to female<br>luer on low pressure<br>connector tubing | N/A. No change. |
| Materials | Syringe Barrel | PET | PET | N/A. No change. |
| | Syringe Barrel ID<br>Coating | Silicone oil | Silicone oil | N/A. No change. |
| | Plunger | Polycarbonate | Polycarbonate | N/A. No change. |
| | Plunger Rubber<br>Cover…