MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit by BAYER MEDICAL CARE INC.

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 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.

AI/ML Overview

The provided document describes the MEDRAD MRXperion MR Injection System and its associated syringe kit. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All testing passed and the demonstrated product performance met all prior established acceptance criteria." However, specific numerical acceptance criteria for each test are not explicitly detailed in the provided text. Instead, it lists the types of tests performed and confirms they met their objectives.

Category	Acceptance Criteria (Not explicitly quantified in text, stated as "met all prior established acceptance criteria")	Reported Device Performance (Summary from text)
Device Performance	Product specifications and performance requirements.	Verification of system disposable filling and preparation, protocol management, flow rates, pressures, timers, and calculator accuracy. Device unaffected by environmental conditions.
Disposables Performance	Mechanical functions and pressure capabilities (ISO-594), compatibility with MR contrast agents and other chemical agents (ISO-8536-4), and packaging (ISO-11607).	Testing performed on aged and shipping-conditioned samples (ASTM 4169). Verification of syringe and connector tubing mechanical functions and pressure capabilities, compatibility with MR contrast agents and other chemical agents, and packaging.
Biocompatibility	Requirements of ISO 10993 for an external communicating, indirect contact, less than 24-hour duration device.	Syringe and connector tubing kit compliant with ISO 10993 including tests for Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Injection, Materials Mediated Pyrogen, Hemolysis, Partial Thromboplastin Time, Platelet & Leukocyte Counts, and USP physiochemical testing.
Sterilization	Sterility Assurance Level (SAL) of 10-6 (ISO 11137-1, 11137-2, 11137-3).	Sterilization conditions validated to provide SAL of 10-6 for syringe and connector tubing kit.
Safety and Compatibility	Configurations, specifications, circuitry, compliance with IEC 60601-1 and EMC, electrical safety controls, detection of failures, programming keys, sensors, and MRI compatibility (0.7T to 3.0T).	Verification of configurations and specifications, circuitry, compliance with IEC 60601-1 and EMC requirements, electrical safety controls, ability to detect failures, programming keys, sensors. MRI compatibility (0.7T to 3.0T) including homogeneity, signal-to-noise, MR artifacts, and susceptibility.
Shelf-Life & Shipping	System performance not affected by three-year aging and shelf-life packaged transit and storage (ISTA 1E).	System performance not affected by three-year aging and packaged transit/storage (ISTA 1E).
Reliability	Capability to sequentially and repeatedly meet system performance requirements with no degradation from simultaneous Informatics processes.	Statistical methods used to demonstrate capability. No degradation when Injection System and Informatics processes run simultaneously.
Simulated Use & Human Factors	Clinical user needs met by design (ANSI/AAMI HE75:2009 and EN 62366:2008), raising no new safety/effectiveness questions.	Device and disposables used in a simulated clinical environment. No new safety or effectiveness questions raised.

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

The document does not explicitly state numerical sample sizes for most of the individual tests. It uses general statements like "testing was performed."

Sample Size: Not specified quantitatively for most tests.
Data Provenance: The testing was conducted by the manufacturer, Bayer Medical Care, Inc. The data is retrospective in the sense that the studies were completed to support the 510(k) submission, but it's not data from clinical practice. The country of origin for the data is not specified, but the manufacturer is based in the USA.

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

This information is not provided in the document. The testing described is non-clinical bench testing, not a study requiring expert-established ground truth in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the described testing is non-clinical bench and performance testing, not a study involving human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The device is an MR injection system, not an AI diagnostic tool.
This section is not applicable to the device described.

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

No, a standalone algorithm performance study was not done. The device is a physical injection system with software control, not a standalone diagnostic algorithm.
This section is not applicable to the device described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" was established by engineering and quality standards, specifications, and regulatory requirements (e.g., ISO, ASTM, IEC standards, and internal product specifications). For example:

Physical measurements (flow rates, pressures, volumes) were compared against defined engineering specifications.
Biocompatibility was assessed against ISO 10993.
Sterility was assessed against ISO 11137 standards.
MRI compatibility was tested against defined performance metrics within specified magnetic field strengths.

8. The sample size for the training set

Not applicable. This device is an injection system and does not involve AI or machine learning algorithms that require a training set in the conventional sense. The "training" here would refer to the development and iterative testing of the device's hardware and software, rather than training a model on data.

9. How the ground truth for the training set was established

Not applicable. As stated above, there is no AI training set as defined in this context. The "ground truth" for the device's design and engineering would be based on established engineering principles, international standards, and internal product specifications validated through extensive bench testing and simulated use.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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)

Page 1 of 1

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Image /page/3/Picture/1 description: The image is the logo for Bayer. The logo consists of the word "BAYER" stacked vertically inside of a circle. The circle is colored with green at the top and blue at the bottom.

510(k) Summary

Submitter:	Bayer Medical Care, Inc.1 Bayer DriveIndianola, PA 15051	Bayer Medical Care Inc.1 Bayer DriveIndianola, PA 15051U.S.A.(412) 767-2400www.ri.bayer.com
Contact Person:	Lisa A. EwingSr. Principal Regulatory Affairs SpecialistPhone: (412) 406-3780Email: lisa.ewing@bayer.com
Date Prepared:	July 2, 2015
Device Trade Name:	MEDRAD MRXperion MR Injection SystemMEDRAD MRXperion Sterile DisposableMRI 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 thefollowing device:Spectris Solaris EP MR Injection SystemK042784, December 10, 2004Reference devices:- Weight Based Dosing Calculator -Nemoto Sonic Shot GX, K091734, May21, 2010- eGFR Calculator - E-Z-EM EmpowerMR Injection System, K062449, April 13,2007

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Image /page/4/Picture/1 description: The image is the logo for Bayer. The logo is a circle with the word "BAYER" written in a cross shape. The top and left sides of the circle are green, while the bottom and right sides are blue. The letters are gray.

Device Description:

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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Image /page/5/Picture/1 description: The image is the logo for Bayer. The logo is a circle with the word "BAYER" written twice, once at the top and once in the middle. The circle is colored with a gradient, starting with green at the top and fading to blue at the bottom. The word "BAYER" is written in gray.

Indications for Use:

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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Image /page/6/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically inside of a circle. The circle has a green gradient at the top and a blue gradient at the bottom.

Feature	MEDRAD MRXperionMR Injection System(Proposed)	Spectris Solaris EP(K042784)	Rationale for Change
Indications for Use/ Intended Use	The MEDRAD®MRXperion MR InjectionSystem is a syringe-basedfluid delivery systemindicated for delivery ofcontrast media and salineduring MR applications. Itis intended to be used forthe specific purpose ofinjecting intravenous MRcontrast media and salineinto the human vascularsystem for diagnosticstudies in magneticresonance imaging (MRI)applications with MRIscanners that have amagnetic field strengthbetween 0.7 and 3.0Tesla. Only trainedhealthcare professionalsare intended to operatethis device.	The Spectris Solaris EPMR Injection System is asyringe-based fluiddelivery system indicatedfor delivery of contrastmedia during MRapplications. It isintended to be used forthe specific purpose ofinjecting intravenous MRcontrast media andcommon flushingsolutions into the humanvascular system fordiagnostic studies inmagnetic resonanceimaging (MRI)procedures. Only trainedhealthcare professionalsare intended to operatethis device.	Updates for clarification ofMR field strength only.
Fill Volume(Syringe A)	0.5 ml to max. syringevolume in:* 0.1 ml incrementsbetween 0.5 and 31 ml* 1 ml increments for 31ml and above	0.5 ml to max. syringevolume in:* 0.1 ml incrementsbetween 0.5 and 31 ml* 1 ml increments for 31ml and above	N/A. No change.
Fill Volume(Syringe B)	1 ml to max. syringevolume in 1 ml increments	1 ml to max. syringevolume in 1 ml increments	N/A. No change.
Fill Speed(low speed)	1.0 to 10.0 ml/s in 0.5 ml/sincrements	1.0 to 10.0 ml/s in 0.5 ml/sincrements	N/A. No change.
Feature	MEDRAD MRXperionMR Injection System(Proposed)	Spectris Solaris EP(K042784)	Rationale for Change
Fill Speed(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 PausePhase.	1 to 300 s in 1 sincrements	MRXP allows Pausephase to be the firstphase of the injection.
Pause Phase	1 to 1200 s	1 to 900 s	Longer Pause Phaseadded for customerconvenience.
ProgrammablePressure Limit(PSI/kPa)	Yes	Yes	N/A. No change.
Keep Vein Open(KVO)	Yes	Yes	N/A. No change.
Protocol Memory	60 protocols of up to 6phases each	32 protocols of up to 6phases each	Additional protocolmemory storage addedfor customerconvenience.
Injection HistoryMemory	Previous 20 successfulinjections	Previous 20 successfulinjections	N/A. No change.
InformationDisplay(Control Room)	Color LCD	Color LCD	N/A. No change.
ProgrammingKeys(Control Room)	Software-generatedvia an LCD touchscreen	Software-generatedvia an LCD touchscreen	N/A. No change.
ProgrammingKeys(Scan Room)	Dedicated keys on injectorhead	Dedicated keys on injectorhead	No change to technology.Additional keys added toMRXperion Injector Headfor increased functionalityin the scan room.
Multi-Phase	6 phases per injection	6 phases per injection	N/A. No change.
Feature	MEDRAD MRXperionMR Injection System(Proposed)	Spectris Solaris EP(K042784)	Rationale for Change
Safety StopMechanism	Software stops andelectromechanical switch	Software stops	Additional safety stopsincluded.
Syringe System	Dual Syringes	Dual Syringes	N/A. No change.
Syringe Docking	Non-rotational orientation	Keyed, rotationalorientation	Customer convenience.
Docking	Manual and Automatic	Manual only	Customer convenience.
Fill Control	Manual and Automatic	Manual only	Automatic fill featureadded for customerconvenience.
Prime Control	Manual and Automatic	Manual only	Automatic prime featureadded for customerconvenience.
Retract Control	Manual and Automatic	Manual only	Automatic retract featureadded for customerconvenience.
Check for AirConfirmation	Operator visualinspection; user confirmed	Operator visualinspection; user confirmed	N/A. No change.
Start/Stop Switch	Control Room and ScanRoom	Control Room	Customer convenience.
Hand Switch	Control Room (optional)	Control Room	Spectris Solaris EP didnot have Start/Stopcapability without theHand Switch. The HandSwitch is not needed forMRXperion, as aStart/Stop switch wasadded to the MRXperionInjector Head and theControl Room Unit.
Communication	Fiber Optic	Fiber Optic	N/A. No change.
Feature	MEDRAD MRXperionMR Injection System(Proposed)	Spectris Solaris EP(K042784)	Rationale for Change
MR Compatibility	0.7T to 3.0T	0.2T to 3.0T	MRXperion iscommercially targeted forscanners used in themajority of the US andworldwide market.
eGFR Calculator	Yes	NoReference Device -E-Z-EM Empower MRInjection System K062449	eGFR Calculator featureadded for customerconvenience.
Weight-BasedDosing Calculator	Yes	NoReference Device -Nemoto Sonic Shot GXK091734	Weight-Based DosingCalculator feature addedfor customerconvenience.
InformaticsCompatibility	Yes	No	Informatics compatibilityadded for customerconvenience.
Powermanagement	The Base supplies powerto the Injector Head andthe main processor via anAC/DC power supply-module. A rechargeablelithium ion battery is usedto power the motors in thebase during an injection.	Rechargeable lead-acidbattery power for the ScanRoom Unit.	Improved powermanagement scheme forlonger battery life.
	Component /Feature	MEDRAD MRXperionMR Injection SystemSyringes (Proposed)	Spectris Solaris EPSyringes (Predicate)	Rationale for Change
Construction	Syringe Volume	65 ml (contrast),115 ml (saline)	65 ml (contrast),115 ml (saline)	N/A. No change.
	Dust Caps	Yes	Yes	N/A. No change.
	Tubing SetCompatibility	Connects to femaleluer on low pressureconnector tubing	Connects to femaleluer on low pressureconnector tubing	N/A. No change.
Materials	Syringe Barrel	PET	PET	N/A. No change.
	Syringe Barrel IDCoating	Silicone oil	Silicone oil	N/A. No change.
	Plunger	Polycarbonate	Polycarbonate	N/A. No change.
	Plunger RubberCover	Polyisoprene/polybutadiene blend	Polyisoprene/polybutadiene blend	N/A. No change.
	Plunger Coating	Silicone oil	Silicone oil	N/A. No change.
	Dust Covers	Polypropylene	Polypropylene	N/A. No change.
	Spikes	ABS	ABS	N/A. No change.
	Type, Material	Tyvek lid coveringpolystyrene tray	Tyvek lid coveringpolystyrene tray	N/A. No change.
Pack-aging	Shelf Life	3 years	5 years	MRXperion Syringe Kitcurrently qualified for 3 yearshelf life.

Biological	Biocompatibility	Compliant toapplicable sections ofISO/AAMI 10993-1:2009	Compliant toapplicable sections ofISO/AAMI 10993-1:2009	N/A. No change.
	Sterilization	E-beam radiation	E-Beam and Gamma	N/A. No change.
	SterilityAssurance Level(SAL)	10-6	10-6	N/A. No change.
	Pyrogenicity	Non-Pyrogenic FluidPath	Non-Pyrogenic FluidPath	N/A. No change.
	Latex content	Not made with naturalrubber latex	Not made with naturalrubber latex	N/A. No change.
Performance	DEHP	No	No	N/A. No change.

	Pressure rating	350 psi (2410 kPa)	350 psi (2410 kPa)	N/A. No change.
Item		MEDRADMRXperionMRXperion MRInjection SystemTubing (Proposed)	Spectris Solaris EPTubing (Predicate)	Rationale for Change
Construction	Description	Low pressureconnector tube withT-connector andcheck valve	Low pressureconnector tube with T-connector and checkvalve	N/A. Same tubing, T-connectorand check valve, no change.
	Syringeconnection	Polycarbonate femaleluer and T-connector	Polycarbonate femaleluer and T-connector	N/A. Same tubing and T-connector, no change.
	AdministrationSet Connection	Polycarbonate maleluer	Polycarbonate maleluer	N/A. Same tubing, no change.
	Tubing Material	PVC	PVC	N/A. Same tubing, no change.
	Tubing Length	96"	96"	N/A. Same tubing, no change.
Packaging	Type, Material	Tyvek lid coveringpolystyrene tray	Tyvek lid coveringpolystyrene tray	N/A. Same tubing, no change.
	Shelf Life	3 years	5 years	MRXperion Syringe Kitcurrently qualified for 3 yearshelf life.
Biological	Biocompatibility	Compliant toapplicable sections ofISO/AAMI 10993-1:2009	Compliant toapplicable sections ofISO/AAMI 10993-1:2009	N/A. Same tubing, no change.
	Pyrogenicity	Non-pyrogenic fluidpath	Non-pyrogenic fluidpath	N/A. Same tubing, no change.
	Latex content	Not made withnatural rubber latex	Not made with naturalrubber latex	N/A. Same tubing, no change.
	DEHP	No	No	N/A. Same tubing, no change.
	SterilizationType	E-beam	E-Beam and Gamma	N/A. Same tubing, no change.
	SterilityAssuranceLevel (SAL)	10-6	10-6	N/A. Same tubing, no change.
Performance	PressureRating	350 psi (2410 kPa)	350 psi (2410 kPa)	N/A. Same tubing, no change.

Table 1. Comparison of Fluid Delivery Features

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Image /page/7/Picture/1 description: The image is the logo for Bayer. The logo is a circle with the word "BAYER" written vertically in the center. The letters are stacked on top of each other. The circle is green at the top and blue at the bottom.

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Image /page/8/Picture/1 description: The image is the logo for Bayer. The logo is a circle with the word "BAYER" in the center. The letters are stacked on top of each other. The circle is green at the top and fades to blue at the bottom. The letters are gray.

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Image /page/9/Picture/1 description: The image is the logo for Bayer. The logo is a circle with the word "BAYER" in the center. The letters are stacked on top of each other. The circle is green at the top and fades to blue at the bottom.

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Image /page/10/Picture/1 description: The image is the logo for Bayer. The logo is a circle with the word "BAYER" stacked vertically in the center. The letters are in a sans-serif font and are gray. The circle is colored with a gradient that transitions from green at the top to blue at the bottom.

Table 2. Comparison of Syringe Kit Features

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Table 3. Comparison of tubing features

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Image /page/12/Picture/1 description: The image is the logo for Bayer. The logo is a circle with the word "BAYER" stacked vertically in the center. The circle is colored with a gradient that transitions from green at the top to blue at the bottom. The letters in "BAYER" are gray.

Summary of Non-Clinical Testing:

Bench testing was performed or leveraged from the predicate to support the MEDRAD MRXperion MR Injection System and results demonstrate the MEDRAD MRXperion MR Injection System meets product specification and performance requirements. The following testing was successfully completed:

Device performance testing included verification of the system disposable filling and preparation, protocol management, flow rates, pressures, timers, and calculator accuracy. Testing also verified that the device was not affected by environmental conditions such as atmospheric conditions and handling. All testing passed and the demonstrated product performance met all prior established acceptance criteria.
. Disposables performance testing included verification of the syringe and connector tubing mechanical functions and pressure capabilities (ISO-594), compatibility with MR contrast agents and other chemical agents (ISO-8536-4), and packaging (ISO-11607). Testing was performed using aged samples that had been sterilized and with samples that had been subjected to shipping conditions (ASTM 4169). All testing passed and the demonstrated product performance met all prior established acceptance criteria.
. Biocompatibility testing was conducted on the syringe and connector tubing kit to verify that it meets the requirements of ISO 10993 for an external communicating, indirect contact, less than 24 hour duration device.
The syringe and connector tubing kit were shown to meet the requirements of ISO 10993 for an external communicating, indirect contact, less than 24 hour duration device. The syringe and connector tubing are supported by the following tests, all of which had acceptable results.
- Cytotoxicity o
- Sensitization O
- Intracutaneous Reactivity O
- Acute Systemic Injection O
- Materials Mediated Pyrogen O
- Hemolysis O
- Partial Thromboplastin Time O
- Platelet & Leukocyte Counts O
- USP physiochemical testing O

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Image /page/13/Picture/1 description: The image is the logo for Bayer. The logo is a circle with the word "BAYER" written twice, once vertically and once horizontally, so that the "Y" is in the center. The circle is colored with a gradient, with green at the top and blue at the bottom. The letters are gray.

Sterilization conditions have been validated on the syringe and connector tubing kit in accordance with ISO 11137-1, ISO 11137-2 and ISO 11137-3 to provide a Sterility Assurance Level of 10-6. All testing passed and the demonstrated product performance met all prior established acceptance criteria.
Safety and Compatibility testing included verification of configurations and specifications, . circuitry, compliance with IEC 60601-1 and EMC requirements, electrical safety controls, ability to detect failures in communication and controls, programming keys, and sensors, and safe operation. Testing was conducted to ensure MRI compatibility with scanners ranging between 0.7T to 3.0T, including homogeneity, signal-to-noise, MR artifacts, susceptibility to gradients and high RF. All testing passed and the demonstrated product performance demonstrated met all prior established acceptance criteria.
. Shelf-life and shipping testing included verification that the system performance was not affected by three year aging and shelf-life packaged transit and storage (ISTA 1E). All testing passed and the demonstrated performance met all prior established acceptance criteria.
. Reliability testing was performed using statistical methods to demonstrate the capability to sequentially and repeatedly meet system performance requirements. Testing verified there was no degradation to performance when the MEDRAD MRXperion Injection System and Informatics processes were run simultaneously. All testing passed and the demonstrated performance met all prior established acceptance criteria.
Simulated Use and Human Factors testing was performed by using the device and . disposables in a simulated clinical environment to validate the clinical user needs were met by the design per ANSI/AAMI HE75:2009 and EN 62366:2008. Testing demonstrated that no new or different questions of safety or effectiveness were raised.

All test results demonstrate that the design, materials, and manufacturing processes of the MEDRAD MRXperion Injection System meet the established performance criteria and will perform as intended.

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for angiographic injectors and syringes.

Clinical Testing:

No clinical testing was required or performed to support this Traditional 510(k) Premarket Notification.

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Statement of Equivalence:

Bayer Medical Care Inc. considers the MEDRAD MRXperion MR Injection System to be substantially equivalent to the predicate device listed above. This conclusion is based upon the device intended use and indications for use, similarities in functional design, materials, fundamental scientific technology, and principle of operation.

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
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.