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 resonance imaging (MR) 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 userprogrammed volume and flow rate.

AI/ML Overview

This document describes a 510(k) premarket notification for the MEDRAD MRXperion MR Injection System, which is an angiographic injector and syringe system. The submission is for a new control room unit (CRU) with integrated hardware components as an alternative to the existing CRU.

The document does not contain information related to an AI/ML powered medical device, therefore it does not provide the details required to answer questions 1-9 regarding acceptance criteria and study data for such a device. The device is a traditional medical device (an injection system) and the performance data described relates to its physical and functional attributes.

Here's a breakdown of what the document does provide and why it can't answer the specific questions about AI/ML acceptance criteria and studies:

What the document tells us about the device and its assessment:

Device Name: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
Regulation Number & Name: 21 CFR 870.1650, Angiographic Injector And Syringe
Regulatory Class: Class II
Product Code: DXT
Predicate Device: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit, K143538
Changes from Predicate: A new control room unit (CRU) with integrated hardware components. The changes are described as "aesthetic improvement, modular design and serviceability." The document explicitly states: "The fundamental scientific technology, principle of operation, and indications for use are unchanged from the predicate device... The differences... do not introduce new issues of safety and effectiveness and do not change the indications for use or result in a different fundamental scientific technology."
Performance Data (General): Verification and validation testing was conducted. This included:
- Device performance testing (fluid delivery, flow rates, volumes, pressures).
- Safety and Compatibility testing (configurations, circuitry, IEC 60601-1, EMC, electrical safety controls, failure detection, programming keys, sensors, safe operation).
- Reliability testing (sequential and repeated performance, simultaneous operation with Informatics processes).
- Simulated Use and Human Factors testing (per EN 62366-1: 2015 and FDA Guidance).
- Cleaning and disinfection validation (per FDA Guidance "Reprocessing Medical Devices in Health Care Settings").
Key Finding: "All testing passed and the demonstrated product performance met all prior established acceptance criteria." "All test results demonstrate that the design and materials... meet the established performance criteria and will perform as intended." "The results of the design verification and validation, including human factors engineering evaluation, demonstrate that the subject device is substantially equivalent to its predicate device."
Clinical Testing: "No clinical testing was required or performed to support this Special 510(k) Premarket Notification." This is common for special 510(k)s where the design changes do not raise new questions of safety or effectiveness.

Why the requested information (1-9) cannot be extracted from this document:

The provided document is a 510(k) summary for a non-AI/ML medical device. The acceptance criteria and study design questions (specifically regarding sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are standard requirements for AI/ML-powered medical devices. This document verifies the substantial equivalence of a physical medical injection system that has undergone minor design changes (specifically, the control room unit).

Therefore, I cannot provide answers to the specific questions regarding AI/ML device acceptance criteria and study details because the document is not about an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

November 1, 2018

Bayer Medical Care Inc. Katie Dillon Regulatory Affairs Manager 1 Bayer Drive Indianola, Pennsylvania 15051

Re: K182276

Trade/Device Name: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: September 28, 2018 Received: October 1, 2018

Dear Katie Dillon:

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael John -S 2018.11.01 14:44:18 -04'00'

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

510(k) Number (if known) K182276

Device Name

MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged in a cross shape, with the letters "B", "A", "Y", "E", and "R" stacked vertically and horizontally. The logo is surrounded by a circle that is half green and half blue.

510(k) Summary

Submitter:	Bayer Medical Care, Inc.
	1 Bayer Drive
	Indianola, PA 15051
Contact Person:	Katie Dillon
	Regulatory Affairs Manager
	Phone: (412) 406-3212
	Email: katie.dillon@bayer.com
Date Prepared:	October 30, 2018
Device Trade Name:	MEDRAD MRXperion MR Injection SystemMEDRAD MRXperion MR InjectionSystem Syringe Kit
Common Name:	Angiographic Injector and Syringe
Classification Name:	Injector and Syringe, Angiographic [21 CFR870.1650]
Product Code:	DXT
Classification:	Class II
Predicate Device:	The subject device is substantiallyequivalent to the following device:MEDRAD MRXperion MR InjectionSystem and MR Injection SystemSyringe Kit, K143538

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Image /page/4/Picture/1 description: The image is the logo for Bayer. The logo is a circle that is split into two colors, green and blue. The word "BAYER" is stacked in the center of the circle in a sans-serif font.

Device Description:

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:

A new control room unit (CRU) has been developed as an alternative to the existing CRU used with the MEDRAD MRXperion MR Injection System. This design change does not involve any changes to the MEDRAD MRXperion MR Injection System Syringe Kit. Table 1 provides a comparison of the proposed MEDRAD MRXperion MR Injection System with the predicate device, the MEDRAD MRXperion MR Injection System cleared per K143538.

The fundamental scientific technology, principle of operation, and indications for use are unchanged from the predicate device, the MEDRAD MRXperion MR Injection System cleared per K143538. The differences between the proposed device and the predicate device do not introduce new issues of safety and effectiveness and do not change the indications for use or result in a different fundamental scientific technology.

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Image /page/5/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically, with each letter in a bold, sans-serif font. The word is surrounded by a circular design, with the top half of the circle in green and the bottom half in blue. The logo is clean and modern, reflecting the company's focus on innovation and technology.

Table 1. Comparison of MEDRAD MRXperion MR Injection System (proposed device) with predicate device.

PARAMETER	PREDICATE DEVICEMRXperion MRInjection System(K143538)	PROPOSED DEVICEMRXperion MRInjection System(K182276)	RATIONALE FORCHANGE
Indications for Use	The MEDRAD®MRXperion MRInjection System is asyringe- based fluiddelivery systemindicated for deliveryof contrast media andsaline during MRapplications. It isintended to be usedfor the specificpurpose of injectingintravenous MRcontrast media andsaline into the humanvascular system fordiagnostic studies inmagnetic resonanceimaging (MRI)applications with MRIscanners that have amagnetic field strengthbetween 0.7 and 3.0Tesla.Only trained healthcareprofessionals areintended to operate thisdevice.	Same	No change
Fill Volume(Syringe A)	0.5 ml to max.syringe volume in:0.1 ml incrementsbetween 0.5 and 31 ml 1 ml increments for31 ml and above	Same	No change
Fill Volume(Syringe B)	1 ml to max. syringevolume in 1 ml	Same	No change
PARAMETER	PREDICATE DEVICE	PROPOSED DEVICE	RATIONALE FORCHANGE
	MRXperion MRInjection System(K143538)	MRXperion MRInjection System(K182276)
	increments
Fill Speed (lowspeed)	1.0 to 10.0 ml/s in 0.5ml/s increments	Same	No change
Fill Speed (highspeed)	1.0 to 10.0 ml/s in 0.5ml/s increments	Same	No change
Flow Rate	0.01 to 10 ml/s inincrements of:* 0.01 ml/s between0.01 and 3.1 ml/s* 0.1 ml/s between 3.1and 10 ml/s	Same	No change
Delay	N/A. Addressed byPause Phase.	Same	No change
Pause Phase	1 to 1200 s in 1 sincrements	Same	No change
ProgrammablePressure Limit(PSI/kPa)	100/690150/1035200/1380250/1725300/2070325/2240	Same	No change
Keep Vein Open(KVO)	Yes; 0.25 ml, timeadjustable. Defaults atevery 30 sec.	Same	No change
Protocol Memory	60 protocols of up to 6phases each	Same	No change
Injection HistoryMemory	Previous 20 successfulinjections	Same	No change
Control Room Unit	Windows-based ControlRoom Unit (CRU) withseparate hardwarecomponents	Windows-basedControl Room Unit withintegrated hardwarecomponents	Integration ofhardware componentsfor aestheticimprovement
PARAMETER	PREDICATE DEVICEMRXperion MRInjection System(K143538)	PROPOSED DEVICEMRXperion MRInjection System(K182276)	RATIONALE FORCHANGE
			modular design andserviceability. Noimpact on safety andeffectiveness.
InformationDisplay (ControlRoom)	Color LCD	Same	No change
Programming Keys(Control Room)	Software-generated viaan LCD resistive touchscreen	Software-generated viaLCD capacitive touchscreen	Touch screencalibration notrequired for capacitivetouch screen. Noimpact on safety andeffectiveness.
Programming Keys(Scan Room)	Dedicated keys oninjector head	Same	No change
Multi-Phase	6 phases per injection	Same	No change
Safety StopMechanism	Software stops andelectromechanicalswitch	Same	No change
Syringe System	Dual Syringes	Same	No change
Syringe Docking	Non-rotationalorientation	Same	No change
Docking	Manual and Automatic	Same	No change
Fill Control	Manual and Automatic	Same	No change
Prime Control	Manual and Automatic	Same	No change
Retract Control	Manual and Automatic	Same	No change
Check for AirConfirmation	Operator visualinspection; userconfirmed	Same	No change
Start/Stop Switch	Control Room and Scan	Same	No change
PARAMETER	PREDICATE DEVICEMRXperion MRInjection System(K143538)	PROPOSED DEVICEMRXperion MRInjection System(K182276)	RATIONALE FORCHANGE
Hand Switch	Control Room (optional)	Same	No change
Communication	Fiber Optic	Same	No change
MR Compatibility	0.7T to 3.0T	Same	No change
eGFR Calculator	Yes	Same	No change
Weight-BasedDosing Calculator	Yes	Same	No change
InformaticsCompatibility	Yes	Same	No change
Power management	The Base supplies power to the Injector Head and the main processor via an AC/DC power supply-module. A rechargeable lithium ion battery is used to power the motors in the base during an injection.	Same	No change
MRXperion MRInjection SystemSyringe Kit	There are no changes to the MRXperion MR Injection System Syringe Kit.		No change

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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 in a bold, sans-serif font. The letters are in a dark blue color. The wordmark is encircled by a ring that is split into two colors: the top half is green, and the bottom half is light blue.

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Image /page/7/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are dark blue. The word is surrounded by a circle that is divided into two halves. The top half of the circle is green, and the bottom half is light blue.

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Image /page/8/Picture/1 description: The image shows the logo for Bayer, a multinational pharmaceutical and life sciences company. The logo features the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are in a dark blue color. The wordmark is encircled by a ring that is split into two colors: a light green on the top half and a light blue on the bottom half.

Performance Data:

Verification and validation testing was conducted to assess the impact of the modification on the MEDRAD MRXperion MR Injection System. The following testing was successfully completed:

Device performance testing included verification of fluid delivery, flow rates, . volumes, and pressures. Testing also verified that the device was not affected by environmental conditions such as atmospheric conditions and handling. All

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Image /page/9/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are in a dark blue color. The wordmark is surrounded by a circular design with two arcs, one in green and one in light blue, creating a ring around the name.

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. All testing passed and the demonstrated product performance demonstrated 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 MR 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 EN 62366-1: 2015 and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." Testing demonstrated that no new or different questions of safety or effectiveness were raised.
. Cleaning and disinfection validation was performed per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," and confirmed that the injection system meets its cleaning and disinfection requirements.

All test results demonstrate that the design and materials of the MEDRAD MRXperion MR Injection System meet the established performance criteria and will perform as intended. The results of the design verification and validation, including human factors engineering evaluation, demonstrate that the subject device is substantially equivalent to its predicate device.

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

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Image /page/10/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are in a dark blue color. The wordmark is encircled by a ring that is split into two colors: the top half is green, and the bottom half is light blue.

Clinical Testing:

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

Conclusion:

Bayer Medical Care Inc. considers the MEDRAD MRXperion MR Injection System to be substantially equivalent to the predicate device listed above. The fundamental scientific technology, principle of operation, and indications for use are unchanged from the predicate device. The differences between the proposed device and the predicate device do not introduce new issues of safety and effectiveness.

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.