(71 days)
No
The summary describes a software-controlled fluid delivery system with user-programmed parameters (volume, flow rate). There is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies focus on traditional device performance, safety, reliability, and human factors, not on the performance of an AI/ML algorithm.
No.
The device is used to deliver contrast media and saline for diagnostic imaging, not for treating a disease or condition.
No
The device is an injection system used to deliver contrast media and saline for diagnostic imaging, but it does not perform the diagnosis itself.
No
The device description explicitly states it is a "syringe-based fluid delivery system" and an "automated injection system," which are hardware components. The performance studies also include verification of fluid delivery, flow rates, volumes, pressures, electrical safety, and cleaning/disinfection, all of which relate to hardware functionality.
Based on the provided information, the MEDRAD® MRXperion MR Injection System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "delivery of contrast media and saline during MR applications" and for "injecting intravenous MR contrast media and saline into the human vascular system for diagnostic resonance imaging (MR) applications." This describes a device used in vivo (within the living body) for administering substances.
- Device Description: The description reinforces this by stating it's used for the "administration of intravenous MR contrast media and saline into the human vascular system."
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not perform such examinations on specimens.
The MEDRAD® MRXperion MR Injection System is a medical device used for administering substances into the body for diagnostic imaging purposes, which is distinct from the function of an IVD.
N/A
Intended Use / 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 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.
Product codes
DXT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Human vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professionals
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
- 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 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.
Key Metrics
Not Found
Predicate Device(s)
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit, K143538
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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)
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.
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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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 System |
| MEDRAD MRXperion MR Injection | |
| System Syringe 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 substantially |
| equivalent to the following device: | |
| MEDRAD MRXperion MR Injection | |
| System and MR Injection System | |
| Syringe 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:
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.
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 DEVICE
MRXperion MR
Injection System
(K143538) | PROPOSED DEVICE
MRXperion MR
Injection System
(K182276) | RATIONALE FOR
CHANGE |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| 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. | Same | No change |
| Fill Volume
(Syringe A) | 0.5 ml to max.
syringe volume in:
*0.1 ml increments
between 0.5 and 31 ml
- 1 ml increments for
31 ml and above | Same | No change |
| Fill Volume
(Syringe B) | 1 ml to max. syringe
volume in 1 ml | Same | No change |
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE | RATIONALE FOR
CHANGE |
| | MRXperion MR
Injection System
(K143538) | MRXperion MR
Injection System
(K182276) | |
| | increments | | |
| Fill Speed (low
speed) | 1.0 to 10.0 ml/s in 0.5
ml/s increments | Same | No change |
| Fill Speed (high
speed) | 1.0 to 10.0 ml/s in 0.5
ml/s increments | Same | No change |
| Flow Rate | 0.01 to 10 ml/s in
increments of: - 0.01 ml/s between
0.01 and 3.1 ml/s - 0.1 ml/s between 3.1
and 10 ml/s | Same | No change |
| Delay | N/A. Addressed by
Pause Phase. | Same | No change |
| Pause Phase | 1 to 1200 s in 1 s
increments | Same | No change |
| Programmable
Pressure Limit
(PSI/kPa) | 100/690
150/1035
200/1380
250/1725
300/2070
325/2240 | Same | No change |
| Keep Vein Open
(KVO) | Yes; 0.25 ml, time
adjustable. Defaults at
every 30 sec. | Same | No change |
| Protocol Memory | 60 protocols of up to 6
phases each | Same | No change |
| Injection History
Memory | Previous 20 successful
injections | Same | No change |
| Control Room Unit | Windows-based Control
Room Unit (CRU) with
separate hardware
components | Windows-based
Control Room Unit with
integrated hardware
components | Integration of
hardware components
for aesthetic
improvement |
| PARAMETER | PREDICATE DEVICE
MRXperion MR
Injection System
(K143538) | PROPOSED DEVICE
MRXperion MR
Injection System
(K182276) | RATIONALE FOR
CHANGE |
| | | | modular design and
serviceability. No
impact on safety and
effectiveness. |
| Information
Display (Control
Room) | Color LCD | Same | No change |
| Programming Keys
(Control Room) | Software-generated via
an LCD resistive touch
screen | Software-generated via
LCD capacitive touch
screen | Touch screen
calibration not
required for capacitive
touch screen. No
impact on safety and
effectiveness. |
| Programming Keys
(Scan Room) | Dedicated keys on
injector head | Same | No change |
| Multi-Phase | 6 phases per injection | Same | No change |
| Safety Stop
Mechanism | Software stops and
electromechanical
switch | Same | No change |
| Syringe System | Dual Syringes | Same | No change |
| Syringe Docking | Non-rotational
orientation | 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 Air
Confirmation | Operator visual
inspection; user
confirmed | Same | No change |
| Start/Stop Switch | Control Room and Scan | Same | No change |
| PARAMETER | PREDICATE DEVICE
MRXperion MR
Injection System
(K143538) | PROPOSED DEVICE
MRXperion MR
Injection System
(K182276) | RATIONALE FOR
CHANGE |
| 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-Based
Dosing Calculator | Yes | Same | No change |
| Informatics
Compatibility | 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 MR
Injection System
Syringe 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.