(242 days)
Spectris Solaris EP MR Injection System K042784
No
The summary describes a software-controlled injection system with user-programmed parameters and calculators (eGFR, weight-based dosing), but there is no mention of AI or ML algorithms being used for tasks like image analysis, predictive modeling, or automated parameter adjustments based on data. The testing described is focused on device performance, safety, and compatibility, not on the validation of AI/ML model performance.
No
The device delivers contrast media and saline for diagnostic imaging, which is a diagnostic purpose, not a therapeutic one. It does not treat or alleviate a disease or condition.
No
Explanation: This device is an injection system used to deliver contrast media and saline to assist in diagnostic studies. It is not designed to diagnose or interpret data itself.
No
The device description clearly outlines multiple hardware components including the Scan Room Unit (SRU) with an injector head, base assembly, pedestal, and power supply, and the Control Room Unit (CRU) with an All-in-One Computer, pod, power supplies, mechanical stand, and optional hand switch. The software controls these hardware components to perform the intended function of fluid delivery.
Based on the provided information, the MEDRAD® MRXperion MR Injection System is not an In Vitro Diagnostic (IVD) 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 studies in magnetic resonance imaging (MRI) applications." This describes a device used in vivo (within the living body) to facilitate an imaging procedure.
- Device Description: The description details a system for physically injecting fluids into a patient. It includes components like an injector head, syringes, and controls for flow rate and volume. This is consistent with an injection system used on a patient.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens outside of the body, such as blood, urine, or tissue samples. IVD devices are specifically designed for testing these types of samples to provide diagnostic information.
- Anatomical Site: The anatomical site is the "Human vascular system," which is an in vivo location.
In summary, the MEDRAD® MRXperion MR Injection System is a medical device used to administer substances to a patient during an imaging procedure, not a device used to perform tests on samples outside the body. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
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
Only trained healthcare professionals are intended to operate this device.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Injection
- Materials Mediated Pyrogen
- Hemolysis
- Partial Thromboplastin Time
- Platelet & Leukocyte Counts
- USP physiochemical testing
- 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.
No clinical testing was required or performed to support this Traditional 510(k) Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Spectris Solaris EP MR Injection System K042784
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Nemoto Sonic Shot GX, K091734, E-Z-EM Empower MR Injection System, K062449
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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
1
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
2
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)
Page 1 of 1
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510(k) Summary
| Submitter: | Bayer Medical Care, Inc.
1 Bayer Drive
Indianola, PA 15051 | Bayer Medical Care Inc.
1 Bayer Drive
Indianola, PA 15051
U.S.A.
(412) 767-2400
www.ri.bayer.com |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa A. Ewing
Sr. Principal Regulatory Affairs Specialist
Phone: (412) 406-3780
Email: lisa.ewing@bayer.com | |
| Date Prepared: | July 2, 2015 | |
| Device Trade Name: | MEDRAD MRXperion MR Injection System
MEDRAD MRXperion Sterile Disposable
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
following device:
Spectris Solaris EP MR Injection System
K042784, December 10, 2004
Reference devices:
- Weight Based Dosing Calculator -
Nemoto Sonic Shot GX, K091734, May
21, 2010 - eGFR Calculator - E-Z-EM Empower
MR 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 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.
5
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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
MR Injection System
(Proposed) | Spectris Solaris EP
(K042784) | Rationale for Change | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Indications for Use
/ 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. | The Spectris Solaris EP
MR Injection System is a
syringe-based fluid
delivery system indicated
for delivery of contrast
media during MR
applications. It is
intended to be used for
the specific purpose of
injecting intravenous MR
contrast media and
common flushing
solutions into the human
vascular system for
diagnostic studies in
magnetic resonance
imaging (MRI)
procedures. Only trained
healthcare professionals
are intended to operate
this device. | Updates for clarification of
MR field strength only. | |
| 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 | 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 | N/A. No change. | |
| Fill Volume
(Syringe B) | 1 ml to max. syringe
volume in 1 ml increments | 1 ml to max. syringe
volume in 1 ml increments | N/A. No change. | |
| Fill Speed
(low speed) | 1.0 to 10.0 ml/s in 0.5 ml/s
increments | 1.0 to 10.0 ml/s in 0.5 ml/s
increments | N/A. No change. | |
| Feature | MEDRAD MRXperion
MR 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 Pause
Phase. | 1 to 300 s in 1 s
increments | MRXP allows Pause
phase to be the first
phase of the injection. | |
| Pause Phase | 1 to 1200 s | 1 to 900 s | Longer Pause Phase
added for customer
convenience. | |
| Programmable
Pressure 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 6
phases each | 32 protocols of up to 6
phases each | Additional protocol
memory storage added
for customer
convenience. | |
| Injection History
Memory | Previous 20 successful
injections | Previous 20 successful
injections | N/A. No change. | |
| Information
Display
(Control Room) | Color LCD | Color LCD | N/A. No change. | |
| Programming
Keys
(Control Room) | Software-generated
via an LCD touch
screen | Software-generated
via an LCD touch
screen | N/A. No change. | |
| Programming
Keys
(Scan Room) | Dedicated keys on injector
head | Dedicated keys on injector
head | No change to technology.
Additional keys added to
MRXperion Injector Head
for increased functionality
in the scan room. | |
| Multi-Phase | 6 phases per injection | 6 phases per injection | N/A. No change. | |
| Feature | MEDRAD MRXperion
MR Injection System
(Proposed) | Spectris Solaris EP
(K042784) | Rationale for Change | |
| Safety Stop
Mechanism | Software stops and
electromechanical switch | Software stops | Additional safety stops
included. | |
| Syringe System | Dual Syringes | Dual Syringes | N/A. No change. | |
| Syringe Docking | Non-rotational orientation | Keyed, rotational
orientation | Customer convenience. | |
| Docking | Manual and Automatic | Manual only | Customer convenience. | |
| Fill Control | Manual and Automatic | Manual only | Automatic fill feature
added for customer
convenience. | |
| Prime Control | Manual and Automatic | Manual only | Automatic prime feature
added for customer
convenience. | |
| Retract Control | Manual and Automatic | Manual only | Automatic retract feature
added for customer
convenience. | |
| Check for Air
Confirmation | Operator visual
inspection; user confirmed | Operator visual
inspection; user confirmed | N/A. No change. | |
| Start/Stop Switch | Control Room and Scan
Room | Control Room | Customer convenience. | |
| Hand Switch | Control Room (optional) | Control Room | Spectris Solaris EP did
not have Start/Stop
capability without the
Hand Switch. The Hand
Switch is not needed for
MRXperion, as a
Start/Stop switch was
added to the MRXperion
Injector Head and the
Control Room Unit. | |
| Communication | Fiber Optic | Fiber Optic | N/A. No change. | |
| Feature | MEDRAD MRXperion
MR Injection System
(Proposed) | Spectris Solaris EP
(K042784) | Rationale for Change | |
| MR Compatibility | 0.7T to 3.0T | 0.2T to 3.0T | MRXperion is
commercially targeted for
scanners used in the
majority of the US and
worldwide market. | |
| eGFR Calculator | Yes | No
Reference Device -
E-Z-EM Empower MR
Injection System K062449 | eGFR Calculator feature
added for customer
convenience. | |
| Weight-Based
Dosing Calculator | Yes | No
Reference Device -
Nemoto Sonic Shot GX
K091734 | Weight-Based Dosing
Calculator feature added
for customer
convenience. | |
| Informatics
Compatibility | Yes | No | Informatics compatibility
added for customer
convenience. | |
| 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. | Rechargeable lead-acid
battery power for the Scan
Room Unit. | Improved power
management scheme for
longer battery life. | |
| | Component /
Feature | MEDRAD MRXperion
MR Injection System
Syringes (Proposed) | Spectris Solaris EP
Syringes (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 Set
Compatibility | Connects to female
luer on low pressure
connector tubing | Connects to female
luer on low pressure
connector tubing | N/A. No change. |
| Materials | Syringe Barrel | PET | PET | N/A. No change. |
| | Syringe Barrel ID
Coating | Silicone oil | Silicone oil | N/A. No change. |
| | Plunger | Polycarbonate | Polycarbonate | N/A. No change. |
| | Plunger Rubber
Cover | 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 covering
polystyrene tray | Tyvek lid covering
polystyrene tray | N/A. No change. |
| Pack-aging | Shelf Life | 3 years | 5 years | MRXperion Syringe Kit
currently qualified for 3 year
shelf life. |
| | | | | |
| Biological | Biocompatibility | Compliant to
applicable sections of
ISO/AAMI 10993-
1:2009 | Compliant to
applicable sections of
ISO/AAMI 10993-
1:2009 | N/A. No change. |
| | Sterilization | E-beam radiation | E-Beam and Gamma | N/A. No change. |
| | Sterility
Assurance Level
(SAL) | 10-6 | 10-6 | N/A. No change. |
| | Pyrogenicity | Non-Pyrogenic Fluid
Path | Non-Pyrogenic Fluid
Path | N/A. No change. |
| | Latex content | Not made with natural
rubber latex | Not made with natural
rubber 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 | | MEDRAD
MRXperion
MRXperion MR
Injection System
Tubing (Proposed) | Spectris Solaris EP
Tubing (Predicate) | Rationale for Change |
| Construction | Description | Low pressure
connector tube with
T-connector and
check valve | Low pressure
connector tube with T-
connector and check
valve | N/A. Same tubing, T-connector
and check valve, no change. |
| | Syringe
connection | Polycarbonate female
luer and T-connector | Polycarbonate female
luer and T-connector | N/A. Same tubing and T-
connector, no change. |
| | Administration
Set Connection | Polycarbonate male
luer | Polycarbonate male
luer | 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 covering
polystyrene tray | Tyvek lid covering
polystyrene tray | N/A. Same tubing, no change. |
| | Shelf Life | 3 years | 5 years | MRXperion Syringe Kit
currently qualified for 3 year
shelf life. |
| Biological | Biocompatibility | Compliant to
applicable sections of
ISO/AAMI 10993-
1:2009 | Compliant to
applicable sections of
ISO/AAMI 10993-
1:2009 | N/A. Same tubing, no change. |
| | Pyrogenicity | Non-pyrogenic fluid
path | Non-pyrogenic fluid
path | N/A. Same tubing, no change. |
| | Latex content | Not made with
natural rubber latex | Not made with natural
rubber latex | N/A. Same tubing, no change. |
| | DEHP | No | No | N/A. Same tubing, no change. |
| | Sterilization
Type | E-beam | E-Beam and Gamma | N/A. Same tubing, no change. |
| | Sterility
Assurance
Level (SAL) | 10-6 | 10-6 | N/A. Same tubing, no change. |
| Performance | Pressure
Rating | 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/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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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.