(242 days)
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 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.
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.
§ 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.