(71 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 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.
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.
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.
§ 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.