(185 days)
RTHawk is an accessory to 1.5T and 3.0T whole-body magnetic devices (MRDD or MR). It is intended to operate alongside, and in parallel with, the existing MR console to acquire traditional, real-time and accelerated images. The Heart Vista Cardiac Package is a collection of RTHawk Apps designed to acquire, reconstruct and display cardiovascular MR (CMR) images.
RTHawk produces static and dynamic transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structures and/or functions of the entire body. The images produced reflect the spatial distribution of nuclei exhibiting magnetic resonance. The magnetic resonance properties that determine image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that may assist in the determination of a diagnosis.
RTHawk is intended for use as an accessory to the following MRI systems:
Manufacturer: GE Healthcare (GEHC) Field Strength: 1.5T and 3.0T Scanner Software Versions: 12, 15, 16, 23, 24, 25
RTHawk is a software platform intended for the efficient real-time MRI data acquisition, data transfer, image reconstruction, and interactive scan control and display of static and dynamic MR imaging data.
As an accessory to clinical 1.5T and 3.0T MR systems, RTHawk operates alongside, and in parallel with, the MR scanner console with no permanent physical modifications to the MRI system required. RTHawk is designed to run on a stand-alone linux-based computer workstation, with color monitor, keyboard and mouse. A private ethernet network connects the RTHawk workstation to the MR scanner computer. When not in use, the RTHawk workstation may be disconnected from the MR scanner with no detrimental, residual impact upon MR scanner function, operation, or throughput.
RTHawk is a linux operating system-level software application that is intended to control the MR scanner, acquiring high quality, real-time MRI image data and performing post-processing. The RTHawk software includes optimized image acquisition applications, a pipelined raw data image reconstruction engine, a rich graphical user interface for interactive scan control, real-time adjustment of pulse sequence parameters, and display of reconstructed images, and drivers and protocols for communications with, and control of, the OEM MR scanner console.
RTHawk Apps (Applications) are comprised of a pulse sequence, predefined fixed and adjustable parameters, reconstruction pipeline(s), and a tailored graphical user interface containing image visualization and scan control tools. RTHawk Apps may provide real-time interactive scanning, conventional) batch-mode scanning, accelerated scanning, or calibration functions, in which data acquired may be used to tune or optimize other Apps.
The HeartVista Cardiac Package is a collection of RTHawk APPs that enables the performance of a comprehensive cardiovascular MR (CMR) study in a clinically feasible amount of time. These APPs are designed and optimized to acquire, reconstruct, and display CMR images, with features including:
- On-the-fly, sub-second latency adjustment of image acquisition parameters (e.g., scan plane, flip angle, field-of-view, etc.)
- . Real-time imaging, enabling less reliance on ECG gating and artifact suppression techniques. Real-time imaging may be used for scan plane localization, instantaneous tracking of patient motion, and clinical user observation of transient events
- . High spatial resolution imaging, including single breath-hold, multi-slice high-resolution GRE app offering near total heart coverage
- . Free-breathing, multi-slice SSFP and GRE apps that rapidly acquire high-quality images - potentially useful for patients who suffer from arrhythmia or who cannot hold their breath
- . Multi-slice dynamic SR GRE app with one heartbeat temporal resolution for time-course imaging.
- . Continuous flow quantification
The conventional MRI concept of anatomy- and indication-specific Protocols is implemented within the HeartVista Cardiac Package. APPs within the HeartVista Cardiac Package are organized into basic Protocols pre-set by HeartVista. The clinical user may modify APP parameters from default values within their ranges. These modified APPs may be saved into new or existing user-created Protocols to create unique CMR-indicated protocols tailored to the user's clinical interests.
The provided text is a 510(k) Summary for the medical device RTHawk, HeartVista Cardiac Package (K170090). This document focuses on demonstrating substantial equivalence to a predicate device (K153740) rather than presenting a performance study against specific acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies in the format of a clinical trial with a test set, ground truth establishment, expert adjudication, or MRMC studies.
The document primarily focuses on:
- Indications for Use: Identical to the predicate device.
- Technological Characteristics Comparison: Demonstrates the core functionalities and structure are the same as the predicate, with a minor update to supported scanner software versions.
- Non-Clinical Tests: Mentions design controls, quality assurance measures (code reviews, design reviews, unit/integration testing, verification testing, safety testing, performance testing, validation testing), and risk management (ISO 14971:2007 compliance).
In summary, the document does not present a study designed to "prove the device meets acceptance criteria" in the sense of a clinical performance study with human readers or standalone algorithm performance. Instead, it argues for substantial equivalence based on identical intended use, similar technological characteristics, and adherence to design control and quality management principles.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.