(189 days)
Not Found
No
The document describes image acquisition, reconstruction, and display software for an MRI accessory, but does not mention AI or ML.
No
The device is described as an accessory to magnetic resonance diagnostic devices, intended to acquire and display images for diagnostic purposes, not for therapeutic intervention.
Yes
The device is described as producing images that, when interpreted by a trained physician, "provide information that may assist in the determination of a diagnosis." This indicates its role in the diagnostic process.
No
The device description explicitly states that the HeartVista Workstation consists of a "stand-alone linux-based computer workstation, color monitor, keyboard and mouse," in addition to the RTHawk software. This indicates the device includes dedicated hardware components beyond just software.
Based on the provided text, the HeartVista Workstation with the RTHawk application software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The HeartVista Workstation with RTHawk is an accessory to an MRI system. It acquires and processes images of the internal structures and/or functions of the entire body using magnetic resonance. It does not analyze specimens derived from the body.
- Intended Use: The intended use is to acquire real-time and accelerated images from an MRI system to assist a trained physician in the determination of a diagnosis based on the interpretation of these images. This is a function of an imaging device, not an IVD.
Therefore, the HeartVista Workstation with the RTHawk application software falls under the category of a medical imaging device accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HeartVista Workstation with the RTHawk application software is an accessory to 1.5T and 3.0T whole-body magnetic resonance diagnostic devices (MRDD or MR). The HeartVista Workstation with the RTHawk application software is intended to operate alongside, and in parallel with, the existing MR console to acquire real-lime and accelerated images. The HeartVista Workstation with the RTHawk application software is indicated for Cardiovascular MR (CMR) applications.
The HeartVista Workstation with the RTHawk application software 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.
The HeartVista Workstation with the RTHawk application software is intended for use as an accessory to the following OEM, MRI system, and software release versions:
- O GE Healthcare (GEHC) Signa HDxt 1.5T, 3.0T. Software versions 15 and 16.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The HeartVista Workstation with the RTHawk application software is an accessory to 1.5T and 3.0T whole-body magnetic resonance systems. The HeartVista Workstation with the RTHawk application software is intended to operate alongside, and in parallel with, the existing MR console to acquire real-time and accelerated images. No hardware modifications are required to be made to the MR system or console to support full functionality of the HeartVista Workstation with the RTHawk application software.
The HearlVista Workstation with the RTHawk application software temporarily controls the existing MR system to acquire MRI raw data and related information accordina to pulse sequence programs within the Workstation, Image reconstruction, post-processing, and image display are performed on the Workstation, independent of the MR system or console. No existing GE scanner functionality is removed or modified, and GE scans may be interleaved with HeartVista scans during the same patient exam.
The HeartVista Workstation with the RTHawk application software and dedicated hardware product intended to provide a platform for efficient real-lime MRI data acquisition, data transfer, image reconstructive scan control, and display of static and dynamic MR imaaing data.
The HeartVista Workstation consists of a stand-alone linux-based computer workstation, color monitor, keyboard and mouse. A private ethernet network connects the HeartVisia Workslation to the MR scanner computer. When not in use, the HeartVista Workslation may be detached 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 applications ("Apps") support real-time interactive imaging, high-resolution imaging, and system tuning and shimming calibration modules. RTHawk apps are currently optimized for cardiovascular MR (CMR) imaging and measurements.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Entire body, Cardiovascular (CMR)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Not Found
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)
Clinical images were acquired using RTHowk, and were compared to images acquired on the same patient during the same imaging session using, where possible, equivalent pulse sequences and postprocessing as necessary from the predicate device. Images from both devices were evaluated and rated on the basis of diagnostic accuracy and image quality. Where no directly comparable images were available from the predicate device, RTHawk images were evaluated directly based upon radiologist expertise.
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.
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.
Not Found
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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the word "HEARTVISTA" in a stylized, bold, black font. The letters are blocky and have a futuristic or technological appearance. The word is presented in all capital letters and is the central focus of the image.
510(k) Summary
RTHawk
510(k) Number: K133848
Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.
1.0 Medical Establishment Registration
Medical Establishment Registration No .: pending
2.0 Contact Information
James Jochen Rogers FDA Regulatory Affairs, Quality Assurance, and Clinical Studies T: 724 713.2298 E: jr@heartvista.com
Establishment Name and Address 3.0
HeartVista, Inc. 998 Hamilton Ave Menlo Park, CA 94025
4.0 Submission Date
December 16, 2013, revised June 19, 2014
5.0 Device Information
Trade/Proprietary Name: RTHawk, or HeartVista Workstation with RTHawk Common Name: RTHawk
Model Number(s):
- 0 9001 HeartVista Workstation with RTHawk
0 9002 RTHawk
Regulation Number: 892.1000 Regulation Name: Magnetic resonance diagnostic device (MRDD) Regulatory Class: Class II Device Classification Name: System, Nuclear Magnetic Resonance Imaging Classification Panel: Radiology Classification Product Code(s): LNH
Predicate Device(s) 6.0
| 510(k) # | Device | 510(k) Sponsor | 510(k) Clearance
Date |
|----------|------------------------------------------|----------------|--------------------------|
| K041476 | GE Signa Excite 1.5T and 3.0T MR Systems | GE Healthcare | 6/17/2004 |
Device Description 7.0
The HeartVista Workstation with the RTHawk application software is an accessory to 1.5T and 3.0T whole-body magnetic resonance systems. The HeartVista Workstation with the RTHawk application software is intended to operate alongside, and in parallel with, the existing MR console to acquire real-time and accelerated images. No hardware modifications are required to be made to the
HeartVista, Inc. · 598 Hamiton Avenue, Mento Park CA 94025 · 1650; 336-6543 · www.heartvista.com
1
MR system or console to support full functionality of the HeartVista Workstation with the RTHawk application software.
The HearlVista Workstation with the RTHawk application software temporarily controls the existing MR system to acquire MRI raw data and related information accordina to pulse sequence programs within the Workstation, Image reconstruction, post-processing, and image display are performed on the Workstation, independent of the MR system or console. No existing GE scanner functionality is removed or modified, and GE scans may be interleaved with HeartVista scans during the same patient exam.
The HeartVista Workstation with the RTHawk application software and dedicated hardware product intended to provide a platform for efficient real-lime MRI data acquisition, data transfer, image reconstructive scan control, and display of static and dynamic MR imaaing data.
The HeartVista Workstation consists of a stand-alone linux-based computer workstation, color monitor, keyboard and mouse. A private ethernet network connects the HeartVisia Workslation to the MR scanner computer. When not in use, the HeartVista Workslation may be detached 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 applications ("Apps") support real-time interactive imaging, high-resolution imaging, and system tuning and shimming calibration modules. RTHawk apps are currently optimized for cardiovascular MR (CMR) imaging and measurements.
| Reference # | Title |
|---|---|
| ANSI/AAMI ES60601-1:2005/ | |
| (R)2012+C1+A2 | Medical electrical equipment - Part 1: General requirements for |
| basic safety and essential performance (IEC 60601-1:2005, MOD) | |
| Section 14 Programmable Electrical Medical Systems (PEMS) | |
| IEC 60601-2-33 Ed 3.0 (2010-03) | Medical electrical equipment - Part 2-33: Particular requirements |
| for the basic safety and essential performance of magnetic | |
| resonance equipment for medical diagnostic (radiology). | |
| MS1-2008 | Determination of Signal-to-Noise Ratio (SNR) in Diagnostic |
| Magnetic Resonance Imaging | |
| MS3-2008 | Determination of Image Uniformity in Diagnostic Magnetic |
| Resonance Images | |
| MS4-2010 | Acoustic Noise Measurement Procedure for Diagnostic Magnetic |
| Resonance Imaging Devices | |
| MS8-2008 | Characterization of the Specific Absorption Rate (SAR) for |
| Magnetic Resonance Imaging Systems | |
| NEMA PS3.1 - 3.20 (2011) | Digital Imaging And Communications In Medicine (DICOM) Set. |
RTHawk has been designed to comply with the FDA Recognized Consensus Standards listed in the table below, as applicable to device features and components:
2
8.0 Indications for Use
The HeartVista Workstation with the RTHawk application software is an accessory to 1.5T and 3.01 whole-body magnetic resonance diagnostic devices (MRDD or MR). The HeartVista Workstation with the RTHawk application software is intended to operate alongside, and in parallel with, the existing MR console to acquire real-lime and accelerated images. The HeartVista Workstation with the RTHawk application software is indicated for Cardiovascular MR (CMR) applications.
The HeartVista Workstation with the RTHawk application software 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.
The HeartVista Workstation with the RTHawk application software is intended for use as an accessory to the following OEM, MRI system, and software release versions:
- O GE Healthcare (GEHC) Signa HDxt 1.5T, 3.0T. Software versions 15 and 16.
Technological Characteristics Comparison to Predicate Device 9.0
The RTHawk software is comprised of the following functional modules, and the predicate device's Operating System contains the same or similar functional modules:
- C Acquisition - responsible for the transfer of MR raw data from the MR scanner to the HeartVista Workstation
- O . Analysis contains the image post-processing tools
- Application HeartVista APPs. Each APP is comprised of a pulse sequence, user parameters, a o reconstruction pipeline, and a specific user interface
- O Information System - the central repository of all relevant MRI system configuration, patient, study, scan, etc., parameters associated with the current patient study
- Reconstruction responsible for the efficient processing of raw data to generate MR images 0 via a flexible, pipelined topology
- Scan Control responsible for the real-time network transfer of controlling orders for APPs, APPs 0 parameters modifications, and dynamic information from the MR host in response to user or program requests
- Sequencer creates and provides a specific set of pulse sequence waveforms to control the o MR scanner
- Storage obtains current patient and scan information, performs non-volatile local storage, O exports images and data in DICOM format, and logs events.
- Visualization implements all aspects of the user iterface, including APP selection, controls to O modify APP parameters, image display, graphical slice prescription, and image review, save, and export.
There are subtle differences between the RTHawk's and the predicate device's intended use; the predicate device produces spectroscopic images and/or spectra, while RTHawk does not.
Both RTHawk and the predicate device offer pulse sequences with high resolution, high signal-tonoise ratio, and short scan times. HeartVista APPs are currently optimized for cardiovascular MR (CMR) applications, and the predicate device's pulse sequences and post-processing offer the same or similar imaging capabilities, including the same indications for use.
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.
www
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10.0 Performance Data - Discussion of Non-Clinical Tests
Design controls quality assurance measures during the development of RTHawk include:
- O Code reviews
- Design reviews o
- Unit and integration level testing O
- Verification testing, including System and Manual testing O
- Safety testing, including SAR, dB/dt, and acoustic noise 0
- Performance testing, including SNR and uniformity O
- O Validation testing
Risk management, compliant with ISO 1497 ::2007, identified hazards, sequences of events, and resultant harms; developed, implemented, and tested isk-controlling miligations; and evaluated residual risks.
| RTHawk | Predicate Device | |
|---|---|---|
| Magnet field strength | 1.5T, 3.0T | 1.5T, 3.0T |
| Operating Modes | ||
| IEC 60601-2-33 (2010-03) | 1st Level Operating Mode | 1st Level Operating Mode |
| Safety Parameter Display | SAR, dB/dt | SAR, dB/dt |
| Max SAR |