RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK
Device Facts
| Record ID | K133848 |
|---|---|
| Device Name | RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK |
| Applicant | Heartvista, Inc. |
| Product Code | LNH · Radiology |
| Decision Date | Jun 25, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1000 |
| Device Class | Class 2 |
Intended 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-time 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: GE Healthcare (GEHC) Signa HDxt 1.5T, 3.0T. Software versions 15 and 16.
Device Story
RTHawk is a Linux-based workstation accessory for 1.5T/3.0T MRI scanners; operates in parallel with OEM consoles to acquire, reconstruct, and display real-time/accelerated MR images. System connects via private Ethernet; controls scanner pulse sequences; performs image reconstruction/post-processing independently. Used in clinical settings by radiologists/technicians. Provides high-resolution CMR imaging; enables real-time interactive scan control and parameter adjustment. Benefits include efficient data acquisition and improved workflow without modifying OEM hardware. Output is viewed by physicians to assist in clinical diagnosis.
Clinical Evidence
Clinical images acquired with RTHawk were compared to images from the predicate device on the same patients during the same session. Images were evaluated by radiologists for diagnostic accuracy and image quality. Where direct comparisons were unavailable, images were evaluated based on expert radiologist assessment.
Technological Characteristics
Linux-based workstation; standalone computer with monitor, keyboard, mouse. Connects via private Ethernet to OEM MR scanner. Implements pulse sequence control, raw data reconstruction, and DICOM export. Complies with IEC 60601-1, IEC 60601-2-33, and NEMA PS3.1-3.20 (DICOM).
Indications for Use
Indicated for Cardiovascular MR (CMR) applications in patients undergoing MRI exams on GE Healthcare Signa HDxt 1.5T or 3.0T systems. Used by trained physicians to assist in diagnosis via static/dynamic cross-sectional imaging of internal structures/functions.
Regulatory Classification
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).
Special Controls
*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.
Predicate Devices
- GE Signa Excite 1.5T and 3.0T MR Systems (K041476)
Related Devices
- K142997 — RTHawk, HeartVista Workstation with RTHawk · Heartvista, Inc. · Dec 17, 2014
- K153740 — RTHawk, HeartVista Cardiac Package · Heartvista, Inc. · Jun 30, 2016
- K183274 — RTHawk, HeartVista Cardiac Package · Heartvista, Inc. · Oct 18, 2019
- K170090 — RTHawk, HeartVista Cardiac Package · Heartvista, Inc. · Jul 14, 2017
- K212233 — RTHawk, HeartVista Cardiac Package · Heartvista, Inc. · Oct 5, 2021
Submission Summary (Full Text)
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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<br>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
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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/<br>(R)2012+C1+A2 | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance (IEC 60601-1:2005, MOD)<br>Section 14 Programmable Electrical Medical Systems (PEMS) |
| IEC 60601-2-33 Ed 3.0 (2010-03) | Medical electrical equipment - Part 2-33: Particular requirements<br>for the basic safety and essential performance of magnetic<br>resonance equipment for medical diagnostic (radiology). |
| MS1-2008 | Determination of Signal-to-Noise Ratio (SNR) in Diagnostic<br>Magnetic Resonance Imaging |
| MS3-2008 | Determination of Image Uniformity in Diagnostic Magnetic<br>Resonance Images |
| MS4-2010 | Acoustic Noise Measurement Procedure for Diagnostic Magnetic<br>Resonance Imaging Devices |
| MS8-2008 | Characterization of the Specific Absorption Rate (SAR) for<br>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:
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### 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.
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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<br>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 | <4W/kg whole-body | <4W/kg whole-body |
| Max dB/dt | 1st Level Operating Mode | 1st Level Operating Mode |
## 11.0 Safety Parameters
## 12.0 Performance Data - Discussion of Clinical Tests
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.
## 13.0 Conclusions
Based upon safety and performance testing and compliance with voluntary standards, the Company believes that the HeartVista Workstation with RTHawk application software is substantially equivalent to the predicate device, and does not raise any new questions of safety or effectiveness.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 a stylized symbol resembling an abstract human figure with three lines representing the head, body, and legs.
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 25, 2014
HEARTVISTA, INC C/O JAMES ROGERS FDA REGULATORY AFFAIRS, QUALITY ASSURANCE 998 HAMILTON AVE MENLO PARK, CA 94025
Re: K133848
Trade/Device Name: RTHawk, or HeartVista Workstation with RTHawk Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 29, 2014 Received: June 5, 2014
Dear Mr. Rogers:
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 of medical device-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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Rogers
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor.You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Michael D. O'Hara
for
Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
### 510(k) Number (if known) K133848
Device Name
RTHawk, or HeartVista Workstation with RTHawk
### Indications for Use (Describe)
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-ime and accelerated images. The Heart Vista 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 (TI), 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:
· GE Healthcare (GEHC) Signa HDxt 1.5T, 3.0T. Software versions 15 and 16.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
