(185 days)
Not Found
No
The document describes a software platform for real-time MRI data acquisition, reconstruction, and display, focusing on interactive control and optimized pulse sequences. There is no mention of AI or ML being used for image analysis, interpretation, or any other function. The "Analysis contains the image post-processing tools" section does not specify AI/ML techniques.
No
The device is an accessory to MRI systems intended for acquiring, reconstructing, and displaying magnetic resonance images to assist in diagnosis, not for treating any condition.
Yes
Explanation: The text states, "When interpreted by a trained physician, these images provide information that may assist in the determination of a diagnosis." This indicates that the device produces information used in the diagnostic process.
No
While the device is primarily software, it is described as an "accessory" to existing MRI systems and operates on a "stand-alone linux-based computer workstation" which is a hardware component. The software controls the MR scanner and performs image reconstruction, but it requires this dedicated hardware platform to function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- RTHawk's Function: RTHawk is described as an accessory to MRI systems that acquires, reconstructs, and displays images of the internal structures and functions of the body. It works by detecting the spatial distribution of nuclei exhibiting magnetic resonance.
- Lack of Sample Analysis: The description focuses entirely on imaging the body directly using magnetic resonance, not on analyzing samples taken from the body.
The device is clearly an imaging device used for diagnostic purposes, but it operates in vivo (within the living body) rather than in vitro (in glass, referring to laboratory analysis of samples).
N/A
Intended Use / Indications for Use
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: 15, 16, 23, 24, 25
Product codes
LNH
Device Description
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 workstation to the MR scanner computer. When not in use, the 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 (fraditional) 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 -O 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 O imaqing.
- Continuous flow quantification o
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Entire body (specifically cardiovascular system for the HeartVista Cardiac Package)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Clinical MR system setting
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: Verification and Validation testing (including System and Manual testing, Safety testing, Performance testing), Bench testing, Clinical evaluation.
Sample size: Not specified.
AUC: Not found.
MRMC: Not found.
Standalone performance: Not found.
Key results:
- Code reviews, Design reviews, Unit and integration level testing, Verification testing (System and Manual testing), Safety testing (SAR, dB/dt, and acoustic noise), Performance testing (SNR and uniformity), Validation testing were performed.
- RTHawk conforms to several FDA Recognized Consensus Standards including ANSI/AAMI ES60601-1:2005/(R)2012 +C1 +A2, IEC 60601-2-33 Ed 3.0 (2010-03), MS1-2008, MS3-2008, MS4-2010, MS8-2008, NEMA PS3.1 - 3.20 (2011), and ISO 14971:2007.
- Risk management, compliant with ISO 14971:2007, identified hazards, sequences of events, and resultant harms; developed, implemented, and tested risk-controlling mitigations; and evaluated residual risks.
- SNR and uniformity data were provided for the new pulse sequences and bench testing results for safety parameters were consistent with previously reported results.
- Clinical images acquired using RTHawk were evaluated by radiologist expertise and found to be diagnostically useful.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized representation of a human figure in profile, repeated three times to symbolize health and well-being. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2016
HeartVista, Inc. James Rogers FDA Regulatory Affairs, Quality Assurance and Clinical Studies 4984 El Camino Real, Suite 102 Los Altos, California 94022
Re: K153740
Trade/Device Name: RTHawk, HeartVista Cardiac Package Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: May 25, 2016 Received: May 31, 2016
Dear James 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 (reporting of medical devicerelated 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Robert Oolo
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153740
Device Name RTHawk, HeartVista Cardiac Package
Indications for Use (Describe)
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: 15, 16, 23, 24, 25
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------- | ---------------------------------------------------------- |
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3
Image /page/3/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized font. The first part of the word, "HEARTVIS," is in black, blocky letters. The "TA" is in red and has a unique design, resembling a mountain peak. There is also a red dot above the "i" in "VISTA".
Section 5: 510(k) Summary
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510(k) Summary RTHawk, HeartVista Cardiac Package 510(k) Number: K153740
Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.
1.0 Medical Establishment Reqistration
Medical Establishment Registration No.: 3011767965
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. 4984 El Camino Real, Suite 102 Los Altos, CA 94022
4.0 Submission Date
December 21, 2015, May 25, 2016, and June 28, 2016
5.0 Device Information
Trade/Proprietary Name: RTHawk, HeartVista Cardiac Package Common Name: RTHawk, HeartVista Cardiac Package Model Number(s):
O RTHawk
- O HeartVista Cardiac Package
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
6.0 Predicate Device(s)
| 510(k) # | Device | 510(k) Sponsor | 510(k) Clearance
Date |
|----------|--------------|----------------|--------------------------|
| K142997 | RTHawk 1.0.1 | HeartVista | 12/17/2014 |
minum
5
7.0 Device Description
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 workstation to the MR scanner computer. When not in use, the 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 (fraditional) 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 -O 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 O imaqing.
- Continuous flow quantification o
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.
RTHawk operates compatible MR scanners within the safety parameters listed in the table below:
| Safety Parameter | Safety Level |
|---|---|
| Magnet field strength | 1.5T, 3.0T |
| Operating Modes IEC 60601-2-33 (2010-03) | 1st Level Operating Mode |
| Safety Parameter Display | SAR, dB/dt |
| Max SAR |