(68 days)
No
The document describes image acquisition, reconstruction, and display software for MRI, 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 diagnosis, and explicitly states that it is not intended for treatment.
No
The device is described as an "accessory to 1.5T and 3.0T whole-body magnetic resonance diagnostic devices (MRDD or MR)" and is explicitly stated that "When interpreted by a trained physician, these images provide information that may assist in the determination of a diagnosis." This indicates it aids in diagnosis but does not perform the diagnosis itself.
No
The device description explicitly states that the HeartVista Workstation with RTHawk application software is a "software and dedicated hardware product" and includes a "stand-alone linux-based computer workstation, color monitor, keyboard and mouse."
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples (like blood, urine, tissue) outside of the body to provide diagnostic information. The HeartVista Workstation with RTHawk application software is an accessory to an MRI system, which is an imaging modality. It acquires and processes images of the internal structures of the body in vivo (within the living organism).
- The intended use clearly states it's an accessory to a magnetic resonance diagnostic device (MRDD) and produces images. These images are then interpreted by a trained physician to assist in diagnosis. This is characteristic of an imaging device, not an IVD.
- The device description focuses on hardware and software for image acquisition, reconstruction, and display. There is no mention of analyzing biological samples.
Therefore, the HeartVista Workstation with the RTHawk application software falls under the category of a medical imaging device accessory, not an In Vitro Diagnostic.
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-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:
- O GE Healthcare (GEHC) Signa HDxt 1.5T, 3.0T. Software versions 15 and 16
- O GE Healthcare (GEHC) DV 1.5T, 3.0T. Software version 24.
Product codes
LNH
Device Description
The HeartVista Workstation with RTHawk application software are a software and dedicated hardware product intended to provide a platform for efficient real-time MRI data acquisition, data transfer, image reconstruction, and interactive scan control and display of static and dynamic MR imaging data.
The HeartVista Workstation consists of a stand-alone linux-based computer workstation, color monitor, keyboard and mouse. It is designed to operate alongside, and in parallel with, the existing MR console with no hardware modifications required to be made to the MR system or console. A private ethernet network connects the HeartVista Workstation to the MR scanner computer. When not in use, the HeartVista Workstation 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 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
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 RTHawk, 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.
Bench testing results for safety parameters of SAR, dB/dt, and acoustic noise were compared to results from K133848 and were consistent with previously reported results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol depicts a stylized eagle with three human profiles incorporated into its design. The profiles are facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2014
HeartVista, Inc. % Mr. James Rogers FDA Regulatory Affairs, Quality Assurance, and Clinical Studies 998 Hamilton Ave. MENLO PARK CA 94025
Re: K142997 Trade/Device Name: RTHawk, or HeartVista Workstation with RTHawk Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: November 5, 2014 Received: November 17, 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 (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 A Ochs
Robert A. Ochs, Ph.D. Acting 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) K142997
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-time and accelerated images. The HeartVista Workstation with the RTHawk application software is indicated for Cardiovascular MR (CMR) applications.
The Heart Vista 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 Heart Vista 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
- · GE Healthcare (GEHC) DVMR 1.5T, 3.0T. Software version 24
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ 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 word is written in black, except for the last letter "A", which is red. There is also a red dot above the "V".
SPECIAL 510(k) Summary RTHawk 510(k) Number: K142997
Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.
Medical Establishment Registration 1.0
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
3.0 Establishment Name and Address
HeartVista, Inc. 998 Hamilton Ave Menlo Park, CA 94025
4.0 Submission Date
October 8, 2014, December 16, 2014
5.0 Device Information
Trade/Proprietary Name: RTHawk, or HeartVista Workstation with RTHawk Common Name: RTHawk, or HeartVista Workstation with RTHawk Model Number(s):
- O 9001 HeartVista Workstation with RTHawk
- 9002 RTHawk O
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 |
|----------|-----------------------------------------------|----------------|--------------------------|
| K133848 | RTHawk, or HeartVista Workstation with RTHawk | HeartVista | 6/25/2014 |
Device Description 7.0
The HeartVista Workstation with RTHawk application software are a software and dedicated hardware product intended to provide a platform for efficient real-time MRI data acquisition, data transfer, image reconstruction, and interactive scan control and display of static and dynamic MR imaging data.
minum
4
The HeartVista Workstation consists of a stand-alone linux-based computer workstation, color monitor, keyboard and mouse. It is designed to operate alongside, and in parallel with, the existing MR console with no hardware modifications required to be made to the MR system or console. A private ethernet network connects the HeartVista Workstation to the MR scanner computer. When not in use, the HeartVista Workstation 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 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. |
| ISO 14971:2007 | Medical devices - Application of risk management to medical |
| devices. |
RTHawk has been designed to comply with the FDA Recognized Consensus Standards listed in the table below, as applicable to device features and components:
8.0 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-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.
Image /page/4/Figure/8 description: The image shows a red wave pattern that starts with a high frequency and gradually decreases. The wave eventually flattens out into a straight line. The number 3 is located in the bottom right corner of the image.
5
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
- O GE Healthcare (GEHC) DV 1.5T, 3.0T. Software version 24.
9.0 Technological Characteristics Comparison to Predicate Device
Identical.
The RTHawk software is identical to comprised of the following functional modules:
- O 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
- O Application - HeartVista APPs. Each APP is comprised of a pulse sequence, user parameters, a reconstruction pipeline, and a specific user interface
- Information System the central repository of all relevant MRI system configuration, patient, ○ study, scan, etc., parameters associated with the current patient study
- O Reconstruction - responsible for the efficient processing of raw data to generate MR images via a flexible, pipelined topology
- Scan Control responsible for the real-time network transfer of controlling orders for APPs. APPs o 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
- o Storage - obtains current patient and scan information, performs non-volatile local storage, exports images and data in DICOM format, and logs events.
- O Visualization - implements all aspects of the user iterface, including APP selection, controls to modify APP parameters, image display, graphical slice prescription, and image review, save, and export.
Instructions for use are included within the device labeling, and the information provided enables the user to operate the device in a safe and effective manner.
10.0 Performance Data - Discussion of Non-Clinical Tests
Design controls quality assurance measures during the development of RTHawk include:
- O Code reviews
- o Design reviews
- O Unit and integration level testing
- O Verification testing, including System and Manual testing
- Safety testing, including SAR, dB/dt, and acoustic noise O
- Performance testing, including SNR and uniformity
- O Validation testing
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.
Image /page/5/Figure/26 description: The image shows a red wave pattern that starts with high frequency and gradually decreases. The wave eventually flattens out into a straight line. The number 4 is present in the bottom right corner of the image.
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11.0 Safety Parameters
| 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 |