RTHawk, HeartVista Cardiac Package

K153740 · Heartvista, Inc. · LNH · Jun 30, 2016 · Radiology

Device Facts

• Record ID: K153740
• Device Name: RTHawk, HeartVista Cardiac Package
• Applicant: Heartvista, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jun 30, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

RTHawk is an accessory to 1.5T and 3.0T whole-body magnetic resonance diagnostic 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 HeartVista 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

Device Story

RTHawk is a software platform accessory for 1.5T/3.0T MRI scanners; operates in parallel with existing MR console via private ethernet connection; requires no permanent physical modifications to scanner. System consists of Linux-based workstation with monitor, keyboard, and mouse. RTHawk Apps (pulse sequences, reconstruction pipelines, GUI) control scanner to acquire, reconstruct, and display cardiovascular MR images. Features include real-time interactive scanning, sub-second latency parameter adjustment, and accelerated imaging (e.g., free-breathing, multi-slice). Physician uses GUI to prescribe scan planes, adjust pulse sequence parameters, and review images. Output assists in clinical diagnosis by providing anatomical and functional cardiovascular data. Benefits include reduced reliance on ECG gating/breath-holding, improved imaging for patients with arrhythmias, and clinically feasible comprehensive CMR study times.

Clinical Evidence

Bench testing only. Evidence includes verification and validation testing, safety testing (SAR, dB/dt, acoustic noise), and performance testing (SNR, uniformity) per consensus standards (IEC 60601-2-33, NEMA MS1, MS3, MS4, MS8). Clinical images were acquired and evaluated by radiologists to confirm diagnostic utility.

Technological Characteristics

Linux-based software platform; operates on standalone workstation connected via Ethernet to OEM MR console. Modules: Acquisition, Analysis, Application, Information System, Reconstruction, Scan Control, Sequencer, Storage, Visualization. Pulse sequences: Cine Cartesian/Spiral SSFP, Gated High-Res GRE, Gated Double-IR FSE, Time Course GRE, Multi-Slice DE GRE, Cardiac T1/T2* Mapping, etc. Connectivity: DICOM. Safety: IEC 60601-1, IEC 60601-2-33. Max SAR <4W/kg.

Indications for Use

Indicated for patients requiring cardiovascular MR (CMR) imaging on 1.5T or 3.0T GE Healthcare MRI systems. Used for acquiring, reconstructing, and displaying static/dynamic cross-sectional images of internal structures/functions based on proton density, T1, T2, and flow properties.

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

• RTHawk 1.0.1 (K142997)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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### 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)

| <div><span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>□ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------|
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------|

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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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Image /page/4/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. The font is modern and geometric, with sharp angles and clean lines.

# 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: [e-mail]

#### 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<br>Date |
|----------|--------------|----------------|--------------------------|
| K142997 | RTHawk 1.0.1 | HeartVista | 12/17/2014 |

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# 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 | <4W/kg whole-body |
| Max dB/dt | 1st Level Operating Mode |

Image /page/5/Picture/15 description: The image shows a red wave pattern that starts with very short wavelengths and gradually increases in wavelength. The wave eventually becomes a straight line. The number 3 is located at the bottom right of the image.

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## 8.0 Indications for Use

RTHawk is an accessory to 1.5T and 3.0T whole-body magnetic resonance diagnostic 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 HeartVista 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 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

#### 9.0 Technological Characteristics Comparison to Predicate Device

The structure of the RTHawk software is identical to the predicate device, and is 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
- 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
- Reconstruction responsible for the efficient processing of raw data to generate MR images O via a flexible, pipelined topology
- O Scan Control responsible for the real-time network transfer of controlling orders for APPs, APPs parameters modifications, and dynamic information from the MR host in response to user or program requests
- O Sequencer creates and provides a specific set of pulse sequence waveforms to control the 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.

The predicate device was described as the "HeartVista Workstation with the RTHawk application software." With the current release of RTHawk software, the workstation is specified and validated by HeartVista, and procured by the end-user.

As with the predicate device, 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 provide real-time interactive, batch-mode, and accelerated scanning, as well as calibration functions, in which data acquired may be used to tune or optimize other Apps. For safety, the RTHawk software is enhanced for display of worst-cast B1 RMS that the APP can potentially reach while scanning, in addition to already-displayed worst-case SAR, dB/dt.

mm/vv

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As a refinement and specialization of the predicate device RTHawk software, the HeartVista Cardiac Package is collection of RTHawk APPs that enables the performance of a comprehensive cardiovascular MR (CMR) study in a clinically feasible amount of time.

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.

The table below summarizes a comparison of the revised technological characteristics to the predicate device:

| Attribute | RTHawk, K142997 | RTHawk, K153740<br>Modified Device |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The HeartVista Workstation with<br>RTHawk application software is<br>an accessory to 1.5T and 3.0T<br>whole-body magnetic resonance<br>diagnostic devices (MRDD or MR).<br>The HeartVista Workstation with<br>the RTHawk application software<br>is intended to operate alongside,<br>and in parallel with, the existing MR<br>console to acquire real-time and<br>accelerated images. The HeartVista<br>Workstation with the RTHawk<br>application software is indicated<br>for Cardiovascular MR (CMR)<br>applications.<br>The HeartVista Workstation with<br>the RTHawk application software<br>produces static and dynamic<br>transverse, coronal, sagittal, and<br>oblique cross-sectional images that<br>display the internal structures and/<br>or functions of the entire body. The<br>images produced re ect the spatial<br>distribution of nuclei exhibiting<br>magnetic resonance.<br>The magnetic resonance properties<br>that determine image appearance<br>are proton density, spin-lattice<br>relaxation time (T1), spin-spin<br>relaxation time (T2) and flow. When<br>interpreted by a trained physician,<br>these images provide information<br>that may assist in the determination<br>of a diagnosis.<br>The HeartVista Workstation with<br>the RTHawk application software is<br>intended for use as an accessory to<br>the following OEM, MRI system, and<br>software release versions:<br>* GE Healthcare (GEHC) Signa HDxt<br>1.5T, 3.0T. Software versions 15 and 16<br>* GE Healthcare (GEHC) DVMR 1.5T,<br>3.0T. Software version 24 | RTHawk is an accessory to 1.5T<br>and 3.0T whole-body magnetic<br>resonance diagnostic devices<br>(MRDD or MR). It is intended to<br>operate alongside, and in parallel<br>with, the existing MR console to<br>acquire traditional, real-time, and<br>accelerated images. The HeartVista<br>Cardiac Package is a collection<br>of RTHawk Apps designed to<br>acquire, reconstruct and display<br>cardiovascular MR (CMR) images.<br>RTHawk produces static and<br>dynamic transverse, coronal, sagittal,<br>and oblique cross-sectional images<br>that display the internal structures<br>and/or functions of the entire body.<br>The images produced reflect the<br>spatial distribution of nuclei exhibiting<br>magnetic resonance. The magnetic<br>resonance properties that determine<br>image appearance are proton<br>density, spin-lattice relaxation time<br>(T1), spin-spin relaxation time (T2) and<br>flow. When interpreted by a trained<br>physician, these images provide<br>information that may assist in the<br>determination of a diagnosis.<br>RTHawk is intended for use as an<br>accessory to the following MRI<br>systems:<br>Manufacturer: GE Healthcare<br>(GEHC)<br>Field Strength: 1.5T and 3.0T<br>Scanner Software Versions: 15, 16, 23,<br>24, 25 |
| Attribute | RTHawk, K142997 | RTHawk, K153740<br>Modified Device |
| Magnetic Field<br>Strength(s) | 1.5T 3.0T | 1.5T 3.0T |
| RF Coils | Up to 32-channel Head, Body,<br>Surface, Phased Array.<br>Supports all coils that are currently<br>available on the MRI console | Up to 32-channel Head, Body,<br>Surface, Phased Array.<br>Supports all coils that are currently<br>available on the MRI console |
| Shift/Advance Table | No | No |
| Imaging Planes | Transverse, Coronal, Sagittal,<br>Oblique, Double Oblique | Transverse, Coronal, Sagittal,<br>Oblique, Double Oblique |
| Pulse sequences | | |
| | Cine Cartesian SSFP | Cine Cartesian SSFP |
| | Cine Spiral SSFP | Cine Spiral SSFP |
| | Gated High-Res GRE | Gated High-Res GRE |
| | Gated Double-IR FSE | Gated Double-IR FSE |
| | Gated Multi-Slice Dyn SR | Time Course GRE (renamed) |
| | Gated IR GRE Cal | FB DE GRE Cal (renamed) |
| | | Cine DE Cal |
| | | Multi-Slice DE GRE |
| | | FB DE SSFP |
| | | Cardiac T1 Map |
| | Gated 3D IR GRE | Single-BH 3D DE GRE (renamed) |
| | Real-Time Loc GRE | Real-Time Loc GRE |
| | Real-Time Loc SSFP | Real-Time Loc SSFP |
| | Real-Time Color PC…