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: 12, 15, 16, 23, 24, 25

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 RTHawk workstation to the MR scanner computer. When not in use, the RTHawk 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) 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 - 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 imaging.
. Continuous flow quantification

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.

AI/ML Overview

The provided text is a 510(k) Summary for the medical device RTHawk, HeartVista Cardiac Package (K170090). This document focuses on demonstrating substantial equivalence to a predicate device (K153740) rather than presenting a performance study against specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies in the format of a clinical trial with a test set, ground truth establishment, expert adjudication, or MRMC studies.

The document primarily focuses on:

Indications for Use: Identical to the predicate device.
Technological Characteristics Comparison: Demonstrates the core functionalities and structure are the same as the predicate, with a minor update to supported scanner software versions.
Non-Clinical Tests: Mentions design controls, quality assurance measures (code reviews, design reviews, unit/integration testing, verification testing, safety testing, performance testing, validation testing), and risk management (ISO 14971:2007 compliance).

In summary, the document does not present a study designed to "prove the device meets acceptance criteria" in the sense of a clinical performance study with human readers or standalone algorithm performance. Instead, it argues for substantial equivalence based on identical intended use, similar technological characteristics, and adherence to design control and quality management principles.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

July 14, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

HeartVista, Inc. % Mr. James Rogers FDA Regulatory Affairs, Quality Assurance, and Clinical Studies 4984 El Camino Real. Suite 102 LOS ALTOS CA 94022

Re: K170090

Trade/Device Name: RTHawk. HeartVista Cardiac Package Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 13, 2017 Received: June 16, 2017

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 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 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 (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" (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.

Michael D. O'Hara
For

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) K170090

Device Name RTHawk, HeartVista Cardiac Package

Indications for Use (Describe)

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: 12, 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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510(k) Summary

RTHawk; HeartVista Cardiac Package 510(k) Number: K170090

Submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.

1.0 Medical Establishment Registration

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

3.0 Establishment Name and Address

HeartVista, Inc. 4984 El Camino Real, Suite 102 Los Altos, CA 94022

4.0 Submission Date

January 5, 2017, June 13, 2017

5.0 Device Information

Trade/Proprietary Name: RTHawk, HeartVista Cardiac Package Common Name: RTHawk, HeartVista Cardiac Package Model Number(s):

HeartVista Cardiac Package (HVCP) ●
. 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

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6.0 Predicate Device(s)

510(k) #	Device	510(k) Sponsor	510(k) ClearanceDate
K153740	RTHawk (ver 2.3.0)HeartVista Cardiac Package	HeartVista	06/30/2016

7.0 Device Description

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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 - 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 imaging.
. Continuous flow quantification

RTHawk has been designed to comply with the FDA Recognized Consensus Standards listed in the table below, as applicable to device features and components:

Reference #	Title
IEC 60601-2-33 Ed 3.0(2010-03)	Medical electrical equipment - Part 2-33: Particularrequirements for the basic safety and essential performance ofmagnetic resonance equipment for medical diagnostic(radiology).
MS1-2008	Determination of Signal-to-Noise Ratio (SNR) in DiagnosticMagnetic Resonance Imaging
MS3-2008	Determination of Image Uniformity in Diagnostic MagneticResonance Images
MS4-2010	Acoustic Noise Measurement Procedure for DiagnosticMagnetic Resonance Imaging Devices
MS8-2008	Characterization of the Specific Absorption Rate (SAR) forMagnetic Resonance Imaging Systems
NEMA PS3.1 - 3.20 (2011)	Digital Imaging And Communications In Medicine (DICOM)Set.

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ISO 14971:2007	Medical Devices - Application Of Risk Management ToMedical Devices
ES60601-1:2005/(R)2012+A1 +C1 +A2	(Consolidated Text) Medical Electrical Equipment - Part 1:General Requirements For Basic Safety And EssentialPerformance (IEC 60601-1:2005, Mod). Section 14Programmable Electrical Medical Systems (PEMS)

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 is a collection of RTHawk Apps designed to acquire, reconstruct and display cardiovascular MR (CMR) images.

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: 12, 15, 16, 23, 24, 25

9.0 Technological Characteristics Comparison to Predicate Device and Discussion

Both the subject device and the predicate device software are intended as an accessory to GEHC 1.5T and 3.0T MRI systems, and are intended to integrate and interact seamlessly with the operating system software within those MRI systems. Both devices support all coils available on the specific installation's MRI console. Neither device supports software-controlled patient table movements and shifts. Both devices support remote access to and imaging on the specific installation's MRI system.

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Image /page/7/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized font. The first five letters, "HEART", are in black, blocky letters. The "I" in "VISTA" is dotted with a red circle, and the "A" is red and shaped like an upside-down "V". The overall design is modern and eye-catching.

The structure of the subject device software is identical to the predicate device software, and is comprised of the following functional modules:

Acquisition - responsible for the transfer of MR raw data from the MR scanner to the HeartVista Workstation
. 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 con guration, patient, study, scan, etc., parameters associated with the current patient study
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 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 MR scanner
. Storage - obtains current patient and scan information, performs non-volatile local storage, exports images and data in DICOM format, and logs events.
. Visualization - implements all aspects of the user interface, including APP selection, controls to modify APP parameters, image display, graphical slice prescription, and image review, save, and export.

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. Orthogonal, oblique, and double oblique imaging planes are fully supported. The HeartVista Cardiac Package is a collection of RTHawk Apps designed to acquire, reconstruct and display cardiovascular MR (CMR) images, and functions and features of those Apps is unchanged from the predicate device.

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 subject device implements FDA Unique Device Identifier (UDI) labeling requirements. Both devices have equivalent statements of Intended Use.

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

Attribute	Predicate Device	Modified Device
	K153740RTHawk (ver 2.3.0)HeartVIsta Cardiac Package	K170090RTHawk (ver 2.3.2)HeartVIsta Cardiac Package
Indications for Use	RTHawk is an accessory to 1.5Tand 3.0T whole-body magneticresonance diagnostic devices(MRDD or MR). It is intended tooperate alongside, and in parallelwith, the existing MR console toacquire traditional, real-time, andaccelerated images. TheHeartVista Cardiac Package is acollection of RTHawk Appsdesigned to acquire, reconstructand display cardiovascular MR(CMR) images.	RTHawk is an accessory to 1.5Tand 3.0T whole-body magneticresonance diagnostic devices(MRDD or MR). It is intended tooperate alongside, and in parallelwith, the existing MR console toacquire traditional, real-time, andaccelerated images. TheHeartVista Cardiac Package is acollection of RTHawk Appsdesigned to acquire, reconstructand display cardiovascular MR(CMR) images.
	RTHawk produces static anddynamic transverse, coronal,sagittal, and obliquecross-sectional images that displaythe internal structures and/orfunctions of the entire body. Theimages produced reflect the spatialdistribution of nuclei exhibitingmagnetic resonance. The magneticresonance properties thatdetermine image appearance areproton density, spin-latticerelaxation time (T1), spin-spinrelaxation time (T2) and flow. Wheninterpreted by a trained physician,these images provide informationthat may assist in the determinationof a diagnosis.	RTHawk produces static anddynamic transverse, coronal,sagittal, and obliquecross-sectional images that displaythe internal structures and/orfunctions of the entire body. Theimages produced reflect the spatialdistribution of nuclei exhibitingmagnetic resonance. The magneticresonance properties thatdetermine image appearance areproton density, spin-latticerelaxation time (T1), spin-spinrelaxation time (T2) and flow. Wheninterpreted by a trained physician,these images provide informationthat may assist in the determinationof a diagnosis.
	RTHawk is intended for use as anaccessory to the following MRIsystems:Manufacturer: GE Healthcare(GEHC)Field Strength: 1.5T and 3.0T	RTHawk is intended for use as anaccessory to the following MRIsystems:Manufacturer: GE Healthcare(GEHC)Field Strength: 1.5T and 3.0T
	Scanner Software Versions: 15, 16,23, 24, 25	Scanner Software Versions: 12, 15,16, 23, 24, 25
Magnetic FieldStrength	1.5T, 3.0T	1.5T, 3.0T
RF Coils	Up to 32-channel Head, Body,Surface, Phased Array. Supportsall coils that are currently availableon the MRI console	Up to 32-channel Head, Body,Surface, Phased Array. Supportsall coils that are currently availableon the MRI console
Shaft/AdvanceTable	No	No
Imaging Planes	Transverse, Coronal, Sagittal,Oblique, Double Oblique	Transverse, Coronal, Sagittal,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
	Time Course GRE	Time Course GRE
	FB DE GRE Cal	FB DE GRE Cal
	Cine DE Cal	Cine DE Cal
	Multi-Slice DE GRE	Multi-Slice DE GRE
	FB DE SSFP	FB DE SSFP
	Cardiac T1 Map	Cardiac T1 Map
	Single-BH 3D DE GRE	Single-BH 3D DE GRE
	Real-Time Loc GRE	Real-Time Loc GRE
	Real-Time Loce SSFP	Real-Time Loce SSFP
	Real-Time Color PC	Real-Time Color PC
	FB Multi-Slice GRE	FB Multi-Slice GRE
	HART GRE	HART GRE
	FB Multi-Slice SSFP	FB Multi-Slice SSFP
	HART SSFP	HART SSFP
	Gated 3D MRA GRE	Gated 3D MRA GRE
	Nav 3D DE GRE	Nav 3D DE GRE
	Cardiac T2* Map	Cardiac T2* Map
Remote Imagingand Support	Yes	Yes

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Image /page/9/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized font. The word is mostly black, except for the last letter, "A", which is red. There is also a red dot above the "I" in "VISTA".

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Image /page/10/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized font. The letters "HEARTVIS" are in black, while the "TA" is in red. There is a red dot above the "I" in "VISTA". The font is bold and geometric, with sharp angles and straight lines.

10.0 Performance Data - Discussion of Non-Clinical Tests

Design controls quality assurance measures during the development of RTHawk include:

Code reviews ●
Design reviews .
Unit and integration level testing
Verification testing, including System and Manual testing ●
Safety testing, including SAR, dB/dt, and acoustic noise .
Performance testing, including SNR and uniformity ●
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.

11.0 Safety Parameters

Safety Parameter	Safety Level
Magnetic 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

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12.0 Conclusions

Based upon verification testing and compliance with voluntary standards, the Company believes that RTHawk, and the HeartVista Cardiac Package, are substantially equivalent to the predicate device, and do not raise any new questions of safety or effectiveness.

Regulation Number and Section

N/A