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

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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study that explicitly demonstrates the device meets specific performance criteria in terms of accuracy, sensitivity, or specificity. The document is primarily a 510(k) summary for the HeartVista Workstation with RTHawk, focusing on its substantial equivalence to a predicate device and adherence to recognized consensus standards.

However, based on the non-clinical tests and performance data discussion, we can infer some aspects relevant to performance.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Image Quality and Diagnostic Accuracy Equivalence: Images acquired with RTHawk should demonstrate comparable image quality and diagnostic accuracy to images acquired using equivalent pulse sequences and post-processing from the predicate device. Where direct comparison is not possible, RTHawk images should be diagnostically acceptable based on radiologist expertise.	Clinical images acquired with RTHawk were compared to images from the predicate device (where possible, using equivalent pulse sequences). Images from both devices were evaluated and rated on the basis of diagnostic accuracy and image quality. Where no direct comparison, RTHawk images were evaluated directly based upon radiologist expertise. The conclusion states substantial equivalence.
Signal-to-Noise Ratio (SNR): Meeting standards for SNR in diagnostic MRI.	Performance testing included SNR, conforming to MS1-2008.
Image Uniformity: Meeting standards for image uniformity in diagnostic MRI.	Performance testing included uniformity, conforming to MS3-2008.
Safety Parameters (SAR, dB/dt, Acoustic Noise): Compliance with IEC 60601-2-33 (2010-03) and specific limits for SAR (<4W/kg whole-body), dB/dt (1st Level Operating Mode), and acoustic noise.	Bench testing results for SAR, dB/dt, and acoustic noise were consistent with previously reported results for the predicate device (K133848) and are within the specified limits.
Risk Management: Identification and mitigation of hazards compliant with ISO 14971:2007, with residual risks evaluated.	Risk management processes, compliant with ISO 14971:2007, were implemented, including hazard identification, mitigation, and evaluation of residual risks.
Compliance with Recognized Standards: Adherence to various recognized consensus standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-2-33, DICOM, ISO 14971).	RTHawk has been designed to comply with the FDA Recognized Consensus Standards listed (see page 4/5 of the document).
Software Quality: Implementation of design controls like code reviews, design reviews, unit/integration testing, verification, and validation testing.	Design controls quality assurance measures were implemented, including code reviews, design reviews, unit and integration level testing, verification testing, and validation testing.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "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 post-processing as necessary from the predicate device."

Sample Size for Test Set: Not explicitly stated. The phrase "same patient" implies a within-subject comparison but doesn’t provide the number of patients or images.
Data Provenance: Not explicitly stated. It's unclear if the data was retrospective or prospective, or the country of origin. "Clinical images were acquired" suggests prospective acquisition for the study, but this is not confirmed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not explicitly stated. The text mentions "radiologist expertise" (singular or plural not specified) for evaluating images without direct comparison to the predicate.
Qualifications of Experts: Not explicitly stated, beyond "radiologist expertise." No experience level (e.g., "10 years of experience") is provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The statement "Images from both devices were evaluated and rated on the basis of diagnostic accuracy and image quality" and "RTHawk images were evaluated directly based upon radiologist expertise" does not describe a specific adjudication process (like 2+1 or 3+1). It implies a subjective rating by radiologists.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Comparative Effectiveness Study: No, this type of study was not described. The study focused on comparing RTHawk images to predicate device images and radiologist evaluation of RTHawk images. It does not assess human reader performance with or without AI assistance. The RTHawk is described as an accessory for image acquisition and processing, not as an AI-assisted diagnostic tool for humans, in the context of this 510(k).

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: The study evaluated the images produced by RTHawk (the algorithm/system), rated for diagnostic accuracy and image quality. This can be considered a form of standalone evaluation of the image output, as the "radiologist expertise" assessment would be against the RTHawk images themselves. However, it's not a quantitative measure of performance like sensitivity/specificity often seen in standalone AI algorithm studies.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for image quality and diagnostic accuracy appears to be based on:
- Comparison to images from a predicate device (assumed to represent a clinical standard).
- Radiologist expertise (subjective evaluation by trained physicians).
- This is not pathology, or long-term outcomes data.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not mentioned or described in the provided document. The 510(k) summary focuses on the device's substantial equivalence and non-clinical testing rather than specific AI model training details.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not mentioned, as training set details are not provided.

Summary

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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.

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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/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

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Indications for Use

510(k) Number (if known) K142997

Device Name

RTHawk, or HeartVista Workstation with RTHawk

Indications for Use (Describe)

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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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) ClearanceDate
K133848	RTHawk, or HeartVista Workstation with RTHawk	HeartVista	6/25/2014

Device Description 7.0

minum

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Reference #	Title
ANSI/AAMI ES60601-1:2005/(R)2012 +C1 +A2	Medical electrical equipment - Part 1: General requirements forbasic 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 requirementsfor the basic safety and essential performance of magneticresonance 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 Diagnostic MagneticResonance 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.
ISO 14971:2007	Medical devices - Application of risk management to medicaldevices.

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 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.

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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 ModesIEC 60601-2-33 (2010-03)	1st Level Operating Mode	1st Level Operating Mode
Safety Parameter Display	SAR, dB/dt	SAR, dB/dt
Max SAR	<4W/kg whole-body	<4W/kg whole-body
Max dB/dt	1st Level Operating Mode	1st Level Operating Mode

12.0 Performance Data - Bench Testing

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.

13.0 Conclusions

Based upon verification and validation testing, safety testing, and compliance with voluntary standards, the Company believes that the RTHawk, or the HeartVista Workstation with the RTHawk application software is substantially equivalent to the predicate device, and does not raise any new questions of safety or effectiveness.

Regulation Number and Section

N/A