Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

Proton density (PD) (also called hydrogen density) .
. Spin-lattice relaxation time (T1)
· Spin-spin relaxation time (T2)
. Flow dynamics
. Chemical Shift

Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

Device Description

The Vantage Titan 3T (Model MRT-3010) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K143008. This submission will include the following software functionalities: UTE (Ultra Short TE), MP-RAGE, T2:mEcho, T2*:mEcho, Improvements to MRS, Multi b-value DWI, SpineLine+, SureVOI, 2D Real-time Motion Correction (2D-RMC) and eFSBB.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Vantage Titan 3T (MRT-3010) MRI system, based on the provided document.

It's important to note that this document is a 510(k) summary for a software update to an existing MRI system. Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating that the new software functionalities do not introduce new safety or effectiveness concerns and that the system continues to perform as specified, maintaining substantial equivalence to its predicate device. This is often validated through technical performance parameters rather than clinical diagnostic accuracy per se in these types of submissions.

1. Table of Acceptance Criteria and Reported Device Performance

Item	Acceptance Criteria (Predicate Device K143008)	Reported Device Performance (Subject Device Vantage Titan 3T, V3.5)	Notes
Safety Parameters
Static field strength	3T	3T	Same as predicate
Operational Modes	Normal and 1st Operating Mode	Normal and 1st Operating Mode	Same as predicate
i. Safety parameter display	SAR dB/dt	SAR dB/dt	Same as predicate
ii. Operating mode access requirements	Allows screen access to 1st level operating mode	Allows screen access to 1st level operating mode	Same as predicate
Maximum SAR (Whole body)	4W/kg (1st operating mode specified in IEC 60601-2-33(2010))	4W/kg (1st operating mode specified in IEC 60601-2-33(2010))	Same as predicate
Maximum dB/dt	<1st operating mode specified in IEC 60601-2-33 (2010)	<1st operating mode specified in IEC 60601-2-33 (2010)	Same as predicate
Potential emergency condition and means provided for shutdown	Shut down by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects	Shut down by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects	Same as predicate
Imaging Performance Parameters	As established for predicate K143008	No change from previous predicate submission (K143008).	This indicates that the imaging performance for the updated system is deemed to be equivalent to the predicate. The document doesn't explicitly list specific imaging performance metrics, but implies they were evaluated to ensure consistency with the cleared device.
New Software Functionalities Performance (implicit acceptance criteria)	Function as intended without degradation of safety or effectiveness.	Testing was done in accordance with applicable recognized consensus standards (listed below).	The study (bench testing, phantom image studies, sample clinical images) demonstrated these new functionalities performed as specified. The "acceptance criteria" here is that they do not negatively impact the system's safety or overall diagnostic capability.

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

The document does not specify a numerical sample size for a "test set" in the context of clinical images used for evaluation. It mentions "sample clinical images" were used, but no quantity or specific details on patients.

Data Provenance: Not explicitly stated for specific images, but the testing was done by Toshiba Medical Systems Corporation (TMSC) in Japan. The nature of the submission (software update for an existing device) suggests a mix of internal testing data. It does not state if data was retrospective or prospective.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for any "clinical images" in the test set. Given the nature of a 510(k) for a software update to an MRI, the primary focus is on technical performance and maintaining equivalence, not necessarily a new clinical trial for diagnostic accuracy. Interpretation of "sample clinical images" would typically be done by radiologists, but no specifics are given here.

4. Adjudication Method for the Test Set

No adjudication method is mentioned for any clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating the safety and effectiveness of new software functionalities against established standards and the predicate device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not a software device in the AI/CAD context. The device is an MRI system. The performance evaluated here relates to the technical capabilities of the MRI system itself and its software. The testing mentioned ("bench testing, phantom image studies") points to standalone technical performance evaluation of the system components and software, rather than an "algorithm only" in the sense of a diagnostic aid. The device is a diagnostic imaging modality intended to be interpreted by a trained physician (human-in-the-loop).

7. Type of Ground Truth Used

The ground truth or reference standard for this submission is primarily tied to:

Technical Specifications: Conformance to safety and performance parameters outlined in recognized consensus standards like IEC 60601-2-33 (2010).
Predicate Device Performance: The cleared performance of the predicate device (Vantage Titan 3T, V2.50 K143008) serves as the benchmark for "substantial equivalence."
Expected Image Quality: For "phantom image studies" and "sample clinical images," the ground truth would be what is considered normal or acceptable image quality and diagnostic information for an MRI of that class. For specific new functionalities (e.g., UTE, MP-RAGE), the 'truth' is whether the sequences generate the expected image characteristics and capabilities for which they were designed.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms. The functionalities described (e.g., pulse sequences, automatic positioning assistance, motion correction, filters) are typically developed and refined through engineering expertise, physics principles, and iterative testing rather than statistical training on a large dataset in the way a deep learning model would be.

9. How Ground Truth for the Training Set Was Established

As no "training set" in the machine learning sense is identified, the concept of establishing ground truth for it does not directly apply. The development of these MRI software features would involve:

Engineering Specifications: Designed to meet specific technical requirements.
Physics Principles: Based on the underlying physics of MRI.
Expert Knowledge: Input from MRI physicists, engineers, and potentially experienced radiologists on desired image characteristics and workflow improvements.
Internal Testing and Iteration: Continuous refinement based on bench testing and phantom images.

Summary

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

October 23, 2015

Toshiba Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K152371

Trade/Device Name: Vantage Titan 3T (MRT-3010) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 18, 2015 Received: August 21, 2015

Dear Ms. Reyes:

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 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)

K152371

Device Name Vantage Titan 3T, MRT-3010

Indications for Use (Describe)

· Proton density (PD) (also called hydrogen density)
· Spin-lattice relaxation time (T1)
· Spin-spin relaxation time (T2)
· Flow dynamics
· Chemical Shift

Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

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 OF SAFETY AND EFFECTIVENESS

1. CLASSIFICATION and DEVICE NAME:

Classification Name:	Magnetic Resonance Diagnostic Device
Regulation Number:	90-LNH (Per 21 CFR 892.1000)
Trade Proprietary Name:	Vantage Titan 3T
Model Number:	MRT-3010

2. ESTABLISHMENT REGISTRATION: 9614698

3. Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

4. CONTACT PERSON, U.S AGENT and ADDRESS:

Contact Person

Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780 (714) 699-7853

U.S. Agent Name:

Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780 (714) 699-7808

5. MANUFACTURING SITE:

Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

6. DATE OF SUBMISSION:

August 11th, 2015

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7. DEVICE DESCRIPTION:

7.1 SUMMARY OF HARDWARE CHANGES

No change from previous predicate submission, K143008.

7.2 SUMMARY OF SOFTWARE CHANGES

a. UTE (Ultra Short TE) pulse sequence
b. MP-RAGE pulse sequence
c. T2:mEcho pulse sequence
d. T2*:mEcho pulse sequence
e. Improvements to MRS
f. Multi b-value DWI
g. SpineLine (automatic positioning assistance for spine)
h. NeuroLine+ (automatic positioning assistance for neuro)
i. SureVOI (automatic cardiac planning assistance)
j. 2D Real-time Motion Correction (2D-RMC)
k. eFSBB (new phase-enhanced filter)

8. SAFETY PARAMETERS

Item	Vantage Titan 3T, V3.5(Subject Device)	Vantage Titan 3T, V2.50 K143008(Predicate Device)	Notes
Static field strength	3T	3T	Same
Operational Modes	Normal and 1st Operating Mode	Normal and 1st Operating Mode	Same
i. Safety parameter display	SAR dB/dt	SAR dB/dt	Same
ii. Operating mode access requirements	Allows screen access to 1st level operating mode	Allows screen access to 1st level operating mode	Same
Maximum SAR	4W/kg for whole body (1st operating mode specified inIEC 60601-2-33(2010))	4W/kg for whole body (1st operating mode specified inIEC 60601-2-33(2010))	Same
Maximum dB/dt	<1st operating mode specified inIEC 60601-2-33 (2010)	<1st operating mode specified inIEC 60601-2-33 (2010)	Same

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Item	Vantage Titan 3T, V3.5(Subject Device)	Vantage Titan 3T, V2.50K143008(Predicate Device)	Notes
Potentialemergencycondition andmeans provided forshutdown	Shut down by EmergencyRamp Down Unit forcollision hazard forferromagnetic objects	Shut down by EmergencyRamp Down Unit forcollision hazard forferromagnetic objects	Same

8. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K143008).

9. INTENDED USE

Proton density (PD) (also called hydrogen density) .
. Spin-lattice relaxation time (T1)
· Spin-spin relaxation time (T2)
. Flow dynamics
. Chemical Shift

Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

No changes to the previously cleared indication (K143008).

10. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for software of changing packages are attached. The test methods used are the same as those submitted in the previously cleared submissions (K143008). A declaration of conformity with design controls is included in this submission.

11. TRUTHFUL AND ACCURACY CERTIFICATION

A certification of the truthfulness and accuracy of the Vantage Titan 3T described in this submission is provided in this submission.

12. SUBSTANTIAL EQUIVALENCE

Toshiba Medical Systems Corporation believes that the Vantage Titan 3T (model MRT-

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Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate devices referenced in this submission.

Testing was done in accordance with applicable recognized consensus standards as listed below.

List of Applicable Standards

IEC60601-1:2005
IEC60601-1-2:2007
· IEC60601-1-8:2003,Amd.1:2006
IEC60601-2-33:2010
· IEC60825-1: 2007
· IEC62304:2006
IEC62366:2007

Based upon bench testing, phantom image studies and sample clinical images Toshiba Medical Systems Corporation believes this system has characteristics that are compatible with currently marketed devices and has proven substantively that this system performed as specified and did not raise new issues of safety and effectiveness. Furthermore, this system does not offer new intended or indicated use when compared to the predicate. Based upon this information, Toshiba believes that it has established substantial equivalence to this device and the predicate.

Regulation Number and Section

§ 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.