Vantaqe Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display analomic 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 mağnetic 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/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K120487. This submission will include the following five software functionalities: Changes in the SAR calculation method, 3D ASL (3 dimensional Arterial Spin Labeling), Advanced Moving Bed (AMB), 3D MRS (3 dimensional MR Spectroscopy) and Distortion correction for entire volume are added to Vantage Titan 3T.

AI/ML Overview

Analysis of K132160 for Acceptance Criteria and Study Details

The provided document K132160 relates to a 510(k) premarket notification for software functionalities added to the Toshiba Vantage Titan 3T MRI system (Model MRT-3010/A5). It's important to note that this submission primarily concerns software changes and their impact on safety and performance parameters, rather than a new diagnostic algorithm or a comparative effectiveness study for a new clinical indication. Therefore, the typical structure for reporting acceptance criteria and study details for an AI/algorithm-driven diagnostic device showing clinical performance metrics may not fully apply in this context.

Based on the document, the "acceptance criteria" and "device performance" are primarily framed around compliance with established safety standards and maintaining equivalence in imaging performance compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for software updates to an existing MRI system, the acceptance criteria are largely focused on demonstrating that the updated system continues to meet safety and performance standards, or improves on flexibility without compromising safety. There aren't specific quantitative accuracy metrics for diagnosing a condition, but rather operational and safety specifications.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Vantage Titan 3T with new software)
Safety Parameters	1. Static Field Strength: Maintain 3T	3T (Same as Predicate)
	2. Operational Modes: Remain in 1st Operating Mode	1st Operating Mode (Same as Predicate)
	3. Safety Parameter Display: Display SAR dB/dt	SAR dB/dt (Same as Predicate)
	4. Operating Mode Access Requirements: Allow screen access to 1st level operating mode	Allows screen access to 1st level operating mode (Same as Predicate)
	5. Maximum SAR: ≤ 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33 (2010)) Note: Updated standard compared to predicate.	4W/kg for whole body (1st operating mode specified in IEC 60601-2-33 (2010)) (Complies with updated standard)
	6. Maximum dB/dt: < 1st operating mode specified in IEC 60601-2-33 (2010) Note: Updated standard compared to predicate.	< 1st operating mode specified in IEC 60601-2-33 (2010) (Complies with updated standard)
	7. Potential Emergency Condition & Shutdown: Provide means for shutdown (e.g., 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	No change in imaging performance from the previous predicate submission (K120487). This implies maintaining or exceeding the previous performance levels for aspects like image quality, signal-to-noise ratio, resolution, etc., for the general imaging capabilities. The specific software updates add new capabilities but are not described as changing the fundamental imaging performance of existing sequences.	"No change from the previous predicate submission (K120487)." This indicates that the imaging performance for the core functionalities remains equivalent, and the added software features are enhancements that are also expected to meet appropriate performance characteristics (though specific metrics for 3D ASL, 3D MRS, etc., are not detailed in this summary).
Intended Use	Maintain the previously cleared indication for use.	Vantaqe 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. Also capable of non-contrast enhanced imaging (MRA). (No changes to previously cleared indication K120487).
Design Control & Standards	Compliance with applicable recognized consensus standards (e.g., IEC60601-1, IEC60601-1-2, IEC60601-2-33, IEC62304, IEC62366).	The submission states "Testing was done in accordance with applicable recognized consensus standards as listed below" and lists relevant IEC standards. The difference in SAR/dBdt criteria is explicitly cited as conforming to the newer IEC 60601-2-33 (2010) standard.

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

The document does not specify a sample size for a test set in the context of clinical studies with patients/images for diagnostic accuracy. This is because the submission is for software updates to an MRI scanner rather than a diagnostic algorithm that analyzes images for a specific condition.

The "testing" mentioned refers to engineering verification and validation (V&V) of the software functionalities and safety parameters, which would typically involve phantom studies, limited human subject testing for comfort/safety, and functional testing on the device itself.

Test Set Sample Size: Not applicable/not specified for diagnostic accuracy. Testing would be against technical specifications and safety standards, likely involving hardware and software in a controlled environment.
Data Provenance: Not applicable for diagnostic image data. The "testing" pertains to the device functionality, and data would be generated from the device itself or phantoms for technical validation. The manufacturing site is in Japan (Toshiba Medical Systems Corporation).

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

This question is not applicable in the context of this 510(k) summary. The ground truth for this type of submission is typically adherence to engineering specifications, safety standards (e.g., SAR limits), and functional performance for image acquisition (e.g., sequence parameters, distortion correction effectiveness). These are validated through technical measurements and comparisons, not expert interpretation of diagnostic images for a clinical outcome.

4. Adjudication Method for the Test Set

Given that the "test set" here refers to technical validation against specifications and safety standards rather than a clinical diagnostic accuracy study, adjudication methods like 2+1 or 3+1 are not applicable. The testing would involve objective measurements and comparisons by engineers and possibly physicists to confirm compliance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done or reported in this summary. This type of study is relevant for evaluating the impact of a diagnostic AI algorithm on human reader performance. This submission is for software updates to an MRI scanner, which primarily affects how images are acquired and processed, not how a human interprets them using an AI assistant.

Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable.

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

No, a standalone performance evaluation (in the sense of a diagnostic algorithm without human input) was NOT done or reported. The device is an MRI scanner, which is an imaging modality. The software updates enhance the imaging capabilities (e.g., 3D ASL, 3D MRS, distortion correction). These are fundamental tools for image acquisition, not standalone diagnostic algorithms.

7. The Type of Ground Truth Used

The "ground truth" for this submission is technical specifications, established safety limits (e.g., SAR limits from IEC standards), and the expected functional behavior of the software. This is verified through engineering testing, phantom studies, and comparison to the predicate device's established performance and indication of use. There is no mention of pathology, expert consensus on disease, or outcomes data as ground truth in this 510(k) summary.

8. The Sample Size for the Training Set

Not applicable. This submission is for software updates to an MRI scanner. It does not describe an AI/ML algorithm that requires a "training set" of data for learning diagnostic patterns. The software functionalities are based on physics principles, signal processing, and numerical algorithms.

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

Not applicable. As there is no "training set" in the context of an AI/ML algorithm, the concept of establishing ground truth for it does not apply to this submission.

Summary

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K132160

Toshiba America Medical Systems, Pre-Market Notification 510(k) Vantage Titan 3T, MRT-3010/A5

510(k) SUMMARY AND EFFECTIVENESS

1. CLASSIFICATION and DEVICE NAME:

Classification Name:	Magnetic Resonance Diagnostic Device
Regulation Number:	21 CFR 892.1000
Product Code:	LNH
Trade Proprietary Name:	Vantage Titan 3T
Model Number:	MRT-3010/A5

2. ESTABLISHMENT REGISTRATION: 2020563

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

Contact Person Charlemagne Chua Manager, Regulatory Affairs (714) 669-7896

OCT 16 2013

U.S. Agent Name: Paul Biggins Director, Regulatory Affairs (714) 730-5000

Establishment Name and Address:

Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780

4. MANUFACTURING SITE:

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

5. DATE OF SUBMISSION:

July 10, 2013

6. DEVICE DESCRIPTION:

The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K120487. This submission will include the following

Page 1 of 4

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five software functionalities: Changes in the SAR calculation method, 3D ASL (3 dimensional Arterial Spin Labeling), Advanced Moving Bed (AMB), 3D MRS (3 dimensional MR Spectroscopy) and Distortion correction for entire volume are added to Vantage Titan 3T.

7. SUMMARY OF HARDWARE CHANGES

There are no major hardware changes associated with the software change.

8. SUMMARY OF SOFTWARE CHANGES

Existing software packages are grouped by functions of software and pulse sequences. New software (V2.30) packages (four software functionalities) as follows:

a) Changes in the SAR calculation method

The new calculation method provides more flexibility in setting scan parameters, which enables scan with increased number of slices per unit time etc.

b) 3D ASL (3 dimensional Arterial Spin Labeling)

This function of software adds a new feature for current ASL imaging so that images can be acquired from 3D volume instead of 2D slice.

c) Advanced Moving Bed (AMB)

AMB enables individual scan settings for each station when Moving Bed is used. It allows acquisition of images with the most appropriate settings for each station.

d) 3D MRS (3 dimensional MR Spectroscopy)

This function of software enables the acquisition of proton spectroscopic data from multiple voxel in a 3 dimensional volume of an object by applying phase encode aradients in three orthogonal directions.

e) Distortion correction for entire volume

This function of software performs correction of image distortion due to gradient magnetic field non-linearity for entire 3D volume including slice direction.

9. SAFETY PARAMETERS

Item	Vantage Titan 3T withnew application softwarepackage(subject device)	Vantage Titan 3T ,K120487(Predicate Device)	Notes
Static field strength	3T	3T	Same
Operational Modes	1st Operating Mode	1st Operating Mode	Same

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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan 3T, MRT-3010/A5

i. Safety parameterdisplay	SAR dB/dt	SAR dB/dt	Same
ii. Operating modeaccessrequirements	Allows screen access to1st level operating mode	Allows screen access to1st level operating mode	Same
Maximum SAR	4W/kg for whole body (1stoperating mode specifiedinIEC 60601-2-33(2010))	4W/kg for whole body (1stoperating mode specifiedinIEC 60601-2-33(2002))	Change*
Maximum dB/dt	<1st operating modespecified inIEC 60601-2-33 (2010)	<1st operating modespecified inIEC 60601-2-33 (2002)	Change*
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

*Note: The difference between predicate and subject device is due to the conformance of the subject device to IEC 60601-2-33 (2010)

10. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K120487).

11. INTEDED USE

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 noncontrast 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.

No changes to the previously cleared indication (K120487).

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12. DESIGN CHANGE

Following software package addition to Vantage Titan 3T (K120487).

a) Changes in the SAR calculation method
b) 3D ASL (3 dimensional Arterial Spin Labeling)
c) Advanced Moving Bed (AMB)
d) 3D MRS (3 dimensional MR Spectroscopy)
e) Distortion correction for entire volume

13. 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 (K120487).

14. 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.

15. SUBSTANTIAL EQUIVALENCE

Toshiba Medical Systems Corporation believes that the Vantage Titan 3T (model MRT-3010/A5) 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

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 16, 2013

TOSHIBA MEDICAL SYSTEMS CORPORATION % Mr. PAUL BIGGINS DIRECTOR REGULATORY AFFAIRS 2441 MICHELLE DRIVE TUSTIN CA 92780

Re: K132160

Trade/Device Name: Vantage Titan 3T, MRT-3010/A5 v2.30 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 6, 2013 Received: September 9, 2013

Dear Mr. Biggins:

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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Page 2-Mr. Biggins

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely vours.

Michael D. O'Hara

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

l'or

Enclosure

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Indications for Use

510(k) Number (if known):

K132160

Device Name:

Vantage Titan 3T, v2.30 (MRT-3010/A5)

Indications for 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.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Michael D. O'Hara

Page 1 of 1

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.