The MRI system is indicated for use as a diagnostic imaging modality that produces crosssectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. In addition, this system supports non-contrast 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 new Vantage Titan (Model MRT-1504/U4) MRI System is comparable to the current 1.5T Vantage Titan MRI System. The Vantage Titan uses the same magnet as the current Vantage Titan (K080038). However, the following modifications have been added: a redefinition of gradient strength, magnet cover and cabinet's configuration changes. In addition, two applications software: Diffusion Tensor Tractography (DTT), and PaceMaker.

AI/ML Overview

This 510(k) premarket notification describes modifications to an existing MRI system (Vantage Titan) rather than a new AI medical device requiring extensive performance studies. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence to predicate devices and adherence to established safety and performance standards for MRI systems, rather than clinical performance metrics for an AI algorithm.

Here's a breakdown of the provided information, framed to address your questions where possible:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (New Vantage Titan MRT-1504/U4)
Safety Parameters	Static field strength	1.5T
	Peak and A-weighted acoustic noise	106.2 dB (A-weighted), 115.4 dB (peak)
	Operational modes	1st operating mode
	Safety parameter display	SAR, dB/dt
	Operating mode access requirements	Allows screen access to 1st level operating mode
	Maximum SAR	4W/kg for whole body (1st operating mode specified in IEC 60601-2-33 (2002))
	Maximum dB/dt	<1st operating mode specified in IEC 60601-2-33 (2002)
	Potential emergency conditions and means for shutdown	Shut down by Emergency Ramp Down Unit for collision hazard by ferromagnetic objects
	Biocompatibility of materials	Confirmed for electrodes and accessories for wireless gating
Imaging Performance Parameters	Overall imaging performance	No change from the previous predicate submission (K080038)
Intended Use	Diagnostic imaging modality, cross-sectional transaxial, coronal, sagittal, and oblique images, display anatomic structures of head or body, non-contrast MRA support. Utilizes NMR properties (PD, T1, T2, flow dynamics, chemical shift). Interpretation by trained physician.	No changes to the previously cleared indication (K080038)
Design Changes	Gradient strength redefinition	Implemented
	Magnet cover changes	Implemented
	Cabinet configuration changes	Implemented
	Addition of Diffusion Tensor Tractography (DTT) software	Implemented
	Addition of PaceMaker (FBI with Auto ECG) software	Implemented
Substantial Equivalence	Demonstrated substantial equivalence to predicate devices (K080038 and K112003)	Claimed and accepted by FDA
Compliance with Standards	Adherence to a list of IEC and NEMA standards (e.g., IEC60601-1, IEC60601-2-33, NEMA MS-1, etc.)	Testing done in accordance with applicable recognized consensus standards

Study Information (as applicable to this device modification):

Sample size used for the test set and the data provenance:
- Test Set: Not applicable in the sense of a clinical trial with patient data to evaluate an AI algorithm's performance. The "testing" referred to in this submission is related to engineering verification and validation of hardware and software changes, and demonstrating compliance with safety and performance standards. This would involve internal testing, phantom studies, and potentially a limited number of human scans to confirm functionality and safety, but not a large-scale clinical test set for diagnostic accuracy.
- Data Provenance: Not specified for a clinical test set. The validation would have been performed by Toshiba Medical Systems Corporation, likely in Japan (manufacturing site).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not a study establishing ground truth for a diagnostic AI algorithm. The safety and performance evaluations would involve engineers and potentially clinical experts to review images and system functionality, but not in the capacity of creating a "ground truth" for a diagnostic accuracy study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the type of submission. Adjudication methods are typically for clinical trials assessing diagnostic accuracy, which is not the focus here.
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:
- No. This submission is for modifications to an MRI scanner and the addition of specific imaging sequences (DTT, PaceMaker), not for an AI-assisted diagnostic tool requiring a MRMC study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. The "applications software" (DTT and PaceMaker) are features of the MRI system, designed to aid in image acquisition and processing, not standalone diagnostic algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of diagnostic "ground truth." For hardware and software functionality, ground truth would be established through engineering specifications, phantom measurements, and known physical principles. For the new software features (DTT, PaceMaker), ground truth would relate to their ability to correctly perform their intended function (e.g., generate diffusion tensor tracts, accurately gate cardiac images) as measured against established technical benchmarks and clinical expectations.
The sample size for the training set:
- Not applicable. This device is not an AI algorithm that learns from a training set of labeled data in the conventional sense. The "training" for the software applications would be their development and optimization by engineers.
How the ground truth for the training set was established:
- Not applicable, as there isn't a "training set" in the context of an AI algorithm learning from data. The functionality of DTT and PaceMaker would be based on well-established MR physics and clinical needs.

Summary

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JUN - 1 2012

K12D 638

Toshiba America Medical Systems, Inc Pre-Market Notification 510(k) Vantage Titan, v2.1, MRT-1504/U4

510(k) SUMMARY AND EFFECTIVENESS

. 1. DEVICE NAME:

Generic Name: Model Name: Trade/ Proprietary Name: Magnetic Resonance Diagnostic Device MRT-1504/U4 Vantage Titan

2. ESTABLISHMENT REGISTRATION: 2020563

3. U.S AGENT INFORMATION:

U.S. Agent Name:

Paul Biggins (714) 730-5000

Establishment Name and Address:

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

MANUFACTURING SITE:

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

DATE OF SUBMISSION:

February 29, 2012

6. DEVICE DESCRIPTION

7. SUMMARY OF MAJOR HARDWARE CHANGES

a. Gradient Strength (redefinition)
b. Magnet Cover
Changes to the cabinet configuration C.

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8. SUMMARY OF MAJOR SOFTWARE CHANGES

a. Addition of 2 applications software

i. Diffusion Tensor Tractography (DTT)
ii. PaceMaker (FBI with Auto ECG)

9. SAFETY PARAMETERS

	New Vantage Titan(Subject device)	Vantage Titan(Predicate, K080038)	Vantage Titan HSR(Predicate, K112003)
a. Static fieldstrength:	1.5T	1.5 T	1.5T
b. Peak and A-weighted acousticnoise:	106.2 dB (A-weighed)115.4 dB(peak)	105.7dB (A-weighted)115.7dB (peak)	113.0 dB (A-weighted)121.6 dB (peak)
c. Operational modes:	1st operating mode	1st operating mode	1st operating mode
i. Safety parameterdisplay:	SAR, dB/dt	SAR, dB/dt	SAR, dB/dt
ii. Operating modeaccessrequirements:	Allows screen access to1st level operating mode	Allows screen access to 1stlevel operating mode	Allows screen access to1st level operating mode
d. Maximum SAR	4W/kg for whole body (1stoperating mode specified inIEC 60601-2-33 (2002))	4W/kg for whole body (1stoperating mode specified inIEC 60601-2-33 (2002))	4W/kg for whole body (1stoperating mode specified inIEC 60601-2-33 (2002))
e. Maximum dB/dt	<1st operating modespecified in IEC 60601-2-33(2002)	<1st operating modespecified in IEC 60601-2-33(2002)	<1st operating modespecified in IEC 60601-2-33(2002)
f. Potential emergencyconditions and meansprovided forshutdown:	Shut down by EmergencyRamp Down Unit forcollision hazard byferromagnetic objects	Shut down by EmergencyRamp Down Unit for collisionhazard by ferromagneticobjects	Shut down by EmergencyRamp Down Unit forcollision hazard byferromagnetic objects
Biocompatibility ofmaterials	Confirmed for electrodesand accessories forwireless gating	Not applicable	Confirmed for electrodesand accessories for wirelessgating

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10. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K080038).

11. INTEDED USE

The MRI system is indicated for use as a diagnostic imaging modality that produces crosssectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. In addition, this system supports non-contrast MRA. MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nucle) 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 (K080038).

12. DESIGN CHANGE

The Vantage Titan MRI System is comparable to the existing 1.5T Vantage Titian MRI System (K080038) and 1.5T Vantage Titan HSR MRI System (K112003) with the following modifications.

Definition of gradient strength has been changed. a.
ﻟﻘ Magnet covers have been changed.
C. Cabinet configurations have been changed.
Two application software have been added d.
- 1. Diffusion Tensor Tractography (DTT)
- 1. PaceMaker (FBI with Auto ECG)

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13. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for software and hardware changes have been is included in this submission. The test methods used are the same as those submitted in the previously cleared submissions (K080038 and K112003). A declaration of conformity with design controls is included in this submission.

14. TRUTHFUL AND ACCURACY CERTIFICATION

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

15. SUBSTANTIAL EQUIVALENCE

Toshiba Medical Systems Corporation believes that the Vantage Titan (model MRT-1504/U4). 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

· IEC60601-1:1988, Amd.1:1991, Amd.2:1995
IEC60601-1-1:2000
IEC60601-1-2:2001, Amd.1:2004
IEC60601-1-4:1996, Amd.1:1999
IEC60601-1-6:2006
· IEC60601-1-8:2003.Amd.1:2006
IEC60601-2-33:2002, Amd.1:2005, Amd.2:2007
IEC60825-1: 2007
· IEC62304:2006
· IEC62366:2007
· NEMA MS-1:2008
· NEMA MS-2:2003
· NEMA MS-3:2008
· NEMA MS-4:2006
· NEMA MS-5.2003
· NEMA PS 3.1-18 (2008)

Page 4 of 4

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K120638

Trade/Device Name: MRT-1504/U4, Vantage Titan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 25, 2012 Received: April 26, 2012

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

JUN - 1 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket whitication. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K120638

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan 1.5T, v2.1, MRT-1504/U4

Indications for Use

510(k) Number (if known):

Device Name:

MRT-1504/U4. Vantage Titan

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 X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Andrew D. Kim

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K120638

Page 1 of 1

Indication for Use Page 1 of 1

510(k): Vantage Titan, MRT-1504/U4, v2.1 Page 15 of 2798

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.