Vantage Titan 3T systems are 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. 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 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 us restricted to the approved drug indications. When interpreted by a trained physician, these images vield 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 (K102489). MRA (MR Angio) software package which functions are same as the MRA package of existing 1.5T MRI Vantage Titan (K080038) is added to Vantage Titan 3T.

AI/ML Overview

The provided document is a 510(k) summary and FDA clearance letter for a Magnetic Resonance Diagnostic Device, the Toshiba Vantage Titan 3T (MRT-3010/A5). It primarily focuses on demonstrating substantial equivalence to a predicate device and safety parameters, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly for AI-related metrics like standalone performance, MRMC studies, sample sizes for test/training sets, and expert-established ground truth, is not present in the provided text. The submission is for an MRI system and its software packages, not an AI/CADe device that typically undergoes such performance evaluations.

Here's a breakdown of what can and cannot be answered based on the input:

1. A table of acceptance criteria and the reported device performance

The document does not specify performance-based acceptance criteria in the way one would for a diagnostic accuracy study. Instead, it details safety parameters to show equivalence to a predicate device.

Item	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device)
Static field strength	3T	3T
Operational Modes	1st Operating Mode	1st Operating Mode
Safety parameter display	SAR dB/dt	SAR dB/dt
Operating mode access requirements	Allows screen access to 1st level operating mode	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))	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)	<1st operating mode specified in IEC 60601-2-33 (2002)
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
Imaging Performance Parameters	No change from previous predicate submission (K102489)	No change from previous predicate submission (K102489)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as it's not a clinical performance study in the context of diagnostic accuracy. The testing mentioned refers to design control activities and conformity with standards, not performance on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The submission does not detail a study involving expert establishment of ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

An MRMC study was not mentioned or performed for this submission. The device is an MRI system, not an AI or CADe product designed to assist human readers.

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

A standalone performance study of an algorithm was not mentioned or performed. The submission is for the MRI system itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. As an MRI system, its "truth" is typically its ability to generate images reflecting the a priori known physics of MRI and depicting anatomical structures. The document states, "When interpreted by a trained physician, these images yield information that can be useful in diagnosis," implying that the final diagnostic "truth" comes from physician interpretation of the images, not from an algorithm.

8. The sample size for the training set

This information is not applicable and not provided. The device is an MRI machine with software packages, not a machine learning model that requires a training set of patient data in the typical sense.

9. How the ground truth for the training set was established

This information is not applicable and not provided.

Summary

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JAN 1 3 2012

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

510(k) SUMMARY AND EFFECTIVENESS

1. DEVICE NAME:

Generic Name: Model Name: Trade/ Proprietary Name: Magnetic Resonance Diagnostic Device MRT-3010/A5 Vantage Titan 3T

2. ESTABLISHMENT REGISTRATION: 2020563

3. U.S AGENT INFORMATION:

U.S. Agent Name:
Paul Biggins (714) 730-5000

2441 Michelle Drive Tustin, Ca. 92780

Establishment Name and Address:

MANUFACTURING SITE:

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

Toshiba America Medical Systems, Inc.

October 17, 2011 5. DATE OF SUBMISSION:

6. DEVICE DESCRIPTION:

7. SUMMARY OF MAJOR HARDWARE CHANGES Not applicable.

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8. SUMMARY OF MAJOR SOFTWARE CHANGES

Existing software (V1.20) packages are grouped by functions of softwares and pulse sequences. New software (V1.35) packages are changed the configuration of imaging targets (for example Body package, Breast package etc.). Three software packages which use V1.20 MRA package are added to Vantage Titan 3T.

a) mCardiovascular package
b) mBreast package
c) mBody package

9. SAFETY PARAMETERS

Item	Vantage Titan 3T with newapplication software package(subject device)	Vantage Titan 3T , K102489(Predicate Device)	Notes
Static field strength	3T	3T	Same
Operational Modes	1st Operating Mode	1st Operating Mode	Same
i.Safety parameterdisplay	SAR dB/dt	SAR dB/dt	Same
ii. Operating modeaccess requirements	Allows screen access to 1st leveloperating mode	Allows screen access to 1st leveloperating mode	Same
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))	Same
Maximum dB/dt	<1st operating mode specified inIEC 60601-2-33 (2002)	<1st operating mode specified inIEC 60601-2-33 (2002)	Same
Potential emergencycondition and meansprovided forshutdown	Shut down by Emergency RampDown Unit for collision hazardfor ferromagnetic objects	Shut down by Emergency RampDown Unit for collision hazard forferromagnetic objects	Same

10. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K102489).

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) .

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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 (K102489).

12. DESIGN CHANGE

Following software package addition to Vantage Titan 3T (K102489).

a) mCardiovascular package
b) mBreast package
c) mBody package

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 (K102489). 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 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.

The version of applicable standard of IEC60601-1-6 (standard of usability) is changed from IEC60601-1-6:2004 to IEC60601-1-6:2006.

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)

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side and top of the 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

JAN 1 3 2012

Re: K113093

Trade/Device Name: MRT-3010/A5, Vantage Titan 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: January 5, 2012 Received: January 6, 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

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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 notification. 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,

Mary S Patel

Mary S. Pastel, Sc.D. 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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Indications for Use

510(k) Number (if known):

K113093

Device Name:

MRT-3010/A5, Vantage Titan 3T

Indications for Use:

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear 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 us restricted to the approved drug indications. When interpreted by a trained physician, these images vield 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)

Mary S. Patel

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

510(k) Number K113093

Page 1 of

Indication for Use 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.