(57 days)
Vantage Titan 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.
The Vantage Titan (Model MRT-1510) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan uses 1.4m short and 4.1 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Titan provides the maximum field of view of 55 x 55 x 50 cm. The Vantage Titan MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K120638), cleared Jun 1, 2012 with the following modifications.
The provided text is a 510(k) summary for the Toshiba Vantage Titan 1.5T MRI system. This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a detailed study proving the device meets specific performance criteria through clinical trials or statistical analysis of diagnostic accuracy.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially those related to diagnostic accuracy, human-AI collaboration, or detailed ground truth establishment) are not available in this document.
However, based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list "acceptance criteria" in the traditional sense of diagnostic performance thresholds for an AI/CAD system. Instead, it focuses on demonstrating that the new Vantage Titan 1.5T MRI system maintains the safety and effectiveness of its predicate device, primarily through technical specifications and adherence to standards. The "performance" reported is related to maintaining safety and imaging capabilities without raising new safety or effectiveness concerns.
| Acceptance Criteria (Implied from Section 8 & 9) | Reported Device Performance (Vantage Titan 1.5T) |
|---|---|
| Safety Parameters: | |
| Static field strength same as predicate | 1.5T (Same as predicate K120638) |
| Operational Modes (Safety parameter display, operating mode access requirements) same as predicate | 1st Operating Mode SAR dB/dt, Allows screen access to 1st level operating mode (Same as predicate K120638) |
| Maximum SAR (compliant with IEC 60601-2-33) | 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33(2010)). Note: This is a change from K120638 (2002) but still compliant with an updated standard, indicating continued safety. |
| Maximum dB/dt (compliant with IEC 60601-2-33) | 1st operating mode specified in IEC 60601-2-33 (2010). Note: Change from K120638 (2002) but compliant with updated standard. |
| Means for emergency shutdown (collision hazard) same as predicate | Shut down by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects (Same as predicate K120638) |
| Imaging Performance Parameters: | |
| Imaging performance maintained relative to predicate (K120638) | No change from the previous predicate submission (K120638) (Section 9 indicates imaging performance is maintained, and various tests were performed to demonstrate this). |
| Substantial Equivalence: | |
| Demonstrates the implementation of modifications retained the safety and effectiveness | "Testing was performed using archived clinical images, simulation testing and bench (phantom) testing. This testing demonstrated that the implementation of the modifications retained the safety and effectiveness of the cleared device." (Section 13) |
| Does not raise new issues of safety and effectiveness | "Based upon bench testing and phantom image studies 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." (End of Section 13) |
| Does not offer new intended or indicated use | "Furthermore, this system does not offer new intended or indicated use when compared to the predicate." (End of Section 13) and "No changes to the previously cleared indication (K120638)." (Section 10) |
| Conformance to applicable recognized consensus standards | Complies with numerous IEC and NEMA standards, including: 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, NEMA MS-1:2008, NEMA MS-2:2008, NEMA MS-3:2008, NEMA MS-4:2010, NEMA MS-5:2010. (Section 13) |
2. Sample sized used for the test set and the data provenance
The document mentions "archived clinical images, simulation testing and bench (phantom) testing" were used for testing (Section 13). However, it does not provide any specific sample sizes for these tests or information on the provenance (e.g., country of origin, retrospective/prospective nature) of the "archived clinical images."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a diagnostic imaging device like an MRI, the "ground truth" for its output (images) is generally understood to be the accurate representation of anatomical structures and their properties, which is then interpreted by a "trained physician" as stated in the Indications for Use (Section 2 and 10). The document does not describe a study involving expert readers establishing ground truth for a test set in the context of diagnostic accuracy assessment for the device as a whole.
4. Adjudication method for the test set
This information is not provided in the document.
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
A MRMC comparative effectiveness study was not done or at least not described in this document. This submission is for an MRI system itself, not an AI/CAD system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an MRI scanner, a diagnostic imaging modality, not an algorithm for standalone diagnosis. Its output (images) requires interpretation by a trained physician.
7. The type of ground truth used
The concept of "ground truth" as typically applied to diagnostic AI systems (e.g., expert consensus, pathology) is not directly applicable in the context presented. For an MRI system, the "ground truth" that it aims to capture is the physical reality of the internal anatomical structures and their NMR properties. The device's performance is gauged by its ability to produce clear, accurate, and consistent images that, when interpreted by a trained physician, yield useful diagnostic information. The testing mentioned (archived clinical images, simulation, bench/phantom testing) would implicitly rely on established methods to verify the accuracy and quality of the generated images against physical or known standards.
8. The sample size for the training set
This information is not provided. The document describes testing of modifications to an existing MRI system, not the training of a new AI model with a specific training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable in the context of this 510(k) submission for an MRI machine where "training set" doesn't refer to an AI model's learning data.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs/ U.S. Agent Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN. CA 92780
Re: K150427
Trade/Device Name: Vantage Titan 1.5T, MRT-1510 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: February 18, 2015 Received: February 19, 2015
Dear Mr. Biggins:
This letter corrects our substantially equivalent letter of April 17, 2015.
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
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. 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 Oolo
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) K150427
Device Name
Vantage Titan 1.5T, MRT-1510
Indications for Use (Describe)
Vantage Titan 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.
| 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 1.5T |
| Model Number: | MRT-1510 |
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:
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:
February 18th, 2015
7. DEVICE DESCRIPTION:
The Vantage Titan (Model MRT-1510) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan uses 1.4m short and 4.1 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Titan provides the maximum field of view of 55 x 55 x 50 cm. The Vantage Titan MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K120638), cleared Jun 1, 2012 with the following modifications.
Page 1 of 4
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7.1 SUMMARY OF HARDWARE CHANGES
- a. Main magnet has been changed from OR76 to TN150 (MRT-1510/1A) or OR200 (MRT-1510/2A).
- b. System power requirements has been changed from 200V and 400V to 380/400/415/480 V.
7.2 SUMMARY OF SOFTWARE CHANGES
- a. New Operating System (Windows 7)
- b. WFS (Water Fat Separation) to provide water dominant images and fat dominant images.
8. SAFETY PARAMETERS
Table 1: Primary Predicate Device
| Item | Vantage Titan(subject device) | Vantage Titan K120638(Predicate Device) | Notes |
|---|---|---|---|
| Static field strength | 1.5T | 1.5T | Same |
| Operational Modesi. Safety parameter display | 1st Operating ModeSAR dB/dt | 1st Operating ModeSAR dB/dt | Same |
| ii. Operating modeaccess requirements | Allows screenaccess to 1st leveloperating mode | Allows screenaccess to 1st leveloperating mode | Same |
| Maximum SAR | 4W/kg for wholebody (1st operatingmode specified inIEC 60601-2-33(2010)) | 4W/kg for wholebody (1st operatingmode specified inIEC 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* |
| Potential emergencycondition and meansprovided forshutdown | Shut down byEmergency RampDown Unit forcollision hazard forferromagneticobjects | Shut down byEmergency RampDown Unit forcollision hazard forferromagneticobjects | Same |
*Note: The difference between predicate and subject device is due to the conformance of the subject device to IEC 60601-2-33 (2010)
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9. IMAGING PERFORMACE PARAMETERS
No change from the previous predicate submission (K120638).
10. INTENDED USE
Vantage Titan 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 (K120638).
11. SUMMARY OF DESIGN CONTROL ACTIVITIES
PS Risk List for system and software are included in this submission. The test methods used are the same as those submitted in the previously cleared submissions (K120638). A declaration of conformity with design controls is included in this submission.
12. TRUTHFUL AND ACCURACY CERTIFICATION
A certification of the truthfulness and accuracy of the Vantage Titan 1.5T described in this submission is provided in this submission.
13. SUBSTANTIAL EQUIVALENCE
This device is substantially equivalent to the 1.5T EXCELART Vantage Titan MRI System (K120638), marketed by Toshiba America Medical Systems. Vantage Titan 1.5T, V3.1. MRT 1510 includes additional software features. The additional software features have the same intended use as the secondary predicate device, listed below in table one. Testing was performed using archived clinical images, simulation testing and bench (phantom) testing. This testing demonstrated that the implementation of the modifications retained the safety and effectiveness of the cleared device.
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Toshiba Medical Systems Corporation believes that the Vantage Titan 1.5T (model MRT-1510) Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate devices referenced in this submission.
| 510 (k) Number | Clearance Date | Device Name | Manufacturer |
|---|---|---|---|
| K120638Primary Predicate(System) | 06/01/2012 | 1.5T EXCELARTVantage Titan | Toshiba AmericaMedical Systems |
| K141472Secondary Predicate(Magnet) | 09/19/2014 | Vantage Elan 1.5 T | Toshiba AmericaMedical Systems |
| K143008Secondary Predicate(Software Features) | RTA - 10/31/2014 | Vantage Titan 3T,V2.50 Software | Toshiba AmericaMedical Systems |
Table 2: Primary and Secondary Predicate Device
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
- NEMA MS-1:2008
- NEMA MS-2:2008
- · NEMA MS-3:2008
- · NEMA MS-4:2010
- · NEMA MS-5:2010
Based upon bench testing and phantom image studies 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.
April 6th, 2015
§ 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.