(117 days)
No
The document mentions an "Improvement of SPEEDER algorithm" which is a post-processing technique, but there is no mention of AI, ML, or related concepts like neural networks, training data, or performance metrics typically associated with AI/ML devices.
No.
The device is described as a diagnostic imaging modality that produces images useful in diagnosis, not for treatment or therapy.
Yes.
The "Intended Use / Indications for Use" section explicitly states that Vantage Titan systems are indicated for use as a "diagnostic imaging modality" and that the images "yield information that can be useful in diagnosis."
No
The device description explicitly states it is a "1.5 Tesla Magnetic Resonance Imaging (MRI) System," which is a hardware device. While it includes software components (like the SPEEDER algorithm enhancement), it is not solely software.
Based on the provided information, the Vantage Titan system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This is typically done in a laboratory setting.
- Vantage Titan Function: The Vantage Titan is an MRI system. It uses magnetic fields and radio waves to create images of the internal structures of the body in vivo (within the living body). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's a "diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body." This is consistent with an imaging device, not an IVD.
- Device Description: The description confirms it's a "1.5 Tesla Magnetic Resonance Imaging (MRI) System."
Therefore, the Vantage Titan system falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes
LNH
Device Description
The Vantage Titan (Model MRT-1510) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K160632. This system is based upon the technology and materials of previously marketed Toshiba MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
Mentions image processing
- Enhancement of SPEEDER post-processing: Improvement of SPEEDER algorithm
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head or body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Performance and/or clinical testing are being provided to demonstrate the safety and effectiveness of the application software.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based upon bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2017
TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS DIRECTOR REGULATORY AFFAIRS 2441 MICHELLE DRIVE TUSTIN CA 92780
Re: K170412
Trade/Device Name: Vantage Titan 1.5T. MRT-1510. M-Power GX Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 16, 2017 Received: May 17, 2017
Dear Mr. Paul 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.
1
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 D. O'Hara
For
Robert A. Ochs. PhD Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K170412
Device Name Vantage Titan 1.5T, MRT-1510, M-Power GX
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is written in large, bold, red letters on the top line. Below it, the word "MEDICAL" is written in the same font and color, but slightly smaller. The logo is simple and clean, with a focus on the company name.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92
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. SUBMITTER'S NAME
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
3. OFFICIAL CORRESPONDENT
Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance
4. CONTACT PERSON, U.S. AGENT and ADDRESS
Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive, Tustin, CA 92780 (714) 730-5000 Fax: (714) 730-1310 pbiggins@tams.com
5. MANUFACTURING SITE
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
-
- ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED February 6, 2017
-
- DEVICE NAME Vantage Titan 1.5T, MRT-1510, V4.0 Software
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Image /page/4/Picture/0 description: The image shows the words "TOSHIBA MEDICAL" stacked on top of each other. The words are in a bold, sans-serif font and are colored red. The word "TOSHIBA" is on the top line, and the word "MEDICAL" is on the second line.
9. TRADE NAME
Vantage Titan 1.5T
10. CLASSIFICATION NAME
Magnetic Resonance Diagnostic Device (MRDD)
11. CLASSIFICATION PANEL
Radiology
12. DEVICE CLASSIFICATION
Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)
13. PRODUCT CODE
90-LNH
14. PREDICATE DEVICE
Primary Predicate Device (system): Vantage Titan 1.5T, MRT-1510, V3.6
Reference Predicate Device (added software functionalities): Vantage Galan 3T, MRT-3020, V4.0
| Subject | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| System | Vantage Titan 1.5T, | ||
| MRT-1510, V4.0 | Vantage Titan 1.5T, | ||
| MRT-1510, V3.6 | Vantage Galan 3T, | ||
| MRT-3020, V4.0 | |||
| Marketed By | Toshiba America | ||
| Medical Systems | Toshiba America Medical | ||
| Systems | Toshiba America | ||
| Medical Systems | |||
| 510(k) Number | This Submission | K160632 | K162183 |
| Clearance Date | August 23, 2016 | November 25, 2016 |
15. REASON FOR SUBMISSION
Modification of a cleared device
16. SUBMISSION TYPE
Traditional 510(k) Premarket Notification
17. DEVICE DESCRIPTION
The Vantage Titan (Model MRT-1510) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K160632. This system is based upon the technology and materials of previously marketed Toshiba MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
18. SUMMARY OF CHANGE(S)
This submission is to report the following software functionalities have been added:
- . FFE3D:
- o mUTE: Ultra short TE T1 weighted sequence with reduced acoustic noise o mUTE 4D-MRA: Ultra short TE time resolved MR angiography with reduced acoustic noise
- o 2D-RMC: Two dimensional real-time motion correction
- MP2RAGE: Images with multiple TI (Inversion time) to create T1 map ●
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Image /page/5/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is written in large, bold, red letters on top of the word "MEDICAL", which is also written in large, bold, red letters. The logo is simple and clean, with a focus on the company name.
Made For life
- FSE2D mEcho: Images with multiple TE (Echo time) to create T2 map
- o FFE2D mEcho: Images with multiple TE (Echo time) to create T2* map
- mASTAR: Multi Phase ASL (Arterial Spin Labeling)
- FASE DWI: Spin Echo based Diffusion Weighted Imaging with reduced acoustic noise
- PSIR: Phase Sensitive Inversion Recovery
- MOLLI: Modified Look Locker Inversion recovery
- V-TISP: Variable Ti1 and TS2 Prep (*1 inversion recovery time; *2 saturation recovery time)
- o Enhancement of SPEEDER post-processing: Improvement of SPEEDER algorithm
- Improvement of surfECG R-wave detection: Morphology-matching based R-wave detection.
| Item | Subject Device: Vantage Titan
1.5T, V4.0 | Predicate Device: Vantage Titan
1.5T, V3.6 (K160632) | Notes |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------|
| Static field strength | 1.5T | 1.5T | 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 in
IEC 60601-2-33:2010
+Amd.1:2013) | 4W/kg for whole body (1st
operating mode specified in
IEC 60601-2-33(2010)) | Same |
| Maximum dB/dt |