(169 days)
No
The document does not mention AI, DNN, or ML, and the description focuses on standard MRI technology and image acquisition based on physical properties.
No
The device is described as a "diagnostic imaging modality" used to "display anatomic structures" to aid in diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use as a diagnostic imaging modality" and that the images "yield information that can be useful in diagnosis."
No
The device is described as a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, which is a hardware-based imaging modality. The summary explicitly mentions the model number (MRT-1510) and the technology of previously marketed Toshiba MRI systems, indicating a physical device.
Based on the provided information, the Vantage Titan system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Vantage Titan Function: The Vantage Titan system is a Magnetic Resonance Imaging (MRI) system. It produces images of the internal structures of the body in vivo (within the living body) using magnetic fields and radio waves.
- 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 describes an imaging system, not a test performed on a sample.
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
The Vantage Titan system is 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 (comma separated list FDA assigned to the subject device)
LNH
Device Description
The Vantage Titan (Model MRT-1510) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K150427. 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.
This submission is to report the following software functionalities have been added:
- UTE (Ultra Short TE) pulse sequence
- MP-RAGE pulse sequence
- T2:mEcho and T2*mEcho pulse sequence
- Improvements in MRS
- Multi b-value DWI
- NeuroLine+ (automatic positioning assistance for neuro)
- CardioLine+ (automatic positioning assistance for cardiac)
- SureVOI (automatic cardiac planning assistance)
- eFSBB (phase-enhanced FSBB filter)
- Temporal Filter
Mentions image processing
Not Found
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
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2016
Toshiba Medical Systems Corporation % Janine Reves Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K160632
Trade/Device Name: Vantage Titan 1.5T, MRT-1510, V3.6 Software Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 27, 2016 Received: July 29, 2016
Dear Ms. Reyes:
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,
Jeff Bollyea
For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Vantage Titan 1.5T, MRT-1510, V3.6 Software
Indications for Use (Describe)
The Vantage Titan system is 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) |
|---|
| ------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | --------------------------------------------- |
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3
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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:
- Contact Person:
Janine Faith Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive, Tustin, CA 92780 (714) 669-7853
5. MANUFACTURING SITE:
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
-
- ESTABLISHMENT REGISTRATION: 9614698
-
- Date Prepared:
July 27, 2016
U.S. Agent:
Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive, Tustin, CA 92780 (714) 669-7808
4
HIBA AMERICA MEDICAL
8. DEVICE NAME:
Vantage Titan 1.5T, MRT-1510, V3.6 Software
9. TRADE NAME(S):
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, V3.1 Reference Predicate Device (added software functionalities): Vantage Titan 3T, MRT-3010, V3.5
| Subject | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| System | Vantage Titan 1.5T, | ||
| MRT-1510, V3.6 | Vantage Titan 1.5T, | ||
| MRT-1510, V3.1 | Vantage Titan 3T, | ||
| MRT-3010, V3.5 | |||
| Marketed By | Toshiba America | ||
| Medical Systems | Toshiba America | ||
| Medical Systems | Toshiba America | ||
| Medical Systems | |||
| 510(k) Number | This Submission | K150427 | K152371 |
| Clearance Date | April 17, 2015 | October 23, 2015 |
15. REASON FOR SUBMISSION
Modification of a cleared device.
16. DEVICE DESCRIPTION
The Vantage Titan (Model MRT-1510) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K150427. 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.
17. SUMMARY OF HARDWARE CHANGES
No change from the previous predicate submission, K150427.
5
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
18. SUMMARY OF SOFWARE CHANGES
This submission is to report the following software functionalities have been added:
- UTE (Ultra Short TE) pulse sequence ●
- MP-RAGE pulse sequence
- T2:mEcho and T2*mEcho pulse sequence ●
- . Improvements in MRS
- Multi b-value DWI
- NeuroLine+ (automatic positioning assistance for neuro)
- CardioLine+ (automatic positioning assistance for cardiac)
- SureVOI (automatic cardiac planning assistance)
- eFSBB (phase-enhanced FSBB filter) ●
- Temporal Filter
19. SAFETY PARAMETERS
| Item | Subject Device: Vantage Titan
1.5T, V3.6 | Predicate Device: Vantage
Titan 1.5T, V3.1 (K150427) | 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)) | 4W/kg for whole body (1st
operating mode specified in
IEC 60601-2-33(2010)) | Same |
| Maximum dB/dt |