(113 days)
No
The document describes a standard MRI system and its features, with no mention of AI, ML, or related concepts in the intended use, device description, or performance summaries. The "Enhancement of SPEEDER post-processing" refers to image processing techniques, not necessarily AI/ML.
No.
The device is indicated for diagnostic imaging purposes, not for treating any medical condition.
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 description explicitly states it is a "3 Tesla Magnetic Resonance Imaging (MRI) System" and details hardware components like the magnet, gradient coil, and WB coil. While it includes software for image processing, it is fundamentally a hardware-based imaging system.
Based on the provided text, the Vantage Galan 3T system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Vantage Galan 3T Function: The description clearly states that the Vantage Galan 3T is a Magnetic Resonance Imaging (MRI) system. It produces images of the internal structures of the head or body by utilizing magnetic fields and radio waves. This is an in vivo imaging modality, meaning it examines the body directly, not specimens taken from the body.
- Intended Use: The intended use is described as a "diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body." This aligns with the function of an MRI system, not an IVD.
Therefore, the Vantage Galan 3T is a diagnostic imaging device, but it operates in vivo and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Vantage Galan 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 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 Galan 3T (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Galan 3T uses 1.6m short and 6.4 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Galan 3T provides the maximum field of view of 50 x 50 x 45 cm. The 3T Vantage Galan MRI System is comparable to the current 3T Vantage Titan MRI System (K152371), cleared October 23rd, 2015 with the following modifications.
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)
bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2016
Toshiba Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K162183
Trade/Device Name: Vantage Galan 3T, MRT-3020, V4.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 14, 2016 Received: November 15, 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.
Michael D'Hara
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Enclosure
2
Toshiba Medical Systems Corporation
510(k) Premarket Notification
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)
Device Name Vantage Galan 3T, MRT-3020, V4.0
Indications for Use (Describe)
Vantage Galan 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 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/2 description: The image shows the words "TOSHIBA MEDICAL" stacked on top of each other. The word "TOSHIBA" is on the top line, and the word "MEDICAL" is on the bottom line. Both words are in a bold, sans-serif font and are colored red. The background of the image is white.
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
CLASSIFICATION AND DEVICE NAME: 1.
| Classification Name: | Magnetic Resonance Diagnostic Device |
|---|---|
| Regulation Number: | 90-LNH (Per 21 CFR § 892.1000) |
| Trade Proprietary Name: | Vantage Galan 3T, MRT-3020, V4.0 |
| Model Number: | MRT-3020 |
SUBMITTER'S NAME: 2.
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
OFFICIAL CORRESPONDENT: 3.
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 Phone No .: (714) 669-7853 E-mail: JFReyes@tams.com
5. MANUFACTURING SITE:
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
6. ESTABLISHMENT REGISTRATION: 9614698
-
- Date Prepared: August 2, 2016
-
- DEVICE NAME: Vantage Galan 3T, MRT-3020, V4.0
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 Michelle Drive, Tustin, CA 92780 / 714.730.5000 / medical.toshiba.com
U.S. Agent:
Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone No.: (714) 669-7808 E-mail: PBiggins@tams.com
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Image /page/4/Picture/2 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is written in large, bold, red letters. 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.
9. TRADE NAME(S):
Vantage Galan 3T, MRT-3020, V4.0
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-гин
14. PREDICATE DEVICE:
Primary Predicate Device (system): Vantage Titan 3T, MRT-3010, V3.5 Reference Predicate Device (added software functionalities): Vantage Titan 1.5T, MRT-1510, V3.6
| Subject | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| System | Vantage Galan 3T, | ||
| MRT-3020, V4.0 | Vantage Titan 3T, | ||
| MRT-3010, V3.5 | Vantage Titan 1.5T, | ||
| MRT-1510, V3.6 | |||
| Marketed By | Toshiba America | ||
| Medical Systems | Toshiba America | ||
| Medical Systems | Toshiba America | ||
| Medical Systems | |||
| 510(k) Number | This Submission | K152371 | K160632 |
| Clearance Date | October 23, 2015 | 510(k) Pending |
15. REASON FOR SUBMISSION
Modification of a cleared device.
16. DEVICE DESCRIPTION
The Vantage Galan 3T (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Galan 3T uses 1.6m short and 6.4 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Galan 3T provides the maximum field of view of 50 x 50 x 45 cm. The 3T Vantage Galan MRI System is comparable to the current 3T Vantage Titan MRI System (K152371), cleared October 23rd, 2015 with the following modifications.
17. SUMMARY OF HARDWARE CHANGES
This submission is to report the following hardware changes have been made:
- RF system: ●
- Maximum RF duty cycle changed from 50% to 100% o
- PURERF Rx/Tx O
AMERICA MEDICAL SYSTEMS.
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Image /page/5/Picture/2 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is written in large, bold, red letters. Below it, the word "MEDICAL" is also written in large, bold, red letters, but slightly smaller than "TOSHIBA". The logo is simple and clean, with a focus on the brand name.
18. SUMMARY OF SOFWARE CHANGES
This submission is to report the following software functionalities have been added:
- Sequence Enhancement:
- FFE3D: o
●
- SPAIR - pre-pulse for fat suppression
- T2 Prep - pre-pulse for T2 weighted contrast
- mUTE - Ulta short TE T1 weighted sequence with reduced acoustic noise
- mUTE 4D-MRA Ultra short TE time resolved MR angiography with reduced ■ acoustic noise
- 2D-RMC - Two dimensional real-time motion correction
- O MP2RAGE - Images with multiple TI (Inversion time) to create T1 map
- 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 O
- mASTAR Multiple phase ASL (Arterial Spin Labeling) O
- FASE DWI Spin Echo based Diffusion Weighted Imaging with reduced acoustic O noise
- Enhancement of SPEEDER post-processing
- EasyTech Cardiac - SUREVOI and CardioLine+
- lmprovement of SUREECG R-wave detection ●
19. SAFETY PARAMETERS
| Item | Subject Device: Vantage Galan
3T, MRT-3020, V4.0 | Predicate Device: Vantage
Titan 3T, MRT-3010, V3.5
(K152371) | Notes |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------|
| Static field strength | 3T | 3T | 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 | 1st operating mode specified in
IEC 60601-2-33 (2010) | 1st operating mode specified in
IEC 60601-2-33 (2010) | Same |
| 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 | Same |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 441 Michelle Drive, Tustin, CA 92780 / 714.730.5000 / medical.tosh
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Image /page/6/Picture/2 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is written in a bold, red font on the top line. Below it, the word "MEDICAL" is written in the same bold, red font. The logo is simple and clean, with a focus on the company name.
20. IMAGING PERFORMANCE PARAMETERS
No change from the previous predicate submission, K152371.
21. INDICATIONS FOR USE
Vantage Galan 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 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.
No changes to the previously cleared indication, K152371.
22. SUMMARY OF DESIGN CONTROL ACTIVITIES
Hazard analysis has been performed and documentation is included in this submission. PS Risk List for new software functionalities and pulse sequences are included in this submission. The test methods used are the same as those submitted in the previously cleared submissions (K152371). A declaration of conformity with design controls is included in this submission.
23. SAFETY
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards.
This device is based upon the same technologies, materials and software as the predicate device. Risk activities were conducted in concurrence with established medical device development standards and guidance. Additionally, testing was done in accordance with applicable recognized consensus standards published by the International Electrotechnical Commission (IEC) for medical devices and the National Electrical Manufacturers Association (NEMA):
HIBA AMERICA MEDICAL SYSTEMS, INC · Drive, Tustin, CA 92780 / 714.730.5000
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Image /page/7/Picture/2 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is in large, bold, red letters. Below it, the word "MEDICAL" is also in large, bold, red letters. The logo is simple and eye-catching, with the red color conveying a sense of urgency and importance.
LIST OF APPLICABLE STANDARDS
- IEC60601-1:2005 ●
- IEC60601-1-2:2007
- IEC60601-1-8:2006,Amd.1:2012 ●
- IEC60601-2-33:2010 ●
- IEC60825-1: 2007 ●
- IEC62304:2006 ●
- o IEC62366:2007+Amd.1:2014
- NEMA MS-1:2008 ●
- NEMA MS-2:2008 ●
- NEMA MS-3:2008 ●
- NEMA MS-4:2010 ●
- NEMA MS-5:2010 ●
24. TESTING
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
25. SUBSTANTIAL EQUIVALENCE
Toshiba Medical Systems Corporation believes that the Vantage Galan 3T, MRT-3020, V4.0 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device referenced in this submission. Toshiba Medical Systems Corporation believes that the changes incorporated into the Vantage Galan 3T, MRT-3020, V4.0 are substantially equivalent to the previously cleared predicate device.
26. CONCLUSION
The modifications incorporated into the Vantage Galan 3T, MRT-3020, V4.0 do not change the indications for use or the intended use of the device. 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.