(88 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard MRI technology and image acquisition principles.
No
The device is described as a "diagnostic imaging modality" that "produces cross-sectional transaxial, coronal, sagittal, and oblique images" which "yield information that can be useful in diagnosis." It does not mention any therapeutic use.
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," which is a hardware device. The summary also mentions "bench testing, phantom imaging, volunteer clinical imaging," which are typical performance studies for hardware imaging systems, not software-only devices.
Based on the provided information, the Vantage Galan 3T system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis.
- The Vantage Galan 3T is an MRI system that produces images of the human body in vivo (inside the body). It uses magnetic fields and radio waves to create images of anatomical structures.
- The intended use clearly states it's a "diagnostic imaging modality" that produces images of the "head or body". This is consistent with in vivo imaging, not in vitro testing of specimens.
Therefore, the Vantage Galan 3T falls under the category of medical imaging devices, not IVD devices.
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
Depending on the region of interest, contrast agents use may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Product codes
LNH
Device Description
The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K162183. 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
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
Bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls. The test methods used are the same as those submitted in the previously cleared submissions of the primary predicate device, Vantage Galan 3T, MRT-3020, V4.0 (K162183), and the reference predicate device, Vantage Titan 3T, MRT-3010/A7, M-Power GX (K172878).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk Management activities 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 of the primary predicate device, Vantage Galan 3T, MRT-3020, V4.0 (K162183), and the reference predicate device, Vantage Titan 3T, MRT-3010/A7, M-Power GX (K172878). A declaration of conformity with design controls is included in this submission.
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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January 26, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size.
Toshiba Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K173382
Trade/Device Name: Vantage Galan 3T, MRT-3020, V4.6 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: October 27, 2017 Received: October 31, 2017
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara 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 Galan 3T, MRT-3020, V4.6
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
Depending on the region of interest, contrast agents use may be used. 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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Image /page/3/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is stacked on top of the word "MEDICAL". Both words are in a bold, sans-serif font and are colored red. The logo is simple and clean, with a focus on the brand 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 Galan 3T, MRT-3020, V4.6 |
| Model Number: | MRT-3020 |
2. SUBMITTER'S NAME
Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
3. OFFICIAL CORRESPONDENT
Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance Toshiba Medical Systems Corporation
4. CONTACT PERSON, U.S. AGENT and ADDRESS
Contact Person
Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7853 Fax: (714) 730-1310 jfreyes@tams.com
Official Correspondent/U.S. Agent
Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7808 Fax: (714) 730-1310 pbiggins@tams.com
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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 bottom line. The background is white.
-
- MANUFACTURING SITE Toshiba Medical Systems Corporation 1385 Shimoishigami
Otawara-shi, Tochigi 324-8550, Japan
- MANUFACTURING SITE Toshiba Medical Systems Corporation 1385 Shimoishigami
-
- ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED November 3rd, 2017
-
- DEVICE NAME Vantage Galan 3T, MRT-3020, V4.6
-
- TRADE NAME
Vantage Galan 3T, MRT-3020, V4.6
10. CLASSIFICATION NAME
Magnetic Resonance Diagnostic Device (MRDD)
11. CLASSIFICATION PANEL
Radiology
-
- DEVICE CLASSIFICATION
Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)
- DEVICE CLASSIFICATION
13. PRODUCT CODE
90-LNH
14. PREDICATE DEVICE
Predicate Device (system): Vantage Galan 3T, MRT-3020, V4.0
Reference Predicate Device (added software functionalities): Vantage Titan 3T, MRT-3010/A7, M-Power GX
| Subject | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| System | Vantage Galan 3T, | ||
| MRT-3020, | |||
| V4.6 | Vantage Galan 3T, | ||
| MRT-3020, | |||
| V4.0 | Vantage Titan 3T, | ||
| MRT-3010/A7, | |||
| M-Power GX | |||
| Marketed By | Toshiba America | ||
| Medical Systems | Toshiba America | ||
| Medical Systems | Toshiba America | ||
| Medical Systems | |||
| 510(k) Number | This Submission | K162183 | K172878 |
| Clearance Date | November 25, 2016 | November 17, 2017 |
15. REASON FOR SUBMISSION
Modification of a cleared device
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Image /page/5/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is on the top line, and the word "MEDICAL" is on the second line. Both words are in a bold, sans-serif font and are colored red. The logo is simple and clean, with a focus on the company name.
16. SUBMISSION TYPE
Traditional 510(k) Premarket Notification
17. DEVICE DESCRIPTION
The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K162183. 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 changes. Additional software functionalities PSIR, MOLLI and V-TISP are being migrated from the listed reference predicate device (K172878):
- XG option with increased gradient strength of 45mT/m ●
- Additional Software Functionalities: ●
- oMultiBand SPEEDER: MultiBand SPEEDER is a technique to acquire multiple slices at one time by using simultaneous multiband excitation RF pulses. MultiBand SPEEDER technique can be used to reduce acquisition time.
- o Sequence Enhancements:
- PSIR: Phase Sensitive Inversion Recovery
- · MOLLI: Modified Look Locker Inversion recovery
- V-TISP: Variable TI1 and TS2 Prep (*1 inversion recovery time / * saturation recovery time)
19. SAFETY PARAMETERS
| Item | Subject Device:
Vantage Galan 3T,
MRT-3020, V4.6 | Predicate Device:
Vantage Galan 3T,
MRT-3020, V4.0 | 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+A1:2013) | 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+A1:2013 | 1st operating mode specified in IEC
60601-2-33: 2010 | Same |
| Potential emergency
condition and means
provided for shutdown | Shutdown by Emergency Ramp Down
Unit for collision hazard for
ferromagnetic objects | Shutdown by Emergency Ramp
Down Unit for collision hazard for
ferromagnetic objects | Same |
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Image /page/6/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.
20. IMAGING PERFORMANCE PARAMETERS
No change from the previous predicate submission, K162183.
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
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
*NOTE: No changes to the previously cleared indication, K162183.
22. SUMMARY OF DESIGN CONTROL ACTIVITIES
Risk Management activities 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 of the primary predicate device, Vantage Galan 3T, MRT-3020, V4.0 (K162183), and the reference predicate device, Vantage Titan 3T, MRT-3010/A7, M-Power GX (K172878). 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):
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Image /page/7/Picture/0 description: The image shows the logo for Toshiba Medical. The logo is in red and consists of two words stacked on top of each other. The top word is "TOSHIBA" and the bottom word is "MEDICAL". The font is bold and sans-serif.
LIST OF APPLICABLE STANDARDS
- IEC60601-1 (2005), Amd.1 (2012) ●
- IEC60601-1-2 (2007)
- IEC60601-1-8 (2006), Amd.1 (2012) ●
- IEC60601-2-33 (2010), Amd.1 (2013) ●
- . IEC60825-1 (2007)
- IEC62304 (2006) ●
- 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, V4.6 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, V4.6 are substantially equivalent to the previously cleared predicate device.
26. CONCLUSION
The modifications incorporated into the Vantage Galan 3T, MRT-3020, V4.6 software 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.