(171 days)
Not Found
No
The document describes a standard MRI system with a specific software functionality (Water Fat Separation) and an optional gradient subsystem. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on image acquisition and processing based on physical principles of MRI.
No
The device is described as a diagnostic imaging modality that produces images for diagnosis, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section 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 includes a "Saturn Gradient Option," which are hardware components. While it includes new software functionality (WFS), the device itself is a hardware system with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
- Device Function: The Vantage Titan 3T system is an imaging modality that produces images of the internal structures of the body using magnetic resonance. It does not analyze biological specimens in vitro.
- Intended Use: The intended use is to produce images that, when interpreted by a trained physician, can be useful in diagnosis. This is a characteristic of an imaging device, not an IVD.
- Input: The input is the patient's body within the MRI scanner, not a biological specimen.
Therefore, based on the provided information, the Vantage Titan 3T system is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Vantaqe Titan 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 maqnetic 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 aqent use is restricted to the approved druq indications. When interpreted by a trained physician, these imaqes 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 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K132160. This submission includes WFS (Water Fat Separation) software functionality and the optional subsystem, Saturn Gradient Option.
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
Additional testing for WFS (Water Fat Separation) pulse sequence and software functionality included both phantom studies and representative volunteer images. This testing demonstrated that the software performed as specified and did not raise new issues of safety and effectiveness.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Additional testing for WFS (Water Fat Separation) pulse sequence and software functionality included both phantom studies and representative volunteer images. This testing demonstrated that the software performed as specified and did not raise new issues of safety and effectiveness. The additional software packages are work flow improvements and their performance was demonstrated to be equal to or better than the current methods for obtaining the same results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs/U.S. Agent 2441 Michelle Drive TUSTIN CA 92780
Re: K143008
Trade/Device Name: Vantage Titan 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: April 6, 2015 Received: April 7, 2015
Dear Mr. 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'Hara
for
Robert Ochs, Ph.D. Acting 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)
Device Name
MRT-3010/A5, Vantage Titan 3T
Indications for Use (Describe)
Vantaqe Titan 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 maqnetic 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 aqent use is restricted to the approved druq indications. When interpreted by a trained physician, these imaqes yield information that can be useful in diagnosis.
Type of Use (Select one or both, as applicable)
ك Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 3T |
| Model Number: | MRT-3010/A5 |
2. ESTABLISHMENT REGISTRATION: 9614698
-
- 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:
October 17, 2014
7. DEVICE DESCRIPTION:
The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K132160. This submission includes WFS (Water Fat Separation) software functionality and the optional subsystem, Saturn Gradient Option.
7.1 SUMMARY OF HARDWARE CHANGES
Saturn Gradient Option with increased gradient field strength of 45mT/m.
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7.2 SUMMARY OF SOFTWARE CHANGES
a. WFS (Water Fat Separation) to provide water dominant images and fat dominant images.
8. SAFETY PARAMETERS
| ltem | Vantage Titan 3T, V2.50 | Vantage Titan 3T, V2.30 | Notes |
|---|---|---|---|
| K132160 | |||
| (subject device) | (Predicate Device) | ||
| Static field strength | 3T | 3T | Same |
| Operational Modes | Normal and 1st Operating | Normal and 1st Operating | Same |
| Mode | Mode | ||
| i. | |||
| Safety parameter | SAR dB/dt | SAR dB/dt | Same |
| display | |||
| ii. Operating mode | Allows screen access to | Allows screen access to | Same |
| access | 1st level operating mode | 1st level operating mode | |
| requirements | |||
| Maximum SAR | 4W/kg for whole body (1st | 4W/kg for whole body (1st | Same |
| operating mode specified | operating mode specified | ||
| in | in | ||
| IEC 60601-2-33(2010) | IEC 60601-2-33(2010) | ||
| Maximum dB/dt |