(108 days)
Vantage Elan 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.
The Vantage Elan (Model MRT-2020) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Elan uses 1.4m short and 4.1 tons light weight magnet. It includes the Toshiba Pianissimo™Σ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Elan provides the maximum field of view of 55 x 50 cm. The Model MRT-2020/A1 is without secondary cooling system and the Model MRT-2020/A2 is with secondary cooling system. The Vantage Elan MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K120638), cleared Jun 1, 2012 with the following modifications.
This document is a 510(k) premarket notification for the Vantage Elan (Model MRT-2020) Magnetic Resonance Imaging (MRI) System. The focus of the submission is to demonstrate substantial equivalence to a predicate device (EXCELART Vantage Titan MRI System, K120638) despite hardware and software changes.
The document does not describe a study to prove acceptance criteria for a device with machine learning or AI components. Instead, it outlines the regulatory review process for a conventional medical imaging device. The "acceptance criteria" and "device performance" in this context refer to the device's conformance to established safety regulations, technical standards, and its ability to produce diagnostic-quality images.
Therefore, for your request, I will interpret "acceptance criteria" as the performance and safety standards the device must meet, and "device performance" as how the Vantage Elan compared to these standards or to its predicate device. Since it's a traditional medical device submission, many of your requested items (like sample sizes for test sets, data provenance, ground truth establishment for AI models, MRMC studies, or standalone algorithm performance) are not applicable or explicitly mentioned in the context you've provided.
Here is an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Regulatory Standards & Predicate Comparison) | Reported Device Performance (Vantage Elan vs. Predicate) |
|---|---|
| Safety Parameters: | |
| - Whole body Maximum SAR (Specific Absorption Rate) conforming to IEC 60601-2-33 (2010), ≤ 4W/kg (1st operating mode) | - 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33 (2010)) |
| - Maximum dB/dt conforming to IEC 60601-2-33 (2010) (1st operating mode) | - <1st operating mode specified in IEC 60601-2-33 (2010) (This is a change from the predicate's IEC 60601-2-33 (2002) but still meets the standard.) |
| - Emergency shutdown mechanism for ferromagnetic object collision hazard | - Shut down by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects (Same as predicate) |
| Imaging Performance: | |
| - Diagnostic imaging modality producing cross-sectional images of anatomic structures of head/body | - Produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body (Same indications for use as predicate) |
| - Capability for non-contrast enhanced imaging (e.g., MRA) | - Capable of non-contrast enhanced imaging, such as MRA (Same indications for use as predicate) |
| - Ability to depict NMR properties (PD, T1, T2, Flow dynamics, Chemical Shift) | - Image correspondence to NMR properties, useful for diagnosis when interpreted by a trained physician (Same as predicate) |
| - Clinical image quality and functionality verification | - Clinical image validation conducted using volunteers to verify image quality and functionality of the system. ("No change from the previous predicate submission (K120638).") |
| - Conformance to applicable recognized consensus standards (e.g., NEMA MS series for MRI standards) | - Conformance to listed standards (IEC, NEMA, etc.) |
| Hardware Changes (Impact on Substantial Equivalence): | |
| - Main magnet (OR76 to TN150) | - Changed from OR76 to TN150 (Evaluated for impact on performance and safety) |
| - RF amplifier max power (20kW to 12kW) | - Decreased from 20kW to 12kW (Evaluated for impact on performance and safety) |
| - Max Gradient field strength (34mT/m to 33mT/m) | - Changed from 34mT/m to 33mT/m (Evaluated for impact on performance and safety) |
| - Max Slew Rate of gradient field (148mT/m/ms to 125mT/m/ms) | - Changed from 148mT/m/ms to 125mT/m/ms (Evaluated for impact on performance and safety) |
| - Patient aperture size (71cm to 63cm) | - Changed from 71cm to 63cm (Evaluated for impact on performance and safety) |
| - Number of units (7 to 5) | - Reduced from 7 to 5 (Evaluated for impact on performance and safety) |
| - Optical transmission of MR signals | - New feature (Evaluated for impact on performance and safety) |
| Software Changes (Impact on Substantial Equivalence): | |
| - SpineLine (automatic positioning assistance for spine) | - New feature (Evaluated for impact on performance and safety) |
| - 2D RMC (2D Real-time motion correction) | - New feature (Evaluated for impact on performance and safety) |
| - New operating system (Windows 7) | - New operating system (Evaluated for impact on performance and safety) |
| - ECG, peripheral pulse, and respiratory gating waveform display | - New feature (Evaluated for impact on performance and safety) |
| - Control for new hardware | - New software to control new hardware (Evaluated for impact on performance and safety) |
Note: The primary "study" mentioned is comparison to the predicate device and conformance to recognized standards, rather than a clinical trial with specific performance metrics for novel AI features.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions "clinical image validation was conducted using volunteers." However, it does not specify the number of volunteers or images used in this validation.
- Data Provenance: Not explicitly stated, but based on Toshiba Medical Systems Corporation being in Japan, and no mention of multi-center international data collection, the data provenance is likely prospective clinical data collected in Japan from volunteers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document states, "When interpreted by a trained physician, these images yield information that can be useful in diagnosis." It does not specify the number or qualifications of experts involved in the "clinical image validation." This is a standard regulatory statement for diagnostic imaging.
4. Adjudication method for the test set
- Not specified. The document does not describe adjudication methods for the clinical image validation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI/ML device. The document describes a conventional MRI system. Therefore, an MRMC comparative effectiveness study regarding human readers improving with AI assistance is not applicable and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device. Therefore, a standalone algorithm performance study is not applicable and was not conducted.
7. The type of ground truth used
- For the "clinical image validation," the ground truth implicitly would be the diagnostic assessment by trained physicians based on the generated MRI images, likely correlated with other clinical information to confirm the accuracy of anatomical representation and diagnostic utility. There is no mention of pathology or outcomes data as direct ground truth for this device's specific validation.
8. The sample size for the training set
- Not applicable. This device is a conventional MRI system, not an AI/ML device, so there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for an AI/ML model for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2014
Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs/U.S. Agent Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K141472
Trade/Device Name: Vantage Elan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 20, 2014 Received: August 21, 2014
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.
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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
Janine M. Morris 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-2020; Vantage Elan
Indications for Use (Describe)
Vantage Elan 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY 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 Elan |
| Model Number: | MRT-2020 |
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 Tel. (714) 669-7808
5. MANUFACTURING SITE:
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
6. DATE OF SUBMISSION:
May 30, 2014
7. DEVICE DESCRIPTION:
The Vantage Elan (Model MRT-2020) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Elan uses 1.4m short and 4.1 tons light weight magnet. It includes the Toshiba Pianissimo™Σ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Elan provides the maximum field of view of 55 x 50 cm. The Model MRT-2020/A1 is without secondary cooling system and the Model MRT-2020/A2 is with secondary cooling system. The Vantage Elan MRI System
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is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K120638), cleared Jun 1, 2012 with the following modifications.
6.1 SUMMARY OF HARDWARE CHANGES
- a. Main magnet has been changed from OR76 to TN150.
- b. Maximum power of RF amplifier has been decreased from 20kW to 12kW.
- c. Maximum Gradient field strength has been changed from 34mT/m to 33mT/m.
d. Maximum Slew Rate of gradient field has been changed from 148mT/m/ms to 125mT/m/ms.
e. Patient aperture size has been changed from 71cm to 63cm.
f. Number of units has been reduced from 7 to 5.
g. Optical transmission of MR signals from gantry to main cabinet.
6.2 SUMMARY OF SOFTWARE CHANGES
- a. SpineLine (automatic positioning assistance for spine)
- b. 2D RMC (2D Real-time motion correction)
- c. New operating system (Windows 7)
d. ECG, peripheral pulse, and respiratory gating waveforms are displayed on the LCD monitor of console.
e. Control for new hardware
| Item | Vantage Elan (subject device) | Vantage Titan K120638 (Predicate Device) | Notes |
|---|---|---|---|
| Static field strength | 1.5T | 1.5T | Same |
| Operational Modes | 1st Operating Mode | 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(2002)) | Change* |
| Maximum dB/dt | <1st operating mode specified in IEC 60601-2-33 (2010) | <1st operating mode specified in IEC 60601-2-33 (2002) | Change* |
8. SAFETY PARAMETERS
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| Item | Vantage Elan(subject device) | Vantage TitanK120638(Predicate Device) | Notes |
|---|---|---|---|
| Potentialemergencycondition andmeans provided forshutdown | Shut down by EmergencyRamp Down Unit forcollision hazard forferromagnetic objects | Shut down by EmergencyRamp Down Unit forcollision hazard forferromagnetic objects | Same |
*Note: The difference between predicate and subject device is due to the conformance of the subiect device to IEC 60601-2-33 (2010)
8. IMAGING PERFORMACE PARAMETERS
No change from the previous predicate submission (K120638).
9. INTENDED USE
Vantage Elan 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 (K120638).
10. SUMMARY OF DESIGN CONTROL ACTIVITIES
Hazard analysis has been performed and documentation is included in this submission. The test methods used are the same as those submitted in the previously cleared submissions (K120638). A declaration of conformity with design controls is included in this submission.
12. SUBSTANTIAL EQUIVALENCE
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 as listed below.
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List of Applicable Standards
- IEC60601-1:2005
- IEC60601-1-2:2007
- IEC60601-1-8:2003,Amd.1:2006
- IEC60601-2-33:2010
- IEC60825-1: 2007
- IEC62304:2006
- IEC62366:2007
- NEMA MS-1:2008
- NEMA MS-2:2008
- NEMA MS-3:2008
- NEMA MS-4:2010
- NEMA MS-5:2010
- NEMA PS 3.1-20 (2011)
In addition to the performance testing stated above, clinical image validation was conducted using volunteers to verify image quality and functionality of the system. Based upon this information Toshiba believes that it has established substantial equivalence to this device and the predicate.
§ 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.