(63 days)
Vantage 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 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 Titan 3T (Model MRT-3010) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K143008. This submission will include the following software functionalities: UTE (Ultra Short TE), MP-RAGE, T2:mEcho, T2*:mEcho, Improvements to MRS, Multi b-value DWI, SpineLine+, SureVOI, 2D Real-time Motion Correction (2D-RMC) and eFSBB.
Here's a breakdown of the acceptance criteria and study information for the Vantage Titan 3T (MRT-3010) MRI system, based on the provided document.
It's important to note that this document is a 510(k) summary for a software update to an existing MRI system. Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating that the new software functionalities do not introduce new safety or effectiveness concerns and that the system continues to perform as specified, maintaining substantial equivalence to its predicate device. This is often validated through technical performance parameters rather than clinical diagnostic accuracy per se in these types of submissions.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Predicate Device K143008) | Reported Device Performance (Subject Device Vantage Titan 3T, V3.5) | Notes |
|---|---|---|---|
| Safety Parameters | |||
| Static field strength | 3T | 3T | Same as predicate |
| Operational Modes | Normal and 1st Operating Mode | Normal and 1st Operating Mode | Same as predicate |
| i. Safety parameter display | SAR dB/dt | SAR dB/dt | Same as predicate |
| ii. Operating mode access requirements | Allows screen access to 1st level operating mode | Allows screen access to 1st level operating mode | Same as predicate |
| Maximum SAR (Whole body) | 4W/kg (1st operating mode specified in IEC 60601-2-33(2010)) | 4W/kg (1st operating mode specified in IEC 60601-2-33(2010)) | Same as predicate |
| Maximum dB/dt |
§ 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.