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510(k) Data Aggregation
(108 days)
The MRI system is 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. In addition, this system supports non-contrast 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 with Helios gradient (Model MRT-1504/U5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan with Helios gradient uses the same magnet as the Vantage Titan (K120638). The gradient performance was modified using. the same gradient amplifier and gradient coil as Vantage Titan HSR (K112003).
The provided text describes a 510(k) premarket notification for a modified MRI device (Vantage Titan with Helios gradient, model MRT-1504/U5). However, it does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria for device performance studies and the specifics of those studies (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
The submission focuses on establishing substantial equivalence to previously cleared predicate devices (K120638: Vantage Titan, K112003: Vantage Titan HSR) by highlighting hardware and software modifications and confirming safety parameters and imaging performance are maintained.
Here's a breakdown of what can be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for imaging performance in a quantifiable way beyond affirming "Imaging Quality metrics utilizing phantoms are provided in this submission." Instead, it compares safety parameters to the predicate devices and states "No change from the previous predicate submission (K120638)." regarding imaging performance parameters.
| Acceptance Criteria (Implied from Predicate Equivalence) | Reported Device Performance (Subject Device: Vantage Titan with Helios gradient, MRT-1504/U5) |
|---|---|
| Safety Parameters (Compared to Predicates) | |
| Static field strength: 1.5T | 1.5T |
| Peak and A-weighted acoustic noise: Comparable to predicates (Predicate K120638: 106.2 dB (A-weighted), 115.4 dB (peak); Predicate K112003: 113.0 dB (A-weighted), 121.6 dB (peak)) | 112.0 dB (A-weighted), 122.9 dB (peak) |
| Operational modes: 1st operating mode | 1st operating mode |
| Safety parameter display: SAR, dB/dt | SAR, dB/dt |
| Operating mode access requirements: Allows screen access to 1st level operating mode | Allows screen access to 1st level operating mode |
| Maximum SAR: 4W/kg for whole body (1st operating mode, IEC 60601-2-33 (2002)) | 4W/kg for whole body (1st operating mode, IEC 60601-2-33 (2002)) |
| Maximum dB/dt: |
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