Search Results
Found 1 results
510(k) Data Aggregation
(62 days)
The Infinion 0.6T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
This submission describes the hardware and software changes for the Philips' 0.6T Open Magnetic Resonance Imaging system, the Infinion 0.6T.The package also includes additional imagin sequences and acquisition/construction techniques. However, the basic features are unchanged.
The provided document is a 510(k) premarket notification for the Philips Infinion 0.6T MR Imaging System. It describes the device and claims substantial equivalence to a predicate device (Philips Proview 0.23T System, K974844).
It's important to understand that a 510(k) submission for a Magnetic Resonance Imaging (MRI) system is primarily a demonstration of "substantial equivalence" to a predicate device, focusing on technological characteristics and intended use, rather than a clinical study proving an AI algorithm's performance against specific acceptance criteria like an AI/CADe device would.
Therefore, the typical acceptance criteria related to sensitivity, specificity, or reader performance improvements common for AI-powered diagnostic aids are not present in this document. This submission is for an MRI hardware and software system, not an AI algorithm performing a diagnostic interpretation.
However, based on the information provided, we can infer "acceptance criteria" through the lens of substantial equivalence and report on the "device performance" by comparing it to its predicate.
Here's the breakdown of what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for an MRI system asserting substantial equivalence, the "acceptance criteria" are implied by demonstrating that the new device's parameters are either the same as or generally improved compared to the predicate device, or meet established safety norms (like IEC 60601-2-33). The "reported device performance" is essentially the specifications of the Infinion 0.6T MR Imaging System compared to the Proview 0.23T System.
| Parameter (Acceptance Criteria, implied as "substantially equivalent to predicate" or "meets standard") | Infinion 0.6T MR Imaging System (Reported Device Performance) | Predicate Device - Philips Proview 0.23T System (K974844) |
|---|---|---|
| Computer Subsystem | ||
| Display/database system | Same as predicate. | Single display for system operation and image reviewing, workstation tower, moveable keyboard and mouse, CD-ROM. Allows for simultaneous scanning and image reconstruction/manipulation. Image storage via magneo-optical disk. |
| Network communications | DICOM Query/Retrieve, DICOM Modality WL Management. | Display/Database computer and scan reconstruction hardware connected together by fast Ethernet communications system. DICOM compliant for transfer of images to other systems. |
| Gradient Subsystem | ||
| Gradient Coils | Same as predicate. | Water-cooled self-shielded gradient system. |
| Max. Gradient Strength | 20 mT/m (Improved from predicate) | 16 mT/m (XY), 18 mT/m (Z) |
| Max. Slew Rate | 40 T/m/s (Improved from predicate) | 25 mT/m/msec (XY), 40 mT/m/msec (Z). |
| RF Subsystem | ||
| RF Amplifiers | Max power 9 kW. (Improved from predicate) | 5 kW solid state. |
| RF transmitter coils | Same as predicate, but with tuning adjusted to proton resonance at 0.6T field strength instead of 0.23 T, and with water cooling. | Upper and lower, planar coils, integrated in the magnet. |
| Receive only RF coils | Head (phased array two-channel) Head and Neck (phased array four-channel). Neck (phased array two-channel) Extremity (phased array two-channel) Body & Spine, different sizes (phased array two-channel) Multipurpose, different sizes (linear single-channel) | Head (phased array two-channel). Brain (phased array two-channel). Head and Neck (phased array four-channel, formerly Vascular Head and Neck). Neck (phased array two-channel). Extremity (phased array two-channel). Body and Spine, different sizes (phased array two-channel) Flexible Spine (phased array two-channel). Flexible Multipurpose, different sizes (linear single-channel). Small Extremity (phased array two-channel, earlier name Small Joints). Large Neck (phased array two-channel). |
| Receive only coil connection | All receive only coils plug into the RF connectors in both ends of the patient couch. | All receive only coils plug into the RF connector on the front of the magnet façade. |
| Magnet Subsystem | ||
| Magnet Type | 0.6 T superconducting (Significantly different, but compared for equivalence) | 0.23 T iron-core electromagnetic. |
| Patient Handling | ||
| Patient couch | Motorized movement in three orthogonal dimensions. Optional trolley. Couch w/capacity 220 kg. Remote control horizontal movement. (Improved capacity) | Computer and couch controlled patient transport system with 200 kg weight capacity. Optional couch with vertical movement. |
| Patient positioning | Same laser positioning marker. Additional automated stepping capabilities. | Laser positioning marker for accurate placement of patient at isocenter. |
| Patient communication | Same as predicate. | Two-way intercom system and hand-held audio alarm. |
| Magnet Enclosure | ||
| Magnet Façade | Same as predicate. | Fiberglass enclosure. |
| Controls | LCD display above bore, two keypads on either side of bore. (Improved/different from predicate) | LED display, control panel in upper front pole. |
| Power Distribution Subsystem | ||
| Subsystem components | Same as predicate. | Isolation transformer, transient suppression circuitry, and power distribution center all contained in a single cabinet. |
| Operating Software | ||
| Base Software | Same as predicate. | Windows 2000 based Graphical User Interface and scan / reconstruction software with multi-tasking capability. |
| Imaging sequences | Field Echo, Spin Echo, Dual Echo, Dual Spin Echo, Inversion Recovery, Dual Inversion Recovery, Fast Spin Echo, EXPRESS, CBASS, MRCP, MRA, STIR, FLAIR, TSHIRT, RF-FAST, CE-FAST, DWISE. (Expanded from predicate) | Field Echo, Spin Echo, Dual Echo, Inversion Recovery, Fast Spin Echo, CBASS, MRCP, MRA, STIR. |
| Acquisition and reconstruction techniques | Same as predicate, and additionally MAO, MAST, presaturation, chemical fat saturation, phase conjugate symmetry, read conjugate symmetry, true res, true slice, elliptic encoding, RAM, CODA, MTC, dynamic examination curve, contrast dynamic imaging, reconstruction filters, respiratory gating, multiplanar reconstruction, maximum intensity projection, phase correction, fat/water suppression, ADC map. (Expanded from predicate) | Presaturation, MAST, ODA, PCS, no phase wrap-around, no slice wrap around, dynamic imaging, cardiac gating, optimized bandwidth, turbo multislice. |
| Time Varying Magnetic Field Normal Operating Mode | According to 60601-2-33 FDISscript 2001-11-02. (References current safety standard) | dB/dt ≤ 20 T/s |
| First Level Controlled Operating Mode | According to 60601-2-33 FDISscript 2001-11-02. (References current safety standard) | Not applicable. |
| Radiofrequency Absorption Normal Operating Mode | Same as predicate. | Limited to a maximum level of 1.2 W/kg. |
| First Level Controlled Operating Mode | Same as predicate. | Limited to a maximum value of 3.2 W/kg. |
| Acoustic Noise Typical | 87 dBA (average), 102 dB (peak) |
Ask a specific question about this device
Page 1 of 1