(129 days)
Elixbo PM545 is indicated for use as magnetic resonance diagnostic device that produces axial, sagittal, coronal and oblique cross sectional images, and that displays the anatomical and pathological information of the head, body, or extremities. When interpreted by a trained physician, these images yield information that can be useful in determining a diagnosis.
The proposed device, Elixbo PM545, is a Magnetic Resonance Imaging System that utilizes a 0.45 Tesla permanent magnet in an open gantry design. It's indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. These images when interpreted by a trained physician vield information that may assist in diagnosis. The MRI system is composed of magnet, gradient & shimming system, RF system, spectrometer, temperature controller, patient table system, isolation transformer, respiratory gating unit, chiller and control system. The system software, Prospect, based on Windows® XP professional operating system is an interactive program with user friendly interface. The proposed device includes twelve receiving coils which are Head Coil, Neck Coil, Knee Coil, Shoulder Coil, Wrist Coil, Breast Coil, Ankle Coil, Body Coil (14"), Body Coil (17"), Body Coil (20"), General Purpose Coil (6"), and General Purpose Coil (9").
The provided document describes the safety and effectiveness information for the Elixbo PM545 Magnetic Resonance Imaging System, submitted as a 510(k) premarket notification. This submission indicates that the device's performance was evaluated through non-clinical bench tests and a comparison to a predicate device, rather than a clinical study with specific acceptance criteria for diagnostic performance metrics like sensitivity or specificity.
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the Elixbo PM545 are primarily based on compliance with international standards for medical electrical equipment and a determination of substantial equivalence (SE) to a legally marketed predicate device (mStar MPF4500, K073457). The "device performance" in this context refers to its ability to meet these technical standards and operate comparably to the predicate device.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance (Elixbo PM545) |
|---|---|---|
| Safety and Electrical | IEC 60601-1: General Requirements for Safety | Conforms to IEC 60601-1:1988 + A1:1991 + A2:1995 |
| IEC 60601-2-33: Basic Safety and Essential Performance of MR Equipment | Conforms to IEC 60601-2-33:2002 + A1:2005 + A2:2007 | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: Electromagnetic Compatibility | Conforms to IEC 60601-1-2: 2007 |
| Image Quality Parameters (NEMA Standards) | NEMA MS 1-2008: Signal-to-Noise Ratio (SNR) | Demonstrated compliance |
| NEMA MS 2-2008: Two-Dimensional Geometric Distortion | Demonstrated compliance | |
| NEMA MS 3-2008: Image Uniformity | Demonstrated compliance | |
| NEMA MS 5-2010: Slice Thickness | Demonstrated compliance | |
| Biocompatibility | ISO 10993-5: In Vitro Cytotoxicity | Conforms to ISO 10993 series standards |
| ISO 10993-10: Irritation & Delayed-Type Hypersensitivity | Conforms to ISO 10993 series standards | |
| ISO 10993-10: Irritation & Skin Sensitization (2010) | Conforms to ISO 10993 series standards | |
| Functional Equivalence | Intended Use | Same as predicate (magnetic resonance diagnostic device producing axial, sagittal, coronal, oblique images for head, body, or extremities for diagnosis) |
| Installation Type | Fixed (Same as predicate) | |
| Magnet Type | Permanent (Same as predicate) | |
| RF Amplifier Max Power | 6 kW (Same as predicate) | |
| Pulse Sequences | SE, GRE, FSE, FSE+FC, FSE+Sat, LSDWI, TOF2D, TOF3D, FLAIR, STIR, SPGR2D, SSFSE2D, SSFSE3D (Same as predicate) | |
| Maximum Gradient Strength | 25mT/m (Same as predicate) | |
| Slew Rate | 78mT/m/ms (Same as predicate) | |
| Static Field Strength | 0.45T (Same as predicate) | |
| Peak and A-Weighted Acoustic Noise | Peak: |
§ 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.