(83 days)
The Picker International EDGE and VISTA systems are 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.
The EDGE/VISTA system enhancement package includes changes in the computer subsystem, the gradient subsystem, the RF subsystem, the magnet subsystem, the patient handling subsystem, and the magnet enclosure. The main features provided with this enhancement are a 61 cm body coil, three gradient performance levels, water cooled gradients, an increase in the SAR first controlled operating mode limit, and optional increased reconstruction rates.
The provided document is a 510(k) summary for a GE Healthcare product, specifically an enhancement package for their EDGE/VISTA MR systems. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific clinical acceptance criteria through a study.
Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria in the way a clinical trial or performance study would. It focuses on comparing the technical specifications and safety parameters of the new device to existing, legally marketed predicate devices.
Here's why the requested information isn't present and what the document does provide:
- No Acceptance Criteria in the context of clinical performance: The document implicitly demonstrates "acceptance" by showing the device's technical specifications and safety profiles are comparable to, or improved upon, predicate devices, indicating it meets general regulatory safety and effectiveness expectations for MR systems. There are no explicit clinical performance metrics (e.g., sensitivity, specificity for a diagnostic task) being tested.
- No "Study" as a traditional clinical trial: The document describes modifications and enhancements to an existing MR system. The "proof" is through a comparative table highlighting substantial equivalence in engineering, safety, and operational features. It's not a study in the sense of a clinical investigation with a test set, ground truth established by experts, etc.
- No details on sample size, data provenance, expert ground truth, adjudication, MRMC, or standalone performance: These concepts are relevant to clinical performance studies, which are not detailed in this 510(k) summary for a system enhancement.
However, I can extract information related to the technical comparisons made for demonstrating "substantial equivalence," which serves as the "proof" in this context:
1. Table of "Acceptance Criteria" (Implicit Safety/Performance Parameters) and Reported Device Performance
Since there are no explicit "acceptance criteria" for clinical performance, I will present the key technical and safety specifications that are being compared to demonstrate substantial equivalence, considering these as the "criteria" for regulatory acceptance in this context.
| Item/Criterion (Implicit) | Predicate Devices (EDGE/VISTA K931544, K954646) Performance | EDGE/VISTA with System Enhancement Package Performance | Comparison Outcome (Proving "Acceptance") |
|---|---|---|---|
| Computer Subsystem | Dedicated Ethernet, single monitor, second Ethernet for external network. | Similar display/database computer, monitor, Ethernet. DICOM v3.0 compliant. Optional increased reconstruction rates. | Substantially Equivalent; added modern communication (DICOM) and optional performance improvements. |
| Image Storage (Short Term/Archival) | Magnetic Disk/Optical Disk | Same | Substantially Equivalent. |
| Gradient Coils | Air-cooled (Standard EDGE) or Water-cooled (High Performance Gradients) | Water-cooled self-shielded for all performance levels. | Improved/Equivalent; standardizes to the higher performance, water-cooled model. |
| Max. Gradient Strength | 16 or 27 mT/m | 16, 20 or 27 mT/m | Improved/Equivalent; adds an intermediate gradient strength option. |
| Max. Slew Rate | 25 or 72 mT/m/msec | 25, 40, 72 mT/m/msec | Improved/Equivalent; adds an intermediate slew rate option. |
| Gradient Amps | 135 A RMS, 220 A peak, 350 V OR 270 A RMS, 440 A peak, 600 V | 150 A RMS, 300 A peak, 400 V OR 270 A RMS, 440 A peak, 600 V | Improved/Equivalent; slight increase in the lower-tier amp values. |
| RF Amplifiers | Single frequency RF amplifiers. | Single frequency RF amplifiers with increased output power (for larger body coil). | Improved/Equivalent; adjusted for new 61cm body coil maintain equivalent B1 field. |
| Body Coil | 58 cm quadrature multi-conductor transmit/receive coil. | 61 cm quadrature multi-conductor transmit/receive coil. | Improved; larger body coil for potentially greater patient comfort/versatility. |
| Patient Handling | Computer controlled patient transport. | Computer controlled patient transport with increased weight capacity. New patient illumination. | Improved; increased capacity and comfort features. |
| Time Varying Magnetic Field (dB/dt) | Standard EDGE: ≤ 20 T/s. High Performance: Normal ≤ 40 T/s, Controlled 40-60 T/s. | Normal Operating Mode: ≤ 40 T/s. First Controlled Operating Mode: **40 T/s |
§ 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.