(83 days)
No
The document describes hardware and software enhancements for an existing MR system, focusing on improved image acquisition and reconstruction speed. There is no mention of AI or ML algorithms for image analysis, interpretation, or other functions.
No.
The device is used to produce images for diagnostic purposes, not to provide treatment.
Yes
The device produces images that, when interpreted by a trained physician, "yield information that can be useful in the determination of a diagnosis."
No
The device description explicitly lists changes to multiple hardware subsystems (computer, gradient, RF, magnet, patient handling, magnet enclosure) and mentions hardware components like a body coil and water-cooled gradients. This indicates it is a hardware-based medical device with software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Picker International EDGE and VISTA systems are NMR (Nuclear Magnetic Resonance) devices that produce images of the head and whole body. These images are then interpreted by a trained physician for diagnosis.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. Its function is to generate images based on the physical properties of the body's tissues.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EDGE/VISTA System Enhancement Package does not change the existing indications for the EDGE/VISTA systems as defined below.
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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) Imaging System
Anatomical Site
head and whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K932693, K941996, K944469, K952530, K945397, K945828
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
General Information 1.
| Classification: | Class II
Magnetic Resonance (MR) Imaging System |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging Option |
| Proprietary Name: | EDGE/VISTA System Enhancement Package |
| Establishment Registration: | Picker International, Inc.
World Headquarters
595 Miner Road
Cleveland, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965 |
| Performance Standards: | No applicable performance standards have been
issued under section 514 of the Food, Drug and
Cosmetic Act. |
2. Intended Uses
The EDGE/VISTA System Enhancement Package does not change the existing indications for the EDGE/VISTA systems as defined below.
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.
3. Device Description
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.
| PICKER INTERNATIONAL, INC. | (EDGE SE) | 11/18/96 | I - |
|---|---|---|---|
| ---------------------------- | ----------- | ---------- | ----- |
1
Safety and Effectiveness 4.
The EDGE/VISTA systems with the system enhancement package are similar in technological characteristics and intended use to EDGE/VISTA systems with standard or high performance gradients. The following chart has been created to demonstrate their substantial equivalence.
| ITEM | EDGE/VISTA with System
Enhancement Package | Predicate Devices
EDGE/VISTA (K931544) &
High Performance Gradients
Option (K954646) |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer Subsystem | Similar display/database
computer, monitor and Ethernet
communications systems.
Ethernet communications link
complies with DICOM v3.0 to
allow image transfer to other MR,
CT, Nuclear, workstation systems
and cameras. Optional packages
available for increased image
reconstruction rates. | Display/Database computer and
scan reconstruction hardware
connected together by a dedicated
Ethernet communications system.
Allows for simultaneous scanning
and image reconstruction/
manipulation. Single monitor for
system operation and image
reviewing. Second Ethernet
interface for communication with
systems on the external network.
(See K931544) |
| Image Storage
Short Term:
Archival: | Same
Same | Magnetic Disk
Optical Disk
(See K931544) |
| ITEM | EDGE/VISTA with System
Enhancement Package | Predicate Devices
EDGE/VISTA (K931544) &
High Performance Gradients
Option (K954646) |
| Gradient Subsystem
Gradient Coils: | Water-cooled self-shielded
gradient system for all
performance levels. | Standard EDGE- Air-cooled self-
shielded gradient system. (see
K931544) |
| | | EDGE with High Performance
Gradients - Water-cooled self
shielded gradient system (see
K954646) |
| Max. Gradient
Strength | 16, 20 or 27 mT/m | 16 or 27 mT/m |
| Max. Slew Rate | 25, 40, 72 mT/m/msec | 25 or 72 mT/m |
| Gradient Amps: | 150 A RMS, 300 A peak, 400 V or
270 A RMS, 440 A peak, 600 V | 135 A RMS, 220 A peak, 350 V
or
270 A RMS, 440 A peak, 600 V |
| RF Subsystem
DTR Spectrometer: | Same | Single Channel with fast
sampling ADC and additional
digital filtering. Three additional
receive channels are available as
an option. |
| RF Amplifiers: | Single frequency RF amplifiers
with increased output power to
give equivalent B1 field with
larger body coil. | Single frequency RF amplifiers.
(See K931544) |
| Body Coil | 61 cm quadrature multi-
conductor transmit/receive coil. | 58 cm quadrature multi-
conductor transmit/receive coil.
(See K931544) |
| Head Coil | Same | Quadrature multi-conductor
receive only.
(See K931544) |
| ITEM | EDGE/VISTA with System
Enhancement Package | Predicate Devices
EDGE/VISTA (K931544) &
High Performance Gradients
Option (K954646) |
| Receive Only Coil
Connection | Same | All receive only coils plug into
single couch RF connector. |
| Transmit/Receive Box | Same | Four receive channels in system.
(See K931544) |
| Magnet Subsystem | Same | Active Shield Magnets offered at
1.5 T and 1.0 T.
(See K931544) |
| Patient Handling | Computer controlled patient
transport system with increased
weight capacity. New method of
patient illumination used to
increase patient comfort. | Computer controlled patient
transport system.
(See K931544) |
| Magnet Facade | Cylindrical fiberglass enclosure.
Hinge on front facade removed. | Cylindrical fiberglass enclosure.
Hinged front facade. (See
K931544) |
| Power Distribution
Subsystem | Same | Isolation transformer, transient
suppression circuitry, and power
distribution center all contained
in a single cabinet. (See
K931544) |
| Operating Software | Same | UNIX - X Windows based
operating software. Graphical
User Interface - windows and
multi-tasking capability provided.
SCAN, VIEW, FILM and
UTILITIES operations all
accessed from single console.
Able to switch between on-going
tasks.
(See K931544) |
| ITEM | EDGE/VISTA with System
Enhancement Package | Predicate Devices
EDGE/VISTA (K931544) &
High Performance Gradients
Option (K954646) |
| Operational Features | Same | SCAN capabilities include: Pilot
positioning on three different
reference images. Preloaded
anatomical protocol categories.
VIEW capabilities include: Multi
planar reconstruction and
curvilinear reformatting.
FILM capabilities include: ability
to set film formats and load print
queue directly from
Display/Database computer.
(See K931544) |
| Standard Imaging
Sequences | Same | 2DFT: Field Echo, Spin Echo,
Multiple Echo, Inversion
Recovery and FAST.
3DFT: FAST |
| Acquisition and
Reconstruction Techniques | Same | Main features include: Multi-
angle oblique, presaturation,
phase conjugate symmetry,
TrueRes and TrueSlice.
(See K931544) |
| ITEM | EDGE/VISTA with System
Enhancement Package | Predicate Devices
EDGE/VISTA (K931544) &
High Performance Gradients
Option (K954646) |
| Optional Receive Only
Coils | All coils for the EDGE/VISTA
are compatible with the system
enhancement package.
New coils/accessories described
in this submission:
Quadrature Lower Extremity Coil
Coil Combiner | Large Joint Coil
Small Joint Coil
Volume Neck Coil
Quad Spine Coil and Positioner
General Purpose Flex Coil
Bilateral TMJ Coil (Linear and
Phased Array versions)
Bilateral Breast Coil
C/T/L Phased Array
Pelvic Phased Array
Head-Neck Vascular Phased
Array
Flexible Body Coil (Quadrature
and Phased Array versions)
Quadrature Wrist Coil
Shoulder Phased Array
(See K931544, K932693,
K941996, K944469, K952530) |
| ITEM | EDGE/VISTA with System
Enhancement Package | Predicate Devices
EDGE/VISTA (K931544) &
High Performance Gradients
Option (K954646) |
| Software Options | Software options are the same
except for the following
additions:
Variable Fast Spin Echo: 2 and
32 echo sequences have been
added. | Angiography
Cardiac Imaging
Variable Fast Spin Echo (4, 8, 16,
48 and 64 echo sequences with
minimum TE's of 16 to 32 msec)
Gradient-Recalled and Spin-Echo
(GRaSE) Technique
Echo Planar Imaging
(See K931544, K945397,
K945828, K954646) |
| Time Varying Magnetic
Field | All gradient performance levels:
Normal Operating Mode:
$dB/dt ≤ 40 T/s$
First Controlled Operating Mode:
$40 T/s