(100 days)
Not Found
No
The summary describes hardware components (gradient coils, amplifiers) and software sequences for faster/higher resolution MR imaging, but makes no mention of AI or ML algorithms for image processing, analysis, or interpretation.
No
The device is described as an NMR device that produces images to aid in diagnosis, not to provide therapy.
Yes
Explanation: The device produces images that, when interpreted by a trained physician, "yield information that can be useful in the determination of a diagnosis." This explicitly states its role in aiding diagnosis.
No
The device description explicitly lists hardware components: water-cooled non-resonant self-shielded gradient coils and high performance gradient amplifiers.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "NMR device that produces images" and that these images are "interpreted by a trained physician" to "yield information that can be useful in the determination of a diagnosis." This describes an imaging device used for diagnostic purposes, not a device that performs tests on biological samples in vitro (outside the body).
- Device Description: The description details components related to magnetic resonance imaging (gradient coils, amplifiers, sequences), which are characteristic of an imaging system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the EPI-II System Option with High Performance Gradients is an imaging device, specifically an MRI system option, and not an IVD.
N/A
Intended Use / Indications for Use
The EPI-II System Option with High Performance Gradients is designed to provide higher gradient output power in order to allow the user to acquire images at a faster rate or acquire images with a higher spatial resolution than would normally be possible with a standard EDGE system with the EPI-I software option. The indications for use are the same as for standard MR imaging.
The Picker International EDGE 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The EPI-II System Option with High Performance Gradients consists of water-cooled non-resonant self-shielded gradient coils, high performance gradient amplifiers, single-shot echo-planar sequences, and modified standard sequences.
Mentions image processing
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
General Information i.
:
| | Classification: | Class II
Magnetic Resonance (MR) Imaging System | |
|----|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Common/Usual Name: | MRI System Option | |
| | Proprietary Name: | EPI-II System Option with High Performance
Gradients | |
| | Establishment Registration: | Picker International, Inc.
World Headquarters
595 Miner Road
Cleveland, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965 | |
| | Performance Standards: | Not applicable | |
| 2. | Intended Uses: | The EPI-II System Option with High
Performance Gradients is designed to provide
higher gradient output power in order to allow
the user to acquire images at a faster rate or
acquire images with a higher spatial resolution
than would normally be possible with a standard
EDGE system with the EPI-I software option.
The indications for use are the same as for
standard MR imaging. | |
| 3. | Device Description: | The EPI-II System Option with High
Performance Gradients consists of water-cooled
non-resonant self-shielded gradient coils, high
performance gradient amplifiers, single-shot echo-
planar sequences, and modified standard
sequences. | |
】- 1 (10/9/95) (EPI-II) PICKER INTERNATIONAL, INC.
1
Safety and Effectiveness 4.
a. Safety
As shown in the chart below, the Picker EPI-II System Option with High As shown in the chart below, the ricker the riskel to the standard EDGE Performance Gradients for an EDGE System is identical to the day and levels and software algorithm.
EDGE with EDGE with Parameter EPI-I Software Option EPI-II System Option Same Static Magnetic Field Same Corresponding to proton Concepce of 63.75 MHz (EDGE). Not to exceed 20 T/s (as Total dB/dt software Time Varying Magnetic measured according to algorithm warns when Field method in IEC 601-2-33). operational level is above 40 T/s and prohibits operation above 60 T/s (as measured by method in FDA's draft guidance document).
SAFETY CHART
(10/9/95) (EPI-II)
I-2
2
| Parameter | EDGE with
EPI-II System Option | EDGE with
EPI-I Software Option |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Radio Frequency
Absorption | Same | Same |
| Power deposition during
imaging is limited by the
SAR algorithm to a
maximum value of:
1.2 W/kg NORMAL
OPERATING MODE
2.4 W/kg FIRST
LEVEL CONTROLLED
OPERATING MODE
2.4 W/kg SECOND
LEVEL CONTROLLED
OPERATING MODE
(Requires human studies
protocol approval
according to local
requirements.) | | |
| Acoustic Noise | Acoustic noise levels of
EPI-II System Option
under worst case
conditions are: 109.1 dBA
(average) and 119.5 dB
(peak). | Acoustic noise levels of
standard EDGE system
under worst case
conditions are: 118.7 dBA
(average) and 127.8 dB
(peak). |
(10/9/95) (EPI-II)
I-3
3
| Parameter | EDGE with
EPI-II System Option | EDGE with
EPI-I Software Option |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Same | Same |
| The Picker International
EDGE 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. | | |
| Parameter | EPI-II System Option | Predicate |
| Gradient Coil Design | Water-cooled, high
performance, self-shielded
non-resonant gradient
system. | Basic EDGE system uses
a standard performance,
air cooled, self-shielded
gradient system. (see
510(k) K931544). |
| Gradient Power | Gradient Amplifiers:
270 A RMS, 440 A peak,
600 V max. | Gradient Amplifiers:
135 A RMS, 220 A peak,
350 V max.
(see 510(k) K931544) |
| Gradient Performance | Maximum Gradient
Strength = 27 mT/m | Maximum Gradient
Strength = 16 mT/m |
| | Maximum Slew Rate =
72 mT/m/msec | Maximum Slew Rate =
25 mT/m/msec |
| Fast Scanning Sequences | Single-shot EPI fast
scanning sequences. Entire
image collected following a
single RF excitation using
multiple gradient recalled
echoes. | Multi-Shot EPI fast
scanning sequences. A
number of RF excitations
are required to collect an
entire image. Multiple
gradient recalled echoes
used to collect data. (see
510(k) K945828) |
| EPI Data Correction | Interactive prescan
process. | Automated process which
does not require operator
involvement. (see 510(k)
K945828) |
| IR Prep Pulse | Improves T1 image
contrast. | Same. (see 510(k)
K945828). |
| Standard Imaging
Sequences | Increased image resolution
or redesigned for: shorter
inter-echo spacing; shorter
echo times; and/or
increase motion artifact
suppression. | Standard image resolution,
inter-echo spacing, echo
times, and motion artifact
suppression, limited by the
lower output power of the
gradient system. |
b. Effectiveness
Compared to the standard EDGE system using the EPI-I software option (see Compared to the standard EDOD of the EPI-II System Option has a gradient system SID(K)S R931344 and 18745020), the dient operational levels and provide faster which is and to produce inguil System Option also includes EPI single shot sequences.
PICKER INTERNATIONAL, INC.
(10/9/95) (EPI-II)
【-4
4
EFFECTIVENESS CHART
PICKER INTERNATIONAL, INC. (EPI-II)
ﻟﺴﻴﺮ-
I-II) (10/9,
I-5
(EPI-II)
NATIONAL