(88 days)
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No
The document describes a new coil for an existing MRI system, focusing on hardware improvements (signal-to-noise ratio, image resolution, acquisition time) and does not mention any software or processing features related to AI or ML.
No.
The device is used to produce images for diagnostic purposes, not for therapeutic treatment.
Yes
The device is described as an "NMR device that produces images" which, "When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis." This explicitly states its role in diagnosis.
No
The device description explicitly states it is a "coil architecture enclosed in a flexible package," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that this device is a component (flexible body coils) for a Magnetic Resonance Imaging (MRI) system. MRI is an imaging modality that produces images of the internal structure of the body using magnetic fields and radio waves. It does not involve testing samples taken from the body.
- Intended Use: The intended use is to produce images that can be interpreted by a trained physician to aid in diagnosis. This is consistent with the function of an imaging device, not an IVD.
Therefore, the Quadrature and Phased Array Flexible Body Coils, as described, are part of an imaging system and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Quadrature and Phased Array Flexible Body Coils do not change the intended use of the Picker 1.5T EDGE system.
The 1.5T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, 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 Quadrature and Phased Array Flexible Body Coils are indicated for use in the following anatomic regions and with the designated nuclei:
Anatomic Regions: Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures
Nuclei Excited: Hydrogen
Product codes
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Device Description
The Picker Flexible Body Coils have either a Quadrature or Phased Array coil architecture enclosed in a flexible package that can be wrapped around the area of interest. The coils are designed to give improved signal-to-noise ratio, image resolution and image acquisition time over that of the standard EDGE body coil.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures
Indicated Patient Age Range
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Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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)
AUG 27 1996
| Classification: | Class II
Magnetic Resonance Imaging (MRI) Accessory |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) Coil |
| Proprietary Name: | Quadrature and Phased Array Flexible Body Coils |
| 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
General Information
The Quadrature and Phased Array Flexible Body Coils do not change the intended use of the Picker 1.5T EDGE system.
The 1.5T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, 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 Quadrature and Phased Array Flexible Body Coils are indicated for use in the following anatomic regions and with the designated nuclei:
| Anatomic Regions: | Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures |
|---|---|
| Nuclei Excited: | Hydrogen |
PICKER INTERNATIONAL, INC. (FBC) 2129/96
I - 1
1
Device Description 3.
The Picker Flexible Body Coils have either a Quadrature or Phased Array coil architecture enclosed in a flexible package that can be wrapped around the area of interest. The coils are designed to give improved signal-to-noise ratio, image resolution and image acquisition time over that of the standard EDGE body coil.
4. Safety and Effectiveness
The Picker Quadrature and Phased Array Flexible Body Coils are substantially equivalent to the MAI Quadrature and Phased Array Abdominal Flex Coils (K954190) in safety and effectiveness. The following chart has been compiled to demonstrate the Flexible Body Coils substantial equivalence to these devices.
ﻬ
| Parameter | Quadrature and Phased
Array Flexible Body Coil | MAI Quadrature and
Phased Array Abdominal
Flex Coil (K954190) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Compatible MRI Systems | Picker International 1.5T
EDGE | GE 1.5T Signa |
| Mode of Operation | Receive-Only | Receive-Only |
| Antenna Configuration | Quadrature: Co-rotating
saddle coil pairs | Quadrature: Co-rotating
saddle coil pairs |
| | Phased Array: Co-rotating
saddle coils and loops | Phased Array: Co-rotating
saddle coils and loops |
| Tuning/Impedance Matching | Fixed tuning and matching.
Factory set. | Fixed tuning and matching.
Factory set. |
| Method of Decoupling | Active PIN diode decoupling | Active PIN diode decoupling |
| Coil Enclosure | Flame rated foam and fabric | Flame rated foam and fabric |
| Number of Receive Channels | Quadrature: 1
Phased Array: 4 | Quadrature: 1
Phased Array: 4 |
| Intended Use | The MAI Quadrature and Phased Array Abdominal Flex
Coils are indicated for use as a receive only antenna of RF
energy at a specific frequency. The signal received by the coil
is dependent upon the MRI parameters (T1 or spin-lattice
relaxation time, T2 or spin-spin relaxation time, density of
nuclei, flow velocity and chemical shift). The images
produced by the imaging coil correspond to the distribution of
nuclei exhibiting nuclear magnetic resonance. | |
| | The Abdominal Flex Coils are intended for use in the
following anatomic regions: liver, kidneys, adrenal glands,
spleen, bilateral hips and knees, and associated
abdominopelvic structures. | |
| | The Picker Quadrature and Phased Array Flexible Body
Coils do not change the intended use of the Picker 1.5T
EDGE system. The 1.5T EDGE system is intended for use as
a NMR device that produces images that: (1) correspond to
the distribution of protons exhibiting NMR, (2) depend upon
NMR parameters (proton density, flow velocity, spin-lattice
relaxation time T1, spin-spin relaxation time T2) and (3)
| |
| | The Flexible Body Coils are indicated for use in the following
anatomic regions and with the designated nuclei: | |
| | Anatomic Regions: Liver, kidneys, adrenal glands,
spleen, bilateral hips and associated abdominopelvic
structures | |
| | Nuclei Excited: Hydrogen | |
(FBC) 5/28/96 ﺔ ﻓ
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(FBC) 5/28/96