(88 days)
No
The summary describes a receive-only coil for MRI, focusing on hardware improvements (SNR, resolution, acquisition time) and does not mention any software or processing capabilities that would involve AI/ML.
No
The device is described as an NMR device that produces images for diagnostic purposes, not for treating a condition.
Yes.
Explanation: The Phased Array Shoulder Coil is part of an NMR device (MRI system) that produces images yielding information "useful in the determination of a diagnosis" when interpreted by a trained physician. This indicates its role in the diagnostic process.
No
The device description explicitly states it is a "receive-only coil," which is a hardware component used in MRI systems.
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states that the Phased Array Shoulder Coil is a receive-only coil used with an MRI system to produce images of the shoulder and other joint structures.
- Intended Use: The intended use is to provide images that, when interpreted by a trained physician, can be useful in determining a diagnosis. This is a function of an imaging device, not an in vitro diagnostic test.
- Lack of Biological Sample Analysis: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is a core characteristic of IVDs.
Therefore, the Phased Array Shoulder Coil is an accessory for a medical imaging device (MRI) and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Phased Array Shoulder Coil does not change the intended use of the Picker 1.5 T EDGE system.
The 1.5 T 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 Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Shoulder and other related joint structures Anatomic Regions:
Nuclei Excited: Hydrogen
Product codes
Not Found
Device Description
The Picker Phased Array Shoulder Coil is a receive-only coil designed to provide imaging of the shoulder and other joint structures. The coil is designed to give improved signalto-noise ration (SNR), image resolution and image acquisition time over that of the Body Coil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Shoulder and other related joint structures
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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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)
1. General Information
| Classification: | Class II
Magnetic Resonance Imaging (MRI) Accessory |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) Coil |
| Proprietary Name: | Phased Array Shoulder Coil |
| Establishment Registration: | Picker International, Inc.
World Headquarters
595 Miner Road
Highland Heights, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965 |
| Performance Standards: | Not Applicable |
2. Intended Uses
The Phased Array Shoulder Coil does not change the intended use of the Picker 1.5 T EDGE system.
The 1.5 T 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 Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Shoulder and other related joint structures Anatomic Regions:
Nuclei Excited: Hydrogen
1
3. Device Description
The Picker Phased Array Shoulder Coil is a receive-only coil designed to provide imaging of the shoulder and other joint structures. The coil is designed to give improved signalto-noise ration (SNR), image resolution and image acquisition time over that of the Body Coil.
4. Safety and Effectiveness
The Picker Phased Array Shoulder Coil is substantially equivalent in safety and effectiveness to the MAI Phased Array Shoulder Coil for the GE 1.5 T Signa system. The following chart has been compiled to demonstrate the Shoulder Coil's substantial equivalence to this device.
| Parameter | Phased Array Shoulder Coil | Predicate Device
MAI Phased Array Shoulder
Coil (K945778) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Compatible MRI Systems | Picker International 1.5 T
EDGE | GE 1.5 T Signa with Phased
Array Hardware Option |
| Mode of Operation | Same | Receive-Only Array |
| Antenna Configuration | Same | Multi-channel Array |
| Tuning/Impedance Matching | Same | Fixed tuning and matching.
Factory set. |
| Method of Decoupling | Same | Passive diode decoupling. |
| Coil Enclosure | Same | Flame rated thermoplastic
enclosure and vinyl pads. |
| Number of Receive Channels | Same | Four |
| Parameter | Phased Array Shoulder Coil | Predicate Device
MAI Phased Array Shoulder
Coil (K945778) |
| Intended Use | The MAI Phased Array Shoulder Coil is indicated for use as a
receive only antenna of RF energy at a specific frequency. The
signal received by the coils is dependent upon 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 MAI Phased Array Shoulder Coil is indicated for use in the
following anatomic regions: shoulder and other related joint
structures.
The Phased Array Shoulder Coil does not change the intended
| |
| | The Phased Array Shoulder Coil is indicated for use in the
following anatomic regions and with the designated nuclei: | |
| | Anatomic Regions: | Shoulder and other related
joint structures. |
| | Nuclei Excited: | Hydrogen |
The Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Shoulder and other related joint structures Anatomic Regions:
Nuclei Excited: Hydrogen
2
PICKER INTERNATIONAL, INC.
(PASC) 8/19/96