(85 days)
Not Found
No
The summary describes a passive RF receive coil for MRI, which is a hardware component for signal acquisition, not a software or processing technology. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an imaging surface coil designed to receive RF excitation for anatomical imaging and diagnosis, not for treating or preventing a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is intended for use in physician diagnosis of impingement syndrome, glenoid labrum tendon tears, rotator cuff tears, edema secondary to the aforementioned, retraction of the supraspinatus muscle and trauma of the long head of the biceps tendon." Additionally, the "Device Description" mentions it is "designed to provide high resolution diagnostic images."
No
The device is a physical coil designed to enhance MRI imaging, with descriptions of its physical components, materials, and testing related to hardware performance and safety. It is not solely software.
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 Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is an accessory for an MRI system. Its function is to receive radiofrequency signals from the patient's body during an MRI scan to produce images. It does not analyze samples taken from the body.
- Intended Use: The intended use is for anatomical imaging of the shoulder region to aid in physician diagnosis based on the resulting images. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro testing.
Therefore, the device falls under the category of medical imaging equipment accessories, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is for use only with the GEMS family of Super Conductor MR Systems. An anterior loop pair is combined with a posterior loop. The coil is designed to receive RF excitation from the protons of the hydrogen nuclei as a result of the scanner exciting these protons. The coil is designed for anatomical imaging of either the right or left shoulder region with a specific size and shape to facilitate placement on the anatomy area of interest. This placement results in a higher Signal To Noise Ratio(SNR) in the region near the surface coil. The greater SNR permits more effective imaging through the use of a smaller FOV and thinner slices,
The intended ROI for imaging includes the anterior and posterior musculoskeletal area of the shoulder. This includes the rotator cuff, humeral head, glenoid, glenoid labrum and glenoid cavity. The region runs superior through the clavicle and acromion and inferior through the infraspinatus. It also extends posterior to the lateral marqin.
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is intended for use in physician diagnosis of impingement syndrome, glenoid labrum tendon tears, rotator cuff tears, edema secondary to the aforementioned, retraction of the supraspinatus muscle and trauma of the long head of the biceps tendon.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is a rigid RF receive only magnetic field pickup coil that is designed to enhance imaging of the human shoulder and associated anatomic region. It consist of an anterior loop contoured to comfortably fit the anterior aspect of the right or left shoulder. The anterior loop cable interfaces with the multi-coil port on the GEMS Signa System. The coil is intended for use in all imaging planes, with a field of view(FOV) of at least 12 centimeters and less than 25 centimeters.
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is designed to provide high resolution diagnostic images under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.
The ABS outer housing of the coil has been designed to provide an enduring enclosure for the coil electrical components. Durability tests are conducted to verify the integrity of the coil structure. Additionally, the coil will not contain any ferrous nickel, ferrite or other magnetic materials which would negatively impact coil performance. The coil is also designed to assure that the components of the coil that come into contact with the patient will not have surface temperatures exceeding 41 degrees Celsius as a result of heating due to dielectric losses.
In summary, the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil utilizes a combination of the proven phased array technology of previous MRI surface coils such as the predicate Signa Phased Array 1.5T Breast Imaging Surface Coil, and the equivalent anatomical region surface imaging as demonstrated with the predicate Signa Linear 1.5T Shoulder Coil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
human shoulder and associated anatomic region.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician who is trained in the field of Diagnostic Magnetic Resonance Imaging.
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)
SIGNAL TO NOISE RATIO(SNR):
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil was evaluated using National Electric Manufacturer's Association (NEMA) Standard No. 6. Characterization of Special Purpose Coils for Diagnostic Resonance Images.
Both the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil and the predicate Linear Surface coil were evaluated with a loaded phantom to determine the SNR for both coils. Both coils were evaluated using the same scan parameters to produce identical images. The results were compared to verify the increased SNR of the proposed coil
IMAGE NON-UNIFORMITY TESTING:
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil was evaluated using NEMA Standards to characterize the non-uniformity of the proposed coil. Contours of the images obtained with the coil were constructed for the axial image, sagittal image, and the coronal image.
TEMPERATURE RISE AND DIELECTRIC STRENGTH SAFETY TESTS:
Safety tests were conducted to present temperature rise test results under moderate duty cycle scan conditions, and also to produce IEC 601-1 dielectric strength test results.
CLINICAL TESTING:
Images were obtained for both the proposed Medrad Phased Array 1.5T Shoulder Imaging Surface Coil and the predicate Linear 1.5T Shoulder Coil and the results were compared to substantiate improved SNR and morphological detail with the proposed coil.
CONCLUSION:
Extensive safety, verification, durability, and clinical testing was conducted with the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil to substantiate the claims of the proposed device and to verify that the proposed device is substantially equivalent to the predicate devices.
Image clarity, morphological detail and increased SNR demonstrate that the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil will produce the required detailed resolution in surface coil imaging .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Increased SNR, Image clarity, morphological detail.
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
MAY 29 1996
Image /page/0/Picture/2 description: The image shows the logo for Medrad, a medical technology company. The logo features a stylized caduceus symbol on the left, followed by the company name in bold, sans-serif font. Below the company name is the tagline "TECHNOLOGY FOR PEOPLE" in a smaller font.
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL
| OFFICIAL CONTACT: | Rodney J. Rylands
Medrad, Inc.
P.O. Box 780, Medrad Drive
Indianola, PA 15051
(412) 967-9700 Ext. 3778 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Magnetic Resonance Diagnostic Accessory[21
CFR 892.1000} |
| COMMON/USUAL NAME: | MRI Surface Coil |
| PROPRIETARY NAME: | Medrad Phased Array 1.5T Shoulder Imaging
Surface Coil |
| PREDICATE DEVICES: | GE Shoulder Coil - K892235
GE Phased Array Breast Coil |
DEVICE DESCRIPTION:
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is a rigid RF receive only magnetic field pickup coil that is designed to enhance imaging of the human shoulder and associated anatomic region. It consist of an anterior loop contoured to comfortably fit the anterior aspect of the right or left shoulder. The anterior loop cable interfaces with the multi-coil port on the GEMS Signa System. The coil is intended for use in all imaging planes, with a field of view(FOV) of at least 12 centimeters and less than 25 centimeters.
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is designed to provide high resolution diagnostic images under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.
The ABS outer housing of the coil has been designed to provide an enduring enclosure for the coil electrical components. Durability tests are conducted to verify the integrity of the coil structure. Additionally, the coil will not contain any ferrous nickel, ferrite or other magnetic materials which would negatively impact coil performance. The coil is also designed to assure that the components of the coil that come into contact with the patient will not have surface temperatures exceeding 41 degrees Celsius as a result of heating due to dielectric losses.
Image /page/0/Picture/10 description: The image shows a logo with a large letter Q inside a black square. Below the square, the words "Quality for Life" are printed in a simple, sans-serif font. The logo appears to be a symbol or emblem associated with a brand or organization that emphasizes quality.
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