(70 days)
Not Found
No
The summary describes a passive RF receive coil for MRI, focusing on its physical design, materials, and performance metrics like SNR and non-uniformity. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is an imaging coil designed to aid physician diagnosis by providing high-resolution diagnostic images, not to treat a condition.
Yes
The device, an MRI coil, explicitly states its intent to "aid physician diagnosis" and to "provide high resolution diagnostic images."
No
The device is described as a rigid RF receive only magnetic field pickup coil with an ABS outer housing and electrical components, clearly indicating it is a hardware device.
Based on the provided text, 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 Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is a component of an MRI system. Its function is to receive radiofrequency signals from the body during an MRI scan to create images. It does not analyze biological specimens.
- Intended Use: The intended use is for anatomical imaging of the shoulder and extremities to aid physician diagnosis. This is a function of an imaging device, not an IVD.
Therefore, this device falls under the category of medical imaging equipment, 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 shoulder region and the upper and lower extremeties 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 and the upper and lower extremeties.
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is intended to aid physician diagnosis in the shoulder, upper, and lower extremety regions.
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 the upper and lower extremeties. It consist of an anterior and posterior coils which 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.
Medrad, Inc. believes the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is substantially equivalent to the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil identified in 510(k) - K960901. The proposed Phased Array 1.5T Shoulder Imaging Surface Coil is the same coil that was determined Substantially Equivalent in 510(k) - K96090. This 510(k) is being submitted for addition of upper and lower extremities imaging to the Intended Use of the device and for the addition of an optional third coil(posterior paddle) to the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
shoulder region, upper extremeties, lower extremeties
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician trained in the field of Diagnostic 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
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 Magnetic Resonance lmages.
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil was evaluated with a loaded phantom to determine the SNR.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 with the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil to substantiate equivalent SNR and morphological detail with the predicate 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 device.
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.)
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
FEB | | 1997
K9644854
ATTACHMENT VIII
SMDA 510(K) SUMMARY
1
Image /page/1/Picture/0 description: The image shows the Medrad logo. The logo consists of a symbol resembling a caduceus on the left, followed by the word "medrad" in a bold, stylized font. Below the word "medrad" is the tagline "TECHNOLOGY FOR PEOPLE."
510(k) SUMMARY MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL
| OFFICIAL CONTACT: | Rodney J. Rylands
Medrad, Inc.
One Medrad Drive
Indianola, PA 15051
(412) 767-2400 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: | Medrad Phased Array 1.5T Shoulder Imaging
Surface Coil - K960901 |
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 the upper and lower extremeties. It consist of an anterior and posterior coils which 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/1/Picture/7 description: The image shows a logo with a large letter Q in a bold, sans-serif font. The Q is white and is set against a black rectangular background. Below the Q, the words "Quality for Life" are printed in a smaller, sans-serif font, also in white. The overall design is simple and modern, with a focus on the letter Q and the phrase "Quality for Life."
2
Image /page/2/Picture/0 description: The image shows the Medrad logo. The logo is in black and white and features the word "medrad" in a bold, sans-serif font. Below the word "medrad" is the phrase "TECHNOLOGY FOR PEOPLE." in a smaller font. The logo is simple and modern.
DEVICE DESCRIPTION (cont.):
Medrad, Inc. believes the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is substantially equivalent to the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil identified in 510(k) - K960901. The proposed Phased Array 1.5T Shoulder Imaging Surface Coil is the same coil that was determined Substantially Equivalent in 510(k) - K96090. This 510(k) is being submitted for addition of upper and lower extremities imaging to the Intended Use of the device and for the addition of an optional third coil(posterior paddle) to the device.
INTENDED 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 shoulder region and the upper and lower extremeties 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 and the upper and lower extremeties.
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is intended to aid physician diagnosis in the shoulder, upper, and lower extremety regions.
Patient fitness and suitability for MRI must be determined by the individual physician trained in the field of Diagnostic Resonance Imaging.
3
MILLING CORPORATE A
TECHNOLOGICAL CHARACTERISTICS COMPARISON WITH PREDICATE DEVICES:
的主体。
| PHASED ARRAY SHOULDER
COIL | PHASED ARRAY SHOULDER
COIL |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Proposed Device | K960901 - Predicate Device |
| Compatible with GE 1.5T Signa,
Super Conductor Scanners -
Phased Array Architecture. | Same |
| Receive only dual loop anterior
phased array coil. | Receive only dual loop anterior
phased array coil with an
optional third loop - posterior coil. |
| Plugs into GE Signa System via
Phased Array quick disconnect
port. | Same |
| No external tuning or matching is
necessary. | Same |
| Intended Uses:
Anatomical Region -
Shoulder
Nuclei Excited - Hydrogen
2D and 3D Imaging | Intended Uses:
Anatomical Region -
Shoulder, Upper and lower
extremities
Nuclei Excited - Hydrogen
2D and 3D Imaging |
| PATIENT CONTACTING MATERIALS COMPARISON
INFORMATION | |
| ABS | ABS |
| Velcro Hook/ Latch Fastener | Velcro Hook/ Latch Fastener |
4
E TEST DATA:
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 Magnetic Resonance lmages.
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil was evaluated with a loaded phantom to determine the SNR.
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 DIFLECTRIC 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 with the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil to substantiate equivalent SNR and morphological detail with the predicate 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 device.
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 .