(71 days)
Not Found
No
The summary describes a receive-only MRI coil and its performance characteristics, with no mention of AI, ML, or image processing capabilities.
No
The device is described as a receive-only coil for enhancing MR imaging of the shoulder anatomy, indicating its use for diagnosis, not treatment.
Yes
Explanation: The device is an MRI coil intended to facilitate complete MR imaging of the shoulder anatomy, and it is explicitly stated that it is used under the supervision of a physician trained in Diagnostic Resonance Imaging. While the coil itself doesn't make a diagnosis, it is a tool used to acquire images for diagnostic purposes.
No
The device description and performance studies clearly indicate this is a physical coil (hardware) used in MRI imaging, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Medrad Shoulder Coil is a component used in an MRI scanner. Its purpose is to receive radiofrequency signals from the body during an MRI scan to create images of the shoulder anatomy. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for "facilitate complete MR imaging of the shoulder anatomy" and "imaging of the shoulder anatomy." This is an imaging device, not a diagnostic test performed on a sample.
The information provided describes a medical imaging accessory, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Medrad Shoulder Coil is a receive only coil intended to be used with the General Electric Superconducting MRI Scanners. This coil is intended to facilitate complete MR imaging of the shoulder anatomy.
The Medrad Shoulder Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the shoulder anatomy.
The Medrad Shoulder Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.
Product codes
MOS
Device Description
The Medrad Shoulder Coil is a receive only coil designed to enhance the MR Imaging of the shoulder anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR Imaging
Anatomical Site
right or left shoulder anatomy
shoulder anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician who is 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
Not Found
Summary of Performance Studies
A Signal to Noise Ratio(SNR) study was conducted to generate a Signal -To-Noise ratio comparison between the proposed Medrad Shoulder coil and the predicate GE Shoulder Coil.
IMAGE UNIFORMITY - The Medrad Shoulder 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 and sagittal image.
GEOMETRIC DISTORTION: None.
TRANSMIT RF FIELD [B1] DISTORTION - Analysis of the electrical design of the coil and its blocking network demonstrates that no significant currents are induced. No artifacts of any type were observed during imaging.
RESOLUTION, SLICE THICKNESS, AND CONTRAST - These performance parameters are not affected by the use of a surface coil and were not separately tested in the performance evaluation of the proposed Medrad Shoulder Coil.
CLINICAL EVALUATION - Clinical images for the proposed 1.5T Shoulder Coil have been provided with this submission to demonstrate the clinical effectiveness of the Shoulder coils. Based on these results, and the SNR results for the proposed .5T and 1.0T Shoulder coil Coils, Medrad concludes that the proposed .5T and 1.0T Shoulder coil Coils will produce similar clinical image results.
Key Metrics
SIGNAL TO NOISE RATIO (SNR)
IMAGE UNIFORMITY
GEOMETRIC DISTORTION
TRANSMIT RF FIELD [B1] DISTORTION
RESOLUTION, SLICE THICKNESS, AND CONTRAST
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
982916
OCT 2 9 1998
510(k) SUMMARY MEDRAD .5T, 1.0T, 1.5T SHOULDER COILS
| OFFICIAL CONTACT: | Jim Ferguson, Jr.
Sr. Regulatory Affairs Associate
Medrad, Inc.
One Medrad Drive
Indianola, PA 15051
(412) 767-2400 Ext. 3326 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Magnetic Resonance Diagnostic Accessory
[21 CFR 892.1000} |
| COMMON/USUAL NAME: | MR Imaging Surface Coil |
| PROPRIETARY NAME: | Medrad Shoulder Coil |
| PREDICATE DEVICES: | General Electric (GE) Shoulder Coil |
| | |
DEVICE DESCRIPTION:
The Medrad Shoulder Coil is a receive only coil designed to enhance the MR Imaging of the shoulder anatomy.
INTENDED USE:
The Medrad Shoulder Coil is a receive only coil intended to be used with the General Electric Superconducting MRI Scanners. This coil is intended to facilitate complete MR imaging of the shoulder anatomy.
| Anatomical Region: | right or left shoulder anatomy |
|---|---|
| Nuclei Excited: | Hydrogen |
| Diagnostic Uses: | 2D and 3D Imaging |
1
PROPOSED MEDRAD SHOULDER COIL TECHNICAL COMPARISON TO PREDICATE DEVICES:
The following table compares the predicate GE Shoulder Coil and the proposed Medrad Shoulder Coil.
| GE Shoulder Coil
| (K892235) | Medrad Shoulder Coil |
|---|---|
| GE labeling | Medrad labeling |
Medrad was responsible for the design and manufacturing of the predicate device, and will remain responsible for the design and manufacturing for the proposed device. The device will be labeled and marketed as "Medrad Product". This is the only change to the device.
PROPOSED MEDRAD SHOULDER TECHNICAL COMPARISON TO PREDICATE DEVICES:
| Patient contacting materials comparison information | |
|---|---|
| GE Shoulder Coil | Medrad Shoulder Coil |
| Reference K892235 for | |
| material information | All materials used are the |
| same as the GE shoulder | |
| coil. (Predicate device) | |
| Certification: Medrad, Inc. certifies that the patient | |
| contacting materials and formulations for | |
| the proposed Medrad Shoulder Coils are | |
| unchanged from currently marketed | |
| devices. |
2
PERFORMANCE TEST DATA:
SIGNAL TO NOISE RATIO (SNR)
A Signal to Noise Ratio(SNR) study was conducted to generate a Signal -To-Noise ratio comparison between the proposed Medrad Shoulder coil and the predicate GE Shoulder Coil.
IMAGE UNIFORMITY - The Medrad Shoulder 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 and sagittal image.
GEOMETRIC DISTORTION: None. Static magnetic field distortion results from the use of magnetic materials in the construction of a surface coil. This device contains slightly magnetic materials or components. However, such components have been positioned within the surface coil so that no observable distortion of the static magnetic field is present.
TRANSMIT RF FIELD [B1] DISTORTION - Analysis of the electrical design of the coil and its blocking network demonstrates that no significant currents are induced. No artifacts of any type were observed during imaging.
RESOLUTION, SLICE THICKNESS, AND CONTRAST - These performance parameters are not affected by the use of a surface coil and were not separately tested in the performance evaluation of the proposed Medrad Shoulder Coil.
CLINICAL EVALUATION - Clinical images for the proposed 1.5T Shoulder Coil have been provided with this submission to demonstrate the clinical effectiveness of the Shoulder coils. Based on these results, and the SNR results for the proposed .5T and 1.0T Shoulder coil Coils, Medrad concludes that the proposed .5T and 1.0T Shoulder coil Coils will produce similar clinical image results.
CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate GE device (K 892235). Mechanically and electrically the proposed device and the predicate device are identical. This labeling change is the only change to the device. The proposed device is deemed by Medrad to be substantially equivalent.
3
Image /page/3/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 29 1998
Jim Ferguson, Jr. Sr. Regulatory Affairs Associate Medrad, Inc. One Medrad Drive Indianola, PA 15051
Re:
K982916 Medrad Shoulder Coil Dated: August 18, 1998 Received: August 19, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Ferguson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdri/dsmardsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear. Nose and Thros and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1
510(k) NUMBER (IF KNOWN) :
DEVICE NAME: Medrad Shoulder Coil
INDICATIONS FOR USE:
The Medrad Shoulder Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the shoulder anatomy.
The Medrad Shoulder Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) √
OR
Over-The-Counter-Use (Optional Format 1-2-96)
David C. Ingram
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number