(71 days)
No
The device description and performance studies focus on the physical characteristics and signal acquisition capabilities of an MRI coil, with no mention of AI or ML for image processing or analysis.
No
The device is described as a "receive only coil" intended for "MR imaging," which is a diagnostic procedure, not a therapeutic one.
Yes
The device is an MRI coil, which is a component used with MRI scanners. MRI scanners are diagnostic imaging devices used to produce images of the body for medical diagnosis. The "intended use" section explicitly states that the coil is "intended to facilitate complete MR imaging" and is for use "under the supervision of a physician who is trained in the field of Diagnostic Magnetic Resonance Imaging," confirming its role in diagnostic procedures.
No
The device is described as a "receive only coil" and includes details about its physical construction (housing material, comfort pad material, connector type), indicating it is a hardware component used in conjunction with an MRI scanner.
Based on the provided information, the Medrad Quad C-Spine Coil is not an In Vitro Diagnostic (IVD) device.
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 about a person's health. This testing is done outside of the body (in vitro).
- Medrad Quad C-Spine Coil Function: The description clearly states that this device is a "receive only coil intended to be used with the General Electric Superconducting MRI Scanners." It's a component of an MRI system used for imaging the human body directly. It does not process or analyze specimens taken from the body.
The device is a medical device used for diagnostic imaging, but it falls under the category of in vivo diagnostic devices (used within the living body) rather than in vitro diagnostic devices.
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 area superior to the sella turcica and inferior to the third thoracic vertabrae. Included is the brachial plexus region, nerve roots and CSF
The Medrad Quad C-Spine Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the Area superior to the top of the sella turcica and inferior to the third thoracic vertebra
The Medrad Quad C-Spine Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Magnetic Resonance Imaging.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The Medrad Quad C-Spine Coil is a receive only coil designed to enhance the MR lmaging of the area superior to the top of the sella turcica and inferior to the third thoracic vertabrae. Included is the brachial plexus region, nerve roots and CSF.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR Imaging
Anatomical Site
The area superior to the top of the sella turcica and inferior to the third thoracic vertabrae. Included is the brachial plexus region, nerve roots and CSF
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
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 Quad C-Spine coil and the predicate Hitachi Quad C-Spine (K954952) and the General Electric Linear C-Spine (K884369).
IMAGE UNIFORMITY - The Medrad Quad C-Spine 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 maqnetic 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 - Images were obtained for the proposed Medrad Shoulder Coil. The clinical images of the predicate devices may be found in their respective 510(k) submissions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Quad C-Spine coil and the predicate Hitachi Quad C-Spine (K954952) and the General Electric Linear C-Spine (K884369).
IMAGE UNIFORMITY: The Medrad Quad C-Spine 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: No significant currents induced, no artifacts observed.
RESOLUTION, SLICE THICKNESS, AND CONTRAST: Not affected by the surface coil, not separately tested.
CLINICAL EVALUATION: Images were obtained for the proposed Medrad Shoulder Coil. The clinical images of the predicate devices may be found in their respective 510(k) submissions.
CONCLUSION: The proposed device is deemed by Medrad to be substantially equivalent.
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
510(k) SUMMARY MEDRAD 1.0T, 1.5T QUAD C-SPINE 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 Quad C-Spine Coil |
| PREDICATE DEVICES: | General Electric (GE) Linear C-Spine
Hitachi Quad C-Spine Coil |
| DEVICE DESCRIPTION: | |
The Medrad Quad C-Spine Coil is a receive only coil designed to enhance the MR lmaging of the area superior to the top of the sella turcica and inferior to the third thoracic vertabrae. Included is the brachial plexus region, nerve roots and CSF.
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 area superior to the sella turcica and inferior to the third thoracic vertabrae. Included is the brachial plexus region, nerve roots and CSF
| Anatomical Region: | The area superior to the top of the sella turcica
and inferior to the third thoracic vertabrae.
Included is the brachial plexus region, nerve
roots and CSF |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nuclei Excited: | Hydrogen |
| Diagnostic Uses: | 2D and 3D Imaging |
1
Proposed Medrad Quad C-Spine Coil Technical Comparison To Predicate Devices:
The following table compares the predicate GE Linear C-Spine Coil, the Hitachi 1.5T Quad C-Spine Coil and the proposed Medrad Quad C-Spine Coil.
| GE Linear C-Spine Coil
(K884369) | Hitachi Quad C-Spine Coil
(K954952) | Medrad Quad C-Spine Coil |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Receive-only linear coil. | Receive-only Quadrature coil | Receive-only Quadrature
coil. |
| Region of interest includes
the area superior to the top
of the sella turcica and
inferior to the third thoracic
vertebrae. Included is the
brachial plexus region, nerve
roots and CSF. | Region of interest includes
the area superior to the top
of the sella turcica and
inferior to the third thoracic
vertebrae. Included is the
brachial plexus region, nerve
roots and CSF. | Region of interest includes
the area superior to the top
of the sella turcica and
inferior to the third thoracic
vertebrae. Included is the
brachial plexus region, nerve
roots and CSF. |
| The linear C-Spine coil is
compatible with all GE Signa
System pulse sequences and
appropriate imaging options. | The Quad C-Spine Coil is
compatible with the MRH-
1500 and Stratis system
pulse sequences and
imaging options. | The Quad C-Spine coil is
compatible with all GE Signa
System pulse sequences and
appropriate imaging options. |
| No external tuning, or
matching, is necessary since
the coil is matched to the
recommended anatomy of
interest. | No external tuning, or
matching, is necessary since
the coil is matched to the
recommended anatomy of
interest. | No external tuning, or
matching, is necessary since
the coil is matched to the
recommended anatomy of
interest. |
| The coil plugs into a common
slip connector. | The coil plugs into the
system via three BNC
connectors | The coil plugs into a common
slip connector. |
Proposed Medrad Quad C-Spine Coil Technical Comparison to Predicate Devices (Cont.):
| Patient contacting materials comparison information | ||
|---|---|---|
| GE Linear C-Spine Coil | Hitachi Quad C-Spine Coil | Medrad Quad C-Spine Coil |
| The housing material is made from Royalite ABS, Fire Rated UL 94V-0 | The housing material is made from Royalite ABS, Fire Rated UL 94V-0 | The housing material is made from Royalite ABS, Fire Rated UL 94V-0 |
| Comfort pad material is made of Unifoam S82N, Fire Rated UL 94 HF-1 with a PVC Film vinyl film fire rated cover. | Comfort pad material is made of Unifoam S82N, Fire Rated UL 94 HF-1 with a PVC Film vinyl film fire rated cover. | Comfort pad material is made of Unifoam S82N, Fire Rated UL 94 HF-1 with a PVC Film vinyl film fire rated cover. |
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 Quad C-Spine coil and the predicate Hitachi Quad C-Spine (K954952) and the General Electric Linear C-Spine (K884369).
IMAGE UNIFORMITY - The Medrad Quad C-Spine 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 maqnetic 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 - Images were obtained for the proposed Medrad Shoulder Coil. The clinical images of the predicate devices may be found in their respective 510(k) submissions.
CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate devices. (K884369 and K954952). The proposed device is deemed by Medrad to be substantially equivalent.
3
Image /page/3/Picture/0 description: The image shows a logo and the words "DEPARTMENT OF". The logo is on the left side of the image and consists of three curved lines. The text is on the right side of the image and is in a bold, sans-serif font. The text is aligned to the left and is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1998 NOV
Jim Ferguson, Jr. Sr. Regulatory Affairs Associate Medrad, Inc. One Medrad Drive Indianola, PA 15051
Re:
Medrad Quad C-Spine Coil Dated: August 21, 1998 Received: August 24, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
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 probibitions 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 Fecteral 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/cdrividsmarcain.html"
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) NUMBER (IF KNOWN): K98 2959
DEVICE NAME: ______________________________________________________________________________________________________________________________________________________________________________
INDICATIONS FOR USE:
The Medrad Quad C-Spine Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the Area superior to the top of the sella turcica and inferior to the third thoracic vertebra
The Medrad Quad C-Spine Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Magnetic Resonance Imaging.
本
(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 b. Srymm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number