(54 days)
Not Found
No
The summary describes a receive-only MRI coil and its performance characteristics, with no mention of AI or ML technologies.
No
This device is a receive only coil for MRI, used to facilitate imaging; it is not intended for treatment or therapy.
Yes
The device is described as an "MR Imaging" coil intended for use by a "Physician trained in the use of Diagnostic Magnetic Resonance Imaging," directly linking its function to diagnostic processes.
No
The device description explicitly states it is a "receive only coil," which is a hardware component used in MRI systems. The performance studies also focus on hardware characteristics like SNR, image uniformity, and geometric distortion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "receive only coil intended to be used with the General Electric Superconducting MRI Scanners" to "facilitate complete MR imaging of the cervical, thoracic and lumbar regions of the spine". This describes a component used in an imaging system, not a device that performs tests on biological samples outside of the body.
- Device Description: The description reinforces that it's a "receive only coil designed to enhance the MR Imaging".
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a component of an imaging system used to acquire images of the body.
N/A
Intended Use / Indications for Use
The Medrad Quadrature CTL 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 cervical, thoracic and lumbar regions of the spine without need of patient repositioning of the device.
The Medrad Quad CTL Array Coil is a receive only coil intended to be used MRI I he Mediad Quad CTC Anay Coll is a receive and lumbar regions of the spinc anatomy.
The Medrad Quad CTI. Array Coil is intended for use only under the supervision of a The Median Quate Of Prefined of Diagnostic Magnetic Resonance Innaging.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Medrad Quad CTL Array Coil is a receive only coil designed to enhance the MR Imaging of the thoracic and lumbar regions of the spine anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR Imaging
Anatomical Site
cervical, thoracic and lumbar regions of the spine anatomy.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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) - A Signal to Noise Ratio(SNR) study was conducted to generate a Signal -To-Noise ratio of the proposed Medrad 1.0T QUADRATURE CTL ARRAY Coil. Due to the different platforms of the predicated devices, a direct comparison between the proposed device and the predicate devices could not be completed.
IMAGE UNIFORMITY - The Medrad Quad CTL Array 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.
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 Quad CTL Array Coil.
CLINICAL EVALUATION - Clinical images for the proposed 1.0T Quad CTL Array Coil have been provided with this submission to demonstrate the clinical effectiveness of the Quad CTL Array coils. Based on these results, and the SNR results for the proposed 1.0T Quad CTL Array Coils, Medrad concludes that the 0.5T and 1.0T Quad CTL Array Coils will produce similar clinical image results.
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
K 98 4159
JAN 1 2 1999
510(k) SUMMARY MEDRAD 0.5T, 1.0T QUAD CTL 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 Quadrature CTL Array Coil |
| PREDICATE DEVICES: | Hitachi Quad C-Spine
General Electric (GE) Quad T/L with Positioner
Coil
Medrad Phased Array Shoulder Coil |
DEVICE DESCRIPTION:
The Medrad Quad CTL Array Coil is a receive only coil designed to enhance the MR Imaging of the thoracic and lumbar regions of the spine anatomy.
INTENDED USE:
The Medrad Quadrature CTL 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 cervical, thoracic and lumbar regions of the spine without need of patient repositioning of the device.
| Anatomical Region: | cervical, thoracic and lumbar regions of the
spine anatomy. |
|--------------------|----------------------------------------------------------------|
| Nuclei Excited: | Hydrogen |
| Diagnostic Uses: | 2D and 3D Imaging |
1
Proposed Medrad Quad CTL Coil Technical Comparison To Predicate Devices:
The following table compares claims made in regard to the Hitachi Quad C-Spine Coil and the Medrad Quad CTL Coil.
| Hitachi Quad C-Spine
Coil (K954952) | GE Quad T/L w/
Positioner Coil
(K902663) | Medrad PA
Shoulder Coil
(K960901) | Medrad Quad CTL Coil |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Receive-only Quadrature
coil | Receive-only
Quadrature coil | Receive-only,
Phased Array Coil | Receive-only, Phased
Array 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 thoracic
and lumbar regions of
the spine. | N/A | Region of interest includes
the cervical, thoracic, and
lumbar regions of the
spine. |
| The Quad C-Spine Coil is
compatible with the MRH-
1500 and Stratis system
pulse sequences and
imaging options. | The quad T/L w/
Positioner coil is
compatible with all
Signa and Contour
System pulse
sequences and
appropriate imaging
options. | The PA Shoulder coil
is compatible with all
Signa System pulse
sequences and
appropriate imaging
options. | The quad CTL coil is
compatible with all Signa
and Contour 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. | No external tuning, or
matching, is necessary
since the coil is matched
to the recommended
anatomy of interest. |
| The coil plugs into the
system via three BNC
connectors | The coil plugs into a
common slip connector. | The coil uses a
Bendix connector for
the MRI Scanner
interface. | The coil uses a Bendix
connector for the MRI
Scanner interface. |
Proposed Medrad Quad CTL Coil Technical Comparison to Predicate Devices (Cont.):
| Patient contacting materials comparison information | ||
|---|---|---|
| Hitachi Quad C-Spine Coil | GE Quad T/L w/ Positioner Coil | |
| Medrad PA Shoulder Coil | Medrad Quad CTL Coil | |
| The housing material is made | ||
| from Royalite ABS, Fire Rated | ||
| UL94V-0 | The housing material is made from | |
| Royalite ABS, Fire Rated UL94V-0 | The housing material is made | |
| from Polyurethane 30% Glass | ||
| Filled, Fire Rated UL 94.5V | ||
| 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 | |
| Recticel Foam (6 lb. density, Fire Rated | ||
| UL 94V HF1 with a PVC Film vinyl or | ||
| Nylon fire rated cover. | Comfort pad material is made | |
| of Unifoam S82N, Fire Rated | ||
| UL 94 HF-1 with a Nylon cover, | ||
| Fire Rated CPAI-84. |
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 of the proposed Medrad 1.0T QUADRATURE CTL ARRAY Coil. Due to the different platforms of the predicated devices, a direct comparison between the proposed device and the predicate devices could not be completed.
IMAGE UNIFORMITY - The Medrad Quad CTL Array 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.
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 Quad CTL Array Coil.
CLINICAL EVALUATION - Clinical images for the proposed 1.0T Quad CTL Array Coil have been provided with this submission to demonstrate the clinical effectiveness of the Quad CTL Array coils. Based on these results, and the SNR results for the proposed 1.0T Quad CTL Array Coils, Medrad concludes that the 0.5T and 1.0T Quad CTL Array Coils will produce similar clinical image results.
CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate GE and/or Hitachi devices. (K954952, K902663 and K960901) The proposed device is deemed by Medrad to be substantially equivalent.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1999
Jim Ferguson, Jr. Sr. Regulatory Affairs Associate Medrad, Inc. One Medrad Drive Indianola, PA 15051
Re:
Medrad Quadrature CTL Array Coil Dated: November 18, 1998 Received: November 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 legally marketed predicate 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 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 requlatory 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/3/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure.
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Page_1_ of _1
510 (k) NUMBER (IF KNOWN): K 98 4159
Medrad Quad CTL Array Coil DEVICE NAME:
INDICATIONS FOR USE:
The Medrad Quad CTL Array Coil is a receive only coil intended to be used MRI I he Mediad Quad CTC Anay Coll is a receive and lumbar regions of the spinc anatomy.
The Medrad Quad CTI. Array Coil is intended for use only under the supervision of a The Median Quate Of Prefined of Diagnostic Magnetic Resonance Innaging.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
Prescription Use __________ OR Over-The Counter-Use __________
(Per 21 CFR 801.109) (Optional Format 1-2-96)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K984159 |