(56 days)
Not Found
No
The summary describes a passive hardware component (a receive-only coil) for MR imaging and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on hardware characteristics like SNR, uniformity, and distortion.
No.
Explanation: The device is designed to enhance MR Imaging for diagnostic purposes, not to provide therapy or treatment.
Yes
The device is an MR imaging coil, and the intended use states it is "designed to enhance the MR Imaging of the head and neck anatomy" and is for use by a "physician who is trained in the field of Diagnostic Resonance Imaging," indicating its role in diagnostic imaging.
No
The device description explicitly states it is a "phased array coil," which is a hardware component used in MR imaging. 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:
- 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 Neurovascular Coil is a component used in Magnetic Resonance (MR) Imaging. It is a receive-only coil designed to enhance the quality of MR images of the head and neck.
- Lack of Biological Sample Analysis: The device does not analyze biological samples. Its function is to improve the signal reception during an imaging procedure performed directly on the patient.
Therefore, the device's purpose and mechanism of action do not align with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medrad Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck anatomy.
The Medrad Quadrature CTL Coil is a receive only coil intended to be used with the General Electric Superconducting MRI Scanners. This coil will facilitate complete MR imaging of the intracranial/extracranial Neurovascular, skull base and C-Spine without need for repositioning the coil on the patient.
The Medrad Phased Array Neurovascular Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Medrad Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR Imaging
Anatomical Site
head and neck anatomy, intracranial/extracranial Neurovascular, skull base and C-Spine, top of the brain to the aortic arch
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
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 1.5T PHASED ARRAY NEUROVASCULAR Coil and the predicate Neurovascular device.
IMAGE UNIFORMITY - The Medrad PHASED ARRAY NEUROVASCULAR coil was evaluated using NEMA Standards to characterize the uniformity of the proposed coil. Contours of the images obtained with the coil were constructed for the axial image, sagittal image and coronal images.
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 PHASED ARRAY NEUROVASCULAR.
CLINICAL EVALUATION - Clinical images for the proposed 1.5T PHASED ARRAY NEUROVASCULAR have been provided with this submission to demonstrate the clinical effectiveness of the PHASED ARRAY Neurovascular.
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 1.5T PHASED ARRAY NEUROVASCULAR COIL
| 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 Phased Array Neurovascular Coil |
| PREDICATE DEVICES: | Medrad Neurovascular Coil
Medrad Phased Array Shoulder Coil |
DEVICE DESCRIPTION:
The Medrad Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck 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 will facilitate complete MR imaging of the intracranial/extracranial Neurovascular, skull base and C-Spine without need for repositioning the coil on the patient.
| Anatomical Region: | intracranial/extracranialNeurovascular, skull
base and C-Spine |
|--------------------|-------------------------------------------------------------------|
| Nuclei Excited: | Hydrogen |
| Diagnostic Uses: | 2D and 3D Imaging |
1
510(k) Summary Medrad PHASED ARRAY NEUROVASCULAR Page 2 of 3
Proposed Medrad 1.5T Neurovascular Array Coil Technical Comparison To Predicate Device:
The following table compares claims made in regard to the Medrad 1.5T Neurovascular Coil to the Medrad 1.5T Neurovascular Array Coil
| Medrad 1.5T
Neurovascular Coil
(K981094) | Medrad Phased Array
Shoulder Coil (K960901) | Medrad 1.5T Neurovascular
Array Coil |
|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Quadrature Transmit-
Receive Coil | Phased Array Receive-Only
Coil | Phased Array Receive-only
Quadrature coil. |
| Region of interest covers
the top of the brain to the
aortic arch. | *N/A | Region of interest covers the
top of the brain to the aortic
arch. |
| The Neurovascular coil is
compatible with all Signa
System pulse sequences
and appropriate imaging
options. | *N/A | The Neurovascular Array coil is
compatible with all 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. | *N/A | No external tuning, or
matching, is necessary since
the coil is matched to the
recommended anatomy of
interest. |
| The coil plugs into the MRI
System by way of the Head
Coil quick disconnect port | *N/A | The coil plugs into the MRI
System by way of the Phased
Array quick disconnect port |
- This predicate device is being used to substantiate the technology equivalence to the proposed device only.
Proposed Medrad 1.5T Neurovascular Array Coil Technical Comparison to Predicate Devices (Cont.):
| Patient contacting materials comparison information | |
|---|---|
| Medrad 1.5T Neurovascular Coil | Medrad 1.5T Neurovascular Array Coil |
| The housing material is made from Glass | |
| Filled Polyester; Fire Rated UL 94V-0 | The housing material is made from Glass |
| Filled Polyester; Fire Rated UL 94V-0 and | |
| Kydex, Fire Rated UL 94V-0 | |
| Comfort pad material is made with a | |
| Buellidyne coating and are fire rated UL-94 | |
| HFI. | Comfort Pad material is made with a cotton |
| material embedded with urethane and is fire | |
| rated to CAL 117 |
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 1.5T PHASED ARRAY NEUROVASCULAR Coil and the predicate Neurovascular device.
IMAGE UNIFORMITY - The Medrad PHASED ARRAY NEUROVASCULAR coil was evaluated using NEMA Standards to characterize the uniformity of the proposed coil. Contours of the images obtained with the coil were constructed for the axial image, sagittal image and coronal images.
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 PHASED ARRAY NEUROVASCULAR.
CLINICAL EVALUATION - Clinical images for the proposed 1.5T PHASED ARRAY NEUROVASCULAR have been provided with this submission to demonstrate the clinical effectiveness of the PHASED ARRAY Neurovascular.
CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate Medrad devices. (K960901, K981094) The proposed device is deemed by Medrad to be substantially equivalent.
3
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 25 1999
Jim Ferguson, Jr. Sr. Regulatory Affairs Associate Medrad, Inc. One Medrad Drive Indianola, PA 15051-0780
Re:
Medrad 1.5T Phased Array Neurovascular Coil Dated: November 25, 1998 Received: November 30, 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). 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.qov/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
4
INDICATION FOR USE
510(k) Number:_ K984257
Medrad 1.5T Phased Array Neurovascular Coil Device Name:
Indications for Use/Intended Use:
The Medrad Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck anatomy.
The Medrad Phased Array Neurovascular 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)
David C. Seggern
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D
510(k) Number K984257
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)