(27 days)
No
The summary describes a hardware component (an MRI coil) and its physical characteristics and compatibility, with no mention of software algorithms, AI, or ML.
No
The device is a receive-only coil for MR imaging, which is a diagnostic tool, not a therapeutic one. It facilitates imaging but does not treat any condition.
No
This device is a receive-only coil for MRI scanners, which facilitates imaging but does not interpret or diagnose medical conditions itself.
No
The device description explicitly details physical components like a coil, housing material, comfort pads, and cables, indicating it is a hardware device.
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 an MRI system. Its purpose is to receive radiofrequency signals from the patient's body during an MRI scan to create images. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "complete MR imaging... of the intracranial/extracranial, neurovascular, skull base and C-spine regions." This is an imaging procedure performed on the patient, not a test on a sample.
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 Neurovascular Coil is a receive-only coil intended to be used with Siemens 1.5T MRI Scanners. The coil will facilitate complete MR imaging, including spectroscopy, of the intracranial/extracranial, neurovascular, skull base and C-spine regions without moving the patient or the coil; i.e., no scan room intervention.
Product codes
MOS
Device Description
The MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device.
The following comparison tables identify the similarities and differences between the new device and the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging
Anatomical Site
intracranial/extracranial, neurovascular, skull base and C-spine regions
Vertex of the skull to the aortic arch
High resolution Head, Neck, or Head + Neck (Full)
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
Not Found
Key Metrics
Not Found
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
K052827
NOV - 1 2005
510(k) Summary
| OFFICIAL CONTACT: | Lisa A. Ewing
Regulatory Affairs Specialist
MEDRAD, INC.
One Medrad Drive
Indianola, PA 15051
(412) 767-2400 Ext. 3780 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Magnetic Resonance Diagnostic Device
(21 CFR 892.1000, Product Code MOS) |
| COMMON NAME(S): | Magnetic Resonance Coil |
| PROPRIETARY NAME: | MEDRAD 8-Receiver Phased Array
Neurovascular Coil for Siemens |
| PREDICATE DEVICE: | MEDRAD 8-Receiver Phased Array
Neurovascular Coil (K023569) |
| INTENDED USE: | The MEDRAD Phased Array Neurovascular Coil
is a receive-only coil intended to be used with
Siemens 1.5T MRI Scanners. The coil will
facilitate complete MR imaging, including
spectroscopy, of the intracranial/extracranial,
neurovascular, skull base and C-spine regions
without moving the patient or the coil; i.e., no scan
room intervention. |
| | DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE: |
The MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device.
The following comparison tables identify the similarities and differences between the new device and the predicate device.
1
Comparison of MEDRAD 8-Receiver Phased Array Neurovascular Coil for GE (Predicate) and MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens (Proposed)
| Feature | (Predicate)
MEDRAD 8-Receiver Phased
Array Neurovascular Coil for
GE | (Proposed)
MEDRAD 8-Receiver Phased
Array Neurovascular Coil for
Siemens |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Coil Type | Phased array receive-only coil. | Phased array receive-only coil. |
| Region of Interest | Vertex of the skull to the aortic
arch | Vertex of the skull to the aortic
arch |
| Compatibility | All phased array GEMS 1.5T
Signa Excite platforms with 8-
receiver capability. All Signa
system pulse sequences and
appropriate imaging options. | All phased array Siemens 1.5T
platforms with 8-receiver
capability. All Siemens system
pulse sequences and
appropriate imaging options. |
| Tuning | 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. |
| System Connection | Coil plugs into the GE MRI
system by way of the phased
array quick disconnect port. | Coil plugs into the Siemens MRI
system by way of cable sockets
in the patient table. |
| Imaging
Configurations | High resolution head, parallel
imaging Fast Brain,
Neurovascular, C-Spine (user
optional), Volume Neck (user
optional), high resolution Head
and C-Spine (user optional) | High resolution Head, Neck, or
Head + Neck (Full), depending
on user-selected coil elements |
Comparison of Patient-Contacting Materials in MEDRAD 8-Receiver Phased Array Neurovascular Coil for GE (Predicate) and MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens (Proposed)
| | (Predicate)
MEDRAD 8-Receiver Phased
Array Neurovascular Coil for
GE | (Proposed)
MEDRAD 8-Receiver Phased
Array Neurovascular Coil for
Siemens |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Housing | Housing material is made from
polyurethane; fire rated UL 94V-0 | Housing material is made from
polyurethane; fire rated UL 94V-0 |
| Comfort pad,
positioning pads,
knee pad | Comfort, positioning and knee
pad material is made from
polyurethane foam sprayed with
a Guardian coating and is fire
rated to C-117 | Comfort, positioning and knee
pad material is made from
polyurethane foam sprayed with
a Guardian coating and is fire
rated to C-117 |
| Table pad | N/A | Table pad material is made from
Ethylene Vinyl Acetate foam
sprayed with a Guardian coating
and is fire rated to C-117 |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Public Health Service
NOV - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa A. Ewing Regulatory Affairs Specialist Medrad, Inc. One Medrad Drive INDIANOLA PA 15051-0780 Re: K052827
Trade/Device Name: MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 4, 2005 Received: October 7, 2005
Dear Ms. Ewing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
Device Name:
MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens
Indications for Use:
The MEDRAD Phased Array Neurovascular Coil is a receive-only coil intended to be used with Siemens 1.5T MRI Scanners. The coil will facilitate complete MR imaging, including spectroscopy, of the intracranial/extracranial, neurovascular, skull base and C-spine regions without moving the patient or the coil; i.e., no scan room intervention.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lygum
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
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