(274 days)
Not Found
No
The summary describes a passive hardware component (a receive-only coil) for an MRI system and contains no mention of AI, ML, image processing, or software-based analysis.
No
The device is a receive-only coil for MRI, used to facilitate imaging (diagnosis), not to treat conditions.
Yes
The device is explicitly stated to be used for "complete MR imaging of the intracranial/extracranial neurovasculature and skull base" and its use is indicated for a "physician or certified MR technologist who is trained in the field of Diagnostic Resonance Imaging." This directly implies its role in diagnostic procedures.
No
The device description explicitly states it is a "receive-only coil," which is a hardware component used in MRI systems.
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 description clearly states that this device is a "receive-only phased-array head coil" used with an MRI scanner. Its purpose is to facilitate the imaging of anatomical structures within the body (intracranial/extracranial neurovasculature and skull base).
- No Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on materials taken from the body. It is a component of an imaging system that interacts with the patient's body directly to acquire image data.
Therefore, this device falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners. The coil is intended to facilitate complete MR imaging of the intracranial/extracranial neurovasculature and skull base.
The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil and is indicated for use only under the supervision of a physician or certified MR technologist who is trained in the field of Diagnostic Resonance Imaging.
Product codes
MOS
Device Description
The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
intracranial/extracranial neurovasculature and skull base.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician or certified MR technologist 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and validation testing was performed as part of product development and in response to risk analysis. Analysis of the collective set of data led to the conclusion that the MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is substantially equivalent to the predicate device for its intended use when used as prescribed in the User Manual.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 description: The image shows a logo for "MR Medical Solutions". The text is in a sans-serif font and is arranged in a stacked format. The logo also includes a stylized atom symbol, which is placed to the right of the word "Solutions". The background of the logo has a textured appearance.
SUMMARY OF SAFETY AND EFFECTIVENESS
AUG 3 1 2010
Submitter's Name: Submitter's Address: Telephone number: Fax number: Official Correspondent: Date:
MR Medical Solutions 310 Vista Park Drive, Pittsburgh PA 15205 412-787-3454 412-787-3490 Fahad Alradady November 13, 2009
Trade/Proprietary Name: Common Name: Classification Number:
1.5 Tesla 16-Channel Receive-only Phased-array Head Coil for Siemans MR Imaging Surface Coil 21 CFR 892.1000
Predicate Device:
1.5 Tesla 8-Receiver Neurovascular Coil, 510(k) number K023596
Substantial Equivalence: The information provided in this premarket notification demonstrates that the proposed device, the MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array, Head Coil, is substantially equivalent to a legally marketed predicate device, the Medrad 1.5 Tesla 8-Receiver Neurovascular Coil, when the Medrad device images a subset of the bodily regions it is intended to image; the proposed MR Medical Solutions device images the (a) Intracranial/extracranial neurovasculature and (b) skull base, whereas the predicate device images the (a) intracranial neurovasculature, (b) skull base and (c) C-spine.
The MR Medical Solutions device (1) maintains the same intended use for imaging the intracranial/extracranial neurovasculature and skull base of the predicate device, (2) has similar operational parameters, (3) has similar labeling and (4) is used in a manner similar to the predicate device.
The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners. The predicate device is a receive-only coil intended to be used with General Electric MRI Superconducting Scanner Systems.
Like the predicate device, the proposed device is indicated to be used only under the supervision of a physician or certified MR technologist who is trained in the field of Diagnostic Magnetic Resonance Imaging. Both devices are designed to be used with similar scanners for imaging similar regions of the body without moving the patient or the coil. No scan room intervention is required.
MR Medical Solutions has established, as part of its Quality System, design controls in compliance with FDA's Quality System Regulations (QSRs). These design controls were applied to the development of the 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil and meet the requirements of the FDA's QSRs. Design verification and validation testing was performed as part of product development and in response to risk analysis.
Analysis of the collective set of data led to the conclusion that the MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is substantially equivalent to the predicate device for its intended use when used as prescribed in the User Manual.
A comparison of features and principles of operation between the proposed device and predicate device is provided in the following table.
1
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.
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J ( - - - -
Image /page/1/Picture/1 description: The image shows handwritten text on a white background. The first line reads "KC93689", which appears to be a code or identification number. The second line reads "P. Z SF2", which could be initials followed by a combination of letters and numbers.
| | Predicate:
Medrad 1.5 Tesla 8-Receiver
Neurovascular Coil
(K023596) | Proposed:
1.5 Tesla 16-Channel Receive-
only Head Coil |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Feature | | |
| Coil Type | Phased Array Receive-Only Coil | Phased Array Receive-Only Coil |
| Region of Interest | Vertex of the skull to the aortic
arch | Head and base of skull |
| Compatibility | All phased array GEMS 1.5T
Signa Excite platforms with 8-
Receiver capability. All Signa
System pulse sequences and
appropriate imaging options. | 1.5 Tesla Siemens Medical
Systems MRI Scanner |
| 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 imaging the head and
skull base. |
| System connection | The coil plugs into the MRI
System by way of the Phased
Array quick disconnect port | The coil plugs into the MRI System
by way of the Phased Array quick
disconnect port. |
| Imaging configurations | High resolution Head, Parallel
imaging Fast Brain,
Neurovasculature, C-Spine (user
optional), Volume Neck (user
optional), High resolution Head
and C-Spine (user optional) | High resolution of Head and skull
base, and Parallel Imaging Fast
Brain. |
| Patient-contacting-materials comparison information | ||
|---|---|---|
| Feature | Medrad 1.5 Tesla 8-Receiver | |
| Neurovascular Coil | 1.5 Tesla 16-Channel Receive- | |
| only Head Coil | ||
| Housing materials | Polyurethane; Fire rated UL | |
| 94V-0 | Polycarbonate; Fire rated UL 94V- | |
| 0 | ||
| Comfort pad | Cotton material embedded with | |
| urethane and fire rated to CAL |
- | Cotton material embedded with
urethane and fire rated to CAL - |
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling human figures or birds in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Fahad Alradady President and CEO MR Medical Solutions LLC 310 Vista Park Drive PITTSBURG PA 15205
AUG 3 1 2010
Re: K093689
Trade/Device Name: 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil for Siemens Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 12, 2010 Received: August 12, 2010
Dear Mr. Alradady:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts-800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Amell Jt. R
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K693689
Device Name: 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil for Siemens
Indications for Use:
The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners. The coil is intended to facilitate complete MR imaging of the intracranial/extracranial neurovasculature and skull base.
The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a receive-only coil and is indicated for use only under the supervision of a physician or certified MR technologist who is trained in the field of Diagnostic Resonance Imaging.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
19368 1 cat
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Beview Evaluation (ODE) OLV
(Division Sign-Off) Division of Radiological Devices on of Hadlological Devices
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