(27 days)
Not Found
No
The description focuses on the hardware components of the head coil and its performance in terms of signal-to-noise ratio and image quality, with no mention of AI or ML algorithms for image processing or interpretation.
No
The device is used to produce images and/or spectra that assist in diagnosis, not to provide therapy.
No
Explanation: The device is a coil for MRI scanners, which produces images and/or spectra of the head. These images, when interpreted by a trained physician, may assist in diagnosis. The device itself does not provide a diagnosis; it is a component of an imaging system used to acquire data that aids in diagnosis.
No
The device description clearly outlines physical hardware components (RF elements, preamplifiers, coil housing, head support/base) and the performance studies involve electrical bench measurements and physical testing, 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 medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states this device is a "Head Coil" used in conjunction with MRI systems to "produce images and/or spectra of the head." This is an imaging device that interacts with the patient's body directly, not with a specimen taken from the body.
- Intended Use: The intended use is to "produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis." This describes an imaging process for diagnostic purposes, not an in vitro test.
Therefore, this device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This coil is indicated for use in conjunction with a Magnetic Resonance Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician vield information that may assist in diagnosis.
Product codes
MOS
Device Description
The MC 1504G-16R (1.5T) and MC 3004G-16R (3.0T) Head Coils are multi-channel receive only coils consisting of 16 RF elements. Each RF element has active and passive blocking networks, and integrated preamplifiers. The MC 1504G-16R RF elements are tuned to 'H at 1.5T (63.9 MHz), while the MC 3004G-16R RF elements are tuned to 'H at 3.0T (127.8 MHz). The coil housing is constructed out of a rigid plastic with an opening for patient viewing and comfort; the head support/base is included with each coil assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / 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
Volunteer scans were performed with the proposed and predicate devices to acquire paired images using routine clinical scan sequences. Scan images were then reviewed in blind fashion by registered technologists in magnetic resonance to demonstrate equivalence in resulting image quality.
Summary of Performance Studies
Non-Clinical Testing:
Electrical bench measurements were performed to ensure proper assembly, function and tuning to established specifications.
Electrical/mechanical device safety and system safety (phantoms) testing were conducted in accordance with IEC 60601-1.
Performance evaluations (phantoms) were completed using the proposed and predicate devices with comparative signal-to-noise (SNR) measurements based on NEMA MS-1.
Volunteer scans were performed with the proposed and predicate devices to acquire paired images using routine clinical scan sequences. Scan images were then reviewed in blind fashion by registered technologists in magnetic resonance to demonstrate equivalence in resulting image quality. All system testing was conducted using 1.5T and 3.0T Magnetic Resonance Scanner systems running standard clinical applications.
Clinical Testing:
No additional clinical evaluations of the head coil devices for this use have been conducted.
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
MAR 2 9 2011
KII0691
r '/3
510(k) Summary (As required by section 21 CFR 807.92(c))
| Contact: | MR Instruments, Inc.
Joshua J. Holwell
Chief Operating Officer
Telephone: 952-746-1435 x326 / Fax: 952-746-1437
Email: jholwell@mrinstruments.com |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 7, 2011 |
| Product Trade Name: | MC 1504G-16R, 1.5T, 16-Channel Head Coil
MC 3004G-16R, 3.0T, 16-Channel Head Coil |
| Common/Usual Name: | Head Coil / Brain Coil |
| Classification Name: | Magnetic Resonance Diagnostic Device, Class II
(21 CFR 892.1000, Product Code MOS) |
| Predicate Device: | HRH-63-8, 1.5T, 8-Channel Head Array,
MRI Devices (K013159) |
| | HRH-127-8, 3.0T, 8-Channel Head Array,
MRI Devices (K022372) |
| Manufacturer: | MR Instruments, Inc.
5610 Rowland Road, Suite 145
Minnetonka, MN 55343 |
Establishment Registration: 3003852428
1
Device Description:
The MC 1504G-16R (1.5T) and MC 3004G-16R (3.0T) Head Coils are multi-channel receive only coils consisting of 16 RF elements. Each RF element has active and passive blocking networks, and integrated preamplifiers. The MC 1504G-16R RF elements are tuned to 'H at 1.5T (63.9 MHz), while the MC 3004G-16R RF elements are tuned to 'H at 3.0T (127.8 MHz). The coil housing is constructed out of a rigid plastic with an opening for patient viewing and comfort; the head support/base is included with each coil assembly.
Statement of Intended Use:
This coil is indicated for use in conjunction with a Magnetic Resonance Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician vield information that may assist in diagnosis.
Summary of Technological Characteristics in Comparison to the Predicate Device:
The MC 1504G-16R (1.5T) and MC 3004G-16R (3.0T) Head Coils are substantially equivalent to the MRI Devices HRH-63-8, 1.5T (K013159) and HRH-127-8, 3.0T (K022372) Head Arrays, respectively.
The proposed and predicate devices are both multi-channel RF receive only head coils that utilize phased array technology. Additionally, both the proposed and predicate devices are designed to work in conjunction with a Magnetic Resonance Scanner, and have similar size, shape and construction.
The primary difference between the proposed and predicate devices is that the predicate utilizes an 8 element phased array RF structure as opposed to a 16 element phased array RF structure. The use of additional elements may increase coil sensitivity and reduce data acquisition time.
Summary of Non-Clinical Testing:
Design verification and validation testing was performed to ensure that the coil design specifications and customer requirements were met.
Electrical bench measurements were performed to ensure proper assembly, function and tuning to established specifications.
Electrical/mechanical device safety and system safety (phantoms) testing were conducted in accordance with IEC 60601-1.
Performance evaluations (phantoms) were completed using the proposed and predicate devices with comparative signal-to-noise (SNR) measurements based on NEMA MS-1.
2
Volunteer scans were performed with the proposed and predicate devices to acquire paired images using routine clinical scan sequences. Scan images were then reviewed in blind fashion by registered technologists in magnetic resonance to demonstrate equivalence in resulting image quality.
All system testing was conducted using 1.5T and 3.0T Magnetic Resonance Scanner systems running standard clinical applications.
Summary of Clinical Testing:
No additional clinical evaluations of the head coil devices for this use have been conducted.
Conclusions:
The MC 1504G-16R (1.5T) and MC 3004G-16R (3.0T) Head Coils are substantially equivalent to the MRI Devices HRH-63-8, 1.5T (K013159) and HRH-127-8, 3.0T (K022372) Head Arrays, respectively.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MR Instruments, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
MAR 2 9 2011
Re: K110591
Trade/Device Name: MR Instruments, Inc., MC 1504G-16R, 1.5T, 16 Channel Head Coil; MC 3004G-16R, 3.0T, 16 Channel Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 16, 2011 Received: March 17, 2011
Dear Mr. Job:
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
4
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.html 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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address . http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): __
Device Name:
MR Instruments, Inc. MC 1504G-16R, 1.5T, 16-Channel Head Coil MC 3004G-16R, 16-Channel Head Coil
MC 3004G-16R, 3.0T, 16-Channel Head Coil
Indications for Use:
This coil is indicated for use in conjunction with 1.5T and 3.0T GE Healthcare Magnetic
interpreted for use in conjunction with 1.5T and 3.0T spectre of the free Resonal and Scated for tse in conjunction with 1.5T and 3.0T GE Healthcare Magnetic
Resonance Scanner systems to produce images and/or spectra of the head, that when the submit wanner bystems to produce images and/or spectra of the head.
interpreted by a trained physician yield information that may assist in diagnosis.
Prescription Use _ × (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 In Vitro Diagnostic Devices Evaluation (OIVD)
Mung S. Patil
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_ રી જિલ્લા
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