(14 days)
Not Found
No
The document describes a hardware component (an RF head coil) for an MRI system and does not mention any software or algorithms that would incorporate AI or ML.
No
The device is described as a head coil for a Magnetic Resonance Scanner used to produce images and/or spectra that assist in diagnosis, not to provide therapy.
No
The device is a head coil for an MRI scanner, which produces images. The "Intended Use" states that these images, "when interpreted by a trained physician yield information that may assist in diagnosis," indicating that the device itself does not perform the diagnosis but provides data for a physician to interpret.
No
The device description clearly states it is a multi-channel receive only RF head coil with physical components like RF elements, blocking networks, preamplifiers, and a rigid plastic housing. This indicates it is a hardware device, not software-only.
No, 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, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The MR Instruments MC 3003G-32R Head Coil is a component of a Magnetic Resonance (MR) scanner. It's used to acquire images and/or spectra directly from the patient's head while they are inside the scanner. This is an in vivo process (within the living body).
- Intended Use: The intended use clearly states it's used "in conjunction with a Magnetic Resonance Scanner to produce images and/or spectra of the head." This is about imaging the body directly, not analyzing samples taken from the body.
Therefore, based on the provided information, the device is a component of an MR imaging system used for in vivo diagnostic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MR Instruments MC 3003G-32R Head Coil is to be used in conjunction with a Magnetic Resonance Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
The MR Instruments MC 3003G-32R Head Coil is to be used in conjunction with a GE Signa 3T Excite MR System to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
Product codes
MOS
Device Description
The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 'H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included.
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
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
Design verification and validation testing was performed to ensure that the coil design specifications and customer requirements were met. Testing activities included electrical bench measurements, electrical/mechanical safety tests, system safety and performance tests with phantoms, predicate device comparison tests and volunteer scans. System tests were conducted using the GE Healthcare Signa 3.0T MR System running standard clinical applications.
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.
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Image /page/0/Picture/0 description: The image shows the logo for MR Instruments INC. The logo consists of four stylized letters, "m", "r", "i", and "i", arranged horizontally. Below the letters, the words "MR INSTRUMENTS INC" are printed in a simple sans-serif font. The logo is black and white.
KC72931
Page 1 of 2
MC 3003G-32R Head C
Section 2 - 510(k) Summary and Certification
[As required by 21 CFR 807.92(c)]
1 : .
1. Contact Person
Mark Watson VP, Engineering Tel: (952) 229-8813 Fax: (952) 746-1437
MR Instruments, Inc., Inc. 5610 Rowland Road, Suite 145 Minnetonka, MN 55343
2. General Information
| Name: | MC 3003G-32R Head Coil |
|---|---|
| Trade Name: | MC 3003G-32R Head Coil |
| Common Name: | Head Coil |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Classification: | This device is classified by the Radiology |
| Panel into Class II. (21 CFR 892.1000) |
3. Device Description
The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 'H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included.
The predicate device, manufactured for General Electric Company, Milwaukee, WI (USA) by MRI Devices Corp., HRH-127-8 Head Array for GE Signa 3T Excite MRI System (K024352), is also a multi-channel receive only RF head coil. The MC 3003G-R32's fundamental construction and use of materials (as defined above) is similar to the predicate device. (See Attachment B for device drawings.)
4. Intended Use
The MR Instruments MC 3003G-32R Head Coil is to be used in conjunction with a Magnetic Resonance Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
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Image /page/1/Picture/0 description: The image shows a logo for MR Instruments INC. The logo consists of a stylized, interconnected set of lowercase letters, with the letters "m" and "r" being the most prominent. Below the stylized letters, the words "MR INSTRUMENTS INC" are printed in a simple, sans-serif font.
KC72931
Page 2 of 2
3G-32R Head Coil
MC 3003G-32R He
5. Substantial Equivalence Comparison
The MC 3003G-32R Head Coil is substantially equivalent to the following device with respect to intended use and design:
- t HRH-127-8 Head Array for GE Signa 3T Excite MRI System (K024352) manufactured for General Electric Company (Milwaukee, WI, USA) by MRI Devices, Waukesha WI, U.S.A.
The similarities between the two devices is that they are both multi-channel receive RF only head coils designed to work with the GE Signa 3.0T Excite MRI System. Both coils are similar in size, shape and construction.
The primary difference between the two devices is that the predicate utilizes an 8 element phased array RF structure as opposed to a 32 element phased array RF structure, which may increase coil sensitivity and may reduce data acquisition time.
6. Summary of Studies
Design verification and validation testing was performed to ensure that the coil design specifications and customer requirements were met. Testing activities included electrical bench measurements, electrical/mechanical safety tests, system safety and performance tests with phantoms, predicate device comparison tests and volunteer scans. System tests were conducted using the GE Healthcare Signa 3.0T MR System running standard clinical applications.
7. Conclusion (statement of equivalence)
The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the MC 3003G-32R Head Coil.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human figures, with the figures appearing to be in motion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 2008
MR Instruments, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K072931
Trade Name: MR Instruments MC 3003G-32R Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class II Product Code: MOS Dated: October 15, 2007 Received: October 16, 2007
Dear Mr. Job:
This letter corrects our substantially equivalent letter of October 30, 2007.
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 (PMA), 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.
3
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MC 3003G-32R Head Coil
Indications for Use Statement
Page 1 of 1
The MR Instruments MC 3003G-32R Head Coil is to be used in conjunction with a GE Signa 3T Excite MR System to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
This device is for prescription use.
Lorn Whaz
(Division Sign Off)
(Division'Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MR Instruments, Inc.
: