(132 days)
GE 1.5T 6-Channel Phased Array Flex Coil (K110610)
Not Found
No
The description focuses on the physical components and functionality of the MRI coil suite, with no mention of AI or ML for image processing or analysis.
No
The device is described as an accessory for a 1.5T MRI scanner to produce 2D and 3D images, which is a diagnostic function, not a therapeutic one.
No
The device is an accessory to an MRI scanner used to produce images, but it does not independently diagnose conditions. Its intended use is to aid in imaging, not to provide diagnostic conclusions.
No
The device description explicitly details physical hardware components including coil paddles, a preamplifier box, and a system connector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "in conjunction with a 1.5T MRI scanner, as an accessory to product 2D and 3D images." This describes a device used for medical imaging, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details different types of coils and a preamplifier box, all components of an MRI system used to acquire images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the DuoFLEX Coil Suite is an accessory for an MRI system, which is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DuoFLEX Coil Suite is indicate for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to product 2D and 3D images. The DuoFLEX Coil Suite is for use with GE Healthcare MR Systems.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The MR Instruments FC1500G-8R DuoFLEX® Coil Suite includes three different sets of coil paddles and a single, shared preamplifier box (the "Connector Box") with a system connector. One set of coil paddles is a pair of 24cm square containing four loops/channels per paddle for a total of eight channels for the two paddles. The second set of paddles is a pair of 10cm square containing four loops/channels per paddle for a total of eight channels for the two paddles. The third set of paddles is a single rectangular, interventional coil containing a single planar loop. All of these paddles connect to the same connector box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 1, 5 or 8 channels for imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following bench testing was conducted on the DuoFLEX Coil Suite:
• EMC and electrical safety testing.
• Electrical and mechanical safety testing.
• System safety testing.
• Performance testing with phantoms.
• Predicate device comparison tests.
• Volunteer scans.
Per IEC 60601-1:
• Humidity Preconditioning for Dielectric Test
• Determination of Accessible Parts
• Legibility of Markings
• Durability of Markings
• Dielectric Strength
• Ball Pressure
• Creepage Distances and Air Clearance
• Surfaces, Corners and Edges
• Instability in Transport Position
• Instability Excluding Transport
• Cleaning, disinfection of ME equipment
• Mold Stress Relief
• Impact Test
• Push Test
• Drop test portable ME equipment
The following testing has been performed to support substantial equivalence (see Table 9):
• Biocompatibility for patient contact materials.
• NEMA MS-1 Signal to Noise Ratio.
• Image Uniformity Comparison.
• Clinical comparison for image quality.
• Phantom (cadaver) simulated interventional use.
The following quality assurance measures were applied during development of this device (appendices D, F, G):
• Failure Mode Effects Analysis/Hazard Analysis (FMEA).
• Design FMEAs for mechanical and RF designs.
• Performance Requirements Testing including Final Bench Testing, ISO 60601 Testing, Surface Temperature Testing, SNR per NEMA MS-1 and MS-6, and Image Uniformity.
Design validation was performed using the DuoFLEX Coil Suite in actual and simulated use settings. The results support substantial equivalence to both predicate devices and demonstrate that the DuoFLEX Coil Suite is safe for its intended use.
This technology is not new, therefore a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing.
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.
GE 1.5T 6-Channel Phased Array Flex Coil (K110610)
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.
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[K130706 · Page 1 of 5
MR Instruments, Inc. Traditional 510(k) Premarket Notification
DuoFLEX® Coil Suite (1.5T) 1500G-8R
510(k) Summary 4
| 510(k) Summary (As required by section 21 CFR 807.92(c)) | |
|---|---|
| Submitter: | MR Instruments, Inc. |
| 5610 Rowland Drive, Suite 145 | |
| Minnetonka, MN 55343 | |
| Contact Person: | Robert Beck |
| Director, RA/QA | |
| Telephone: 952-200-0297 | |
| Email: rbeck@mrinstruments.com | |
| Date Prepared: | December 13, 2012 |
| JUL 2 5 2013 | |
| Trade Name: | DuoFLEX® Coil Suite, Model FC1500G-8R |
| Common/Usual Name: | Specialty Magnetic Resonance Coil |
| Classification: | 21 CFR 892.1000 |
| Magnetic Resonance Diagnostic Device, Class II | |
| Product Code: | MOS |
| Manufacturer: | MR Instruments, Inc. |
| 5610 Rowland Road, Suite 145 | |
| Minnetonka, MN 55343 | |
| Establishment Registration: | 3003852428 |
| Predicate Device: | • GE 1.5T 6-Channel Phased Array Flex Coil (K110610) |
| 510(k) Summary (As required by section 21 CFR 807.92(c)) | |
| Device Description: | The MR Instruments FC1500G-8R DuoFLEX® Coil Suite |
| includes three different sets of coil paddles and a single, | |
| shared preamplifier box (the "Connector Box") with a system | |
| connector. One set of coil paddles is a pair of 24cm square | |
| containing four loops/channels per paddle for a total of eight | |
| channels for the two paddles. The second set of paddles is a | |
| pair of 10cm square containing four loops/channels per | |
| paddle for a total of eight channels for the two paddles. The | |
| third set of paddles is a single rectangular, interventional coil | |
| containing a single planar loop. All of these paddles connect | |
| to the same connector box containing eight preamplifiers; | |
| only one pair can be connected at a time. The coil design for | |
| all of the paddles has the same, simple antennae design and | |
| the same system connectivity configuration. The coils can be | |
| used in several configurations, including any single coil and | |
| any two coils, providing 1, 5 or 8 channels for imaging. | |
| Intended Use | The DuoFLEX Coil Suite is indicate for use on the order of the |
| physician in conjunction with a 1.5T MRI scanner, as an accessory | |
| to product 2D and 3D images. The DuoFLEX Coil Suite is for use | |
| with GE Healthcare MR Systems. | |
| Comparison of | |
| Technological | |
| Characteristics: | Similarities between the subject device and the predicate |
| device are that they are all receive-only RF coils designed to | |
| be flexibly positioned on the human anatomy. All devices are | |
| designed for ease of positioning to deal with variations | |
| between patient anatomies. |
The primary difference is in the number of RF elements.
The subject device as well as the predicate device uses the
same basic technology to perform the same basic function,
which is the use of Magnetic Resonance Imaging systems to
provide images of various body parts. The GE 1.5T 6-Channel
Phased Array Flex Coil (K110610) is designed to be used either
as a pair of coils or as a single coil, and is designed to be
flexible enough to accommodate itself to various anatomical
positions. These same statements can be made for the
DuoFLEX Coil Suite. |
| 510(k) Summary (As required by section 21 CFR 807.92(c)) | |
| Summary of Technical Comparisons | The comparison of the DuoFLEX Coil Suite to the predicate device with respect to intended use, target population, technological characteristics and principles of operation confirms substantial equivalence. The fundamental performance and functional characteristics of the DuoFLEX Coil Suite is very similar to the predicate GE 1.5T 6-Channel Phased Array Flex Coil (K110610). The DuoFLEX Coil Suite includes three sizes of coils that are more flexible than the GE 1.5 6-Channel Phased Array Flex Coil. |
| | The following bench testing was conducted on the DuoFLEX Coil Suite:
• EMC and electrical safety testing.
• Electrical and mechanical safety testing.
• System safety testing.
• Performance testing with phantoms.
• Predicate device comparison tests.
• Volunteer scans. |
| Non-Clinical Testing: | Per IEC 60601-1:
• Humidity Preconditioning for Dielectric Test
• Determination of Accessible Parts
• Legibility of Markings
• Durability of Markings
• Dielectric Strength
• Ball Pressure
• Creepage Distances and Air Clearance
• Surfaces, Corners and Edges
• Instability in Transport Position
• Instability Excluding Transport
• Cleaning, disinfection of ME equipment
• Mold Stress Relief
• Impact Test
• Push Test
• Drop test portable ME equipment
The following testing has been performed to support substantial
equivalence (see Table 9):
• Biocompatibility for patient contact materials.
• NEMA MS-1 Signal to Noise Ratio.
• Image Uniformity Comparison.
• Clinical comparison for image quality.
• Phantom (cadaver) simulated interventional use.
The following quality assurance measures were applied during
development of this device (appendices D, F, G): |
| | • Failure Mode Effects Analysis/Hazard Analysis (FMEA).
• Design FMEAs for mechanical and RF designs.
• Performance Requirements Testing including Final Bench Testing,
ISO 60601 Testing, Surface Temperature Testing, SNR per NEMA MS-1 |
| Design Validation | and MS-6, and Image Uniformity.
Design validation was performed using the DuoFLEX Coil Suite
in actual and simulated use settings. The results support
substantial equivalence to both predicate devices and
demonstrate that the DuoFLEX Coil Suite is safe for its |
| 510(k) Summary (As required by section 21 CFR 807.92(c)) | |
| Clinical Testing: | This technology is not new, therefore a clinical study was not
considered necessary prior to release. Additionally, there was
no clinical testing required to support the medical device as
the indications for use is equivalent to the predicate device.
The substantial equivalence of the device is supported by the
non-clinical testing. |
| Conclusion: | We conclude that the results of testing show the DuoFLEX
Coil Suite to be substantially equivalent to the predicate
devices.
The DuoFLEX Coil Suite has the same technological
characteristics as the predicate device in that all devices are
receive-only RF coils intended for use with MRI equipment.
The DuoFLEX Coil Suite has the same intended uses as the
predicate devices in that all devices are intended for
diagnostic imaging.
It has been shown in this 510(k) submission that the
differences between the DuoFLEX Coil Suite and the GE 1.5T
6-Channel Phased Array Flex Coil (K110610). do not raise any
questions regarding safety and effectiveness. The DuoFLEX
Coil Suite, as designed and manufactured, is substantially
equivalent to, and as safe and effective as, the referenced
predicate device. |
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DuoFLEX® Coil Suite (1.5T) 1500G-8R
MR Instruments, Inc. Traditional 510(k) Premarket Notification
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MR Instruments, Inc. Traditional 510(k) Premarket Notification
DuoFLEX® Coil Suite (1.5T) 1500G-8R
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized representation of the HHS symbol, consisting of three overlapping horizontal lines that curve upwards and to the right. The symbol is black, and the background is white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2013
MR Instruments, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K130706
Trade/Device Name: DuoFLEX Coil Suite (1.5T) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 10, 2013 Received: July 11, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
6
Page 2 - Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K130706
Device Name:
MR Instruments, Inc. DuoFLEX® Coil Suite FC1500G-8R
Indications for Use:
The DuoFLEX Coil Suite is indicate for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to product 2D and 3D images. The DuoFLEX Coil Suite is for use with GE Healthcare MR Systems.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Oft) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) _______________________________________________________________________________________________________________________________________________________________________ K130706_______________________________________________________________________________________________________________________________________________________________________
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