(132 days)
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.
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.
The DuoFLEX® Coil Suite (1.5T) 1500G-8R is a specialty magnetic resonance coil used in conjunction with a 1.5T MRI scanner to produce 2D and 3D images. The device is intended for use with GE Healthcare MR Systems and is classified as a Class II medical device (21 CFR 892.1000).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Summary) |
|---|---|
| EMC and electrical safety | Testing conducted. Results support substantial equivalence. |
| Electrical and mechanical safety | Testing conducted. Results support substantial equivalence. |
| System safety | Testing conducted. Results support substantial equivalence. |
| Performance testing with phantoms | Testing conducted. Results support substantial equivalence. |
| Predicate device comparison tests | Testing conducted. Results support substantial equivalence. |
| Volunteer scans | Testing conducted. Results support substantial equivalence. |
| IEC 60601-1 standards | All specified tests conducted (humidity preconditioning, accessible parts, markings legibility/durability, dielectric strength, ball pressure, creepage distances, surfaces/corners/edges, instability in transport/excluding transport, cleaning/disinfection, mold stress relief, impact test, push test, drop test). Results support substantial equivalence. |
| Biocompatibility | Testing conducted for patient contact materials. Results support substantial equivalence. |
| NEMA MS-1 Signal to Noise Ratio | Testing conducted. Results support substantial equivalence. |
| Image Uniformity Comparison | Testing conducted. Results support substantial equivalence. |
| Clinical comparison for image quality | Testing conducted. Results support substantial equivalence. |
| Phantom (cadaver) simulated interventional use | Testing conducted for interventional usage. Results support substantial equivalence. |
| FMEA/Hazard Analysis | Conducted 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. |
2. Sample Size Used for the Test Set and Data Provenance
The documentation provided does not specify a distinct "test set" in the context of a clinical study or a separate dataset for evaluating an AI algorithm. The device is a hardware component (MRI coil), and its performance was primarily evaluated through non-clinical testing including bench tests, phantom studies, and volunteer scans. The exact number of volunteers or phantoms used for these tests is not specified, nor is the country of origin of the data. Given the nature of a 510(k) for a device like an MRI coil, the focus is on engineering and performance validation rather than large-scale clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. As per the submission, "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." Therefore, there was no "test set" in the sense of a clinical image dataset requiring expert-established ground truth for performance evaluation against a diagnostic standard. The "clinical comparison for image quality" described in the non-clinical testing refers to an evaluation of the images produced by the coil, not a diagnostic accuracy study.
4. Adjudication Method for the Test Set
Not applicable. As explained in point 3, there was no clinical study with a test set requiring adjudication in the context of diagnostic accuracy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission explicitly states that "This technology is not new, therefore a clinical study was not considered necessary prior to release." The device is an accessory to an MRI scanner, and its equivalence was demonstrated through non-clinical performance and safety testing compared to a predicate device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is an MRI coil, which is a hardware component, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance evaluation focuses on the engineering and image acquisition capabilities of the coil.
7. Type of Ground Truth Used
For the non-clinical testing, the "ground truth" was established through:
- Engineering specifications and regulatory standards: for electrical safety, EMC, mechanical properties, and compliance with IEC 60601-1.
- Physical measurements: for SNR (NEMA MS-1 and MS-6) and image uniformity.
- Visual assessment: for image quality (clinical comparison for image quality, volunteer scans, and phantom/cadaver studies), likely made by engineers or experienced MRI operators, comparing the new device's output to established benchmarks or the predicate device's output.
8. Sample Size for the Training Set
Not applicable. This device is a hardware component and does not involve AI algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
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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 145Minnetonka, MN 55343 |
| Contact Person: | Robert BeckDirector, RA/QATelephone: 952-200-0297Email: rbeck@mrinstruments.com |
| Date Prepared: | December 13, 2012JUL 2 5 2013 |
| Trade Name: | DuoFLEX® Coil Suite, Model FC1500G-8R |
| Common/Usual Name: | Specialty Magnetic Resonance Coil |
| Classification: | 21 CFR 892.1000Magnetic Resonance Diagnostic Device, Class II |
| Product Code: | MOS |
| Manufacturer: | MR Instruments, Inc.5610 Rowland Road, Suite 145Minnetonka, 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 Suiteincludes three different sets of coil paddles and a single,shared preamplifier box (the "Connector Box") with a systemconnector. One set of coil paddles is a pair of 24cm squarecontaining four loops/channels per paddle for a total of eightchannels for the two paddles. The second set of paddles is apair of 10cm square containing four loops/channels perpaddle for a total of eight channels for the two paddles. Thethird set of paddles is a single rectangular, interventional coilcontaining a single planar loop. All of these paddles connectto the same connector box containing eight preamplifiers;only one pair can be connected at a time. The coil design forall of the paddles has the same, simple antennae design andthe same system connectivity configuration. The coils can beused in several configurations, including any single coil andany two coils, providing 1, 5 or 8 channels for imaging. |
| Intended Use | The DuoFLEX Coil Suite is indicate for use on the order of thephysician in conjunction with a 1.5T MRI scanner, as an accessoryto product 2D and 3D images. The DuoFLEX Coil Suite is for usewith GE Healthcare MR Systems. |
| Comparison ofTechnologicalCharacteristics: | Similarities between the subject device and the predicatedevice are that they are all receive-only RF coils designed tobe flexibly positioned on the human anatomy. All devices aredesigned for ease of positioning to deal with variationsbetween patient anatomies.The primary difference is in the number of RF elements.The subject device as well as the predicate device uses thesame basic technology to perform the same basic function,which is the use of Magnetic Resonance Imaging systems toprovide images of various body parts. The GE 1.5T 6-ChannelPhased Array Flex Coil (K110610) is designed to be used eitheras a pair of coils or as a single coil, and is designed to beflexible enough to accommodate itself to various anatomicalpositions. These same statements can be made for theDuoFLEX 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 equipmentThe following testing has been performed to support substantialequivalence (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 duringdevelopment 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 Suitein actual and simulated use settings. The results supportsubstantial equivalence to both predicate devices anddemonstrate 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 notconsidered necessary prior to release. Additionally, there wasno clinical testing required to support the medical device asthe indications for use is equivalent to the predicate device.The substantial equivalence of the device is supported by thenon-clinical testing. |
| Conclusion: | We conclude that the results of testing show the DuoFLEXCoil Suite to be substantially equivalent to the predicatedevices.The DuoFLEX Coil Suite has the same technologicalcharacteristics as the predicate device in that all devices arereceive-only RF coils intended for use with MRI equipment.The DuoFLEX Coil Suite has the same intended uses as thepredicate devices in that all devices are intended fordiagnostic imaging.It has been shown in this 510(k) submission that thedifferences between the DuoFLEX Coil Suite and the GE 1.5T6-Channel Phased Array Flex Coil (K110610). do not raise anyquestions regarding safety and effectiveness. The DuoFLEXCoil Suite, as designed and manufactured, is substantiallyequivalent to, and as safe and effective as, the referencedpredicate device. |
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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.
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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
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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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§ 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.