DUOFLEX COIL SUITE (1.5T)

K130706 · Mr Instruments, Inc. · MOS · Jul 25, 2013 · Radiology

Device Facts

• Record ID: K130706
• Device Name: DUOFLEX COIL SUITE (1.5T)
• Applicant: Mr Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Jul 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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.

Device Story

DuoFLEX Coil Suite consists of three sets of flexible RF coil paddles and a shared preamplifier connector box. Paddles include 24cm square (4-loop), 10cm square (4-loop), and a single rectangular interventional coil. Only one pair of paddles connects to the preamplifier box at a time. Device functions as a receive-only RF coil accessory for 1.5T MRI scanners. Operated by MRI technicians or physicians in clinical imaging environments. Coils are positioned on patient anatomy to capture MR signals; signals are processed by the host MRI system to generate 2D/3D diagnostic images. Provides 1, 5, or 8-channel imaging configurations. Benefits include flexible positioning to accommodate varying patient anatomies, improving image acquisition for diagnostic purposes.

Clinical Evidence

No clinical study performed. Substantial equivalence supported by non-clinical bench testing, including EMC/electrical safety, NEMA MS-1 SNR measurements, image uniformity comparisons, and phantom/cadaver simulated interventional use.

Technological Characteristics

Receive-only RF coil suite. Materials: biocompatible patient-contact materials. Connectivity: proprietary system connector for GE Healthcare 1.5T MRI systems. Configuration: 8-channel preamplifier box with interchangeable paddle sets (24cm, 10cm, and interventional). Standards: IEC 60601-1 (electrical/mechanical safety), NEMA MS-1 (SNR).

Indications for Use

Indicated for use on physician order in conjunction with 1.5T MRI scanners for 2D and 3D imaging; compatible with GE Healthcare MR Systems.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• GE 1.5T 6-Channel Phased Array Flex Coil (K110610)

Submission Summary (Full Text)

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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)) | |
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| Submitter: | MR Instruments, Inc.<br>5610 Rowland Drive, Suite 145<br>Minnetonka, MN 55343 |
| Contact Person: | Robert Beck<br>Director, RA/QA<br>Telephone: [phone]<br>Email: [e-mail] |
| Date Prepared: | December 13, 2012<br>JUL 2 5 2013 |
| Trade Name: | DuoFLEX® Coil Suite, Model FC1500G-8R |
| Common/Usual Name: | Specialty Magnetic Resonance Coil |
| Classification: | 21 CFR 892.1000<br>Magnetic Resonance Diagnostic Device, Class II |
| Product Code: | MOS |
| Manufacturer: | MR Instruments, Inc.<br>5610 Rowland Road, Suite 145<br>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<br>includes three different sets of coil paddles and a single,<br>shared preamplifier box (the "Connector Box") with a system<br>connector. One set of coil paddles is a pair of 24cm square<br>containing four loops/channels per paddle for a total of eight<br>channels for the two paddles. The second set of paddles is a<br>pair of 10cm square containing four loops/channels per<br>paddle for a total of eight channels for the two paddles. The<br>third set of paddles is a single rectangular, interventional coil<br>containing a single planar loop. All of these paddles connect<br>to the same connector box containing eight preamplifiers;<br>only one pair can be connected at a time. The coil design for<br>all of the paddles has the same, simple antennae design and<br>the same system connectivity configuration. The coils can be<br>used in several configurations, including any single coil and<br>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<br>physician in conjunction with a 1.5T MRI scanner, as an accessory<br>to product 2D and 3D images. The DuoFLEX Coil Suite is for use<br>with GE Healthcare MR Systems. |
| Comparison of<br>Technological<br>Characteristics: | Similarities between the subject device and the predicate<br>device are that they are all receive-only RF coils designed to<br>be flexibly positioned on the human anatomy. All devices are<br>designed for ease of positioning to deal with variations<br>between patient anatomies.<br><br>The primary difference is in the number of RF elements.<br><br>The subject device as well as the predicate device uses the<br>same basic technology to perform the same basic function,<br>which is the use of Magnetic Resonance Imaging systems to<br>provide images of various body parts. The GE 1.5T 6-Channel<br>Phased Array Flex Coil (K110610) is designed to be used either<br>as a pair of coils or as a single coil, and is designed to be<br>flexible enough to accommodate itself to various anatomical<br>positions. These same statements can be made for the<br>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:<br>• EMC and electrical safety testing.<br>• Electrical and mechanical safety testing.<br>• System safety testing.<br>• Performance testing with phantoms.<br>• Predicate device comparison tests.<br>• Volunteer scans. |
| Non-Clinical Testing: | Per IEC 60601-1:<br>• Humidity Preconditioning for Dielectric Test<br>• Determination of Accessible Parts<br>• Legibility of Markings<br>• Durability of Markings<br>• Dielectric Strength<br>• Ball Pressure<br>• Creepage Distances and Air Clearance<br>• Surfaces, Corners and Edges<br>• Instability in Transport Position<br>• Instability Excluding Transport<br>• Cleaning, disinfection of ME equipment<br>• Mold Stress Relief<br>• Impact Test<br>• Push Test<br>• Drop test portable ME equipment<br>The following testing has been performed to support substantial<br>equivalence (see Table 9):<br>• Biocompatibility for patient contact materials.<br>• NEMA MS-1 Signal to Noise Ratio.<br>• Image Uniformity Comparison.<br>• Clinical comparison for image quality.<br>• Phantom (cadaver) simulated interventional use.<br>The following quality assurance measures were applied during<br>development of this device (appendices D, F, G): |
| | • Failure Mode Effects Analysis/Hazard Analysis (FMEA).<br>• Design FMEAs for mechanical and RF designs.<br>• Performance Requirements Testing including Final Bench Testing,<br>ISO 60601 Testing, Surface Temperature Testing, SNR per NEMA MS-1 |
| Design Validation | and MS-6, and Image Uniformity.<br>Design validation was performed using the DuoFLEX Coil Suite<br>in actual and simulated use settings. The results support<br>substantial equivalence to both predicate devices and<br>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<br>considered necessary prior to release. Additionally, there was<br>no clinical testing required to support the medical device as<br>the indications for use is equivalent to the predicate device.<br>The substantial equivalence of the device is supported by the<br>non-clinical testing. |
| Conclusion: | We conclude that the results of testing show the DuoFLEX<br>Coil Suite to be substantially equivalent to the predicate<br>devices.<br>The DuoFLEX Coil Suite has the same technological<br>characteristics as the predicate device in that all devices are<br>receive-only RF coils intended for use with MRI equipment.<br>The DuoFLEX Coil Suite has the same intended uses as the<br>predicate devices in that all devices are intended for<br>diagnostic imaging.<br>It has been shown in this 510(k) submission that the<br>differences between the DuoFLEX Coil Suite and the GE 1.5T<br>6-Channel Phased Array Flex Coil (K110610). do not raise any<br>questions regarding safety and effectiveness. The DuoFLEX<br>Coil Suite, as designed and manufactured, is substantially<br>equivalent to, and as safe and effective as, the referenced<br>predicate 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 [phone] or [phone] 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 [phone] or [phone] 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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