IMRIS ONCOLOGY PACKAGE

{0}------------------------------------------------ K121997 ## IMRIS AUG 1 0 2012 510(k) Summary for Oncology Package ### 510(k) SUMMARY FOR IMRIS ONCOLOGY PACKAGE (As required by 21 CFR 807.92) #### 1. GENERAL INFORMATION Establishment: IMRIS Inc. Address: 100-1370 Sony Place Winnipeg, Manitoba Canada, R3T 1N5 3003807210 Registration Number: Mr. Sanjay Shah Contact Person: QA and Regulatory Engineer Email: sshah@imris.com Phone: 1-204-480-7070 Fax: 1-204-480-7071 Date of Summary July 23, 2012 Preparation: Device Name / Trade name IMRIS Oncology Package Classification Name: Magnetic resonance diagnostic device. Classification Panel: Radiology Classification (CFR section): 21 CFR 892.1000 Class: Class II Product Code: LNH ### 2. PREDICATE DEVICES The IMRIS Oncology Package is substantially equivalent to the following predicate medical devices. | NAME OF THE DEVICE | 510(K) NUMBER | DATE OF<br>CLEARANCE | MANUFACTURER | |-------------------------------|---------------|----------------------|---------------------------| | MR Radiation Oncology Options | K102155 | August 31, 2010 | GE Medical System,<br>LLC | {1}------------------------------------------------ ## IMBIS ### 510(k) Summary for Oncology Package ### 3. DEVICE DESCRIPTION The IMRIS Oncology Package provides an additional patient tabletop (MR SIMS table top) that can be used with IMRIS Neuro 1.5T / Siemens MAGNETOM 1.5T MRI scanners for radiation therapy planning. The MR SIMS table top allows patients to be imaged on a flat surface that matches the imaging patient position. The oncology package includes Head and Neck coil (HNC150) and Pelvic coil (PCC 150). Used in the IMRISneuro 1.5Tsystem/Siemens MAGNETOM 1.5 Tesla, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal, and oblique images of the internal structures of the head, neck and pelvic regions. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The IMRIS HNC150 and PCC150 coils can also be used as standard diagnostic head coils and pelvic coil respectively for diagnostic examinations. The Oncology package may be used with MR-conditional/ MR safe patient immobilization accessories to assist in consistent positions throughout multiple imaging sessions. ### 4. INDICATION FOR USE The IMRIS Oncology package uses the IMRISneuro family of Intra-operative MRI systems /Siemens MAGNETOM MR systems indicated for use as a diagnostic imaging device that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that display the internal structure and / or function of the entire body, including, but not limited to head, neck, and pelvis regions. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician vield information that may assist in diagnosis. The IMRIS Oncology Package provides an additional patient tabletop for IMRIS MR systems /Siemens MAGNETOM that allows patients to be imaged on a flat surface. The flat patient surface enables IMRIS MR system/Siemens MAGNETOM to acquire images in patient positions similar to other modalities that also utilize a flat patient surface such as X-ray. CT, PET and radiation therapy. The IMRIS MR systems/Siemens MAGNETOM MR systems with IMRIS Oncology Package may also be used with MR safe/MR conditional patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions. | Characteristic | GE MR Radiation Oncology Options | IMRIS Oncology Package | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA 510(k) # | K102155 | Current Submission | | Manufactured<br>by | GE Medical Systems, LLC | IMRIS Inc. | | Intended use<br>/Indications for<br>use | The MR Radiation Oncology Options<br>are a patient positioning package<br>intended for use with the GE wide bore<br>MR Scanners. The MR Radiation<br>Oncology Options when used with a<br>GE wide bore MR scanner is a whole<br>body magnetic resonance scanner<br>designed to support high resolution, | The IMRIS Oncology package<br>uses the IMRISneuro family of<br>Intra-operative MRI<br>systems/Siemens MAGNETOM<br>MR systems indicated for use as<br>a diagnostic imaging device that<br>produce transverse, sagittal,<br>coronal and oblique cross | | | | 510(k) Summary for Oncology Package | | | high signal-to-noise ratio and short<br>scan times. The GE wide bore MR<br>scanners with MR Radiation Oncology<br>Options are indicated for use as a<br>diagnostic imaging device to provide<br>axial, sagittal, coronal, and oblique<br>images, spectroscopic images, and/or<br>spectra, dynamic images of the internal<br>structures and organs of the entire<br>body, including but not limited to head,<br>neck, TMJ, spine, breast, heart,<br>abdomen, pelvis joints, prostate, blood<br>vessels, and musculoskeletal regions<br>of the body. The images produced by<br>the GE wide bore scanners with MR<br>Radiation Oncology Options reflect the<br>spatial distribution of protons (hydrogen<br>nuclei) exhibiting magnetic resonance.<br>These images and/or spectra when<br>interpreted by a trained physician yield<br>information that may assist in<br>diagnosis.<br>The MR Radiation Oncology Options<br>include a removable patient table insert<br>for GE wide bore MR scanners that<br>allow patients to be imaged on a flat<br>surface. The flat patient surface allows<br>image acquisition in patient positions<br>similar to other modalities that also use<br>a flat patient surface such as X-Ray,<br>CT, PET, and radiation therapy.<br>The GE wide bore MR scanners with<br>the MR Radiation Oncology Options<br>may also be used with MR- compatible<br>patient positioning and immobilization<br>accessories to assist in obtaining<br>consistent patient positions throughout<br>multiple imaging sessions. | sectional images, spectroscopic<br>images and / or spectra, and<br>that display the internal<br>structure and / or function of the<br>entire body, including, but not<br>limited to head, neck, and pelvis<br>regions. Depending on the<br>region of interest, contrast<br>agents may be used. These<br>images and / or spectra when<br>interpreted by a trained<br>physician yield information that<br>may assist in diagnosis.<br>The IMRIS Oncology Package<br>provides an additional patient<br>tabletop for IMRIS MR<br>systems/Siemens MAGNETOM<br>that allows patients to be<br>imaged on a flat surface. The<br>flat patient surface enables<br>IMRIS MR system/Siemens<br>MAGNETOM to acquire images<br>in patient positions similar to<br>other modalities that also utilize<br>a flat patient surface such as X-<br>ray, CT, PET and radiation<br>therapy.<br>The IMRIS MR<br>systems/Siemens MAGNETOM<br>MR systems with IMRIS<br>Oncology Package may also be<br>used with MR safe/MR<br>conditional patient positioning<br>and immobilization accessories<br>to assist in obtaining consistent<br>patient positions throughout<br>multiple imaging sessions. | | Where used | Hospital Diagnostic room | Hospital Diagnostic room | | Anatomical<br>sites | Entire body, including but not limited to<br>head, neck, TMJ, spine, breast, heart,<br>abdomen, pelvis joints, prostate, blood<br>vessels, and musculoskeletal regions<br>of the body | Entire body, including, but not<br>limited to head, neck, and pelvis<br>regions | ### 5. COMPARISION TO PREDICATE DEVICES {2}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ K121997 . : {3}------------------------------------------------ K12/997 ## IMRIS ### 510(k) Summary for Oncology Package 6. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE: (807.92 (A) (6)) . | Characteristic | GE MR Radiation Oncology<br>Options | IMRIS Oncology Package | Comparison | |--------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------| | FDA 510(k) # | K102155 | Current Submission | | | | MR-SIM table Top and S Frame mask adaptor | | | | | MR radiation oncology<br>position insert | MR-SIM table top and S-<br>frame adaptor | | | MRI system<br>Compatibility | GE 1.5T MRI scanners | Siemens MAGNETOM 1.5T<br>MRI systems IMRIS 1.5T<br>MRI systems | Same field<br>Strength<br>1.5Tesla | | Surface | Flat Surface | Flat Surface | Same | | | Mobile patient table top with<br>embedded high-density,<br>posterior RF coil array | Table top with cavity allows<br>mounting of posterior coils | Similar<br>design | | Material | Fiber glass with foam core | Acetal | Different | | MRI safety | MR compatible | MR safe | Same | | S-Frame and mask<br>connecting with<br>table top | Yes | Yes | Same | | IEC 60601-1<br>compliance | Yes | Yes | Same | | Head and Neck Coil (HNC 150) | | | | | | GE head and neck coil (6-<br>channel flex coil) | IMRIS Head and neck<br>coil (HNC150) | Comparison | | MRI system<br>Compatibility | GE 1.5T MRI Scanners | Siemens 1.5T MRI<br>scanners<br>IMRIS 1.5T MRI system | Same field<br>strength -<br>1.5T MRI<br>Scanners | | Coil Type | Receive-only six channel<br>phased array coil | Receive-only eighteen<br>channel phased array coil | Similar | | RF Cable Interface | Interface Cable with<br>Insulated Cable Traps | Interface Cable with<br>Insulated Cable Traps | Same | | Tune and Match | No tune, no match | No tune, no match | Same | | Safety features | Active and Passive<br>Decoupling | Active and Passive<br>Decoupling | Same | | | | RF Fuse | New | | Coil Enclosure<br>Material and design | Vinyl coating closed cell<br>foam | Vinyl coating closed cell<br>foam | Same | . . {4}------------------------------------------------ ## K121997 # IMRIS 510(k) Summary for Oncology Package | Characteristic | GE MR Radiation Oncology Options | IMRIS Oncology Package | Comparison | |---------------------------------------|-------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------| | FDA 510(k) # | K102155 | Current Submission | | | | Flexible | Flexible | Same | | IEC 60601-1 Compliance | Yes | Yes | Same IEC<br>standards | | Pelvic Coil (PCC 150) | | | | | | GEM anterior array coil<br>GEM posterior array coil | IMRIS Pelvic coil<br>(PCC150) | Comparison | | MRI system Compatibility | GE 1.5T MRI Scanners | Siemens 1.5T MRI<br>Scanners<br>IMRIS 1.5T MRI system | Same field<br>strength -<br>1.5T MRI<br>Scanners | | Coil Type | Receive-only up to 36<br>channel phased array coil | Receive-only eleven<br>channel phased array coil | Similar | | System connection | The coil plugs into the MRI<br>System | The coil plugs into the MRI<br>System | Same | | RF Cable Interface | Interface Cable with<br>Insulated Cable Traps | Interface Cable with<br>Insulated Cable Traps | Same | | Tune and Match | No tune, no match | No tune, no match | Same | | Safety features | Active and Passive<br>Decoupling | Active and Passive<br>Decoupling | Same | | | | RF Fuse | New | | Coil Enclosure<br>Material and design | Plastic, Vinyl coated closed<br>cell foam<br>Flexible | Plastic, Vinyl coated<br>closed cell foam<br>Flexible | Same | | IEC 60601-1<br>Compliance | Yes | Yes | Same | . : : · {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '121997'. The numbers are written in a simple, slightly slanted style, and the overall impression is that of a quickly jotted down code or identifier. # IMRIS 510(k) Summary for Oncology Package ### 7. SUMMARY OF NON-CLINICAL DATA ### Design Verification and Validation Test (Bench Testing) The IMRIS Oncology Package passed the following tests and meets product specifications. IMRIS has performed a number of V&V tests. The main tests include - IEC 60601-1 compliance . - . IEC 60601-2-33 compliance - Clinical image comparison . - MRI compatibility test (MR image artifacts test, MR heating test), . - Surface heating (normal and single fault conditions) . - Single fault condition unplugged (passive detuning test) . - Workflow . - Loading test . - The Head and Neck coil (HNC150) and Pelvic coil (PCC 150) Image Non-Uniformity and . SNR was measured and is reported in accordance with NEMA MS 9-2008 Characterization of Special Purpose Coils for Diagnostic Resonance Images. The NEMA MS 9-2008 references the ALTERNATE MEASUREMENT PROCEDURE as described in NEMA MS 6-2008. The oncology package is tested for electrical, mechanical, and flammability hazards. The IMRIS Oncology package complies with voluntary standards (IEC 60601-2-33, and UL 94). The Oncology Package provided clinical images which demonstrate the clinical effectiveness of the Oncology package. The HNC 150 and PCC 150 coils are tested for MR image artifacts and surface heating test. The HNC 150 and PCC 150 coils SNR and Image non-uniformity are tested according to NEMA standards. The tests outlined above have been executed with acceptable results. Performance data demonstrate safety and effectiveness of the IMRIS Oncology Package. ### 8. CONCLUSION The IMRIS Oncology Package has the same intended use and indications for use as the predicate devices. Performance data demonstrate safety and effectiveness of the IMRIS Oncology Package with the new characteristics. The IMRIS Oncology Package verification results and performance/safety standard results show that the device is safe and effective and substantially equivalent to the currently available predicate device, GE MR Radiation Oncology options. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three curved lines representing its wings or body. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 —AUG—1-0—2012— ### Mr. Sanjay Shah QA and Regulatory Engineer IMRIS Inc. 100-1370 Sony Place WINNIPEG MANITOBA R3T 1N5 CANADA . Re: K121997 Trade/Device Name: IMRIS Oncology Package Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and MOS Dated: July 4, 2012 Received: July 9, 2012 ### Dear Mr. Shah: 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 11 your dowled to the birting 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 r lease of actived and I Drimination that your device complies with other requirements of the Act that 1 Dr Has Intact a and regulations administered by other Federal agencies. You must or any I vatual 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 {7}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice mourements 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 will anow you to oogin finding of substantial equivalence of your device to a legally marketed nothleation. THE FDTS imanly of tication 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-GFR-Parts 801-and If you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5-150. Thise, productions are veganding the reporting the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Tou may other bates generational 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, Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ### Indications for Use | 510(k) Number (if known): | <121997 | |---------------------------|---------| |---------------------------|---------| . Device. Name: IMRIS Oncology Package -Indications for Use: - The IMRIS Oncology package uses the IMRISneuro family of Intra-operative MRI systems/Siemens MAGNETOM MR systems indicated for use as a diagnostic imaging device that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that display the internal structure and / or function of the entire body, including, but not limited to head, neck, and pelvis regions. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The IMRIS Oncology Package provides an additional patient tabletop for IMRIS MR systems /Siemens MAGNETOM that allows patients to be imaged on a flat surface. The flat patient surface enables IMRIS MR system/Siemens MAGNETOM to acquire images in patient positions similar to other modalities that also utilize a flat patient surface such as X-ray, CT, PET and radiation therapy. The IMRIS MR systems/Siemens MAGNETOM MR Systems with IMRIS Oncology Package may also be used with MR safe/MR conditional patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions. 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 Diagnostic Devices (OIVD) (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number K121997 IMRIS Oncology package 510(k) Premarket Notification Page 1 of 1