SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM

{0}------------------------------------------------ KB1896 Page 1 of 8 Exhibit #3 510 (k) Summary Project #: M0072013Ad # Exhibit #3 510(k) Summary. This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: K131896 - 1. Date of Submission: 06/10/2013 - Sponsor Identification 2. Suzhou Anke Medical System Co., Ltd Building K, 128 Xingpu Road. Suzhou Industrial Park, Jiangsu. 215126, China Establishment Registration Number: Not yet registered Contact Person: Weijie Xia Position: Registration specialist Tel: +86-10-51530223 Fax: +86-512-62956068 Email: xiaweijie@ankemri.com - 3. Submission Correspondent Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net {1}------------------------------------------------ #### Proposed Device Identification 4. Proposed Device Name: SuperVan 1.5T Magnetic Resonance Imaging System Proposed Device Common Name: Magnetic Resonance Imaging System Regulatory Information: Classification Name: system. nuclear magnetic resonance imaging: Classification: II; Product Code: LNH ; Regulation Number: 21 CFR 892.1000; Review Panel: Radiology; ### Intended Use Statement: SuperVan 1.5T Magnetic Resonance Imaging System is a MRI system that produces transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (12) and flow. These images when interpreted by a trained physician, vield information that may assist in diagnosis. - Predicate Device Identification 5. 510(k) Number: K052013 Product Name: ACHIEVA 1.5T & INTERA 1.5T family Manufacturer: Philips Medical Systems Nederland BV #### Device Description 6. The proposed device, SuperVan 1.5T, is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in an open gantry design. It's indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (172) and flow. These images when interpreted by a trained physician, vield information that may assist in diagnosis. The MRI system is composed of magnet. RF Amplifier, Gradient Amplifier, RF Coils. control computer, intercom system and water chiller. The system software, AnkeStation, based on Windows XP E3-2 {2}------------------------------------------------ operating system is an interactive program with user friendly interface. #### 7. Non-Clinical Test Conclusion Non clinical tests were conducted to verily that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1. Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. IEC 60601-1-1:2000. Medical electrical equipment -- Part 1-1: General requirements for salety -Collateral standard: Safety requirements for medical electrical systems. IEC 60601-2-33, Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic. 2002; Amendment 1. 2005. Amendment 2, 2007. IEC 60601-1-2: 2007. Medical Electrical Equipment -Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility -Requirements and Tests. IEC 62366: 2007. Medical devices - Application of usability engineering to medical devices. ISO 10993-1: 2009. Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 150 10993-10:2010. Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. NEMA MS 1-2008, Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging. NEMA MS 2-2008, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images. NEMA MS 3-2008, Determination of Image Uniformity in Diagnostic Resonance Images. NEMA MS 4-2010. Acoustic Noise Measurement Procedure for Diagnosing Magnetic. NEMA MS 5-2010, Determination of Slice Thickness in Diagnostic Resonance Imaging. NEMA MS 6-2008, Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging. NEMA MS 8-2008, Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems. #### 8. Substantially Equivalent (SE) Conclusion The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc. {3}------------------------------------------------ | Item | Proposed Device | Predicate Device | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | Product Code | LNH | Same | | Regulation No. | 21 CFR 892.1000 | Same | | Class | Class II | Same | | Intended Use | SuperVan 1.5T Magnetic Resonance Imaging System<br>is a MRI system that produces transversal, sagittal and<br>coronal and oblique cross-section images of the<br>internal structure of the whole body. The images<br>produced by the SuperVan 1.5T system reflect the<br>spatial distribution of protons (hydrogen nuclei)<br>exhibiting magnetic resonance. The NMR properties<br>that determine the image appearance are proton<br>density, spin-lattice relaxation time (T1), spin-spin<br>relaxation time (T2) and flow. These images when<br>interpreted by a trained physician, yield information<br>that may assist in diagnosis. | Similar | | Installation Type | Fixed | Same | | Magnet Type | Super-conducting | Same | | Field Strength | 1.5T | Same | | Coil | Head coil, neck coil, body coil, knee coil | Similar | | Electrical Safety | Conforms to IEC 60601-1:1988 + A1:1991 + A2:1995.<br>IEC 60601-2-33:2002 + A1:2005 + A2:2007 | Same | | EMC | Conforms to IEC 60601-1-2: 2007 | Same | | Patient Contact | Synthetic resin | Similar | | Material | Acrylic acid lacquer | Same | | Biocompatibility | Conforms to the requirements of ISO 10993 series<br>standards | Same | | Label and Labeling | Conforms to FDA Regulatory Requirements | Same | | Level of Concern of<br>the Software | Moderate | Same | Table 3-1 Comparison of Technology Characteristics The proposed device and predicate devise share same classification and safety characteristics, similar intended use and technical specifications, the difference is too slight, will not affectiveness and safety of proposed device. The proposed device. SuperVan 1.5T Magnetic Resonance Imaging System, is determined to be Substantially Equivalent (SE) to the predicate device, ACHIEVA 1.5T & INTERA 1.5T family (K052013). in respect of safety and effectiveness. {4}------------------------------------------------ # Exhibit #3 510(k) Summary This 510(k) Summary of 510(k) safety and effectivencss information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: ___K131896_ - Date of Submission: 06/10/2013 1. - 2. Sponsor Identification Suzhou Anke Medical System Co., Ltd Building K. 128 Xingpu Road. Suzhou Industrial Park, Jiangsu. 215126, China Establishment Registration Number: Not yet registered Contact Person: Weijie Xia Position: Registration specialist Tel: +86-10-51530223 Fax: +86-512-62956068 Email: xiawcijic@ankemri.com - 3. Submission Correspondent - Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120. China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net {5}------------------------------------------------ - Proposed Device Identification 4. Proposed Device Name: SuperVan 1.5T Magnetic Resonance Imaging System Proposed Device Common Name: Magnetic Resonance Imaging System Regulatory Information: Classification Name: system, nuclear magnetic resonance imaging; Classification: II: Product Code: LNH ; Regulation Number: 21 CFR 892.1000; Review Panel: Radiology; ### Intended Use Statement: SuperVan 1.5T Magnetic Resonance Imaging System is a MRI system that produces transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (II), spin-spin relaxation time (T2) and flow. These images when interpreted by a trained physician. yield information that may assist in diagnosis. - Predicate Device Identification 5. 510(k) Number: K052013 Product Name: ACHIEVA 1.5T & INTERA 1.5T family Manufacturer: Philips Medical Systems Nederland BV #### Device Description 6. The proposed device, SuperVan 1.5T, is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in an open gantry design. It's indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.57 system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (11), spin-spin relaxation time (12) and flow. These images when interpreted by a trained physician, yield information that may assist in diagnosis. The MRI system is composed of magnet. RF Amplifier. RF Coils. console, console, control computer, intercom system and water chiller. The system software, AnkeStation, based on Windows XP E3-2 {6}------------------------------------------------ operating system is an interactive program with user friendly interface. 7. Non-Clinical Test Conclusion > Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: > IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. > IEC 60601-1-1:2000. Medical equipment -- Part 1-1: General requirements for safety -Collateral standard: Safety requirements for medical electrical systems. > IEC 60601-2-33, Medical electrical equipment - Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic. 2002; Amendment 1. 2005, Amendment 2, 2007. > IEC 60601-1-2: 2007, Medical Electrical Equipment -Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility -Requirements and Tests. IEC 62366: 2007, Medical devices - Application of usability engineering to medical devices. ISO 10993-1: 2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity. ISO 10993-10:2010. Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. NEMA MS 1-2008, Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging. NEMA MS 2-2008, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images. NEMA MS 3-2008, Determination of Image Uniformity in Diagnostic Resonance Images. NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic. RDMRTRD 1-2018, Procedure Noise Measurement Procedure for Diagnosing Magnetics. NEMA MS 5-2010, Determination of Slice Thickness in Diagnostic Resonance Imaging. NEMA MS 6-2008, Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging, NEMA MS 8-2008, Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems. #### 8. Substantially Equivalent (SE) Conclusion The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc. {7}------------------------------------------------ | Item | Proposed Device | Predicate Device | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | Product Code | LNH | Same | | Regulation No. | 21 CFR 892.1000 | Same | | Class | Class II | Same | | Intended Use | SuperVan 1.5T Magnetic Resonance Imaging System<br>is a MRI system that produces transversal, sagittal and<br>coronal and oblique cross-section images of the<br>internal structure of the whole body. The images<br>produced by the SuperVan 1.5T system reflect the<br>spatial distribution of protons (hydrogen nuclei)<br>exhibiting magnetic resonance. The NMR properties<br>that determine the image appearance are proton<br>density, spin-lattice relaxation time (T1), spin-spin<br>relaxation time (T2) and flow. These images when<br>interpreted by a trained physician, yield information<br>that may assist in diagnosis. | Similar | | Installation Type | Fixed | Same | | Magnet Type | Super-conducting | Same | | Field Strength | 1.5T | Same | | Coil | Head coil, neck coil, body coil, knee coil | Similar | | Electrical Safety | Conforms to IEC 60601-1:1988 + A1:1991 + A2:1995.<br>IEC 60601-2-33:2002 + A1:2005 + A2:2007 | Same | | EMC | Conforms to IEC 60601-1-2: 2007 | Same | | Patient Contact | Synthetic resin | Similar | | Material | Acrylic acid lacquer | Same | | Biocompatibility | Conforms to the requirements of ISO 10993 series<br>standards | Same | | Label and Labeling | Conforms to FDA Regulatory Requirements. | Same | | Level of Concern of<br>the Software | Moderate | Same | Table 3-1 Comparison of Technology Characteristics The proposed device and predicate devise share classification and safety characteristics, similar intended use and technical specifications, the difference is too slight, will not affectiveness and safety of proposed device. The proposed device. SuperVan 1.5T Magnetic Resonance Imaging System, is determined to be Substantially Equivalent (SE) to the predicate device, ACHIEVA 1.5T & INTERA 1.5T family (K052013), in respect of safety and effectiveness. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 28, 2014 Suzhou Anke Medical Systems Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. BOX 120-119 SHANGHAI 200120 CHINA Re: K131896 Trade/Device Name: Supervan 1.5T Magnetic Resonance Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: January 27, 2014 Received: January 31, 2014 Dear Ms. Hong: 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {9}------------------------------------------------ Page 2-Ms. Hong 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 htm//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/Reportal?roblem/default.html 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.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.html Sincerely yours. - William D. Hara for Janine M: Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K131896 Device Name SuperVan 1.5T Magnetic Resonance Imaging System Indications for Use (Describe) SuperVan 1.57 Magnetic Resonance Imaging System is a MRI system that produces transversal, sagittal and coronal and oblique cross-section images of the internal structure of the images produced by the SuperVan 1.5T1 system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-latice relaxation time (T1), spin-spin relaxation time (T2) and flow. These images when interpreted by a trained physician, yield information that may assist in diagnosis. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure) Michael D. O'Hara This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (1/14)