Achieva 1.5T, 3.0T and Intera 1.5T MR Systems

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. Philips Medical Systems Nederland B.V. Susan Quick Regulatory Affairs Specialist 595 Miner Road Cleveland, Ohio 44143 June 4, 2019 Re: K190461 Trade/Device Name: Achieva 1.5T, 3.0T and Intera 1.5T MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: April 29, 2019 Received: April 30, 2019 Dear Susan Quick: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use ## 510(k) Number (if known) ## K190461 Device Name Achieva 1.5T, 3.0T and Intera 1.5T MR Systems #### Indications for Use (Describe) Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent. The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition. and synchronize with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user. In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with R Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------|--| | <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | | | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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. 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Magnetic Resonance Imaging Abbreviated 510(k) K190461 # Achieva 1.5T, 3.0T and Intera 1.5T MR Systems Section 5 510(k) Summary {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue letters. ## 510(k) Summary of Safety and Effectiveness ## K190461 This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. | Date Prepared: | February 25, 2019 | | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | Manufacturer: | Philips Medical Systems Nederland B.V.<br>Veenpluis 4-6, 5684 PC, Best, The Netherlands<br>Establishment Registration Number: 3003768277 | | | Primary Contact<br>Person: | Jan van de Kerkhof<br>Sr. Manager Regulatory Affairs<br>Phone: +31 613300542<br>E-mail: jan.van.de.kerkhof@philips.com | | | Secondary Contact<br>Person | Susan Quick<br>Regulatory Affairs Specialist<br>Telephone: 440 869-4612<br>E-mail: susan.quick@philips.com | | | Device Name: | Achieva 1.5T, 3.0T and Intera 1.5T MR Systems | | | Classification: | Classification name: Magnetic Resonance Diagnostic Device (MRDD)<br>Classification Regulation: 21CFR 892.1000<br>Classification Panel: Radiology<br>Device Class: Class II<br>Primary Product Code: 90LNH<br>90LNI | | | Primary Predicate<br>Device: | Trade name: Achieva, Intera & Panorama 1.0T R2.5<br>Manufacturer: Philips Medical Systems Nederland B.V.<br>510(k) Clearance: K063559<br>Classification Regulation: 21CFR 892.1000<br>Classification name: Magnetic Resonance Diagnostic Device (MRDD)<br>Classification Panel: Radiology<br>Device class Class II<br>Product Code: 90LNH<br>90LNI | | | 1st Reference<br>Device: | Trade name: Ingenia, Ingenia CX, Ingenia Elition, and Ingenia<br>Ambition<br>Manufacturer: Philips Medical Systems Nederland B.V.<br>510(k) Clearance: K183063<br>Classification Regulation: 21CFR 892.1000<br>Classification name: Magnetic Resonance Diagnostic Device (MRDD)<br>Classification Panel: Radiology<br>Device class Class II | | | | Product Code: | 90LNH | | | | 90LNI | | 2nd Reference<br>Device: | Trade name: | Achieva R4 1.5T and Achieva R4 3.0T (aka Ingenia) | | | Manufacturer: | Philips Medical Systems Nederland B.V. | | | 510(k) Clearance: | K110151 | | | Classification Regulation: | 21CFR 892.1000 | | | Classification name: | Magnetic Resonance Diagnostic Device (MRDD) | | | Classification Panel: | Radiology | | | Device class | Class II | | | Product Code: | 90LNH | | | | 90LNI | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The font is sans-serif and appears to be a standard typeface. | Device Description: | This submission covers the proposed Achieva 1.5T, Achieva 3.0T, and the<br>Intera 1.5T MR Systems R5.6, hereafter to be known as Achieva 1.5T, 3.0T,<br>and Intera 1.5T MR Systems. The proposed Achieva 1.5T, 3.0T, and Intera<br>1.5T MR Systems are 60 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T)<br>Magnetic Resonance Diagnostic Devices. This submission of the proposed<br>Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems contains a description of the<br>software and hardware modifications made since the last 510(k) clearance of the<br>primary predicate Achieva, Intera & Panorama 1.0T R2.5 (K063559,<br>01/04/2007). The Achieva 1.5T and Intera 1.5T systems differ in outside covers<br>only, both systems function in an identical manner.<br><br>The proposed Achieva 1.5T, 3.0T and Intera 1.5T MR Systems are<br>substantially equivalent to the primary predicate Achieva, Intera & Panorama<br>1.0T R2.5 (K063559, 01/04/2007), and the 1st legally marketed reference device<br>Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition (K183063,<br>02/14/2019) and the 2nd legally marketed reference device Achieva R4 1.5T and<br>Achieva R4 3.0T (aka Ingenia, K110151, 03/22/2011).<br><br>The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems are intended to<br>be marketed with the following pulse sequences and coils that were previously<br>cleared by FDA:<br>1. mDIXON (K102344)<br>2. SWIp (K131241)<br>3. mDIXON-Quant (K133526)<br>4. MRE (K140666)<br>5. mDIXON XD (K143128)<br>6. O-MAR (K143253)<br>7. MultiBand SENSE (K143606)<br>8. 3D APT (K172920)<br>9. Achieva and Intera Coils | |--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: | The indications for use of the proposed Achieva 1.5T, 3.0T and Intera 1.5T MR<br>Systems adds more detail to the primary predicate Achieva, Intera & Panorama<br>1.0T R2.5 (K063559, 01/04/2007) indications for use statement for clarity and is | | | currently cleared with the 1st legally marketed reference device Ingenia, Ingenia<br>CX, Ingenia Elition, and Ingenia Ambition (K183063, 02/14/2019). | | | Philips Magnetic Resonance (MR) systems are Medical Electrical Systems<br>indicated for use as a diagnostic device. | | | This MR system enables trained physicians to obtain cross-sectional images,<br>spectroscopic images and/or spectra of the internal structure of the head, body or<br>extremities, in any orientation, representing the spatial distribution of protons or<br>other nuclei with spin. | | | Image appearance is determined by many different physical properties of the<br>tissue and the anatomy, the MR scan technique applied, and presence of contrast<br>agents. The use of contrast agents for diagnostic imaging applications should be<br>performed consistent with the approved labeling for the contrast agent. | | | The trained clinical user can adjust the MR scan parameters to customize image<br>appearance, accelerate image acquisition, and synchronize with the patient's<br>breathing or cardiac cycle. | | | The systems can use combinations of images to produce physical parameters,<br>and related derived images. Images, spectra, and measurements of physical<br>parameters, when interpreted by a trained physician, provide information that may<br>assist diagnosis and therapy planning. The accuracy of determined physical<br>parameters depends on system and scan parameters, and must be controlled and<br>validated by the clinical user. | | | In addition the Philips MR systems provide imaging capabilities, such as MR<br>fluoroscopy, to guide and evaluate interventional and minimally invasive<br>procedures in the head, body and extremities. | | | MR Interventional procedures, performed inside or adjacent to the Philips MR<br>system, must be performed with MR Conditional or MR Safe instrumentation as<br>selected and evaluated by the clinical user for use with the specific MR system<br>configuration in the hospital. The appropriateness and use of information from a<br>Philips MR system for a specific interventional procedure and specific MR system<br>configuration must be validated by the clinical user. | | Design Features/<br>Fundamental<br>Scientific<br>Technology: | The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems are based on<br>the principle that certain atomic nuclei present in the human body will emit a weak<br>relaxation signal when placed in a strong magnetic field and excited by a radio<br>signal at the precession frequency. The emitted relaxation signals are analyzed<br>by the system and a computed image reconstruction is displayed on a video<br>screen. | | | The principal technological components (magnet, transmit body coil, gradient<br>coil, receive coils and patient support) of the proposed Achieva 1.5T, 3.0T, and<br>Intera 1.5T MR Systems are identical to those used in the primary predicate<br>Achieva, Intera & Panorama 1.0T R2.5 (K063559, 01/04/2007), and the 2nd<br>legally marketed reference device Achieva R4 1.5T and Achieva R4 3.0T (aka<br>Ingenia, K110151, 03/22/2011). | | | The proposed Achieva 1.5T, 3.0T and Intera 1.5T MR Systems includes proposed software feature additions and modifications that were made to the primary predicate Achieva, Intera & Panorama 1.0T R2.5 (K063559, 01/04/2007). All software additions and modifications are cleared with previous 510K)s or with the 1st legally marketed reference device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition (K183063, 02/14/2019). | | | Based on the information provided, the proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems do not raise different questions of safety and effectiveness compared to the primary predicate Achieva, Intera & Panorama 1.0T R2.5 (K063559, 01/04/2007). | | Summary of Non-Clinical<br>Performance Data: | The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems comply with the following international and FDA-recognized consensus standards:<br>IEC 62304 Edition 1 ISO 14971 Edition 2 Device specific guidance document, entitled "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices" (issued November 18, 2016 – document number 340) Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005 – document number 337) Guidance for Industry and FDA Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014 - document number 1825) Guidance for Industry and FDA Staff Applying Human Factors and Usability Engineering to Medical Devices (issued February 3, 2016 – document number 1757) Guidance for Industry and FDA Staff – Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016 – document number 1811) Guidance for Industry and FDA Staff - Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (issued July 11, 2016 - document number 1400057) Guidance for Industry and FDA Staff Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices (issued September 6, 2017 – document number 1500015) Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results.<br>The verification and/or validation test results demonstrate that the proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems:<br>Comply with the aforementioned international and FDA recognized consensus standards and Device specific guidance document, entitled "Guidance for the Submission Of Premarket Notifications for Magnetic | | | • Meet the acceptance criteria and is adequate for its intended use. | | | Therefore, the proposed <b>Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems</b> are<br>substantially equivalent to the primary predicate Achieva, Intera & Panorama 1.0T<br>R2.5 (K063559, 01/04/2007) in terms of safety and effectiveness. | | Summary of<br>Clinical Data: | The proposed <b>Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems</b> did not require<br>a clinical study since substantial equivalence to the primary predicate device was<br>proven with the verification/validation testing. | | Substantial<br>Equivalence: | The proposed <b>Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems</b> and the<br>primary predicate Achieva, Intera & Panorama 1.0T R2.5 (K063559, 01/04/2007)<br>and the 1st legally marketed reference device Ingenia, Ingenia CX, Ingenia<br>Elition, and Ingenia Ambition (K183063, 02/14/2019) have the same indications<br>for use with respect to the following: | | | • Providing cross-sectional images based on the magnetic resonance<br>phenomenon<br>• Interpretation of the images is the responsibility of trained physicians<br>• Images can be used for interventional and treatment planning purposes | | | The proposed <b>Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems</b> are substantially<br>equivalent to the primary predicate Achieva, Intera & Panorama 1.0T R2.5<br>(K063559, 01/04/2007) and the 1st legally marketed reference device Ingenia,<br>Ingenia CX, Ingenia Elition, and Ingenia Ambition (K183063, 02/14/2019) and the<br>2nd legally marketed reference device Achieva R4 1.5T and Achieva R4 3.0T (aka<br>Ingenia, K110151, 03/22/2011) in terms of design features, fundamental scientific<br>technology, indications for use, and safety and effectiveness. | | Conclusion: | Additionally, substantial equivalence is demonstrated with non-clinical<br>performance (verification and validation) tests, which complied with the<br>requirements specified in the international and FDA-recognized consensus<br>standards and device-specific guidance. | | | The results of these tests demonstrate that the proposed <b>Achieva 1.5T, 3.0T,</b><br><b>and Intera 1.5T MR Systems</b> meet the acceptance criteria and are adequate for<br>their intended use. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The background is plain white, which makes the blue letters stand out. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue text. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters against a white background. The font is sans-serif and the letters are evenly spaced. The overall impression is clean and modern, reflecting the brand's identity.